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IntroductionCOVID-19 has led to an unprecedented increase in demand on health systems to care for people infected, necessitating the allocation of significant resources, especially medical resources, towards the response. This, compounded by the restrictions on movement instituted may have led to disruptions in the provision of essential services, including sexual and reproductive health (SRH) services. This study aims to assess the availability of contraception, comprehensive abortion care, sexually transmitted infection prevention and treatment and sexual and gender-based violence care and support services in local health facilities during COVID-19 pandemic. This is a standardised generic protocol designed for use across different global settings.Methods and analysisThis study adopts both quantitative and qualitative methods to assess health facilities’ SRH service availability and readiness, and clients’ and providers’ perceptions of the availability and readiness of these services in COVID-19-affected areas. The study has two levels: (1) perceptions of clients (and the partners) and healthcare providers, using qualitative methods, and (2) assessment of infrastructure availability and readiness to provide SRH services through reviews, facility service statistics for clients and a qualitative survey for healthcare provider perspectives. The health system assessment will use a cross-sectional panel survey design with two data collection points to capture changes in SRH services availability as a result of the COVID-19 epidemic. Data will be collected using focus group discussions, in-depth interviews and a health facility assessment survey.Ethics and disseminationEthical approval for this study was obtained from the WHO Scientific and Ethics Review Committee (protocol ID CERC.0103). Each study site is required to obtain the necessary ethical and regulatory approvals that are required in each specific country.

IntroductionWHO has generated standardised clinical and epidemiological research protocols to address key public health questions for SARS-CoV-2 (COVID-19) pandemic. We present a standardised protocol with the aim to fill a gap in understanding the needs, attitudes and practices related to sexual and reproductive health in the context of COVID-19 pandemic, focusing on pregnancy, pregnancy prevention and abortion.Methods and analysis planThis protocol is a prospective qualitative research, using semi-structured interviews with at least 15 pregnant women at different gestational ages and after delivery, 6 months apart from the first interview. At least 10 partners, 10 non-pregnant women and 5 healthcare professionals will be interviewed once during the course of the research. Higher number of subjects may be needed if a saturation is not achieved with these numbers. Data collection will be performed in a standardised way by skilled trained interviewers using written notes or audio-record of the interview. The data will be explored using the thematic content analysis and the researchers will look for broad patterns, generalisations or theories from these categories.Ethics and disseminationThe current protocol was first technically assessed and approved by the WHO scientific committee and then approved by its ethics review committee as a guidance document. It is expected that each country/setting implementing such a generic protocol adapted to their conditions also obtain local ethical approval. Comments for the user’s consideration are provided the document, as the user may need to modify methods slightly because of the local context in which this study will be carried out.

Highlights • Evidence that calcium suppl. may reduce blood pressure is inconsistent in the general population. • We found a greater reduction in blood pressure in the calcium group for systolic pressure and MAP. • We found no interaction between previous pre-eclampsia severity and calcium supplementation., Background Low dietary calcium is associated with the hypertensive disorders of pregnancy, and evidence suggests that the risks associated with pre-eclampsia are reduced by calcium supplementation. In the general (non-pregnant) population, low dietary calcium intake is associated with hypertension with inconsistent evidence that calcium supplementation may reduce blood pressure. Women with pre-eclampsia are also at risk of hypertension later in life. An exploratory sub-study among early participants enrolled in the WHO long-term calcium supplementation in women at high risk of pre-eclampsia (CAP) study reported a trend to more blood pressure reduction with calcium in non-pregnant women with previous severe as opposed to non-severe pre-eclampsia. The current study reports the effects of low-dose calcium supplementation in non-pregnant women in the complete trial cohort. Methods The CAP Study was a multi-country randomized, double-blind placebo-controlled clinical trial to test the hypothesis that calcium deficiency may play a role in the genesis of pre-eclampsia in early pregnancy. From 2011 to 2016, non-pregnant women who had pre-eclampsia or eclampsia in their most recent pregnancy were randomized to receive either 500 mg/day elemental calcium or placebo. In this sub-study we compared the change in blood pressure from baseline to the 12-week visit between participants receiving calcium versus placebo for those not pregnant at the 12-week visit. Results Of 1355 women randomized, 810 attended a 12-week visit without being pregnant, of whom 791 had blood pressure measurements available for both baseline and 12-week visits. There was a greater reduction in blood pressure in the calcium group compared with the placebo group for systolic pressure (difference 3.1 mmHg, 95% CI 0.8 to 5.4) and mean arterial pressure (MAP) (difference 2.0 mmHg, 95% CI 0.1 to 3.8). The difference in diastolic blood pressure reduction (1.4 mmHg, 95% CI −0.5 to 3.3) was not statistically significant (p = 0.140). For women with previous pre-eclampsia with severe features (n = 447), there was significantly greater reduction in blood pressure in the calcium than the placebo group (difference for systolic 4.0, 95% CI 0.7 to 7.3; diastolic 3.0, 95% CI 0.5 to 5.5 and mean arterial pressure 3.3, 95% CI 0.8 to 5.9 mmHg). For women with previous pre-eclampsia without severe features (n = 344), there were no significant differences between calcium and placebo groups. ANOVA analysis found no statistically significant interaction between previous pre-eclampsia severity and treatment, for systolic (p = 0.372), diastolic (p = 0.063) or mean blood pressure (p = 0.103). Conclusions Low-dose calcium supplementation significantly reduced systolic and mean arterial pressure in non-pregnant women with previous pre-eclampsia. We did not confirm a greater calcium effect in women with previous pre-eclampsia with severe versus non-severe features. The effect of low-dose calcium is of importance since even modest blood pressure reductions at a population level may have important benefits in terms of reduced major complications of hypertension. This study adds to the mounting evidence of health benefits which could be achieved for populations with low dietary calcium through strategies to increase calcium intake, particularly among women at high risk due to previous pre-eclampsia. Clinical Trial Registration The trial was registered with the Pan-African Clinical Trials Registry, registration number PACTR201105000267371 (https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=267).

Introduction: Obesity is a major and challenging public health problem. The aim of this substudy is to evaluate the effect of calcium supplementation on body weight in women recruited in the Calcium and Preeclampsia trial. Methods: Women were recruited before pregnancy and randomized to receive a calcium supplement containing 500 mg of elemental calcium or placebo until 20 weeks’ gestation; all women received 1.5 g from 20 weeks until delivery. Results: A total of 630 women conceived during the study, 322 allocated to calcium and 308 to placebo. Among these, 230 allocated to calcium and 227 allocated to placebo had information on body weight at baseline and at 8 weeks' gestation. During the study period, women allocated to calcium had a mean weight increase of 1.1 (SD ±5.5) kg, whereas those allocated to placebo had a mean increase of 1.5 (SD ±6.1) kg, a mean difference of 0.4 kg (95% −0.4 (−1.4 to 0.6); P =.408). Women classified as obese at the start of the trial had a lower body weight gain at 8 weeks’ gestation (1.0 kg; 95% CI: −3.2 to 1.2; P =.330) and at 32 weeks’ gestation (2.1 kg; 95% CI: 5.6-1.3; P =.225) if they received calcium as compared to placebo. However, none of these differences were statistically significant. Conclusion: The smaller increase in body weight found in women supplemented with 500 mg elemental calcium daily is quantitatively consistent with previous studies. However, in this study, the difference was not statistically significant. Fil: Cormick, Gabriela. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina. Universidad Nacional de La Matanza; Argentina. University of Cape Town; Sudáfrica Fil: Betrán, Ana Pilar. Organizacion Mundial de la Salud; Argentina Fil: Harbron, Janetta. University of Cape Town; Sudáfrica Fil: Seuc, Armando. Instituto Nacional de Higiene; Cuba Fil: White, Cintia. Universidad Nacional de La Matanza; Argentina Fil: Roberts, James M.. University of Pittsburgh; Estados Unidos Fil: Belizan, Jose. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina Fil: Hofmeyr, G. Justus. University of the Witwatersrand; Sudáfrica

ObjectivesPortugal has the highest HIV incidence rate in Western Europe. The proportion assigned to sexual contact between men recently increased to more than 30% of all HIV infections. Men who have sex with men (MSM) are vulnerable to the acquisition of other sexually transmitted infections (STIs), increasing the per-contact risk of HIV infection. Building on syndemic theory, the aim of this analysis was to identify patterns of current sexual behaviour in MSM, and explore their relationship with self-reported current, past STI diagnoses and HIV positive serostatus.DesignA cross-sectional behavioural survey was conducted in Portugal among MSM, using a community-based participatory research approach. Hierarchical cluster analysis was used to identify patterns including behavioural and demographic factors.ResultsThe analysis resulted in six clusters. Three clusters showed higher rates of current STI diagnosis (ranging from 11.7% to 17.1%), past STI diagnosis (ranging from 25.5% to 41.5%) and HIV positive serostatus (ranging from 13.0% to 16.7%). From the three clusters scoring lower on current and past STI and HIV diagnoses, one was characterised by a high number of sexual partners (62% had more than 12 partners in the last year), a high proportion (94.6%) of frequent visits to gay venues to meet sexual partners and high alcohol use (46.1%). The other two clusters scored lower on high risk sexual behaviour.ConclusionFactors other than sexual behaviour appear to reinforce the vulnerability to STIs and HIV of some MSM in this study, suggesting a syndemic of STIs, HIV and other adverse conditions. More research is needed to better understand the drivers of the STI/HIV epidemic in Portuguese MSM, using a concept that goes beyond risk behaviour, to develop effective combination prevention interventions.

Background: Reducing deaths from hypertensive disorders of pregnancy is a global priority. Low dietary calcium might account for the high prevalence of pre-eclampsia and eclampsia in low-income countries. Calcium supplementation in the second half of pregnancy is known to reduce the serious consequences of pre-eclampsia; however, the effect of calcium supplementation during placentation is not known. We aimed to test the hypothesis that calcium supplementation before and in early pregnancy (up to 20 weeks' gestation) prevents the development of pre-eclampsia Methods: We did a multicountry, parallel arm, double-blind, randomised, placebo-controlled trial in South Africa, Zimbabwe, and Argentina. Participants with previous pre-eclampsia and eclampsia received 500 mg calcium or placebo daily from enrolment prepregnancy until 20 weeks' gestation. Participants were parous women whose most recent pregnancy had been complicated by pre-eclampsia or eclampsia and who were intending to become pregnant. All participants received unblinded calcium 1·5 g daily after 20 weeks' gestation. The allocation sequence (1:1 ratio) used computer-generated random numbers in balanced blocks of variable size. The primary outcome was pre-eclampsia, defined as gestational hypertension and proteinuria. The trial is registered with the Pan-African Clinical Trials Registry, number PACTR201105000267371. The trial closed on Oct 31, 2017. Findings: Between July 12, 2011, and Sept 8, 2016, we randomly allocated 1355 women to receive calcium or placebo; 331 of 678 participants in the calcium group versus 320 of 677 in the placebo group became pregnant, and 298 of 678 versus 283 of 677 had pregnancies beyond 20 weeks' gestation. Pre-eclampsia occurred in 69 (23%) of 296 participants in the calcium group versus 82 (29%) of 283 participants in the placebo group with pregnancies beyond 20 weeks' gestation (risk ratio [RR] 0·80, 95% CI 0·61–1·06; p=0·121). For participants with compliance of more than 80% from the last visit before pregnancy to 20 weeks' gestation, the pre-eclampsia risk was 30 (21%) of 144 versus 47 (32%) of 149 (RR 0·66, CI 0·44–0·98; p=0·037). There were no serious adverse effects of calcium reported. Interpretation: Calcium supplementation that commenced before pregnancy until 20 weeks' gestation, compared with placebo, did not show a significant reduction in recurrent pre-eclampsia. As the trial was powered to detect a large effect size, we cannot rule out a small to moderate effect of this intervention. Funding: The University of British Columbia, a grantee of the Bill & Melinda Gates Foundation; UNDP–UNFPA–UNICEF–WHO–World Bank Special Programme of Research, Development and Research Training in Human Reproduction, WHO; the Argentina Fund for Horizontal Cooperation of the Argentinean Ministry of Foreign Affairs; and the Centre for Intervention Science in Maternal and Child Health. Fil: Hofmeyr, G. Justus. Eastern Cape Department Of Health; Sudáfrica Fil: Betrán, Ana Pilar. Organizacion Mundial de la Salud; Argentina Fil: Singata Madliki, Mandisa. Eastern Cape Department Of Health; Sudáfrica Fil: Cormick, Gabriela. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina Fil: Munjanja, Stephen P.. University Of Zimbabwe; Zimbabue Fil: Fawcus, Sue. University of Cape Town; Sudáfrica Fil: Mose, Simpiwe. Baragwanath Hospital; Sudáfrica Fil: Hall, David. Tygerberg Hospital; Sudáfrica Fil: Ciganda, Alvaro. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Seuc, Armando H.. Organizacion Mundial de la Salud; Argentina Fil: Lawrie, Theresa A.. Organizacion Mundial de la Salud; Argentina Fil: Bergel, Eduardo. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Roberts, James M.. No especifíca; Fil: von Dadelszen, Peter. King's College London; Reino Unido Fil: Belizan, Jose. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina

Objective: The impact of early hormonal contraception (HC) exposure during breastfeeding on child growth and pubertal and behavioural development was assessed using data from the Avon Longitudinal Study of Parents and Children (Avon study).Study design: The Avon study is a prospective cohort study designed to identify environmental factors affecting child health and development (n=14,541; delivery dates: 1 April 1991-31 December 1992). This secondary analysis was restricted to breastfed singleton infants. The main independent predictor variable was HC exposure during the first 8 weeks postpartum. Growth variables were changes from baseline in weight and height at ages 2 and 4 years. Behavioural variables were assessed at age 47 months. Pubertal development was evaluated between ages 8- and 16-years using Tanner scales. Results: 9,508 children were breastfed during the first 4 weeks postpartum; 8,927 had complete data for breastfeeding and HC exposure. Multivariate analyses demonstrated no difference in growth outcome variables between breastfed infants exposed to HC and those who were not. Similarly, no differences in behavioural problems or pubertal development were observed between the two groups.Conclusions: Early HC exposure during breastfeeding did not appear to influence negatively child growth and development. Limitations include short-term exposure to HC, the discrepancy between the timepoints when HC intake and breastfeeding were measured and the missing data, particularly regarding growth measurements Further clinical studies are required to confirm this lack of negative impact.Implications statement: Guidance on the use of HC during breastfeeding remains controversial; however, the Avon study did not detect any signal to suggest that early exposure to HC via breastfeeding has a negative impact on child growth, development or behaviour.

Background The YAM DAABO study (“your choice” in Mooré) takes place in Burkina Faso and the Democratic Republic of Congo. It has the objective to identify a package of postpartum family planning (PPFP) interventions to strengthen primary healthcare services and determine its effectiveness on contraceptive uptake during the first year postpartum. This article presents the process of identifying the PPFP interventions and its detailed contents. Methods Based on participatory action research principles, we adopted an inclusive process with two complementary approaches: a bottom-up formative approach and a circular reflective approach, both of which involved a wide range of stakeholders. For the bottom-up component, we worked in each country in three formative sites and used qualitative methods to identify barriers and catalysts to PPFP uptake. The results informed the package design which occurred during the circular reflective approach – a research workshop gathering service providers, members of both country research teams, and the WHO coordination team. Results As barriers and catalysts were found to be similar in both countries and with the view to scaling up our strategy to other comparable settings, we identified a common package of six low-cost, low-technology, and easily-scalable interventions that addressed the main service delivery obstacles related to PPFP: (1) refresher training of service providers, (2) regularly scheduled and strengthened supportive supervision of service providers, (3) enhanced availability of services 7 days a week, (4) a counseling tool, (5) appointment cards for women, and (6) invitation letters for partners. Conclusions Our research strategy assumes that postpartum contraceptive uptake can be increased by supporting providers, enhancing the availability of services, and engaging women and their partners. The package does not promote any modern contraceptive method over another but prioritizes the importance of women’s right to information and choice regarding postpartum fertility options. The effectiveness of the package will be studied in the experimental phase. If found to be effective, this intervention package may be relevant to and scalable in other parts of Burkina Faso and the DRC, and possibly other Sub-Saharan countries. Trial registration Retrospectively registered in the Pan African Clinical Trials Registry (PACTR201609001784334, 27 September 2016). Electronic supplementary material The online version of this article (10.1186/s12905-018-0573-5) contains supplementary material, which is available to authorized users.

Objective To demonstrate the feasibility and safety of training midlevel healthcare providers (midwives and family nurses) to provide medical abortion and postabortion contraception in underserved areas in Kyrgyzstan. Study design This was an implementation study at four referral facilities and 28 Felsher Obstetric Points in two districts to train their midwives and family nurses to deliver safe and effective abortion care with co-packaged mifepristone–misoprostol and provide contraceptives postabortion. The outcome of abortion — complete abortion, incomplete abortion or o-going pregnancy — was the primary end point measured. An international consultant trained 18 midwives and 14 family nurses (with midwifery diplomas) to provide medical abortion care. Supervising gynecologists based in the referral centers and study investigators based in Bishkek provided monthly monitoring of services and collection of patient management forms. A voluntary self-administered questionnaire at the follow-up visit documented women's acceptability of medical abortion services. All study data were cross-checked and entered into an online data management system for descriptive analysis. Results Between August 2014 and September 2015, midwives provided medical abortion to 554 women with a complete abortion rate of 97.8%, of whom 62% chose to use misoprostol at home. No women were lost to follow-up. Nearly all women (99.5%) chose a contraceptive method postabortion; 61% of women receiving services completed the acceptability form, of whom more than 99% indicated a high level of satisfaction with the service and would recommend it to a friend. Conclusion This study demonstrates that trained Kyrgyz midwives and nurses can provide medical abortion safely and effectively. This locally generated evidence can be used by the Kyrgyz Ministry of Health to reduce unintended pregnancy and expand safe abortion care to women in underserved periurban and rural settings. Implications Success in scaling up midwife/nurse provision of medical abortion in Kyrgyzstan will require registration of mifepristone–misoprostol, regulations permanently allowing midwife/nurse provision, strengthened procurement and distribution systems to prevent stockouts of supplies, preservice training of midwives/nurses and their involvement in district level supervision, monitoring and reporting, and support from supervisors.

BACKGROUND:In rural Burkina Faso, a package of six low-technology, post-partum contraceptive interventions (ie, refresher training for providers, a counselling tool, supportive supervision, daily availability of contraceptive services, client appointment cards, and invitation letters to attend appointments for partners), aimed at strengthening existing primary health-care services and enhancing demand for them, doubled the use of modern contraceptives at 12 months post partum (ie, 55% uptake in intervention recipients vs 29% in routine-care users). This study assessed the effect of a similar package but in urban settings of Kinshasa province, Democratic Republic of the Congo, in an effort to reduce the unmet need for post-partum family planning. METHODS:Yam Daabo was a multi-intervention, single-blinded, cluster-randomised controlled trial done in six primary health-care centres (clusters) in Kinshasa. Centres were randomly allocated to receive the six-component intervention or standard antenatal and postnatal care in matched pairs (1:1) on the basis of number of monthly births, the ratio of health workers per population in the health zone, and the urban and suburban settings. Only data analysts could be masked to cluster allocation. Health-care facilities were eligible if they provided a continuum of antenatal, delivery, and postnatal care, were well stocked with contraceptives, and were situated close to the main study centre. All pregnant women presenting to the six centres were eligible if they were in their third pregnancy trimester and had no counterindications to deliver in the facility. The main outcome was prevalence of use of modern contraceptives at 12 months after delivery. Analysis was by modified intention-to-treat using generalised linear mixed models or Fisher's exact test for small groups. Prevalence ratios were adjusted for cluster effects and baseline characteristics. This study was registered with the Pan-African Clinical Trials Registry (PACTR201609001784334). FINDINGS:From July 1, 2016, to Feb 2, 2017, eight of 52 clinics assessed for eligibility met the criteria and were randomised. Of 690 women approached, 576 (83%) women were enrolled: 286 in the four intervention clusters and 290 in the four control clusters. Of them, 519 (90%) completed the 12-month study exit interview (252 in the intervention group and 267 in the control group) and were included in the intention-to-treat analysis. At 12 months, 115 (46%) of 252 women in the intervention group and 94 (35%) of 267 in the control group were using modern contraceptives (adjusted prevalence ratio [PR] 1·58, 95% CI 0·74-3·38), with significant differences in the use of contraceptive implants (22% vs 6%; adjusted PR 4·36, 95% CI 1·96-9·70), but without difference in the use of short-acting contraceptives (23% vs 28%; 0·92, 0·29-2·98) and non-modern or inappropriate methods (7% vs 18%; 0·45, 0·13-1·54). There were no serious adverse events or maternal deaths related to the study. INTERPRETATION:The Yam Daabo intervention package did not have a significant effect on the overall use of effective modern contraceptives but significantly increased implant use in women post partum who live in urban settings in Kinshasa up to a year after childbirth. However, interferences from external family planning initiatives in the control group might have diminished differences between the services received. Such an intervention could be potentially relevant in similar contexts in DR Congo and other countries. FUNDING:Government of France; UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction.

Summary Background In rural Burkina Faso, a package of six low-technology, post-partum contraceptive interventions (ie, refresher training for providers, a counselling tool, supportive supervision, daily availability of contraceptive services, client appointment cards, and invitation letters to attend appointments for partners), aimed at strengthening existing primary health-care services and enhancing demand for them, doubled the use of modern contraceptives at 12 months post partum (ie, 55% uptake in intervention recipients vs 29% in routine-care users). This study assessed the effect of a similar package but in urban settings of Kinshasa province, Democratic Republic of the Congo, in an effort to reduce the unmet need for post-partum family planning. Methods Yam Daabo was a multi-intervention, single-blinded, cluster-randomised controlled trial done in six primary health-care centres (clusters) in Kinshasa. Centres were randomly allocated to receive the six-component intervention or standard antenatal and postnatal care in matched pairs (1:1) on the basis of number of monthly births, the ratio of health workers per population in the health zone, and the urban and suburban settings. Only data analysts could be masked to cluster allocation. Health-care facilities were eligible if they provided a continuum of antenatal, delivery, and postnatal care, were well stocked with contraceptives, and were situated close to the main study centre. All pregnant women presenting to the six centres were eligible if they were in their third pregnancy trimester and had no counterindications to deliver in the facility. The main outcome was prevalence of use of modern contraceptives at 12 months after delivery. Analysis was by modified intention-to-treat using generalised linear mixed models or Fisher's exact test for small groups. Prevalence ratios were adjusted for cluster effects and baseline characteristics. This study was registered with the Pan-African Clinical Trials Registry (PACTR201609001784334). Findings From July 1, 2016, to Feb 2, 2017, eight of 52 clinics assessed for eligibility met the criteria and were randomised. Of 690 women approached, 576 (83%) women were enrolled: 286 in the four intervention clusters and 290 in the four control clusters. Of them, 519 (90%) completed the 12-month study exit interview (252 in the intervention group and 267 in the control group) and were included in the intention-to-treat analysis. At 12 months, 115 (46%) of 252 women in the intervention group and 94 (35%) of 267 in the control group were using modern contraceptives (adjusted prevalence ratio [PR] 1·58, 95% CI 0·74–3·38), with significant differences in the use of contraceptive implants (22% vs 6%; adjusted PR 4·36, 95% CI 1·96–9·70), but without difference in the use of short-acting contraceptives (23% vs 28%; 0·92, 0·29–2·98) and non-modern or inappropriate methods (7% vs 18%; 0·45, 0·13–1·54). There were no serious adverse events or maternal deaths related to the study. Interpretation The Yam Daabo intervention package did not have a significant effect on the overall use of effective modern contraceptives but significantly increased implant use in women post partum who live in urban settings in Kinshasa up to a year after childbirth. However, interferences from external family planning initiatives in the control group might have diminished differences between the services received. Such an intervention could be potentially relevant in similar contexts in DR Congo and other countries. Funding Government of France; UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction.

INTRODUCTION Mortality analysis based on a single cause of death is not, in most cases, fully informative. There are several more illuminating procedures using a multiple cause of death approach; these are little known and rarely used in Cuba. The simplest of these methods, while methodologically limited, consists of summing all deaths from a specific cause mentioned on death certificates, regardless of whether the cause is listed as underlying or contributing. OBJECTIVE Using Cuban data, critically assess and implement two of the most recognized approaches to analyzing multiple causes of death. METHODS Multiple causes of death in Cuba were assessed for the years 2005, 2010 and 2015, employing death records from the National Medical Records and Health Statistics Bureau of Cuba's Ministry of Public Health. With the example of diabetes mellitus as underlying cause, we explored connections between underlying and associated (antecedent and contributing) causes on death certificates using two approaches from the international literature: the simple method and the cause-of-death association indicator. RESULTS The study identified main trends in multiple causes of death identified in 2005, 2010 and 2015, overall and by age group and sex. We observed a trend to increasing mean number of causes of death per death certificate between 2005 and 2015. The number of causes reported showed no substantial differences by age group or sex. Diseases of the arteries, arterioles and capillaries were by far the most frequently associated with diabetes mellitus as underlying cause. CONCLUSIONS The multiple causes of death approach affords more nuanced understanding of patterns of disease, comorbidity and death in the Cuban population. The indicators used fulfill different roles: the simple method brings to light the full range of ways in which a given cause contributes to mortality, and the cause-of-death association indicator enables exploration of links between different causes of death, not possible with the simple method. KEYWORDS Mortality, multifactorial causality, causes of death, diabetes mellitus, Cuba.

© 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license Background: Post-partum family planning services can prevent maternal and child morbidity and mortality in low-resource settings. We assessed the effect of a family planning intervention package on modern contraceptive use at 12 months post partum in predominantly rural Burkina Faso. Methods: Yam Daabo was a two group, multi-intervention, single-blinded, cluster randomised controlled trial. Primary health-care centres were randomly allocated to intervention or control clusters in a 1:1 ratio with only data analysts masked to the allocation assignment. Interventions comprised refresher training for the provider, a counselling tool, supportive supervision, availability of contraceptive services 7 days a week, client appointment cards, and invitation letters for partners. The primary outcome was modern contraceptive prevalence at 12 months, and secondary outcomes were modern contraceptive prevalence at 6 weeks and 6 months post partum. Analysis was by modified intention to treat. Prevalence ratios were adjusted for cluster effects and baseline characteristics. This study was registered with the Pan-African Clinical Trials Registry (PACTR201609001784334). Findings: From July 27–Oct 17, 2016, eight clinics were randomised and 571 women were enrolled and allocated: 286 to four intervention clusters and 285 to four control clusters. Of these, 523 completed the 12-month study exit interview (260 in the intervention group, 263 in the control group) and 523 were included in the intention-to-treat analysis. At 12 months, modern contraceptive prevalence was 55% among women who received the package and 29% among those who received routine care in control clusters (adjusted prevalence ratio 1·79, 95% CI 1·30–2·47). Significant differences in modern contraceptive prevalence were also seen between intervention and control groups at 6 weeks (42% and 10%, respectively; adjusted prevalence ratio 3·88, 95% CI 1·46–10·35) and 6 months (59% and 24%, respectively; 2·31, 1·44–3·71). Interpretation: A package of six low-technology interventions, aimed at strengthening existing primary health-care services and enhancing demand for these services, can effectively increase modern contraceptive use for up to a year post partum in rural settings in Burkina Faso and has the potential to be suitable in similar settings in this country and others. Funding: Government of France.

Background: Maternal nutritional status before and during pregnancy is an important contributor to pregnancy outcomes and early child health. The aim of this study was to describe the preconceptional nutritional status and dietary intake during pregnancy in high-risk women from South Africa and Zimbabwe. Methods: This is a prospective observational study, nested to the CAP trial. Anthropometric measurements before and during pregnancy and dietary intake using 24-h recall during pregnancy were assessed. The Intake Distribution Estimation software (PC-SIDE) was used to evaluate nutrient intake adequacy taking the Estimated Average Requirement (EAR) as a cut-off point. Results: Three hundred twelve women who had pre-eclampsia in their last pregnancy and delivered in hospitals from South Africa and Zimbabwe were assessed. 73.7 and 60.2% women in South Africa and Zimbabwe, respectively started their pregnancy with BMI above normal (BMI ≥ 25) whereas the prevalence of underweight was virtually non-existent. The majority of women had inadequate intakes of micronutrients. Considering food and beverage intake only, none of the micronutrients measured achieved the estimated average requirement. Around 60% of pregnant women reported taking folic acid or iron supplements in South Africa, but almost none did so in Zimbabwe. Conclusion: We found a high prevalence of overweight and obesity and high micronutrient intake inadequacy in pregnant women who had the previous pregnancy complicated with pre-eclampsia. The obesity figures and micronutrient inadequacy are issues of concern that need to be addressed. Pregnant women have regular contacts with the health system; these opportunities could be used to improve diet and nutrition. Fil: Cormick, Gabriela. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina. University of Cape Town; Sudáfrica Fil: Betrán, Ana Pilar. World Health Organization; Suiza Fil: Harbron, Janetta. University of Cape Town; Sudáfrica Fil: Dannemann Purnat, Tina. World Health Organization; Dinamarca Fil: Parker, Catherine. University of Fort Hare; Sudáfrica. Walter Sisulu University; Sudáfrica. University of the Witwatersrand; Sudáfrica Fil: Hall, David. Stellenbosch University; Sudáfrica Fil: Seuc, Armando H.. Instituto Nacional de Higiene; Cuba Fil: Roberts, James M.. University of Pittsburgh; Estados Unidos Fil: Belizan, Jose. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina Fil: Hofmeyr, G. Justus. University of the Witwatersrand; Sudáfrica. Walter Sisulu University; Sudáfrica. University of Fort Hare; Sudáfrica

To assess the side effects unrelated to disease activity and the acceptability of combined oral contraceptives (COCs), progestin-only pills (POPs) and copper-releasing intrauterine devices (IUDs) in women with systemic lupus erythematosus (SLE).A randomized clinical trial including 162 women with SLE, assigned to COC (n=54), POP (n=54) or IUD (n=54). Follow-up visits were conducted after 1, 2, 3, 6, 9 and 12 months of treatment to monitor the presence of symptoms, changes in body weight and blood pressure as well as the development of health problems other than those relating to lupus. Reasons for discontinuation and satisfaction with the use of the assigned method were recorded at the end of treatment. Statistical analysis included descriptive statistics, repeated measure analyses and Kaplan-Meier curves.Significantly different discontinuation rates due to any reason [35%, 55%, 29% (p0.01)] or nonmedical reasons [(11%, 31%, 4% (p0.05)] were observed among the COC, POP and IUD groups. Nausea was most frequent among COC users, dysmenorrhea among IUD users and acne and hirsutism among POP users. Mean blood pressures remained unchanged. Mild increases in body weight were observed over time in all treatment groups. Most women were satisfied with the use of the assigned contraceptive method.Oral contraceptives and IUD are acceptable birth control methods for patients with lupus, when counseling and specialized health attention are provided; however, the acceptability of POP appears to be inferior. Side effects unrelated to lupus disease activity are not frequent reasons to discontinue the contraceptive methods.This study delves into an area that has not been explored among patients with lupus. Our findings on the associated side effects and reasons for discontinuing COCs, POPs or copper-bearing IUDs may be useful in improving contraceptive counseling for women with lupus. Furthermore, they also heighten our knowledge on the reasons that may preclude the widespread use of effective contraceptives among lupus patients.

To develop a global research agenda that will guide investment in effective interventions to satisfy the large unmet need for modern methods of family planning.In a global survey, experts on contraception were invited to identify and rank the types of research that would be needed--and the knowledge gaps that would have to be filled--to reduce the unmet need for family planning in the next decade. The experts were then asked to score the research on a given topic in terms of the likelihood of its leading to an intervention that would: (i) be deliverable, affordable and sustainable; (ii) substantially reduce the unmet need for contraceptives; (iii) be effective and efficient in improving health systems; (iv) be ethically implemented; and (v) improve equity in the target population. The overall scores were then ranked.Most of the topics that received the 15 highest scores fell into three categories: implementation of policies in family planning; the integration of services to address barriers to contraceptive use; and interventions targeted at underserved groups, such as adolescents.Experts on contraception gave top priority ranking to research on improving the implementation and integration of health services and on strengthening the health systems supporting family planning services. The results of the exercise may help decision-makers, researchers and funding agencies to develop a clear and focused approach to satisfying the global need for family planning and reach the target set by the Family Planning 2020 initiative.Développer un agenda de recherche mondial qui guidera les investissements dans les interventions efficaces pour répondre aux grands besoins non satisfaits en méthodes modernes de planification familiale.Dans une enquête mondiale, les experts dans le domaine de la contraception ont été invités à identifier et classer les types de recherche qui seraient nécessaires – et les lacunes en termes de connaissances qui devront être comblées – pour réduire le besoin non satisfait de planification familiale dans la prochaine décennie. Les experts ont ensuite été invités à noter la recherche dans un domaine particulier et à évaluer ses chances de déboucher sur une intervention qui: (i) serait livrable, abordable et durable; (ii) réduirait substantiellement le besoin non satisfait de moyens contraceptifs; (iii) serait efficace et efficiente dans l'amélioration des systèmes de santé; (iv) serait mise en œuvre de manière éthique; et (v) améliorerait l'équité dans la population cible. Les notes globales ont ensuite été classées.La plupart des sujets qui ont reçu les 15 meilleures notes appartiennent à trois catégories: la mise en œuvre de politiques en matière de planification familiale; l'intégration de services pour surmonter les obstacles à l'utilisation des moyens contraceptifs; et les interventions ciblées vers des groupes mal desservis, comme les adolescents.Les experts dans le domaine de la contraception ont classé comme hautement prioritaire: l'amélioration de la mise en œuvre et de l'intégration des services de santé et le renforcement des systèmes de santé qui soutiennent les services de planification familiale. Les résultats de l'exercice peuvent aider les décideurs, les chercheurs et les organismes de financement à développer une approche claire et ciblée pour satisfaire les besoins mondiaux en matière de planification familiale et pour atteindre l'objectif fixé par l'initiative de la Planification Familiale 2020.Desarrollar una agenda global de investigación que guíe la inversión en intervenciones efectivas para cubrir la gran necesidad insatisfecha de métodos modernos de planificación familiar.En una encuesta mundial, se invitó a expertos en anticoncepción a identificar y clasificar los tipos de investigación que serían necesarios, así como las lagunas de conocimientos que deben colmarse para reducir la necesidad insatisfecha de planificación familiar en la próxima década. A continuación, se pidió a los expertos que puntuaran la investigación de una materia concreta en términos de la probabilidad de que condujera a una intervención que: (i) fuera viable, asequible y sostenible; (ii) redujera sustancialmente la necesidad insatisfecha de anticonceptivos; (iii) fuera eficaz y eficiente en la mejora de los sistemas sanitarios; (iv) pudiera aplicarse con ética; y (v) mejorara la equidad en la población meta. A continuación, se clasificaron las puntuaciones generales.La mayoría de los temas que recibieron las 15 calificaciones más altas se dividieron en tres categorías: la aplicación de las políticas de planificación familiar, la integración de servicios para abordar las barreras al uso de anticonceptivos y las intervenciones dirigidas a grupos desatendidos, como los adolescentes.Los expertos en anticoncepción dieron máxima prioridad a la investigación destinada a mejorar la aplicación e integración de los servicios sanitarios y al fortalecimiento de los sistemas sanitarios que apoyan los servicios de planificación familiar. Los resultados del ejercicio pueden ayudar a los gobernantes, investigadores y organismos de financiación a desarrollar un enfoque claro y a satisfacer la necesidad internacional de planificación familiar, así como a alcanzar el objetivo fijado por la iniciativa Planificación Familiar 2020.وضع جدول أعمال عالمي للبحوث سيقوم بتوجيه الاستثمار في التدخلات الفعالة لإشباع الحاجة الكبيرة غير الملباة للوسائل الحديثة في تنظيم الأسرة.تم دعوة الخبراء في وسائل منع الحمل، من خلال دراسة استقصائية عالمية، إلى تحديد وترتيب أنواع البحوث التي ستكون مطلوبة - والفجوات المعرفية التي سيلزم سدها - بُغية تقليل الحاجة غير الملباة لتنظيم الأسرة في العقد القادم. ثم طُلب من الخبراء وضع درجات البحث حول موضوع معين من حيث احتمال أن يؤدي إلى تدخل يتسم بما يلي: (1) سهل الإيتاء وميسور التكلفة ومستدام؛ (2) يقلل بشكل كبير من الحاجة غير الملباة إلى وسائل منع الحمل؛ (3) يتسم بالفعالية والكفاءة في تحسين النظم الصحية؛ (4) يتم تنفيذه بشكل أخلاقي؛ و(5) يحسّن الإنصاف في الفئة السكانية المستهدفة. وبعد ذلك، تم ترتيب الدرجات الإجمالية.كانت معظم المواضيع التي حازت على أعلى 15 درجة تندرج ضمن ثلاث فئات، هي: تنفيذ السياسات في تنظيم الأسرة؛ ودمج الخدمات لتذليل العقبات التي تحول دون استخدام وسائل منع الحمل؛ والتدخلات المستهدفة لدى الفئات التي تعاني من نقص الخدمات، مثل المراهقين.منح خبراء وسائل منع الحمل الأولوية القصوى للبحوث المعنية بتحسين تنفيذ الخدمات الصحية وتكاملها وبتعزيز النظم الصحية التي تدعم خدمات تنظيم الأسرة. ومن الممكن أن تساعد نتائج الممارسة صناع القرار والباحثين ووكالات التمويل في وضع نهج واضح ومركز لتلبية الحاجة العالمية لتنظيم الأسرة وبلوغ الهدف الذي حددته مبادرة تنظيم الأسرة 2020.制定全球研究议程，用以引导有效干预措施方面的投资，以满足计划生育现代方法的大量未得到满足的需求。在全球调查中，邀请避孕专家识别和评价为减少未来十年计划生育未满足的需求所需的研究类型和必须填补的知识空白。然后要求专家们对给定主题的研究在形成干预可能性方面进行评分，这种干预应具有以下特征：(i) 可交付成果、可负担得起且可持续；(ii) 大大减少对避孕药的未满足的需求；(iii) 在改善卫生系统方面高效并富有成效；(iv) 在伦理上可实现；并且 (v) 提高目标人群公平性。然后对总分进行排名。得到最高15 分的大部分主题为这三类：计划生育政策实施；解决避孕障碍的服务整合；以及针对青少年等需求未满足人群的干预措施。避孕专家将提高卫生服务的实施和整合的研究以及加强卫生系统支持计划生育服务的研究列为当务之急。此练习的结果可以帮助决策者、研究人员和资助机构制定一个清晰、有针对性的方法来满足全球计划生育需要并达到计划生育2020 倡议设定的目标。Разработать глобальный план исследований, позволяющий управлять инвестициями в эффективные мероприятия, направленные на удовлетворение высокой потребности в современных методах планирования семьи.В рамках глобального исследования были приглашены эксперты по вопросам контрацепции, в задачи которых входило определение и ранжирование типов необходимых исследований, а также выявление информационных пробелов, которые требуется восполнить, с целью сокращения в следующем десятилении масштабов неудовлетворенной потребности, связанной с планированием семьи. Экспертов попросили оценить заданные темы исследования с точки зрения вероятности того, что исследование по данной теме приведет к разработке проектных мероприятий, которые: (i) будут выполнимыми, доступными и экономически устойчивыми; (ii) существенно сократят неудовлетворенную потребность в средствах контрацепции; (iii) будут результативными и эффективными с точки зрения совершенствования систем здравоохранения; (iv) будут этически приемлемыми; и (v) будут содействовать развитию справедливости в заданной популяции. После этого общие баллы были ранжированы.Большинство тем, получивших 15 максимальных показателей, распределялись по трем категориям: внедрение политик в отношении семейного планирования; интеграция услуг для преодоления барьеров, препятствующих использованию средств контрацепции; и проектные мероприятия, направленные на группы, не получающие услуги в достаточном объеме, например, такие как подростки.Эксперты в вопросах контрацепции охарактеризовали исследования по вопросам усовершенствования стратегий реализации и интеграции услуг здравоохранения, а также исследования по вопросам укрепления услуг систем здравоохранения в области планирования семьи, как наиболее важные с точки зрения необходимости. Результаты предпринятых усилий могут помочь лицам, принимающим решения, исследователям и финансирующим организациям разработать четкий и направленный подход, который позволит удовлетворить глобальные потребности, связанные с семейным планированием, и добиться целей, сформулированных в рамках инициативы «Планирование семьи 2020».

Background To investigate the association between type of episiotomy and obstetric outcomes among 6,187 women with type 3 Female Genital Mutilation (FGM). Methods We conducted a secondary analysis of women presenting in labor to 28 obstetric centres in Burkina Faso, Ghana, Kenya, Nigeria, Senegal and Sudan between November 2001 and March 2003. Data were analysed using cross tabulations and multivariable logistic regression to determine if type of episiotomy by FGM classification had a significant impact on key maternal outcomes. Our main outcome measures were anal sphincter tears, intrapartum blood loss requiring an intervention, and postpartum haemorrhage. Results Type of episiotomy performed varied significantly by FGM status. Among women without FGM, the most common type of episiotomy performed was posterior lateral (25.4 %). The prevalence of the most extensive type of episiotomy, anterior and posterior lateral episiotomy increased with type of FGM. Among women without FGM, 0.4 % had this type of episiotomy. This increased to 0.6 % for women with FGM Types 1, 2 or 4 and to 54.6 % of all women delivering vaginally with FGM Type 3. After adjustment, women with an anterior episiotomy, (AOR = 0.15 95 %; CI 0.06–0.40); posterior lateral episiotomy (AOR = 0.68 95 %; CI 0.50–0.94) or both anterior and posterior lateral episiotomies performed concurrently (AOR = 0.21 95 % CI 0.12–0.36) were all significantly less likely to have anal sphincter tears compared to women without episiotomies. Women with anterior episiotomy (AOR = 0.08; 95%CI 0.02–0.24), posterior lateral episiotomy (AOR = 0.17 95 %; CI 0.05–0.52) and the combination of the two (AOR = 0.04 95 % CI 0.01–0.11) were significantly less likely to have postpartum haemorrhage compared with women who had no episiotomy. Conclusions Among women living with FGM Type 3, episiotomies were protective against anal sphincter tears and postpartum haemorrhage. Further clinical and research is needed to guide clinical practice of when episiotomies should be performed.

BackgroundThis review aimed to synthesize and analyze the diagnostic accuracy and the likelihood of providing correct treatment of the syndromic approach Vaginal Discharge Flowchart in managing cervical infections caused by Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT), and vaginal infections caused by Trichomonas vaginalis (TV) and Bacterial vaginosis (BV) and Candida albicans. This review will inform updating the WHO 2003 guidelines on Vaginal Discharge syndromic case management.MethodsA systematic review was conducted on published studies from 01-01-2000 to 30-03-2015 in multiple databases. Studies evaluating the diagnostic accuracy and validation of the WHO Vaginal Discharge Flowchart were included. Validation parameters including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) and the 95% confidence intervals for the different types of the flowchart were taken as outcomes, re-calculated, and analysed using a fixed model meta-analysis for data pooling. The level of agreement between the index and reference test were determined by the Cohen’s Kappa co-efficiency test. Each individual study was assessed on quality using the QUADAS-2 tool.FindingsThe search yielded 2,845 studies of which 16 met the eligibility criteria for final analysis. The diagnostic performance to identify cervical infections was low and resulted in a high proportion of over and missed treatment. The four flowcharts had a sensitivity between 27.37% in history and risk assessment and 90.13% with microscopy, with the inverse in specificity rates. The treatment performances between the flowcharts were inconsistent. The same applies to the use of vaginal discharge flowchart for treating vaginal infections. For vaginal infections the vaginal discharge flowchart had a good performance in flowchart 3 with 91.68% of sensitivity; 99.97% specificity; 99.93% PPV and 0.02% who missed their treatment and 8.32% of women who were over treated by the vaginal discharge flowchartConclusionThe vaginal discharge flowchart should focus on management of vaginal infection. It could be used as an intermediate approach for cervical infections for sex workers until a point of care test is available in resource poor settings.

The official WHO estimates of preterm birth are an essential global resource for assessing the burden of preterm birth and developing public health programmes and policies. This protocol describes the methods that will be used to identify, critically appraise and analyse all eligible preterm birth data, in order to develop global, regional and national level estimates of levels and trends in preterm birth rates for the period 1990 – 2014. We will conduct a systematic review of civil registration and vital statistics (CRVS) data on preterm birth for all WHO Member States, via national Ministries of Health and Statistics Offices. For Member States with absent, limited or lower-quality CRVS data, a systematic review of surveys and/or research studies will be conducted. Modelling will be used to develop country, regional and global rates for 2014, with time trends for Member States where sufficient data are available. Member States will be invited to review the methodology and provide additional eligible data via a country consultation before final estimates are developed and disseminated. This research will be used to generate estimates on the burden of preterm birth globally for 1990 to 2014. We invite feedback on the methodology described, and call on the public health community to submit pertinent data for consideration. Registered at PROSPERO CRD42015027439 Contact: pretermbirth@who.int

Background: The assessment of treatment success in clinical trials when multiple (repeated) doses (courses) are involved is quite common, for example, in the case of infertility treatment with assisted reproductive technology (ART), and medical abortion using misoprostol alone or in combination with mifepristone. Under these or similar circumstances, most researchers assess success using binomial proportions after a certain number of consecutive doses, and some have used survival analysis. In this paper we discuss the main problems in using binomial proportions to summarize (the overall) efficacy after two or more consecutive doses of the relevant treatment, particularly for the case of misoprostol in medical abortion studies. We later discuss why the survival analysis is best suited under these circumstances, and illustrate this by using simulated data. Methods: The formulas required for the binomial proportion and survival analysis (without and with competing risks) approaches are summarized and analytically compared. Additionally, numerical results are computed and compared between the two approaches, for several theoretical scenarios. Results: The main conceptual limitations of the binomial proportion approach are identified and discussed, caused mainly by the presence of censoring and competing risks, and it is demonstrated how survival analysis can solve these problems. In general, the binomial proportion approach tends to underestimate the "real" success rate, and tends to overestimate the corresponding standard error. Conclusions: Depending on the rates of censored observations or competing events between repeated doses of the treatment, the bias of the binomial proportion approach as compared to the survival analysis approaches varies; however, the use of the binomial approach is unjustified as the survival analysis options are well known and available in multiple statistical packages. Our conclusions also apply to other situations where success is estimated after multiple (repeated) doses (courses) of the treatment.

Background Epidemiological findings suggest that the link between poverty and pre-eclampsia might be dietary calcium deficiency. Calcium supplementation has been associated with a modest reduction in pre-eclampsia, and also in blood pressure (BP). Methods This exploratory sub-study of the WHO Calcium and Pre-eclampsia (CAP) trial aims to determine the effect of 500 mg/day elemental calcium on the blood pressure of non-pregnant women with previous pre-eclampsia. Non-pregnant women with at least one subsequent follow-up trial visit at approximately 12 or 24 weeks after randomization were included. Results Of 836 women randomized by 9 September 2014, 1st visit data were available in 367 women of whom 217 had previously had severe pre-eclampsia, 2nd visit data were available in 201 women. There was an overall trend to reduced BP in the calcium supplementation group (1-2.5 mmHg) although differences were small and not statistically significant. In the subgroup with previous severe pre-eclampsia, the mean diastolic BP change in the calcium group (-2.6 mmHg) was statistically larger than in the placebo group (+0.8 mmHg), (mean difference -3.4, 95% CI -0.4 to -6.4; p = 0.025). The effect of calcium on diastolic BP at 12 weeks was greater than in those with non-severe pre-eclampsia (p = 0.020, ANOVA analysis). Conclusions There is an overall trend to reduced BP but only statistically significant in the diastolic BP of women with previous severe pre-eclampsia. This is consistent with our hypothesis that this group is more sensitive to calcium supplementation, however results need to be interpreted with caution. Fil: Hofmeyr, G. J.. University of the Witwatersrand; Sudáfrica Fil: Seuc, A. H.. World Health Organization; Suiza Fil: Betrán, A. P.. World Health Organization; Suiza Fil: Purnat, T. D.. World Health Organization; Dinamarca Fil: Ciganda, Álvaro. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Munjanja, S. P.. University of Zimbabwe; Zimbabue Fil: Manyame, S.. University of Zimbabwe; Zimbabue Fil: Singata, M.. Fort Hare University; Sudáfrica Fil: Fawcus, S.. University of Cape Town; Sudáfrica. Mowbray Maternity Hospital; Sudáfrica Fil: Frank, K.. University of the Witwatersrand; Sudáfrica Fil: Hall, D. R.. Stellenbosch University; Sudáfrica. Tygerberg Hospital; Sudáfrica Fil: Cormick, Gabriela. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina Fil: Roberts, J. M.. University of Pittsburgh; Estados Unidos Fil: Bergel, Eduardo F.. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Drebit, S.K.. University of British Columbia; Canadá Fil: von Dadelszen, P.. University of British Columbia; Canadá Fil: Belizan, Jose. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina Fil: Calcium and Pre-eclampsia Study Group. No especifica

Aim of this study was to determine the dimensions of the service quality in the public hospitals and evaluate the determinants of client satisfaction in obstetric health in the context of Pakistan.The present research evaluates the application of an integrated client satisfaction model that draws mainly from the original SERVQUAL framework in obstetric health services. We conducted a cross-sectional study, in four public district hospitals in Pakistan, enrolling 1101 clients attending obstetric health care services. Measures of service quality and determinants of client satisfaction were factor-analysed and multiple regression analysis was used to test the hypothesis.The client satisfaction increased significantly with increases in respondent's age, number of children, number of visits and with decrease in educational status. Factor analysis revealed five service quality dimensions; and multiple regression analysis showed that all five dimensions of service quality in obstetric care were significant in explaining client satisfaction. The most powerful predictor for client satisfaction was provider communication with clients, followed by responsiveness and discipline.Interventions aimed at improving client provider interaction would not only advance the clinical provision of services, butwould also result in greater patient satisfaction with the services provided, leading to higher levels of facility utilization and continuity of care. Better client provider interaction can be accomplished at hospital's level through focused training of all cadre of service providers sensitizing them on clients' needs. Results also showed that the proposed framework is a valid and flexible instrument in assessing and monitoring service quality and enabling staff to identify where improvements are needed, from the clients' perspective.

Objective. The aim of this study was to estimate the age at natural menopause in women with SLE. Methods. One thousand and thirty-nine consecutive SLE patients

bacterial meningitis is a real concern for physicians and general health systems of any country as well as the international bodies.to estimate burdens of disease from morbidity and mortality caused by bacterial meningitis in Cuba during 2006.the mortality and the incidence data of the epidemiological survey from the National Surveillance of Bacterial Meningitis of "Pedro Kourí Institute of Tropical Medicine were used. The estimation methods were based on the WHO recommendations by using the DISMOD and the required Excel spreadsheets.the global burden of bacterial meningitis was estimated at a total of 3527.26 Disability Adjusted Lost Years (DALYs), which accounted for 31.3 years lost per 100 000 inhabitants. Morbidity and mortality burden of bacterial meningitis without sequel weighing was 2056.25 disability adjusted lost years, being the 55.9 % caused by unidentified agent, followed by S. pneumoniae (30.9 %), N. meningitidis (9.5 %) and H influenza type b (3.6 %). The mortality burden was 2 039 years of life lost from premature death, that is, 57.8 % of the global burden. Children under five years of age contributed the biggest global burden of disability adjusted lost years, and S. penumoniae generated the biggest burden.the burden of bacterial meningitis was high. Burden of disease is an important measure to assess health problems.

UNDP/UNFPA/WHO/World Bank Special Program of Research, Development and Research Training in Human Reproduction (HRP) Department of Reproductive Health and Research (RHR) Ministry of Health, Labour and Welfare of Japan United States Agency for International Development (USAID) Ministry of Public Health, Beijing, China Indian Council of Medical Research, Delhi, India ObjectiveTo investigate the risk of adverse pregnancy outcomes and caesarean section among adolescents in low- and middle-income countries.DesignSecondary analysis using facility-based cross-sectional data from the World Health Organization (WHO) Global Survey on Maternal and Perinatal Health.SettingTwenty-three countries in Africa, Latin America, and Asia.PopulationWomen admitted for delivery in 363 health facilities during 2-3months between 2004 and 2008.MethodsWe constructed multilevel logistic regression models to estimate the effect of young maternal age on risks of adverse pregnancy outcomes.Main outcome measuresRisk of adverse pregnancy outcomes among young mothers.ResultsA total of 78646 nulliparous mothers aged 24years and their singleton infants were included in the analysis. Compared with mothers aged 20-24years, adolescents aged 16-19years had a significantly lower risk of caesarean section (adjusted OR 0.75, 95% CI 0.71-0.79). When the analysis was restricted to caesarean section indicated for presumed cephalopelvic disproportion, the risk of caesarean section was significantly higher among mothers aged 15years (aOR 1.27, 95% CI 1.07-1.49) than among those aged 20-24years. Higher risks of low birthweight and preterm birth were found among adolescents aged 16-19years (aOR 1.10, 95% CI 1.03-1.17; aOR 1.16, 95% CI 1.09-1.23, respectively) and 15years (aOR 1.33, 95% CI 1.14-1.54; aOR 1.56, 95% CI 1.35-1.80, respectively).ConclusionsAdolescent girls experiencing pregnancy at a very young age (i.e.

Australian Postgraduate Award A & A Saw Scholarship Background: Twin pregnancies in low- and middle-income countries (LMICs) pose a high risk to mothers and newborns due to inherent biological risks and scarcity of health resources. We conducted a secondary analysis of the WHO Global Survey dataset to analyze maternal and perinatal outcomes in twin pregnancies and factors associated with perinatal morbidity and mortality in twins.Methods: We examined maternal and neonatal characteristics in twin deliveries in 23 LMICs and conducted multi-level logistic regression to determine the association between twins and adverse maternal and perinatal outcomes.Results: 279,425 mothers gave birth to 276,187 (98.8%) singletons and 6,476 (1.2%) twins. Odds of severe adverse maternal outcomes (death, blood transfusion, ICU admission or hysterectomy) (AOR 1.85, 95% CI 1.60-2.14) and perinatal mortality (AOR 2.46, 95% CI 1.40-4.35) in twin pregnancies were higher, however early neonatal death (AOR 2.50, 95% CI 0.95-6.62) and stillbirth (AOR 1.22, 95% CI 0.58-2.57) did not reach significance. Amongst twins alone, maternal age < 18, poor education and antenatal care, nulliparity, vaginal bleeding, non-cephalic presentations, birth weight discordance > 15%, born second, preterm birth and low birthweight were associated with perinatal mortality. Marriage and caesarean section were protective.Conclusions: Twin pregnancy is a significant risk factor for maternal and perinatal morbidity and mortality in low- resource settings; maternal risk and access to safe caesarean section may determine safest mode of delivery in LMICs. Improving obstetric care in twin pregnancies, particularly timely access to safe caesarean section, is required to reduce risk to mother and baby. Univ Western Australia, Sch Populat Hlth, Fac Med Dent & Hlth Sci, Perth, WA 6009, Australia UNDP UNFPA UNICEF WHO World Bank Special Programm, Dept Reprod Hlth & Res, World Hlth Org, Geneva, Switzerland Universidade Federal de São Paulo, Dept Obstet, São Paulo, Brazil Brazilian Cochrane Ctr, São Paulo, Brazil Universidade Federal de São Paulo, Dept Obstet, São Paulo, Brazil Web of Science

A multicentre trial was conducted to compare efficacy of postpartum sterilisation with clip and partial salpingectomy. Life-table estimates of pregnancy probabilities were compared through 2 years of follow up. A significantly different risk of pregnancy between the clip and partial salpingectomy groups was observed. Nine pregnancies were observed in the clip group versus two in the partial salpingectomy group. Cumulative probability of pregnancy through 2 years was 0.017 with the clip and 0.004 [correction added after online publication 25 September 2012; 0.044 has been replaced with 0.004] for partial salpingectomy (P0.04). Equivalent efficacy of the clip compared with partial salpingectomy has not been demonstrated in postpartum women.

Background About 20 million cesareans occur each year in the world and rates have steadily increased in almost all middle- and high-income countries over the last decades. Maternal request is often argued as one of the key forces driving this increase. Italy has the highest cesarean rate of Europe, yet there are no national surveys on the views of Italian women about their preferences on route of delivery. This study aimed to assess Italian women´s preference for mode of delivery, as well as reasons and factors associated with this preference, in a nationally representative sample of women. Methods This cross sectional survey was conducted between December 2010-March 2011. An anonymous structured questionnaire asked participants what was their preferred mode of delivery and explored the reasons for this preference by assessing their agreement to a series of statements. Participants were also asked to what extent their preference was influenced by a series of possible sources. The 1st phase of the study was carried out among readers of a popular Italian women´s magazine (Io Donna). In a 2nd phase, the study was complemented by a structured telephone interview. Results A total of 1000 Italian women participated in the survey and 80% declared they would prefer to deliver vaginally if they could opt. The preference for vaginal delivery was significantly higher among older (84.7%), more educated (87.6%), multiparous women (82.3%) and especially among those without any previous cesareans (94.2%). The main reasons for preferring a vaginal delivery were not wanting to be separated from the baby during the first hours of life, a shorter hospital stay and a faster postpartum recovery. The main reasons for preferring a cesarean were fear of pain, convenience to schedule the delivery and because it was perceived as being less traumatic for the baby. The source which most influenced the preference of these Italian women was their obstetrician, followed by friends or relatives. Conclusion Four in five Italian women would prefer to deliver vaginally if they could opt. Factors associated with a higher preference for cesarean delivery were youth, nulliparity, lower education and a previous cesarean.

To compare women's acceptance of misoprostol-only medical termination of pregnancy (TOP) with surgical TOP.Prospective cohort study.Termination of pregnancy clinics in New Delhi, Mumbai, Hanoi, Tbilisi, Trivandrum and Yerevan.Women requesting TOP, at 63 days of gestation or less, at study sites where both medical and surgical methods were available.Serial surveys eliciting measures of women's satisfaction and acceptance of TOP method were administered. Data were analysed using cross-tabulation and logistic regression to determine if TOP method was predictive of acceptability.Patient acceptance.High acceptability of both surgical and misoprostol-only TOP.Where medical TOP with mifepristone is not available, misoprostol-only medical TOP is acceptable to women who have the choice between medical or surgical techniques.

Background A vaginal fistula is a devastating condition, affecting an estimated 2 million girls and women across Africa and Asia. There are numerous challenges associated with providing fistula repair services in developing countries, including limited availability of operating rooms, equipment, surgeons with specialized skills, and funding from local or international donors to support surgeries and subsequent post-operative care. Finding ways of providing services in a more efficient and cost-effective manner, without compromising surgical outcomes and the overall health of the patient, is paramount. Shortening the duration of urethral catheterization following fistula repair surgery would increase treatment capacity, lower costs of services, and potentially lower risk of healthcare-associated infections among fistula patients. There is a lack of empirical evidence supporting any particular length of time for urethral catheterization following fistula repair surgery. This study will examine whether short-term (7 day) urethral catheterization is not worse by more than a minimal relevant difference to longer-term (14 day) urethral catheterization in terms of incidence of fistula repair breakdown among women with simple fistula presenting at study sites for fistula repair service. Methods/Design This study is a facility-based, multicenter, non-inferiority randomized controlled trial (RCT) comparing the new proposed short-term (7 day) urethral catheterization to longer-term (14 day) urethral catheterization in terms of predicting fistula repair breakdown. The primary outcome is fistula repair breakdown up to three months following fistula repair surgery as assessed by a urinary dye test. Secondary outcomes will include repair breakdown one week following catheter removal, intermittent catheterization due to urinary retention and the occurrence of septic or febrile episodes, prolonged hospitalization for medical reasons, catheter blockage, and self-reported residual incontinence. This trial will be conducted among 512 women with simple fistula presenting at 8 study sites for fistula repair surgery over the course of 24 months at each site. Discussion If no major safety issues are identified, the data from this trial may facilitate adoption of short-term urethral catheterization following repair of simple fistula in sub-Saharan Africa and Asia. Trial registration ClinicalTrials.gov Identifier NCT01428830.

Objective To define the effects of continuous sequential estrogen plus progestin therapy on menopausal symptoms in women with systemic lupus erythematosus (SLE). Methods We performed a randomized, double-blind, 24-month clinical trial involving 106 women with SLE who were in the menopausal transition or early or late postmenopause. Patients received continuous sequential estrogen plus progestin (n = 52) or placebo (n = 54). Menopausal symptoms were assessed using the Greene Climacteric Scale at 0, 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24 months. A new factor analysis of the scale reduced 21 items to 5 factors. The primary outcome was improvement of menopausal symptoms throughout the followup period. Results were analyzed by the intent-to-treat principle. Results At baseline, demographic and disease characteristics were similar in both groups. Fifteen of 21 menopausal symptoms had a prevalence of ≥50%, with a similar distribution between groups. Vasomotor factor scores decreased over time in both groups (P = 0.002), but in the estrogen plus progestin group the reduction was more pronounced than in the placebo group (1.5–2.0 versus 0.35–0.8 points on a scale of 0–6; P = 0.03). Maximum effects were observed among the most symptomatic women. Psychological, subjective–somatic, and organic–somatic factors scores also improved along time (P < 0.001), but the treatment and placebo arms improved to a similar degree. Thromboses occurred in 3 patients receiving estrogen plus progestin and in 1 patient receiving placebo. Conclusion Menopausal symptoms are highly prevalent in peri- and postmenopausal lupus patients. Estrogen plus progestin improved vasomotor symptoms at a clinically significant level, but not other menopausal symptoms. Given the thrombotic risks of menopausal hormone therapy, this should be used only in women with significant vasomotor symptoms.

The objective of this study was to estimate the evolution of the burden of disease in Cuba for 20 major causes at five year intervals from 1990 to 2005, in terms of mortality and years of life lost due to premature death (YLL), using national mortality registries. Six summary measures were computed for each of the 20 major causes of death which characterized the evolution of the disease burden over the period studied. The 20 causes were then grouped according to their behaviour in these summary measures; hierarchical cluster analysis was used to support this grouping process. We compute YLL results with and without age-weighting and time discounting (3%). The 20 major causes were grouped into 12 subgroups, each with a particular pattern. The burden of disease in Cuba during the period 1990-2005 has a peculiar pattern that does not reproduce the one characteristic of other low- and middle-income countries. The approach used in this study supports a better description of mortality and YLL trends for major causes, for identifying possible explanations, and for supporting public health policy making. It seems convenient to reproduce this analysis using shorter time intervals, e.g. annually. El objetivo fue estimar la evolución de la carga de enfermedades en Cuba para 20 enfermedades a intervalos de 5 años desde 1990 al 2005, en términos de años de vida perdidos por muerte prematura (YLL), usando los registros de mortalidad nacionales. Se obtuvieron seis indicadores resúmenes para cada enfermedad, que caracterizaban su evolución en el periodo de estudio 1990-2005. Las 20 enfermedades se agruparon según su comportamiento en estos seis indicadores, usando un análisis de conglomerados jerárquico. Los YLL se obtuvieron con y sin descuento en el tiempo (3%) y ponderación por edad. Se agruparon las 20 enfermedades en 12 subgrupos, cada uno con un patrón particular. El patrón de evolución observado es peculiar y no reproduce el patrón típico de los países de medio y bajo ingreso en el mundo. El enfoque adoptado en este trabajo permite una mejor descripción de la evolución de la carga por mortalidad para un grupo grande de enfermedades, desarrollar posibles explicaciones para el comportamiento identificado, y apoyar la toma de decisiones en salud pública. Sería conveniente reproducir este análisis para periodos de tiempo más cortos, por ejemplo, anualmente.

The aim of this study was to analyze the possibility of predicting short-term major lower-limb amputation (SMLA) in patients with vascular diagnoses, based only on clinical variables measured on admission.A longitudinal, retrospective cohort study of patients with peripheral vascular diagnoses admitted at our Institute was carried out. A stratified sample of 463 patients admitted during 1997, 2000 and 2003, was studied. Logistic regression was used to identify significant predictors of amputation; twelve clinical variables measured on admission were considered as potential predictors.Of the 463 patients, 93 (20%) were amputated. Significant predictors of amputation identified by the logistic regression analysis were ''type of lesion'' (none; neuro-infectious; ischemic; mixture), ''initial diagnosis'' (phlebolymphopathies, acute arterial insufficiency, chronic arterial insufficiency, diabetic foot, others), ''plantar region lesion'' (no; yes), ''diabetes'' (no; yes), ''number of toes affected'' (none; 1-2; 3 or more), and ''area of leg affected'' (none; lower third; + lower third). More than 80% of patients were correctly classified with the final model: sensitivity was 42% and specificity 96%.It seems that SMLA in patients with vascular diagnoses can be predicted reasonably well using as predictors only clinical variables measured on admission. This is a potentially useful result for Angiology Services located in developing/poor communities. The amputation probability for each patient obtained from the logistic regression model can be used in several ways: 1) the medical care of patients can be customized so that the amputation rate of the whole Service can be reduced, and 2) the amputation probability of the statistical model can be used as an estimation of the severity of the disease in each patient, which in turn can be used to standardize the amputation rates computed on different years; this would allow a better assessment of the Institutional performance over time.

To describe the burden of disease, using morbidity and mortality in Cuba from 1990-2002, by cancer type and location.A descriptive study of the disease burden in the years 1990, 1995, 2000, and 2002, by Cuba's most frequently associated cancer types and locations. Official Cuban sources were used to calculate years of potential life lost (YPLL) due to mortality (based on life expectancy) and morbidity (based on the incidence, average duration, and severity of the disease), as well as years of potential life lost per death (YPLL/D) and the disability-adjusted life years (DALY), for each cancer type and location, by sex and age group.The locations with higher YPLL were also those with the greatest total burden: lung, breast, prostate, colon and rectum, and cervix, and showed an upward trend for all cancer types and locations, except leukemia. The morbidity-related YPLL were concentrated in: breast, lung, prostate, colon and rectum, and cervix. In men, the highest mortality-related YPLL values were in the oral cavity and oropharynx, esophagus, stomach, lung, bladder, melanoma, lymphoma, and leukemia; women were more affected by cancer of the colon and rectum. The highest YPLL/D values were observed for cervix, breast, ovaries, leukemia, and lymphoma. The cancer types and locations with more DALYs were: lung, breast, prostate, colon and rectum, cervix, and endometrium.The burden of disease from cancer increased in Cuba from 1990-2002, mostly due to a rise in the mortality burden.

Summary Background We assessed whether the safety of first-trimester manual vacuum aspiration abortion done by health-care providers who are not doctors (mid-level providers) is equivalent to that of procedures done by doctors in South Africa and Vietnam, where mid-level providers are government trained and accredited to do first-trimester abortions. Methods We did a randomised, two-sided controlled equivalence trial to compare rates of complication in abortions done by the two groups of providers. An a-priori margin of equivalence of 4·5% with 80% power and 95% CI (α=0·05) was used. 1160 women participated in South Africa and 1734 in Vietnam. Women presenting for an induced abortion at up to 12 weeks' gestation were randomly assigned to a doctor or a mid-level provider for manual vacuum aspiration and followed-up 10–14 days later. The primary outcome was complication of abortion. Complications were recorded during the abortion procedure, before discharge from the clinic, and at follow-up. Per-protocol and intention-to-treat analyses were done. This trial is registered at Clinicaltrials.gov with the identifier NCT00370487. Findings In both countries, rates of complication satisfied the predetermined statistical criteria for equivalence: rates per 100 patients in South Africa were 1·4 (eight of 576) for mid-level providers and 0 for doctors (difference 1·4, 95% CI 0·4 to 2·7); in Vietnam, rates were 1·2 (ten of 824) for mid-level providers and 1·2 (ten of 812) for doctors (difference 0·0, 95% CI −1·2 to 1·1). There was one immediate complication related to analgesics. Delayed complications were caused by retained products and infection. Interpretation With appropriate government training, mid-level health-care providers can provide first trimester manual vacuum aspiration abortions as safely as doctors can.

The effects of estrogen-containing contraceptives on disease activity in women with systemic lupus erythematosus have not been determined.We conducted a single-blind clinical trial involving 162 women with systemic lupus erythematosus who were randomly assigned to combined oral contraceptives, a progestin-only pill, or a copper intrauterine device (IUD). Disease activity was assessed at 0, 1, 2, 3, 6, 9, and 12 months according to the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI). The primary outcome was global disease activity, which we estimated by measuring the area under the SLEDAI curve. Secondary outcomes included the maximum SLEDAI score, change in SLEDAI score, incidence of lupus flares, median time to first flare, systemic lupus erythematosus treatment, and adverse events. The results were analyzed by the intention-to-treat method.At baseline, all demographic features and disease characteristics were similar in the three groups. The mean (+/-SD) SLEDAI score was 6.1+/-5.6 in the group assigned to combined oral contraceptives, 6.4+/-4.6 in the group assigned to the progestin-only pill, and 5.0+/-5.3 in the group assigned to the IUD (54 patients in each group) (P=0.36). Disease activity remained mild and stable in all groups throughout the trial. There were no significant differences among the groups during the trial in global or maximum disease activity, incidence or probability of flares, or medication use. The median time to the first flare was three months in all groups. Thromboses occurred in four patients (two in each of the two groups receiving hormones), and severe infections were more frequent in the IUD group. One patient receiving combined oral contraceptives died from amoxicillin-related severe neutropenia.Global disease activity, maximum SLEDAI score, incidence of flares, time to first flare, and incidence of adverse events were similar among women with systemic lupus erythematosus, irrespective of the type of contraceptive they were using.

INTRODUCTION:Disability-adjusted life years is a composite measure that integrates the components of mortality and morbidity. It is a useful indicator of overall disease burden and is particularly useful for evaluating health intervention outcomes. In the cases of breast and reproductive system cancers, these can also negatively affect childbearing opportunities for young women. OBJECTIVE: Determine disability-adjusted life years for breast and reproductive system cancers in Cuban women aged 15-44 years during the period 1990-2006. METHODS: A national epidemiological study was conducted using Cuba's disease and vital statistics registry data for 1990, 1995, 2000 and 2006. Disability-adjusted life years in women aged 15-44 years were calculated for breast cancer and three female reproductive system cancers (cervical, endometrial and ovarian), by summing years of life lost due to premature mortality and years lived with disability. Years of life lost due to premature mortality were determined based on age-specific estimates of life expectancy. Years lived with disability were calculated as the product of severities (provided by the 1990 Global Burden of Disease study) and incidence and average duration, both obtained via the DISMOD II program. Data entered in the program include national statistics on incidence, prevalence, and mortality. RESULTS: Breast cancer and cervical cancer proved to have the highest rates of potential years of life lost due to premature mortality, with the sharpest increases in the period (from 139 to 206.5 and 114.7 to 215.2 per 100,000, respectively). Endometrial and ovarian neoplasms crept up more slowly. An increase in years lived with disability was seen in three of these four types of cancer; only cervical cancer saw a decline (from 12.7 to 9 per 100,000). Breast cancer and cervical cancer presented the highest levels of disability-adjusted life years for all four years studied, rising from 146.9 to 227.8 and 127.4 to 224.2 per 100,000, respectively between 1990 and 2006. CONCLUSIONS: An unfavorable trend in disability-adjusted life years was seen for breast and cervical cancer between 1990 and 2006 in Cuban women of childbearing age.

Using multinational surveillance data, Lori Newman and colleagues estimate global rates of active syphilis in pregnant women, adverse effects, and antenatal coverage and treatment needed to meet WHO goals., Background The World Health Organization initiative to eliminate mother-to-child transmission of syphilis aims for ≥90% of pregnant women to be tested for syphilis and ≥90% to receive treatment by 2015. We calculated global and regional estimates of syphilis in pregnancy and associated adverse outcomes for 2008, as well as antenatal care (ANC) coverage for women with syphilis. Methods and Findings Estimates were based upon a health service delivery model. National syphilis seropositivity data from 97 of 193 countries and ANC coverage from 147 countries were obtained from World Health Organization databases. Proportions of adverse outcomes and effectiveness of screening and treatment were from published literature. Regional estimates of ANC syphilis testing and treatment were examined through sensitivity analysis. In 2008, approximately 1.36 million (range: 1.16 to 1.56 million) pregnant women globally were estimated to have probable active syphilis; of these, 80% had attended ANC. Globally, 520,905 (best case: 425,847; worst case: 615,963) adverse outcomes were estimated to be caused by maternal syphilis, including approximately 212,327 (174,938; 249,716) stillbirths (>28 wk) or early fetal deaths (22 to 28 wk), 91,764 (76,141; 107,397) neonatal deaths, 65,267 (56,929; 73,605) preterm or low birth weight infants, and 151,547 (117,848; 185,245) infected newborns. Approximately 66% of adverse outcomes occurred in ANC attendees who were not tested or were not treated for syphilis. In 2008, based on the middle case scenario, clinical services likely averted 26% of all adverse outcomes. Limitations include missing syphilis seropositivity data for many countries in Europe, the Mediterranean, and North America, and use of estimates for the proportion of syphilis that was “probable active,” and for testing and treatment coverage. Conclusions Syphilis continues to affect large numbers of pregnant women, causing substantial perinatal morbidity and mortality that could be prevented by early testing and treatment. In this analysis, most adverse outcomes occurred among women who attended ANC but were not tested or treated for syphilis, highlighting the need to improve the quality of ANC as well as ANC coverage. In addition, improved ANC data on syphilis testing coverage, positivity, and treatment are needed. Please see later in the article for the Editors' Summary, Editors' Summary Background Syphilis—a sexually transmitted bacterial infection caused by Treponema pallidum—can pass from a mother who is infected to her unborn child. Screening pregnant women for syphilis during routine antenatal care by looking for a reaction to T. pallidum in the blood (seropositivity) and then treating any detected infections with penicillin injections has been feasible for many years, even in low-resource settings. However, because coverage of testing and treatment of syphilis remains low in many countries, mother-to-child transmission of syphilis—“congenital syphilis”—is still a global public health problem. In 2007, the World Health Organization (WHO) estimated that there were 2 million syphilis infections among pregnant women annually, 65% of which resulted in adverse pregnancy outcomes: the baby's death during early or late pregnancy (fetal death and stillbirth, respectively) or soon after birth (neonatal death), or the birth of an infected baby. Babies born with syphilis often have a low birth weight and develop problems such as blindness, deafness, and seizures if not treated. Why Was This Study Done? In 2007, WHO launched an initiative to eliminate congenital syphilis that set targets of at least 90% of pregnant women being tested for syphilis and at least 90% of seropositive pregnant women receiving adequate treatment by 2015. To assess the initiative's progress and to guide policy and advocacy efforts, accurate global data on the burden of syphilis in pregnancy and on associated adverse outcomes are needed. Unfortunately, even in developed countries with good laboratory facilities, definitive diagnosis of congenital syphilis is difficult. Estimates of the global burden can be obtained, however, using mathematical models. In this study, the researchers generate global and regional estimates of the burden of syphilis in pregnancy and associated adverse outcomes for 2008 using a health services delivery model. What Did the Researchers Do and Find? The researchers developed a mathematical model to estimate the number of syphilis-infected pregnant women in each country and in each region, and to estimate the regional and global numbers of adverse pregnancy outcomes associated with syphilis. They used national syphilis seropositivity data and information on antenatal care coverage from WHO and estimates of the effectiveness of screening and treatment from published literature. Using these data and their model, the researchers estimated that, in 2008, 1.4 million pregnant women, 80% of whom had attended antenatal care services, had an active syphilis infection. Assuming a scenario in which the percentage of pregnant women tested for syphilis and adequately treated ranged from 30% for Africa and the Mediterranean region to 70% for Europe (a scenario defined in consultation with WHO advisors), the researchers estimated that maternal syphilis caused 520,000 adverse outcomes in 2008, including 215,000 stillbirths or fetal deaths, 90,000 neonatal deaths, 65,000 preterm or low birth weight infants, and 150,000 infants with congenital disease. About 66% of these adverse effects occurred in women who had attended antenatal care but were either not tested or not treated for syphilis. Finally, the researchers estimated that in 2008, clinical services averted 26% of all adverse outcomes. What Do These Findings Mean? These findings, which update and extend previous estimates of the global burden of congenital syphilis, indicate that syphilis continues to affect a large number of pregnant women and their offspring. The current findings, which cannot be directly compared to previous estimates because of the different methodologies used, are likely to be affected by the accuracy of the data fed into the researchers' model. In particular, the data on the percentage of the population infected with syphilis in individual countries used in this study came from the HIV Universal Access reporting system and may not be nationally representative. Nevertheless, these findings suggest that syphilis continues to be an important cause of adverse outcomes of pregnancy, partly because pregnant women often do not receive syphilis screening and prompt treatment during routine antenatal care. The researchers recommend, therefore, that all countries should ensure that all pregnant women receive an essential package of high-quality antenatal care services that includes routine and easy access to syphilis testing and treatment. Congenital syphilis, they conclude, can only be eliminated if decision-makers at all levels prioritize the provision, quality, and monitoring of this basic antenatal care service, which has the potential to reduce infant mortality and improve maternal health. Additional Information Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001396. The World Health Organization provides information on sexually transmitted diseases, including details of its strategy for the global elimination of congenital syphilis, the investment case for the elimination of mother-to-child transmission of syphilis, and regional updates on progress towards elimination (some information is available in several languages) The Pan American Health Organization provides information on efforts to eliminate congenital syphilis in Latin America (in English and Spanish), and the Asia-Pacific Prevention of Parent-to-Child Transmission Task Force provides information on efforts to eliminate congenital syphilis in Asia Pacific The US Centers for Disease Control and Prevention has a fact sheet on syphilis (in English and Spanish) The UK National Health Service Choices website also has a page on syphilis MedlinePlus provides information on congenital syphilis and links to additional syphilis resources (in English and Spanish) The London School of Hygiene and Tropical Medicine provides a toolkit for the introduction of rapid syphilis tests Haiti: Congenital Syphilis on the Way Out is a YouTube video describing the introduction of rapid diagnostic tests for syphilis in remote parts of Haiti

OBJECTIVE: We sought to describe obstetric care capacity of nongovernment organization (NGO)-/faith-based organization (FBO)-run institutions compared to government-run institutions in 3 African countries using the World Health Organization Global Survey. We also compared delivery characteristics and outcomes. STUDY DESIGN: This is a descriptive analysis of the 22 NGO-/FBO-run institutions in Uganda, Kenya and Democratic Republic of Congo delivering11,594women,comparedto20government-runinstitutionsdelivering 25,825 women in the same countries and period. RESULTS: Infrastructure, obstetric services, diagnostic facilities, and anesthesiology at NGO/FBO institutions were comparable to government institutions. Women delivering at NGO/FBO institutions had more antenatal care, antenatal complications, and cesarean delivery. NGO/ FBO institutions had higher obstetrician attendance and lower rates of eclampsia, preterm birth, stillbirth, Apgar7, and neonatal near miss. CONCLUSION: NGO/FBOinstitutionsarecomparabletogovernmentinstitutions in capacity to deliver obstetric care. NGO/FBOs have been found effective in providing delivery care in developing countries and should be appropriately recognized by stakeholders in their efforts to assist nations achieve international goals.

Combined atrial pacing and thallium-201 scintigraphy were performed in a man with multiple coronary artery lesions unable to perform exercise stress testing. Severe angina and ischemic ST depression in the inferior and anterior ECG leads occurred at a peak double product of 22,400 beats-mm Hg/min; thallium-201 scintigraphy showed reversible perfusion defects of the inferior, posterior, and septal segments. After angiographically successful angioplasty of a 95% right coronary artery lesion, repeat atrial pacing/thallium-201 scintig raphy (peak double product 27,750 beats-mm Hg/min) produced mild angina no ST depression in the inferior leads, and a normal thallium-201 scan. This case illustrates the value of the atrial pacing/thallium-201 stress test for evaluat ing the need for, and results of, coronary angioplasty in patients unable to per form exercise stress testing.

Objective To estimate the effect of increased body weight and body mass index (BMI) on pregnancy rates with levonorgestrel (LNG) 1.5mg used as emergency contraception (EC). Methods The study reviewed data from 6873 women in four WHO-HRP randomized trials on EC conducted between 1993 and 2010. Participants took either 1.5mg of LNG as a single dose or in two doses 12h apart, up to 120h of unprotected intercourse. Contraceptive efficacy (pregnancy rates) at different weight and BMI categories was evaluated. Results Overall pregnancy rate was low at 1.2%. Pregnancy rates were also low in women weighing over 80kg (0.7%) and who were obese (BMI over 30kg/m 2 ) (2.0%). The pooled analyses for pregnancy demonstrated that BMI over 30kg/m 2 decreased efficacy significantly (odds ratio 8.27, 95% confidence interval=2.70–25.37) when compared to women in lower BMI categories, mainly influenced by pregnancies in obese women from one study site. Sensitivity analyses excluding that site showed that obesity was no longer a risk factor; however, the other studies included too few obese women in the sample to exclude a substantial decrease in efficacy. Conclusions Pregnancy rates with use of LNG 1.5mg for EC were low at less than 3% across different weight and BMI categories. Pooled analyses showed an increase in pregnancy rates among obese women (BMI more than 30kg/m 2 ) compared to women with normal BMI levels, influenced by pregnancies all coming from one study site. Implications Access to LNG as EC should still be promoted to women who need them, and not be restricted in any weight or BMI category, with additional attention for counselling and advice for obese women.

An alteration in sex hormones has been considered a risk factor for myocardial infarction. In this study, estradiol (E2) and testosterone (T) levels were evaluated in healthy firefighters, patients with myocardial infarction acutely and during their convalescence, patients with no evidence of occlusive coronary artery disease on arteriography, and patients with chronic angina pectoris in whom there was at least one vessel that indicated 50% occlusive coronary artery disease. Although T levels were similar in all groups, E2 levels were substantially higher in patients with myocardial infarction and in patients with chronic angina pectoris. These results support the hypothesis that elevated estrogen levels may be a risk factor for myocardial infarction and coronary artery disease, possibly by promoting clotting or coronary spasm.

Background Fundal pressure (pushing on the upper part of the uterus in the direction of the birth canal) is often performed in routine practice, however the benefit and indications for its use are unclear and vigorous pressure is potentially harmful. There is some evidence that it may be applied routinely or to expedite delivery in some situations (e.g. fetal distress or maternal exhaustion), particularly in settings where other methods of achieving delivery (forceps, vacuum) are not available. Gentle assisted pushing (GAP) is an innovative method of applying gentle but steady pressure to the uterine fundus with the woman in an upright posture. This trial aims to evaluate the use of GAP in an upright posture, or upright posture alone, on reducing the mean time of delivery and the associated maternal and neonatal complications in women not having delivered following 15-30 min in the second stage of labour. Methods/Design We will conduct a multicentre, randomized, unblinded, controlled trial with three parallel arms (1:1:1). 1,145 women will be randomized at three hospitals in South Africa. Women will be eligible for inclusion if they are ≥18 years old, nulliparous, gestational age ≥ 35 weeks, have a singleton pregnancy in cephalic presentation and vaginal delivery anticipated. Women with chronic medical conditions or obstetric complications are not eligible. If eligible women are undelivered following 15-30 min in the second stage of labour, they will be randomly assigned to: 1) GAP in the upright posture, 2) upright posture only and 3) routine practice (recumbent/supine posture). The primary outcome is the mean time from randomization to complete delivery. Secondary outcomes include operative delivery, adverse neonatal outcomes, maternal adverse events and discomfort. Discussion This trial will establish whether upright posture and/or a controlled method of applying fundal pressure (GAP) can improve labour outcomes for women and their babies. If fundal pressure is found to have a measurable beneficial effect, this gentle approach can be promoted as a replacement for the uncontrolled methods currently in use. If it is not found to be useful, fundal pressure can be discouraged.

Background Intermediate outcomes are common and typically on the causal pathway to the final outcome. Some examples include noncompliance, missing data, and truncation by death like pregnancy (e.g. when the trial intervention is given to non-pregnant women and the final outcome is preeclampsia, defined only on pregnant women). The intention-to-treat approach does not account properly for them, and more appropriate alternative approaches like principal stratification are not yet widely known. The purposes of this study are to inform researchers that the intention-to-treat approach unfortunately does not fit all problems we face in experimental research, to introduce the principal stratification approach for dealing with intermediate outcomes, and to illustrate its application to a trial of long term calcium supplementation in women at high risk of preeclampsia. Methods Principal stratification and related concepts are introduced. Two ways for estimating causal effects are discussed and their application is illustrated using the calcium trial, where noncompliance and pregnancy are considered as intermediate outcomes, and preeclampsia is the main final outcome. Results The limitations of traditional approaches and methods for dealing with intermediate outcomes are demonstrated. The steps, assumptions and required calculations involved in the application of the principal stratification approach are discussed in detail in the case of our calcium trial. Conclusions The intention-to-treat approach is a very sound one but unfortunately it does not fit all problems we find in randomized clinical trials; this is particularly the case for intermediate outcomes, where alternative approaches like principal stratification should be considered.