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Background: Improving the understanding of non-clinical factors that lead to the increasing caesarean section (CS) rates in many low- and middle-income countries is currently necessary to meet the challenge of implementing effective interventions in hospitals to reverse the trend. The objective of this study was to study the influence of organizational factors on the CS use in Argentina, Vietnam, Thailand and Burkina Faso. Methods: A cross-sectional hospital-based postpartum survey was conducted in 32 hospitals (8 per country). We selected women with no potential medical need for CS among a random sample of women who delivered at each of the participating facilities during the data collection period. We used multilevel multivariable logistic regression to analyse the association between CS use and organizational factors, adjusted on women's characteristics. Results: A total of 2,092 low-risk women who had given birth in the participating hospitals were included. The overall CS rate was 24.1%, including 4.9% of pre-labour CS and 19.3% of intra-partum CS. Pre-labour CS was significantly associated with a 24-hour anaesthetist dedicated to the delivery ward (ORa = 3.70 [1.41; 9.72]) and with the possibility to have an individual room during labour and delivery (ORa = 0.28 [0.09; 0.87]). Intra-partum CS was significantly associated with a higher bed occupancy level (ORa = 1.45 [1.09; 1.93]): intrapartum CS rate would increase of 6.3% points if the average number of births per delivery bed per day increased by 10%. Conclusion: Our results suggest that organisational norms and convenience associated with inadequate use of favourable resources, as well as the lack of privacy favouring women's preference for CS, and the excessive workload of healthcare providers drive the CS overuse in these hospitals. It is also crucial to enhance human and physical resources in delivery rooms and the organisation of intrapartum care to improve the birth experience and the working environment for those providing care. Trial registration: The QUALI-DEC trial is registered on the Current Controlled Trials website (https://www.isrctn.com/) under the number ISRCTN67214403. [ABSTRACT FROM AUTHOR]

The project 'Quality Decision-making by women and providers' (QUALI-DEC) combines four non-clinical interventions to promote informed decision-making surrounding mode of birth, improve women's birth experiences, and reduce caesarean sections among low-risk women. QUALI-DEC is currently being implemented in 32 healthcare facilities across Argentina, Burkina Faso, Thailand, and Viet Nam. In this paper, we detail implementation processes and the planned process evaluation, which aims to assess how and for whom QUALI-DEC worked, the mechanisms of change and their interactions with context and setting; adaptations to intervention and implementation strategies, feasibility of scaling-up, and cost-effectiveness of the intervention. We developed a project theory of change illustrating how QUALI-DEC might lead to impact. The theory of change, together with on the ground observations of implementation processes, guided the process evaluation strategy including what research questions and perspectives to prioritise. Main data sources will include: 1) regular monitoring visits in healthcare facilities, 2) quantitative process and output indicators, 3) a before and after cross-sectional survey among post-partum women, 4) qualitative interviews with all opinion leaders, and 5) qualitative interviews with postpartum women and health workers in two healthcare facilities per country, as part of a case study approach. We foresee that the QUALI-DEC process evaluation will generate valuable information that will improve interpretation of the effectiveness evaluation. At the policy level, we anticipate that important lessons and methodological insights will be drawn, with application to other settings and stakeholders looking to implement complex interventions aiming to improve maternal and newborn health and wellbeing. Trial registration: ISRCTN67214403. [ABSTRACT FROM AUTHOR]

Objectives: To compare the risk of severe adverse maternal outcomes (SMO) and neonatal outcomes (SNO) and analyse their maternal correlates in adolescent mother-newborn and young mother-newborn dyads in secondary and tertiary care users in Latin America. Methods: We performed a secondary analysis of the WHO Multicountry Survey on Maternal and Newborn Health database in 83 secondary and tertiary hospitals in seven countries in Latin America. We constructed a composite indicator of both SMO and SNO and estimated odds ratios (OR) comparing adolescent mothers (aged 12–19) with young mothers (aged 20–24). Our unit of analysis was the mother-newborn dyad. Results: We found that the combination of SMO and SNO was three times more likely in adolescent mother as compared to young mother dyads (OR 3.56; 95% CI 1.67–7.59). SNO either alone or in combination with SMO were more likely in adolescents aged 12 to 16 than in young women (OR 1.27 and 4.87, respectively). Conclusions for Practice: Adolescent mothers and their newborns are at an increased risk of severe adverse outcomes during child birth and in the first week postpartum compared to young mother dyads, especially young adolescents. Focusing on the dyad as a whole may facilitate a step towards integrated care which maximizes the health benefits of both mother and newborn. Continued efforts are needed to improve health care and prevention initiatives directed towards adolescent women and their newborns in Latin America. [ABSTRACT FROM AUTHOR]

Background: Obstetric haemorrhage continues to be a leading cause of maternal mortality, contributing to more than a quarter of the 2,443,000 maternal deaths reported between 2003 and 2009. During this period, about 70% of the haemorrhagic deaths occurred postpartum. In addition to other identifiable risk factors for greater postpartum blood loss, the duration of the third stage of labour (TSL) seems to be important, as literature shows that a longer TSL can be associated with more blood loss. To better describe the association between the duration of TSL and postpartum blood loss in women receiving active management of third stage of labour (AMTSL), this secondary analysis of the WHO CHAMPION trial data has been conducted. Methods: This was a secondary analysis of the WHO CHAMPION trial conducted in twenty-three sites in ten countries. We studied the association between the TSL duration and blood loss in the sub cohort of women from the CHAMPION trial (all of whom received AMTSL), with TSL upto 60 min and no interventions for postpartum haemorrhage. We used a general linear model to fit blood loss as a function of TSL duration on the log scale, arm and center, using a normal distribution and the log link function. We showed this association separately for oxytocin and for Heat stable (HS) carbetocin. Results: For the 10,040 women analysed, blood loss rose steeply with third stage duration in the first 10 min, but more slowly after 10 min. This trend was observed for both Oxytocin and HS carbetocin and the difference in the trends for both drugs was not statistically significant (p-value = 0.2070). Conclusions: There was a positive association between postpartum blood loss and TSL duration with either uterotonic. Blood loss rose steeply with TSL duration until 10 min, and more slowly after 10 min. Study registration The main trial was registered with Australian New Zealand Clinical Trials Registry ACTRN12614000870651 and Clinical Trial Registry of India CTRI/2016/05/006969 Plain Language Summary: The duration of the third stage of labour (TSL) seems to be an important risk factor for greater postpartum blood loss, as literature shows that a longer TSL can be associated with more blood loss. Active management of third stage of labour (AMTSL), included in the WHO guidelines for prevention of postpartum haemorrhage (PPH), is effective in reducing both the amount of postpartum blood loss and the duration of the third stage. To better describe the association between duration of TSL and postpartum blood loss in women receiving AMTSL, we conducted this secondary analysis of WHO CHAMPION trial data. To assess the association between the duration of third stage of labour and postpartum blood loss, a subcohort of the CHAMPION modified ITT population was selected by excluding women with missing blood loss or missing TSL duration or TSL duration more than 60 min and women with interventions. Thus, the subcohort consisted of 10,040 women. In women with vaginal birth and not receiving interventions for treating atonic PPH or other sources of bleeding, and with TSL duration up to 60 min, there was a positive association between duration of the TSL and postpartum blood loss. The blood loss rose steeply with duration in women with TSL of 10 min or less, while in women with longer TSL duration the slope was less steep. There was no evidence of a difference between oxytocin and HS carbetocin in the pattern of association of duration of the TSL and blood loss. [ABSTRACT FROM AUTHOR]

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Objective: We assessed the impact of intravenous (IV) infusion versus intramuscular (IM) oxytocin on postpartum blood loss and rates of postpartum hemorrhage (PPH) when administered during the third stage of labor. While oxytocin is recommended for prevention of PPH, few double-blind studies have compared outcomes by routes of administration. Methods: A double-blind, placebo-controlled randomized trial was conducted at a hospital in Argentina. Participants were assigned to receive 10 IU oxytocin via IV infusion or IM injection and a matching saline ampoule for the other route after vaginal birth. Blood loss was measured using a calibrated receptacle for a 1-hour minimum. Shock index (SI) was also calculated, based on vital signs measurements, and additional interventions were recorded. Primary outcomes included: the frequency of blood loss ≥500ml and mean blood loss. Results: 239 (IV infusion) and 241 (IM) women were enrolled with comparable baseline characteristics. Mean blood loss was 43ml less in the IV infusion group (p = 0.161). Rates of blood loss ≥500ml were similar (IV infusion = 21%; IM = 24%, p = 0.362). Women in the IV infusion group received significantly fewer additional uterotonics (5%), than women in the IM group (12%, p = 0.007). Women with PPH in the IM group experienced a larger increase in SI after delivery, which may have influenced recourse to additional interventions. Conclusions: The route of oxytocin administration for PPH prevention did not significantly impact measured blood loss after vaginal birth. However, differences were observed in recourse to additional uterotonics, favoring IV infusion over IM. In settings where IV lines are routinely placed, oxytocin infusion may be preferable to IM injection. [ABSTRACT FROM AUTHOR]

Objective: To characterise the current clinical practice patterns regarding the use of magnesium sulphate (MgSO4 ) for eclampsia prevention and treatment in a multi-country network of health facilities and compare with international recommendations.Design: Cross-sectional survey.Setting: A total of 147 health facilities in 15 countries across Africa, Latin America and Asia.Population: Heads of obstetric departments or maternity units.Methods: Anonymous online and paper-based survey conducted in 2015.Main Outcome Measures: Availability and use of MgSO4 ; availability of a formal clinical protocol for MgSO4 administration; and MgSO4 dosing regimens for eclampsia prevention and treatment.Results: Magnesium sulphate and a formal protocol for its administration were reported to be always available in 87.4% and 86.4% of all facilities, respectively. MgSO4 was used for the treatment of mild pre-eclampsia, severe pre-eclampsia and eclampsia in 24.3%, 93.5% and 96.4% of all facilities, respectively. Regarding the treatment of severe pre-eclampsia, 26.4% and 7.0% of all facilities reported using dosing regimens that were consistent with Zuspan and Pritchard regimens, respectively. Across regions, intramuscular maintenance regimens were more commonly used in the African region (45.7%) than in the Latin American (3.0%) and Asian (22.9%) regions, whereas intravenous maintenance regimens were more often used in the Latin American (94.0%) and Asian (60.0%) regions than in the African region (21.7%). Similar patterns were found for the treatment of eclampsia across regions.Conclusions: The reported clinical use of MgSO4 for eclampsia prevention and treatment varied widely, and was largely inconsistent with current international recommendations.Tweetable Abstract: MgSO4 regimens for eclampsia prevention and treatment in many hospitals are inconsistent with international recommendations. [ABSTRACT FROM AUTHOR]

[This corrects the article DOI: 10.1371/journal.pmed.1002220.]. [ABSTRACT FROM AUTHOR]

Background: Perinatal mortality and morbidity continue to be major global health challenges strongly associated with prematurity and reduced fetal growth, an issue of further interest given the mounting evidence that fetal growth in general is linked to degrees of risk of common noncommunicable diseases in adulthood. Against this background, WHO made it a high priority to provide the present fetal growth charts for estimated fetal weight (EFW) and common ultrasound biometric measurements intended for worldwide use.Methods and Findings: We conducted a multinational prospective observational longitudinal study of fetal growth in low-risk singleton pregnancies of women of high or middle socioeconomic status and without known environmental constraints on fetal growth. Centers in ten countries (Argentina, Brazil, Democratic Republic of the Congo, Denmark, Egypt, France, Germany, India, Norway, and Thailand) recruited participants who had reliable information on last menstrual period and gestational age confirmed by crown-rump length measured at 8-13 wk of gestation. Participants had anthropometric and nutritional assessments and seven scheduled ultrasound examinations during pregnancy. Fifty-two participants withdrew consent, and 1,387 participated in the study. At study entry, median maternal age was 28 y (interquartile range [IQR] 25-31), median height was 162 cm (IQR 157-168), median weight was 61 kg (IQR 55-68), 58% of the women were nulliparous, and median daily caloric intake was 1,840 cal (IQR 1,487-2,222). The median pregnancy duration was 39 wk (IQR 38-40) although there were significant differences between countries, the largest difference being 12 d (95% CI 8-16). The median birthweight was 3,300 g (IQR 2,980-3,615). There were differences in birthweight between countries, e.g., India had significantly smaller neonates than the other countries, even after adjusting for gestational age. Thirty-one women had a miscarriage, and three fetuses had intrauterine death. The 8,203 sets of ultrasound measurements were scrutinized for outliers and leverage points, and those measurements taken at 14 to 40 wk were selected for analysis. A total of 7,924 sets of ultrasound measurements were analyzed by quantile regression to establish longitudinal reference intervals for fetal head circumference, biparietal diameter, humerus length, abdominal circumference, femur length and its ratio with head circumference and with biparietal diameter, and EFW. There was asymmetric distribution of growth of EFW: a slightly wider distribution among the lower percentiles during early weeks shifted to a notably expanded distribution of the higher percentiles in late pregnancy. Male fetuses were larger than female fetuses as measured by EFW, but the disparity was smaller in the lower quantiles of the distribution (3.5%) and larger in the upper quantiles (4.5%). Maternal age and maternal height were associated with a positive effect on EFW, particularly in the lower tail of the distribution, of the order of 2% to 3% for each additional 10 y of age of the mother and 1% to 2% for each additional 10 cm of height. Maternal weight was associated with a small positive effect on EFW, especially in the higher tail of the distribution, of the order of 1.0% to 1.5% for each additional 10 kg of bodyweight of the mother. Parous women had heavier fetuses than nulliparous women, with the disparity being greater in the lower quantiles of the distribution, of the order of 1% to 1.5%, and diminishing in the upper quantiles. There were also significant differences in growth of EFW between countries. In spite of the multinational nature of the study, sample size is a limiting factor for generalization of the charts.Conclusions: This study provides WHO fetal growth charts for EFW and common ultrasound biometric measurements, and shows variation between different parts of the world. [ABSTRACT FROM AUTHOR]

Background: Every year millions of women around the world suffer from pregnancy, childbirth and postpartum complications. Women who survive the most serious clinical conditions are regarded as to have experienced a severe acute maternal complication called maternal near miss (MNM). Information about MNM cases may complement the data collected through the analysis of maternal death, and was proposed as a helpful tool to identify strengths and weaknesses of health systems in relation to maternal health care. The purpose of this study is to evaluate the performance of a systematized form to detect severe maternal outcomes (SMO) in 20 selected maternity hospitals from Latin America (LAC). Methods: Cross-sectional study. Data were obtained from analysis of hospital records for all women giving birth and all women who had a SMO in the selected hospitals. Univariate and multivariate adjusted logistic regression models were used to assess the predictive ability of different conditions to identify SMO cases. In parallel, external auditors were hired for reviewing and reporting the total number of discharges during the study period, in order to verify whether health professionals at health facilities identified all MNM and Potentially life-threatening condition (PLTC) cases. Results: Twenty hospitals from twelve LAC were initially included in the study and based on the level of coverage, 11 hospitals with a total of 3,196 records were included for the final analysis. The incidence of SMO and MNM outcomes was 12.9 and 12.3 per 1,000 live births, respectively. The ratio of MNM to maternal death was 19 to 1, with a mortality index of 5.1%. Both univariate and multivariate analysis showed a good performance for a number of clinical and laboratory conditions to predict a severe maternal outcome, however, their clinical relevance remains to be confirmed. Coherence between health professionals and external auditors to identify SMO was high (around 100 %). Conclusions: The form tested, was well accepted by health professionals and was capable of identifying 100 % of MNM cases and more than 99 % of PLTC variables. Altered state of consciousness, oliguria, placenta accrete, pulmonary edema, and admission to Intensive Care Unit have a high (LR+ ≥80) capacity to anticipate a SMO. [ABSTRACT FROM AUTHOR]

Background: Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and contributes to nearly a quarter of maternal deaths globally. The current available interventions for prevention of postpartum haemorrhage, oxytocin and carbetocin, are limited by their need for refrigeration to maintain potency, as the ability to maintain a cold chain across the drug distribution and storage network is inconsistent, thus restricting their use in countries with the highest burden of maternal mortality. We describe a randomized, double-blind non-inferiority trial comparing a newly developed room temperature stable formulation of carbetocin to the standard intervention (oxytocin) for the prevention of PPH after vaginal birth.Methods/design: Approximately 30,000 women delivering vaginally will be recruited across 22 centres in 10 countries. The primary objectives are to evaluate the non-inferiority of room temperature stable carbetocin (100 μg intramuscular) versus oxytocin (10 IU intramuscular) in the prevention of PPH and severe PPH after vaginal birth. The primary endpoints are blood loss ≥500 mL or the use of additional uterotonics (composite endpoint required by drug regulatory authorities) and blood loss ≥1,000 mL (WHO requirement). Non-inferiority will be assessed using a two-sided 95 % confidence interval for the relative risk of the above endpoints for room temperature stable carbetocin versus oxytocin. The upper limit of the two-sided 95 % confidence interval for the relative risk for the composite endpoint of blood loss ≥500 mL or the use of additional uterotonics, and for the endpoint of blood loss ≥1,000 mL, will be compared to a non-inferiority margin of 1.16 and 1.23, respectively. If the upper limit is below the corresponding margin, non-inferiority will have been demonstrated. The safety analysis will include all women receiving treatment. Safety and tolerability will be assessed by a review of adverse events, by conducting inferential testing with significance levels for between-group comparisons.Discussion: If the results of the study show that room temperature stable carbetocin is a safe and effective alternative to oxytocin, this could have a substantial impact on the prevention of postpartum haemorrhage and maternal survival worldwide.Trial Registration: ACTRN12614000870651 (14 August 2014). [ABSTRACT FROM AUTHOR]

Background: Maternal mortality has declined by nearly half since 1990, but over a quarter million women still die every year of causes related to pregnancy and childbirth. Maternal-health related targets are falling short of the 2015 Millennium Development Goals and a post-2015 Development Agenda is emerging. In connection with this, setting global research priorities for the next decade is now required. Methods: We adapted the methods of the Child Health and Nutrition Research Initiative (CHNRI) to identify and set global research priorities for maternal and perinatal health for the period 2015 to 2025. Priority research questions were received from various international stakeholders constituting a large reference group, and consolidated into a final list of research questions by a technical working group. Questions on this list were then scored by the reference working group according to five independent and equally weighted criteria. Normalized research priority scores (NRPS) were calculated, and research priority questions were ranked accordingly. Results: A list of 190 priority research questions for improving maternal and perinatal health was scored by 140 stakeholders. Most priority research questions (89%) were concerned with the evaluation of implementation and delivery of existing interventions, with research subthemes frequently concerned with training and/or awareness interventions (11%), and access to interventions and/or services (14%). Twenty-one questions (11%) involved the discovery of new interventions or technologies. Conclusions: Key research priorities in maternal and perinatal health were identified. The resulting ranked list of research questions provides a valuable resource for health research investors, researchers and other stakeholders. We are hopeful that this exercise will inform the post-2015 Development Agenda and assist donors, research-policy decision makers and researchers to invest in research that will ultimately make the most significant difference in the lives of mothers and babies. [ABSTRACT FROM AUTHOR]

Background: In 2006 WHO presented the infant and child growth charts suggested for universal application. However, major determinants for perinatal outcomes and postnatal growth are laid down during antenatal development. Accordingly, monitoring fetal growth in utero by ultrasonography is important both for clinical and scientific reasons. The currently used fetal growth references are derived mainly from North American and European population and may be inappropriate for international use, given possible variances in the growth rates of fetuses from different ethnic population groups. WHO has, therefore, made it a high priority to establish charts of optimal fetal growth that can be recommended worldwide. Methods: This is a multi-national study for the development of fetal growth standards for international application by assessing fetal growth in populations of different ethnic and geographic backgrounds. The study will select pregnant women of high-middle socioeconomic status with no obvious environmental constraints on growth (adequate nutritional status, non-smoking), and normal pregnancy history with no complications likely to affect fetal growth. The study will be conducted in centres from ten developing and industrialized countries: Argentina, Brazil, Democratic Republic of Congo, Denmark, Egypt, France, Germany, India, Norway, and Thailand. At each centre, 140 pregnant women will be recruited between 8 + 0 and 12 + 6 weeks of gestation. Subsequently, visits for fetal biometry will be scheduled at 14, 18, 24, 28, 32, 36, and 40 weeks (+/- 1 week) to be performed by trained ultrasonographers. The main outcome of the proposed study will be the development of fetal growth standards (either global or population specific) for international applications. Discussion: The data from this study will be incorporated into obstetric practice and national health policies at country level in coordination with the activities presently conducted by WHO to implement the use of the Child Growth Standards. [ABSTRACT FROM AUTHOR]

Background: Mode of delivery remains a topic of debate in vertex/non-vertex twin pregnancies. We used the WHO Global Survey dataset to determine the risk of adverse maternal/perinatal outcomes associated with presentation of the second twin, following vaginal delivery of a vertex first twin. Methods: We analysed a derived dataset of twin pregnancies = 32 weeks gestation where the first twin was vertex and delivered vaginally. Maternal, delivery and neonatal characteristics and adverse outcomes were reported by presentation of the second twin. Logistic regression models (adjusted for maternal and perinatal confounders, mode of delivery and region) were developed to determine odds of adverse outcomes associated with presentation. Results: 1,424 twin pregnancies were included, 25.9% of these had a non-vertex second twin and Caesarean was more common in non-vertex presentations (6.2% vs 0.9%, p < 0.001). While the odds of Apgar < 7 at 5 minutes were higher in non-vertex presenting second twins (16.0% vs 11.4%, AOR 1.42 95% CI 1.01-2.00), the odds of maternal ICU admission (4.6% vs 1.7%, AOR 1.30, 95% CI 0.88-1.94), blood transfusion (6.0% vs 3.4%, AOR 1.23, 95% CI 0.67-2.25), stillbirth (7.6% vs 4.7%, AOR 1.15, 95% CI 0.72-1.73), early neonatal death (3.8% vs 2.1%, AOR 1.68, 95% CI 0.96-2.94), and NICU admission (26.6% vs 23.2%, AOR 0.93, 95% CI 0.62-1.39) were not. Conclusion: After a vaginal delivery of a vertex first twin, non-vertex presentation of the second twin is associated with increased odds of Apgar <7 at 5 minutes, but not of other maternal/perinatal outcomes. Presentation of the second twin is not as important a consideration in planning twin vaginal birth as previously considered. [ABSTRACT FROM AUTHOR]

Background: In 2001, the WHO Antenatal Care Trial (WHOACT) concluded that an antenatal care package of evidence-based screening, therapeutic interventions and education across four antenatal visits for low-risk women was not inferior to standard antenatal care and may reduce cost. However, an updated Cochrane review in 2010 identified an increased risk of perinatal mortality of borderline statistical significance in three cluster-randomized trials (including the WHOACT) in developing countries. We conducted a secondary analysis of the WHOACT data to determine the relationship between the reduced visits, goal-oriented antenatal care package and perinatal mortality. Methods: Exploratory analyses were conducted to assess the effect of baseline risk and timing of perinatal death. Women were stratified by baseline risk to assess differences between intervention and control groups. We used linear modeling and Poisson regression to determine the relative risk of fetal death, neonatal death and perinatal mortality by gestational age. Results: 12,568 women attended the 27 intervention clinics and 11,958 women attended the 26 control clinics. 6,160 women were high risk and 18,365 women were low risk. There were 161 fetal deaths (1.4%) in the intervention group compared to 119 fetal deaths in the control group (1.1%) with an increased overall adjusted relative risk of fetal death (Adjusted RR 1.27; 95% CI 1.03, 1.58). This was attributable to an increased relative risk of fetal death between 32 and 36 weeks of gestation (Adjusted RR 2.24; 95% CI 1.42, 3.53) which was statistically significant for high and low risk groups. Conclusion: It is plausible the increased risk of fetal death between 32 and 36 weeks gestation could be due to reduced number of visits, however heterogeneity in study populations or differences in quality of care and timing of visits could also be playing a role. Monitoring maternal, fetal and neonatal outcomes when implementing antenatal care protocols is essential. Implementing reduced visit antenatal care packages demands careful monitoring of maternal and perinatal outcomes, especially fetal death. [ABSTRACT FROM AUTHOR]

The article discusses the effects of implementation of electronic-learning type of evidence based medicine (EBM) courses for medical students on their knowledge, skills and educational environment compared with traditional EBM courses. It highlights advantages of EBM courses which help to assimilates and implement scientific knowledge skills by health care professionals through methods implied via their clinical work. The study methodologies compiled of assessment of EBM knowledge in various medical interns during their training period. The results outcome revealed that electronic learning based knowledge on reproductive health helps to better impart skills to medical personnel. INSET: Box. An Overview of Clinically Integrated e-Learning Course....

Background and objectives: Evidence-based health care requires clinicians to engage with use of evidence in decision-making at the workplace. A learner-centred, problem-based course that integrates e-learning in the clinical setting has been developed for application in obstetrics and gynaecology units. The course content uses the WHO reproductive health library (RHL) as the resource for systematic reviews. This project aims to evaluate a clinically integrated teaching programme for incorporation of evidence provided through the WHO RHL. The hypothesis is that the RHL-EBM (clinically integrated e-learning) course will improve participants' knowledge, skills and attitudes, as well as institutional practice and educational environment, as compared to the use of standard postgraduate educational resources for EBM teaching that are not clinically integrated. Methods: The study will be a multicentre, cluster randomized controlled trial, carried out in seven countries (Argentina, Brazil, Democratic Republic of Congo, India, Philippines, South Africa, Thailand), involving 50-60 obstetrics and gynaecology teaching units. The trial will be carried out on postgraduate trainees in the first two years of their training. In the intervention group, trainees will receive the RHL-EBM course. The course consists of five modules, each comprising self-directed e-learning components and clinically related activities, assignments and assessments, coordinated between the facilitator and the postgraduate trainee. The course will take about 12 weeks, with assessments taking place pre-course and 4 weeks post-course. In the control group, trainees will receive electronic, self-directed EBM-teaching materials. All data collection will be online. The primary outcome measures are gain in EBM knowledge, change in attitudes towards EBM and competencies in EBM measured by multiple choice questions (MCQs) and a skills-assessing questionniare administered eletronically. These questions have been developed by using questions from validated questionnaires and adapting them to the current course. Secondary outcome measure will be educational environment towards EBM which will be assessed by a specifically developed questionnaire. Expected outcomes: The trial will determine whether the RHL EBM (clinically integrated e-leraning) course will increase knowledge, skills and attitudes towards EBM and improve the educational environment as compared to standard teaching that is not clinically integrated. If effective, the RHL-EBM course can be implemented in teaching institutions worldwide in both, low-and middle income countries as well as industrialized settings. The results will have a broader impact than just EBM training because if the approach is successful then the same educational strategy can be used to target other priority clinical and methodological areas. [ABSTRACT FROM AUTHOR]

Abalos E, Merialdi M, Wojdyla D, Carroli G, Campodónico L, Yao S-E, Gonzalez R, Deter R, Villar J, Van Look P. Effects of calcium supplementation on fetal growth in mothers with deficient calcium intake: a randomised controlled trial. Paediatric and Perinatal Epidemiology 2010; 24: 53–62. Calcium supplementation in mothers with low calcium intake has been of interest recently because of its association with optimal fetal growth and improved pre-eclampsia-related outcomes. While the effects of calcium supplementation have demonstrated benefits in prolonging gestation and subsequently improving birthweight, no specific studies have identified the longitudinal effects of supplementation on fetal growth in utero. Data were analysed in the context of the World Health Organization trial of calcium supplementation in calcium-deficient women. Five hundred and ten healthy, primiparous pregnant Argentinean women were randomised (at <20 weeks gestation) to either placebo ( n = 230) or calcium supplements (1500 mg calcium/day in 3 divided doses; n = 231). Growth parameters in utero were assessed with serial ultrasound scans. Birthweight, length, head, abdominal and thigh circumferences were recorded at delivery. No differences were found in fetal biometric measurements recorded at 20, 24, 28, 32 and 36 weeks gestation between fetuses of women who were supplemented with calcium and those who were not. Similarly, neonatal characteristics and anthropometric measurements recorded at delivery were comparable in both groups. We conclude that calcium supplementation of 1500 mg calcium/day in pregnant women with low calcium intake does not appear to impact on fetal somatic or skeletal growth. [ABSTRACT FROM AUTHOR]

This study aims to determine whether variables reflecting an adverse intrauterine environment are associated with childhood blood pressure. The authors conducted a secondary analysis of data from a prospective cohort of children born to healthy, nulliparous women enrolled in a randomized controlled trial. A total of 518 children were traced in 1995–1996 from 614 eligible children born in a clinic in Rosario, Argentina. The outcome was systolic blood pressure at 5–9 years. Hemoglobin during pregnancy was positively associated with children's pressure. Other maternal characteristics during pregnancy (blood pressure, smoking, weight gain, weight at 20 weeks' gestation, and glycemia) and size at birth (birth weight, ponderal index, head circumference/length ratio, and small for gestational age) were not associated with children's pressure. Among children in the upper quartile of body mass index, there was a weak inverse correlation between birth weight and systolic pressure, and systolic pressure was 14.8 mmHg (95 percent confidence interval: 3.3, 26.4) higher in low birth weight children than in others. The main predictors of childhood pressure were childhood body mass index and maternal pressure outside pregnancy. In this healthy population, the authors found weak support for an association between variables reflecting an adverse fetal environment and childhood blood pressure. Low birth weight was a risk factor for high blood pressure only in overweight children. Am J Epidemiol 2000;151:594–601. [ABSTRACT FROM PUBLISHER]

Background: Caesarean section rates continue to increase worldwide with uncertain medical consequences. Auditing and analysing caesarean section rates and other perinatal outcomes in a reliable and continuous manner is critical for understanding reasons caesarean section changes over time. Methods: We analyzed data on 97,095 women delivering in 120 facilities in 8 countries, collected as part of the 2004-2005 Global Survey on Maternal and Perinatal Health in Latin America. The objective of this analysis was to test if the "10-group" or "Robson" classification could help identify which groups of women are contributing most to the high caesarean section rates in Latin America, and if it could provide information useful for health care providers in monitoring and planning effective actions to reduce these rates. Results: The overall rate of caesarean section was 35.4%. Women with single cephalic pregnancy at term without previous caesarean section who entered into labour spontaneously (groups I and 3) represented 60% of the total obstetric population. Although women with a term singleton cephalic pregnancy with a previous caesarean section (group 5) represented only 11.4% of the obstetric population, this group was the largest contributor to the overall caesarean section rate (26.7% of all the caesarean sections). The second and third largest contributors to the overall caesarean section rate were nulliparous women with single cephalic pregnancy at term either in spontaneous labour (group I) or induced or delivered by caesarean section before labour (group 2), which were responsible for 18.3% and 15.3% of all caesarean deliveries, respectively. Conclusion: The 10-group classification could be easily applied to a multicountry dataset without problems of inconsistencies or misclassification. Specific groups of women were clearly identified as the main contributors to the overall caesarean section rate. This classification could help health care providers to plan practical and effective actions targeting specific groups of women to improve maternal and perinatal care. [ABSTRACT FROM AUTHOR]

Background: The third stage of labour refers to the period between birth of the baby and complete expulsion of the placenta. Some degree of blood loss occurs after the birth of the baby due to separation of the placenta. This period is a risky period because uterus may not contract well after birth and heavy blood loss can endanger the life of the mother. Active management of the third stage of labour (AMTSL) reduces the occurrence of severe postpartum haemorrhage by approximately 60-70%. Active management consists of several interventions packaged together and the relative contribution of each of the components is unknown. Controlled cord traction is one of those components that require training in manual skill for it to be performed appropriately. If it is possible to dispense with controlled cord traction without losing efficacy it would have major implications for effective management of the third stage of labour at peripheral levels of health care. Objective: The primary objective is to determine whether the simplified package of oxytocin 10 IU IM/IV is not less effective than the full AMTSL package. Methods: A hospital-based, multicentre, individually randomized controlled trial is proposed. The hypothesis tested will be a non-inferiority hypothesis. The aim will be to determine whether the simplified package without CCT, with the advantage of not requiring training to acquire the manual skill to perform this task, is not less effective than the full AMTSL package with regard to reducing blood loss in the third stage of labour. The simplified package will include uterotonic (oxytocin 10 IU IM) injection after delivery of the baby and cord clamping and cutting at approximately 3 minutes after birth. The full package will include the uterotonic injection (oxytocin 10 IU IM), controlled cord traction following observation of uterine contraction and cord clamping and cutting at approximately 3 minutes after birth. The primary outcome measure is blood loss of 1000 ml or more at one hour and up to two hours for women who continue to bleed after one hour. The secondary outcomes are blood transfusion, the use of additional uterotonics and measure of severe morbidity and maternal death. We aim to recruit 25,000 women delivering vaginally in health facilities in eight countries within a 12 month recruitment period. Management: Overall trial management will be from HRP/RHR in Geneva. There will be eight centres located in Argentina, Egypt, India, Kenya, Philippines, South Africa, Thailand and Uganda. There will be an online data entry system managed from HRP/RHR. The trial protocol was developed following a technical consultation with international organizations and leading researchers in the field. Expected outcomes: The main objective of this trial is to investigate whether a simplified package of third stage management can be recommended without increasing the risk of PPH. By avoiding the need for a manual procedure that requires training, the third stage management can be implemented in a more widespread and cost-effective way around the world even at the most peripheral levels of the health care system. This trial forms part of the programme of work to reduce maternal deaths due to postpartum haemorrhage within the RHR department in collaboration with other research groups and organizations active in the field. [ABSTRACT FROM AUTHOR]

Cluster-based studies involving aggregate units such as hospitals or medical practices are increasingly being used in healthcare evaluation. An important characteristic of such studies is the presence of intracluster correlation, typically quantified by the intracluster correlation coefficient (ICC). Sample size calculations for cluster-based studies need to account for the ICC, or risk underestimating the sample size required to yield the desired levels of power and significance. In this article, we present values for ICCs that were obtained from data on 97 095 pregnancies and 98 072 births taking place in a representative sample of 120 hospitals in eight Latin American countries. We present ICCs for 86 variables measured on mothers and newborns from pregnancy to the time of hospital discharge, including ‘process variables’ representing actual medical care received for each mother and newborn. Process variables are of primary interest in the field of implementation research. We found that overall, ICCs ranged from a minimum of 0.0003 to a maximum of 0.563 (median 0.067). For maternal and newborn outcome variables, the median ICCs were 0.011 (interquartile range 0.007–0.037) and 0.054 (interquartile range 0.013–0.075) respectively; however, for process variables, the median was 0.161 (interquartile range 0.072–0.328). Thus, we confirm previous findings that process variables tend to have higher ICCs than outcome variables. We demonstrate that ICCs generally tend to increase with higher prevalences (close to 0.5). These results can help researcherscalculate the required sample size for future research studies in maternal and perinatal health. [ABSTRACT FROM AUTHOR]

Episiotomy, the unkindest cut of all, persists despite clinical practice guidelines recommending its restrictive use. The purpose of this paper was to compile international statistics on the use of this practice and examine whether current guidance on the restrictive use of episiotomy was being followed. Methods: We searched government websites and the Internet, contacted colleagues for references, and checked the references of retrieved citations. Results: Statistics from around the world revealed overall high rates of episiotomy with a decreasing trend in some countries. Considerable variation occurs in the use of the operation by country, within countries, and even within the same professional provider group. Conclusions: Greater efforts are needed than currently in place to reduce the episiotomy rate, particularly in the developing world. [ABSTRACT FROM AUTHOR]

Examines the efficacy of nutritional interventions in treating impaired fetal growth. Reduction in the risk of small gestational growth; Protection against low birth weight; Presentation of a positive effects on fetal long bone growth.

Presents a chart depicting the characteristics of randomized controlled trials in the systematic review of nutritional interventions for gestational age and birth weight outcomes. Improvement of the quality of diet versus no dietary advice; Supplementation of protein and energy nutrients; Administration of folic acid in women with singleton pregnancies.

Assesses the effectiveness of nutritional interventions in treating maternal morbidity, mortality and preterm delivery. Supplementation of fish oil and zinc; Importance of giving nutritional advice; Dissemination of evidence-based information on maternal health care.

This overview assesses the effectiveness of nutritional interventions to prevent or treat maternal morbidity, mortality and preterm delivery. Cochrane systematic reviews and other up-to-date systematic reviews and individual randomized controlled trials were sought. Searches were carried out up to July 2002. Iron and folate supplements reduce anemia and should be included in antenatal care programs. Calcium supplementation to women at high risk of hypertension during pregnancy or low calcium intake reduced the incidence of both preeclampsia and hypertension. Fish oil and vitamins E and C are promising for preventing preeclampsia and preterm delivery and need further testing. Vitamin A and beta-carotene reduced maternal mortality in a large trial; ongoing trials should provide further evaluation. No specific nutrient supplementation was identified for reducing preterm delivery. Nutritional advice, magnesium, fish oil and zinc supplementation appear promising and should be tested alone or together in methodologically sound randomized controlled trials. Anema in pregnancy can be prevented and treated effectively. Considering the multifactorial etiology of the other conditions evaluated, it is unlikely that any specific nutrient on its own, blanket interventions or magic bullets will prevent or treat preeclampsia, hemorrhage, obstructed labor, infections, preterm delivery or death during pregnancy. The few promising interventions for specific outcomes should be tested or reconsidered when results of ongoing trials become available. Until then, women and their families should receive support to improve their diets as a general health rule, which is a basic human right. [ABSTRACT FROM AUTHOR]

Background: The results of a qualitative study carried out in four developing countries (Cuba, Thailand, Saudi Arabia and Argentina) are presented. The study was conducted in the context of a randomised controlled trial to test the benefits of a new antenatal care protocol that reduced the number of visits to the doctor, rationalised the application of technology, and improved the provision of information to women in relation to the traditional protocol applied in each country. Methods: Through focus groups discussions we were able to assess the concepts and expectations underlying women's evaluation of concepts and experiences of the care received in antenatal care clinics. 164 women participated in 24 focus groups discussion in all countries. Results: Three areas are particularly addressed in this paper: a) concepts about pregnancy and health care, b) experience with health services and health providers, and c) opinions about the modified Antenatal Care (ANC) programme. In all three topics similarities were identified as well as particular opinions related to country specific social and cultural values. In general women have a positive view of the new ANC protocol, particularly regarding the information they receive. However, controversial issues emerged such as the reduction in the number of visits, particularly in Cuba where women are used to have 18 ANC visits in one pregnancy period. Conclusion: Recommendations to improve ANC services performance are being proposed. Any country interested in the application of a new ANC protocol should regard the opinion and acceptability of women towards changes. [ABSTRACT FROM AUTHOR]

Background: This study assessed women and providers' satisfaction with a new evidence-based antenatal care (ANC) model within the WHO randomized trial conducted in four developing countries. The WHO study was a randomized controlled trial that compared a new ANC model with the standard type offered in each country. The new model of ANC emphasized actions known to be effective in improving maternal or neonatal health, excluded other interventions that have not proved to be beneficial, and improved the information component, especially alerting pregnant women to potential health problems and instructing them on appropriate responses. These activities were distributed within four antenatal care visits for women that did not need any further assessment. Methods: Satisfaction was measured through a standardized questionnaire administered to a random sample of 1,600 pregnant women and another to all antenatal care providers. Results: Most women in both arms expressed satisfaction with ANC. More women in the intervention arm were satisfied with information on labor, delivery, family planning, pregnancy complications and emergency procedures. More providers in the experimental clinics were worried about visit spacing, but more satisfied with the time spent and information provided. Conclusions: Women and providers accepted the new ANC model generally. The safety of fewer visits for women without complications with longer spacing would have to be reinforced, if such a model is to be introduced into routine practice. [ABSTRACT FROM AUTHOR]

[This corrects the article DOI: 10.1371/journal.pmed.1002220.]. [ABSTRACT FROM AUTHOR]

Background: While cesarean sections (CSs) are a life-saving intervention, an increasing number are performed without medical reasons in low- and middle-income countries (LMICs). Unnecessary CS diverts scarce resources and thereby reduces access to healthcare for women in need. Argentina, Burkina Faso, Thailand, and Vietnam are committed to reducing unnecessary CS, but many individual and organizational factors in healthcare facilities obstruct this aim. Nonclinical interventions can overcome these barriers by helping providers improve their practices and supporting women's decision-making regarding childbirth. Existing evidence has shown only a modest effect of single interventions on reducing CS rates, arguably because of the failure to design multifaceted interventions effectively tailored to the context. The aim of this study is to design, adapt, and test a multifaceted intervention for the appropriate use of CS in Argentina, Burkina Faso, Thailand, and Vietnam.Methods: We designed an intervention (QUALIty DECision-making-QUALI-DEC) with four components: (1) opinion leaders at heathcare facilities to improve adherence to best practices among clinicians, (2) CS audits and feedback to help providers identify potentially avoidable CS, (3) a decision analysis tool to help women make an informed decision on the mode of birth, and (4) companionship to support women during labor. QUALI-DEC will be implemented and evaluated in 32 hospitals (8 sites per country) using a pragmatic hybrid effectiveness-implementation design to test our implementation strategy, and information regarding its impact on relevant maternal and perinatal outcomes will be gathered. The implementation strategy will involve the participation of women, healthcare professionals, and organizations and account for the local environment, needs, resources, and social factors in each country.Discussion: There is urgent need for interventions and implementation strategies to optimize the use of CS while improving health outcomes and satisfaction in LMICs. This can only be achieved by engaging all stakeholders involved in the decision-making process surrounding birth and addressing their needs and concerns. The study will generate robust evidence about the effectiveness and the impact of this multifaceted intervention. It will also assess the acceptability and scalability of the intervention and the capacity for empowerment among women and providers alike.Trial Registration: ISRCTN67214403. [ABSTRACT FROM AUTHOR]

Discusses the antenatal care model of the United Nations World Health Organization. Trial of the model in antenatal clinics; Eclampsia cases before hospital discharge; Hemoglobin levels of women during pregnancy.

Background: Effective interventions to reduce mortality and morbidity in maternal and newborn health already exist. Information about quality and performance of care and the use of critical interventions are useful for shaping improvements in health care and strengthening the contribution of health systems towards the Millennium Development Goals 4 and 5. The near-miss concept and the criterion-based clinical audit are proposed as useful approaches for obtaining such information in maternal and newborn health care. This paper presents the methods of the World Health Organization Multicountry Study in Maternal and Newborn Health. The main objectives of this study are to determine the prevalence of maternal near-miss cases in a worldwide network of health facilities, evaluate the quality of care using the maternal near-miss concept and the criterion-based clinical audit, and develop the near-miss concept in neonatal health.Methods/design: This is a large cross-sectional study being implemented in a worldwide network of health facilities. A total of 370 health facilities from 29 countries will take part in this study and produce nearly 275,000 observations. All women giving birth, all maternal near-miss cases regardless of the gestational age and delivery status and all maternal deaths during the study period comprise the study population. In each health facility, medical records of all eligible women will be reviewed during a data collection period that ranges from two to three months according to the annual number of deliveries.Discussion: Implementing the systematic identification of near-miss cases, mapping the use of critical evidence-based interventions and analysing the corresponding indicators are just the initial steps for using the maternal near-miss concept as a tool to improve maternal and newborn health. The findings of projects using approaches similar to those described in this manuscript will be a good starter for a more comprehensive dialogue with governments, professionals and civil societies, health systems or facilities for promoting best practices, improving quality of care and achieving better health for mothers and children. [ABSTRACT FROM AUTHOR]