Search

Background: One of the major threats to the COVID-19 vaccines rollout and successful mitigation of the pandemic is vaccine hesitancy. Vaccine hesitancy refers to delay in acceptance or refusal of vaccination despite availability of vaccination services. The COVID-19 vaccine trials generated very limited data on safety and efficacy for pregnant women and children, since pregnant women were not included in any of the phase I/II or III trials. Hence the authors made an attempt to understand vaccine hesitancy among women healthcare and frontline workers with a focus on vaccination during pregnancy and lactation. Methods: The recruitment of participants was done by purposive snowballing technique over a period of 15 days. The data collection was done through an online questionnaire generated with the help of Google forms. After excluding women who exceeded the age criteria and incompletely filled questionnaires, 101 responses were considered for analysis. Data analysis was done using SPSS software version 22. Results: From a total of 101 responses for analysis, 26% had comorbidities. Of the 9 women who were pregnant, majority was in the second trimester (55.6%). Majority of the women, 63.6% had been feeding for more than six months. Of the respondents who had refused vaccination, most wanted to wait longer for further research on safety and efficacy (47.8%). Conclusions: The reasons for pregnant women to decline COVID-19 vaccination during pregnancy even if the vaccine were safe and free were that they did not want to expose their developing baby to any possible harmful side effects, would like to see more safety data among pregnant women and unclear recommendations from the healthcare provider. As HCWs are envoys for evidence based medical interventions, and they are critical in promoting vaccine acceptance amongst the general population, it is important to design effective strategies to improve vaccine acceptance amongst this population.

Background Ischemia-modified albumin (IMA) is looked upon as a newer marker of myocardial ischemia. There is a paucity of literature however with regard to studies correlating levels of IMA in patients with hypertensive disorders of pregnancy. The present study therefore aimed at estimating the levels of IMA in patients with gestational hypertension and assessing its utility in predicting hypertensive disorders of pregnancy. Methods The present study was a hospital-based case-control study conducted in the Department of Biochemistry, All India Institute of Medical Sciences (AIIMS), Nagpur. IMA was estimated in 30 controls (Group I) and 20 cases of gestational hypertension (Group II) using a spectrophotometric assay detecting free unbound Cobalt left behind. The clinical data and lab results were presented as mean ± SD. Student's t-test was applied and Pearson's correlation coefficient was calculated. A value of p0.05 was taken as statistically significant. The ROC (Receiver Operator Characteristic) curve was used to establish the cut-off of serum IMA levels in pregnancy-induced hypertension (PIH). Results There was no significant difference in age and period of gestation (POG) at the time of sample collection between the groups. There was a significant difference in the systolic and diastolic blood pressures (BPs) of both groups. The mean level of serum IMA was significantly higher in cases of gestational hypertension (0.88 ± 0.14 absorbance units {ABSU}) as compared to controls (0.69 ± 0.08 ABSU) (p0.001). On correlation analysis, the systolic and diastolic BPs were found to be highly positively correlated with serum IMA levels (p0.001). ROC curve analysis suggested that at a cut-off of 0.73 ABSU, IMA has 85% sensitivity and 80% specificity for predicting gestational hypertension. Conclusion Statistically significant results of serum IMA levels obtained in gestational hypertension which falls on the lesser severe spectrum of the disease imply that serum IMA can be used for early diagnosis of gestational hypertension and impending Pre-eclampsia (PE) and Eclampsia.

Introduction: Maternal birthing positions refer to the various physical postures a pregnant mother may assume at the time of delivery. The World Health Organisation recommends that woman should be given an opportunity to make a choice on the type of position to use during labour. Alternative birth positions are associated with lower incidence rates of performing episiotomy, less perineal tears and less use of instrumental deliveries. Nurses' perspective on women's positions has rarely been explored in India. Present study aims at assessing the knowledge regarding alternative birth positions among nursing officers. Materials and Methods: This cross-sectional observational study was conducted on 52 nursing officers who were posted in the labour room. A pretested questionnaire was administered to them. Data analysis was done using SPSS software version 22. Results: Majority (82.7%) of nursing officers felt that there is a need of giving a choice to the woman regarding alternate birth position. 76.9% of them were aware of position other than lithotomy. Around 48.1% would recommend squatting position to a woman in labour. Ease and convenience in conducting the delivery was the foremost reason chosen in advocating a birth position. Whereas overcrowding in the labour room, ignorance about alternate positions and difficulty in converting to instrumental delivery were cited as reasons of not recommending these positions. Conclusion: Educating nursing officers about emerging evidence regarding birthing positions will enable them to give accurate information to women.

Objective To compare the effectiveness and safety of Foley catheter and oral misoprostol for induction of labor (IOL). Methods The Cochrane Review on Mechanical Methods for Induction of Labour and Ovid MEDLINE, EMBASE via Ovid, Ovid Emcare, CINAHL Plus, ClinicalTrials.gov and Scopus, from inception to April 2019, were searched for randomized controlled trials (RCTs) comparing Foley catheter to oral misoprostol for IOL in viable singleton gestations. Eligible trials for which raw data were obtained were included and individual participant data meta-analysis was performed. Primary outcomes were vaginal birth, a composite of adverse perinatal outcome (including stillbirth, neonatal death, neonatal seizures, admission to the neonatal intensive care unit, severe respiratory compromise or meconium aspiration syndrome) and a composite of adverse maternal outcome (including admission to the intensive care unit, maternal infection, severe postpartum hemorrhage, maternal death or uterine rupture). The quality of the included RCTs was assessed using the Cochrane Risk of Bias 2 tool and the certainty of evidence was evaluated using the GRADE approach. A two-stage random-effects model was used for meta-analysis according to the intention-to-treat principle and interactions between treatment and baseline characteristics were assessed. Results Of seven eligible trials, four provided individual participant data for a total of 2815 participants undergoing IOL, of whom 1399 were assigned to Foley catheter and 1416 to oral misoprostol. All four trials provided data for each of the primary outcomes in all 2815 women. Compared with those receiving oral misoprostol, Foley catheter recipients had a slightly decreased chance of vaginal birth (risk ratio (RR), 0.95 (95% CI, 0.91-0.99); I2 , 2.0%; moderate-certainty evidence). A trend towards a lower rate of composite adverse perinatal outcome was found in women undergoing IOL using a Foley catheter compared with oral misoprostol (RR, 0.71 (95% CI, 0.48-1.05); I2 , 14.9%; low-certainty evidence). Composite adverse maternal outcome did not differ between the groups (RR, 1.00 (95% CI, 0.97-1.03); I2 , 0%; moderate-certainty evidence). Meta-analyses of effect modifications did not show significant interactions between intervention and parity or gestational age for any of the primary outcomes. Conclusions For women undergoing IOL, Foley catheter is less effective than oral misoprostol, as it was associated with fewer vaginal births. However, while we found no significant difference in maternal safety, Foley catheter induction may reduce adverse perinatal outcomes. Copyright © 2020 ISUOG. Published by John Wiley & Sons Ltd.

Objectives Induction of labour (IOL), or starting labour artificially, can be a lifesaving intervention for pregnant women and their babies, and rates are rising significantly globally. As rates increase, it becomes increasingly important to fully evaluate all available data, especially that from low income settings where the potential benefits and harms are greater. The goal of this paper is to describe the datasets collected as part of the Induction with Foley OR Misoprostol (INFORM) Study, a randomised trial comparing two of the recommended methods of cervical ripening for labour induction, oral misoprostol and Foley catheter, in women being induced for hypertension in pregnancy, at two sites in India during 2013–15. Data description This dataset includes comprehensive data on 602 women who underwent IOL for hypertensive disorders in pregnancy. Women were randomly assigned to cervical ripening with oral misoprostol or a transcervical Foley catheter in two government hospitals in India. The main dataset has 367 variables including monitoring during the induction of labour, medications administered, timing and mode of delivery, measures of neonatal morbidity and mortality, maternal mortality and morbidity, maternal satisfaction and health economic data. The dataset is anonymised and available on ReShare.

Background Every year approximately 30,000 women die from hypertensive disease in pregnancy. Magnesium sulphate and anti-hypertensives reduce morbidity, but delivery is the only cure. Low dose oral misoprostol, a prostaglandin E1 analogue, is a highly effective method for labour induction. Usually, once active labour has commenced, the misoprostol is replaced with an intravenous oxytocin infusion if ongoing stimulation is required. However, some studies have shown that oral misoprostol can be continued into active labour, a simpler and potentially more acceptable protocol for women. To date, these two protocols have never been directly compared. Methods This pragmatic, open-label, randomised trial will compare a misoprostol alone labour induction protocol with the standard misoprostol plus oxytocin protocol in three Indian hospitals. The study will recruit 520 pregnant women being induced for hypertensive disease in pregnancy and requiring augmentation after membrane rupture. Participants will be randomised to receive either further oral misoprostol 25mcg every 2 h, or titrated intravenous oxytocin. The primary outcome will be caesarean birth. Secondary outcomes will assess the efficacy of the induction process, maternal and fetal/neonatal complications and patient acceptability. This protocol (version 1.04) adheres to the SPIRIT checklist. A cost-effectiveness analysis, situational analysis and formal qualitative assessment of women’s experience are also planned. Discussion Avoiding oxytocin and continuing low dose misoprostol into active labour may have a number of benefits for both women and the health care system. Misoprostol is heat stable, oral medication and thus easy to store, transport and administer; qualities particularly desirable in low resource settings. An oral medication protocol requires less equipment (e.g. electronic infusion pumps) and may free up health care providers to assist with other aspects of the woman’s care. The simplicity of the protocol may also help to reduce human errors associated with the delivery of intravenous infusions. Finally, women may prefer to be mobile during labour and not restricted by an intravenous infusion. There is a need, therefore, to assess whether augmentation using oral misoprostol is superior clinically and economically to the standard protocol of intravenous oxytocin. Trial registration Clinical Trials.gov, NCT03749902, registered on 21st Nov 2018.

Developing and under-developed countries bear more than 80% of the global burden of cervical cancer. It can largely be prevented by prevention and treatment of sexually transmitted infections such as human papilloma virus (HPV). Both condom usage and protective inoculation (HPV vaccine) may be considered as primary prevention since cervical cancer screening only detects the pre-invasive lesions. At present, two vaccines licensed globally are available in India: a quadrivalent vaccine, Gardasil marketed by Merck, and a bivalent vaccine, Cervarix marketed by Glaxo Smith Kline. The WHO recommends the HPV vaccine as the main approach for the prevention of cervical cancer, to be preferably administered prior to first sexual contact especially in adolescent girls. The most important step in creating an effective coverage program is to develop accurate forms of communication and information about HPV so that people understand the importance of prevention and problems associated with this virus. Since the vaccine is most effective when administered prior to sexual contact, it is essential to inform the youth about the availability of this vaccine. Most of the studies for knowledge, awareness and practice of HPV infection and vaccination are aimed at women in the community. This study attempts to assess the awareness among medical graduates studying at various institutions spread over Southern and Central India. The current study is designed as a cross-sectional observational study for final year medical graduates at various medical colleges across India. The recruitment of participants was done by purposive snowballing technique over a period of two months. The data collection was done through an online questionnaire generated with the help of Google Forms. Mean age of the participants was 21.73 (+ _1.33) years with a range between 20 and 24 years (n = 354). A total of 196 (55.4%) participants knew that cervical cancer is the second most common cancer among women in India and 83.6% knew all the risk factors for cervical cancer. Approximately 51.6% were aware of the conditions that may be associated with HPV, and 69.2% were aware of the various methods of protection from HPV infection. Knowledge about the types of vaccine available in India and the dosage schedule was poor. Medical schools should modify their curricula to include teaching methods aimed at improving HPV vaccination and its related information. There is a need for a well-designed HPV education program integrated into a national cervical cancer prevention and control program for greater uptake of vaccination.

Coronavirus 2019 (COVID-19) pandemic has become the most severe intercontinental health challenge and pregnant women are deemed to be a special population group. The COVID-19-related restrictions on visiting the hospital for antenatal check-up and procedures may be distressing for them. The present study aims at assessing the level of anxiety and risk perception of pregnant women during the pandemic.This cross-sectional observational study included all pregnant women who were above 18 years of age, irrespective of their gestational age. They were administered the pre-designed, pre-tested questionnaire via face-to-face interview. The effect of the COVID-19 pandemic and its influence on women's experience including her worries were collected. Data analysis was done using SPSS software version 22.A total of 130 pregnant women with a mean maternal age of 26.1 ± 6.5 years were enrolled in the study. The mean gestational age of the women was 19 ± 4.7 weeks and most of them were in the second trimester (48.5%). Most of the pregnant women encountered the adverse socioeconomic influence of COVID-19 on their daily life (55.6% somewhat, 9.1% moderately so, 1.1% very much). Majority of them reported that they had limited their social activities (78.5%) and amorous relationship with their partner (30.8%). Also, around 59.2% of antenatal women experienced a moderate level and 40.7% had a mild level of anxiety.It is essential for obstetric providers to do prompt identification of mental health concerns in perinatal women and to liaise with mental health professionals to provide relevant interference.

Background: Hypertension is the most common medical disorder in pregnancy, complicating one in ten pregnancies. Treatment of severely increased blood pressure is widely recommended to reduce the risk for maternal complications. Regimens for the acute treatment of severe hypertension typically include intravenous medications. Although effective, these drugs require venous access and careful fetal monitoring and might not be feasible in busy or low-resource environments. We therefore aimed to compare the efficacy and safety of three oral drugs, labetalol, nifedipine retard, and methyldopa for the management of severe hypertension in pregnancy. Methods: In this multicentre, parallel-group, open-label, randomised controlled trial, we compared these oral antihypertensives in two public hospitals in Nagpur, India. Pregnant women were eligible for the trial if they were aged at least 18 years; they were pregnant with fetuses that had reached a gestational age of at least 28 weeks; they required pharmacological blood pressure control for severe hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥110 mm Hg); and were able to swallow oral medications. Women were randomly assigned to receive 10 mg oral nifedipine, 200 mg oral labetalol (hourly, in both of which the dose could be escalated if hypertension was maintained), or 1000 mg methyldopa (a single dose, without dose escalation). Masking of participants, study investigators, and care providers to group allocation was not possible because of different escalation protocols in the study groups. The primary outcome was blood pressure control (defined as 120–150 mm Hg systolic blood pressure and 70–100 mm Hg diastolic blood pressure) within 6 h with no adverse outcomes. This study is registered with ClinicalTrials.gov, number NCT01912677, and the Clinical Trial Registry, India, number ctri/2013/08/003866. Findings: Between April 1, 2015, and Aug 21, 2017, we screened 2307 women for their inclusion in the study. We excluded 1413 (61%) women who were ineligible, declined to participate, had impending eclampsia, were in active labour, or had a combination of these factors. 11 (4%) women in the nifedipine group, ten (3%) women in the labetalol group, and 11 (4%) women in the methyldopa group were ineligible for treatment (because they had only one qualifying blood pressure measurement) or had treatment stopped (because of delivery or transfer elsewhere). 894 (39%) women were randomly assigned to a treatment group and were included in the intention-to-treat analysis: 298 (33%) women were assigned to receive nifedipine, 295 (33%) women were assigned to receive labetalol, and 301 (33%) women were assigned to receive methyldopa. The primary outcome was significantly more common in women in the nifedipine group than in those in the methyldopa group (249 [84%] women vs 230 [76%] women; p=0·03). However, the primary outcome did not differ between the nifedipine and labetalol groups (249 [84%] women vs 228 [77%] women; p=0·05) or the labetalol and methyldopa groups (p=0·80). Seven serious adverse events (1% of births) were reported during the study: one (Interpretation: All oral antihypertensives reduced blood pressure to the reference range in most women. As single drugs, nifedipine retard use resulted in a greater frequency of primary outcome attainment than labetalol or methyldopa use. All three oral drugs—methyldopa, nifedipine, and labetalol—are viable initial options for treating severe hypertension in low-resource settings. Funding: PREEMPT (University of British Columbia, Vancouver, BC, Canada; grantee of Bill & Melinda Gates Foundation).

The National Family Health Survey (NFHS-4) data show that 31.1% of women faced domestic violence in 2015-2016, with no reduction since 2005-2006. Emerging data show that since the outbreak of the coronavirus disease (COVID-19), reports of intimate partner violence have increased worldwide because of mandatory lockdowns to curb the spread of the virus. The nature of the current pandemic, which has forced women to spend time with their abusers and restricted their mobility, has made them more vulnerable to abuse. We aimed to determine the proportion of domestic violence among Indian women during the lockdown period.This is a cross-sectional study, conducted in June-August 2020 on married, Indian women of reproductive age who attended the obstetrics-gynecology outpatient department during the COVID-19 pandemic. The Abuse Assessment Screening questionnaire validated during NFHS-4 (2015-2016) was used as a data collection tool. Our primary objective was to determine the proportion of women presenting to the hospital who were exposed to domestic violence during the lockdown period. Analysis was done using SPSS Statistics V22.0.A total of 412 women were recruited for the study. The mean age was 23 years (range 19-52 years). The prevalence of domestic violence in any form was found to be 32.5%, with the majority being verbal abuse in the form of insults, threats of physical violence, or public humiliation.The results of this study indicated a high proportion of women with a history of domestic violence during the pandemic. Thus, health care policy makers and experts involved in women's care-particularly during crisis conditions such as the COVID-19 pandemic-should be aware of the extent of this problem and take measures to properly address it.

Objective To compare the efficacy and safety of recombinant anti-D (R-anti-D) with conventional polyclonal anti-D (Poly anti-D) in preventing maternal-fetal rhesus D (RhD) alloimmunization and to investigate the immunogenicity of R-anti-D. Methods This was a randomized, open-label, multi-center clinical trial conducted in RhD-negative pregnant women who did not receive antenatal anti-D who delivered RhD-positive babies and showed negative indirect Coombs tests (ICTs) at baseline. The women were randomized in a 2:1 ratio to R-anti-D or Poly anti-D groups and were administered 300 mcg (IM) of the corresponding drug within 72 hours of delivery. ICT was performed 72 hours, 90 days, and 180 days after anti-D injection. Serum samples were collected to check for the development of antibodies against R-anti-D at days 90 and 180, using bridging enzyme-linked immunosorbent assay. The proportion of subjects who had positive ICT results at days 90 and 180 were compared between the groups using Fisher's exact test. Results A total of 144 women were randomized to the R-anti-D group and 71 to the Poly anti-D group. Three women in the R-anti-D and none in the Poly anti-D group had a positive ICT result at day 90. No woman in either group had positive ICT result at day 180. Both drugs were well tolerated with only 4 reports of adverse events in each group-all were mild, non-serious, and resolved without sequelae. No subject developed antibodies against R-anti-D. Conclusion The studied R-anti-D is comparable in efficacy to conventional Poly anti-D and is safe and non-immunogenic.Trial Registration: Clinical Trials Registry of India Identifier: Trial Registration: Clinical Trials Registry of India Identifier: CTRI/2017/03/008101.

Pyogenic liver abscess during pregnancy is an extremely dangerous condition, both from general as well as obstetric point of view. An interesting case of 24-year primigravida reported at 28 weeks gestation with high grade fever and chills with features of peritonitis is being presented here, which on investigations subsequently was diagnosed to be a case of ruptured pyogenic liver abscess. The case was managed successfully with higher antibiotics and percutaneous drainage of the abscess. The obstetric outcome was successful as well, with spontaneous preterm delivery of 920 gm male child which cried immediately after birth and was managed with appropriate care in premature baby unit.

Introduction Management of severe hypertension in pregnancy requires prompt treatment – most commonly with intravenous medications. This strategy presents significant barriers to care, particularly in low resource environments. Objective To compare the effectiveness of three oral antihypertensive regimens in pregnant women with severe hypertension. Methods In an open-labeled trial in two hospitals in Nagpur, India, (NCT01912677), pregnant women ⩾28 weeks’ gestation with sBP ⩾160 mmHg or dBP ⩾110 mmHg were randomized to: (1) nifedipine 10 mg orally repeated hourly up to 2 additional doses for sBP >155 mmHg or dBP >105 mmHg, (2) labetalol 200 mg orally repeated hourly for 2 additional doses as above, or (3) methyldopa 1000 mg as a single dose. The primary outcome was achieving a sBP 120–150 mmHg and dBP 70-100mHg at 6 h without an adverse outcome or fetal compromise. Results 894 women were randomized: nifedipine (n = 298), 83.2% achieved primary outcome, (0.7% required additional drugs); labetalol (n = 295), 77.3% achieved primary outcome, (3.1% required additional drugs); methyldopa (n = 301), 76.4% achieved primary outcome, (18.3% required additional drugs), (NvsMD p = 0.04) X 2 ; (LvsMD p = 0.08), X 2 ; (NvsL p = 0.07) X 2. Without use of additional drugs, nifedipine and labetalol were superior to methyldopa, (P 0.001) X 2. Nifedipine was associated with maternal tachycardia, (p 0.001) X 2 ; persistence of headache, (p = 0.005) X 2 ; and a greater likelihood of neonatal admission to the NICU, (NvsMD p = 0.01) X 2 ; (LvsMD p = 0.6), X 2 ; (NvsL p = 0.06) X 2. MgSO 4 use was limited, 11.7%. The eclampsia rate was 0.1%. There were no maternal deaths or ICU admissions. 96% of infants were born alive; 95% of live-born were alive at discharge. Discussion Each regimen achieved some success. As a single agent, nifedipine and labetalol were superior to methyldopa. A structured approach of measuring BP and intervention with oral medications in a high risk environment achieved low rates of maternal and neonatal complications despite some differences in BP control across groups. This was achieved with a low rate of MgSO 4 utilization.

Objective To compare magnesium sulphate concentrations achieved by intramuscular and intravenous regimens used for the prevention of eclampsia. Setting Low-resource obstetric hospitals in Nagpur and Vellore, India. Population Pregnant women at risk for eclampsia due to hypertensive disease. Methods A pharmacokinetic study was performed as part of a randomised trial that enrolled 300 women comparing intramuscular and intravenous maintenance regimens of magnesium dosing. Data from 258 enrolled women were analysed in the pharmacokinetic study. A single sample was drawn per woman with the expectation of using samples in a pooled data analysis. Main outcome measures Pharmacokinetic parameters of magnesium distribution and clearance. Results Magnesium clearance was estimated to be 48.1 dl/hour, volume of distribution to be 156 dl and intramuscular bioavailability to be 86.2%. The intramuscular regimen produced higher initial serum concentrations, consistent with a substantially larger loading dose. At steady state, magnesium concentrations in the intramuscular and intravenous groups were comparable. With either regimen, a substantial number of women would be expected to have serum concentrations lower than those generally held to be therapeutic. Conclusions Clinical implications were that a larger loading dose for the intravenous regimen should be considered; where feasible, individualised dosing of magnesium sulphate would reduce the variability in serum concentrations and might result in more women with clinically effective magnesium concentrations; and lower dose magnesium suphate regimens should be considered with caution.

Objective To test the safety, efficacy, and acceptability of a simple, mechanically flow-controlled pump (Springfusor®) for the delivery of magnesium sulfate for the treatment of preeclampsia. Design Eligible women ( n =300) had blood pressure ⩾140/100mmHg, and proteinuria ⩾1+ (30mgdL); the clinic team determined that they were likely to benefit from magnesium sulfate. Women were randomized to 24h of magnesium sulfate by either IV administered by the Springfusor® pump ( n =147) or standard hospital practice – IV loading dose administered manually followed by maintenance therapy using an IM route of administration ( n =153). Main outcome measures Our primary outcome of interest was the safety and efficacy of the Springfusor pump including the side and adverse effects experienced during drug administration. Data on side effects, patient acceptability, delivery complications, and maternal and neonatal outcomes were collected. Results Fewer women stopped treatment due to side effects, toxicity, oliguria or renal failure, or women's request in the Springfusor arm (4% or 6 of 147 women) compared to the Standard of Care arm (6.5% or 10 of 153 women). Women in the Springfusor arm reported significantly less nausea, headache, and pain than women in the Standard of Care arm. Almost all women (97%) in the Springfusor arm reported their pain level as ‘acceptable' or ‘very acceptable' compared to only 30% of women given the Standard of Care. Conclusion The Springfusor pump may offer an alternative to intramuscular administration of magnesium sulfate where electronic pumps are not available.

Between 62,000 and 77,000 women die annually from pre-eclampsia/eclampsia. Prompt delivery, preferably by the vaginal route, is vital for good maternal and neonatal outcomes. Two low cost interventions -low dose oral misoprostol tablets and transcervical Foley catheterisation- are already used in low resource settings. In this open label, parallel randomised study, our objective was to compare their relative risks and benefits. 602 women with a live fetus requiring delivery for pre-eclampsia or hypertension were randomly assigned to labour induction with oral misoprostol 25 micrograms every 2 h (maximum of 12 doses) or a transcervical Foley catheter (size 18 F with 30 ml balloon) which remained until active labour started, the Foley catheter fell out, or 12 h elapsed. Randomisation was computer-generated with allocation concealment by opaque sequentially numbered sealed envelopes. Induction continued with artificial membrane rupture and oxytocin, administered through a micro-drip gravity infusion set. Fetal monitoring was by intermittent auscultation. The primary outcome was vaginal birth within 24 h, and trial registration as with ClinicalTrials.gov (NCT01801410). 302 women were allocated to misoprostol and 300 women to Foley catheter; all were analysed. More women in the misoprostol arm had a vaginal birth within 24 h (57.0% vs. 47.0%; absolute risk difference (RD) 10.0%, with 95%CI 2.0% to 17.9%). Rates of uterine hyperstimulation were very low in both groups (0.7% vs 0.3%; RD 0.3%; −0.8% to 1.5%) and no differences were seen in neonatal morbidity. More women in the misoprostol group would use the same method in the future should they require another induction (82.8% vs. 72.0%; RD 10.8%; 4.2% to 17.4%). Oral misoprostol 25 micrograms was more effective and more acceptable to women than a transcervical Foley catheter for induction of labour in women requiring delivery because of pre-eclampsia or hypertension. MRC/DFID/Wellcome Trust Joint Global Health Trials Scheme (Ref. G1100686/1).

Background Between 40,000 and 80,000 pregnant women die annually from pre-eclampsia and eclampsia. Although magnesium sulphate and anti-hypertensive therapies can reduce the morbidity and mortality associated with pre-eclampsia, the only cure comes with delivery. Prompt delivery of the baby, preferably by vaginal route, is vital in order to achieve good maternal and neonatal outcomes. Induction of labour is therefore a critical intervention in order to prevent morbidity to both mother and baby. Two low cost interventions – oral misoprostol tablets and transcervical Foley catheterization – are already used by some in low resource settings, but their relative risks and benefits are not known. The trial will compare the risks, benefits, and trade-offs in efficacy, safety, acceptability and cost of misoprostol and Foley catheter for induction in women with preeclampsia or uncontrolled hypertension. Methods/Design A total of 602 women with an ongoing pregnancy with a live fetus requiring delivery because of pre-eclampsia or uncontrolled hypertension will be randomly assigned to labor induction with a transcervical Foley catheter or oral misoprostol 25 micrograms. Women will be recruited at two hospitals in Nagpur, India. The misoprostol group will receive oral misoprostol 25 microgram every 2 hours for a maximum of 12 doses or until active labor commences. The Foley group will undergo induction using a Foley catheter (silicone, size 18 F with 30 ml balloon) which will remain until active labor starts, the Foley catheter falls out, or 12 hours have elapsed. The primary outcome will be the attainment of vaginal delivery within 24 hours. Providers administering the treatment and those assessing the outcomes will not be blinded to group assignment. Trial registration NCT01801410 (ClinicalTrials.gov).

Objective To test the effectiveness and acceptability of an outpatient medical abortion protocol with 200 mg mifepristone and 400 mcg sublingual misoprostol at 64–70 days' last menstrual period (LMP) and compare it to the already known efficacy of the 57–63 days' LMP gestational age range. Study Design We conducted a prospective, comparative open-label trial in six hospitals and clinics in Ukraine, Georgia, India and Tunisia. We enrolled 714 reproductive age women with pregnancies 57 to 70 days who presented requesting abortion. Medical abortions were managed with the current service delivery protocol (200 mg oral mifepristone followed in 24–48 h by 400 mcg sublingual misoprostol). Data on safety, efficacy and acceptability were collected. The main outcome measure was complete abortion without surgical intervention at any point. Results A total of 703 cases were analyzable for efficacy. Success rates did not differ significantly in the two groups [57–63-day group: 94·8%; 64–70-day group: 91.9%; Relative Risk (RR): 0.79 (0.61–1.04)]. Ongoing pregnancy rates also did not differ significantly (57–63 days: 1.8%; 64–70 days: 2.2%; RR: 1.10 (0.65–1.87)]. Conclusion A medical abortion regimen of 200 mg mifepristone followed in 24–48 h by 400 mcg sublingual misoprostol is effective through 70 days' gestation and may be offered within existing outpatient abortion services. Implications A regimen of 200 mg mifepristone followed in 24–48 h by 400 mcg sublingual misoprostol is effective up to 70 days' LMP. The findings have important implications for expanding access to outpatient medical abortion services in settings where the cost of misoprostol is of concern or a two-pill misoprostol regimen is the standard of care.

Background Although legal, access to safe abortion remains limited in India. Given positive experiences of task-shifting from other developing countries, there is a need to explore the feasibility of expanding the manual vacuum aspiration (MVA) provider base to include nurses in India. Study Design A prospective, two-sided equivalence study was undertaken in five facilities of a non-government organisation in Bihar and Jharkhand to explore whether efficacy and safety rates associated with MVA provided by newly trained nurses were equivalent to those provided by physicians. Eight hundred and ninety-seven consenting women with gestation ages of ≤10 weeks were recruited. Results Nurses were as skilled as physicians in assessing gestation age and completed abortion status, performing MVA and obtaining patient compliance. Overall failure and complication rates were low and equivalent between the two provider types, and both provider types were equally acceptable to women who underwent the procedure (98%). Conclusion Findings of the study make a compelling case for amending existing laws to expand the MVA provider base in order to increase access to safe abortion in India.

Objective To identify factors at the health facility and health professional levels that might hinder or facilitate the appropriate use of magnesium sulfate for the treatment of pre-eclampsia and eclampsia. Methods Seven focus group discussions were conducted with a purposively sampled group of obstetricians/gynecologists, medical residents, and nurses at 3 hospitals in Nagpur, India. Data were collected on facility and drug availability, criteria for diagnosis and management of pre-eclampsia and eclampsia, attitudes about magnesium sulfate use, and perceived barriers to the treatment of pre-eclampsia and eclampsia. Results Senior gynecologists seemed to encourage the use of magnesium sulfate, especially management prior to transfer to a higher facility. However, clinicians noted a lack of specific institutional guidelines on dose, timing, and indications, particularly in cases in which delivery was not imminent. In all facilities, service providers noted that their clinical care decisions were sometimes influenced by political and social factors, making management of eclampsia and pre-eclampsia cases difficult. Care was further challenged by limited drug availability, particularly at the tertiary-care center. Conclusion Limited drug supply and lack of specific institutional guidelines, equipment, and trained staff hinder the translation of evidence-based policy on magnesium sulfate into practice.

Objectives To examine the feasibility of a randomized trial to determine whether oral regimens of nifedipine, labetalol or methyldopa are effective for acute control of severe hypertension in pregnancy. Methods In an open label pilot study, 30 pregnant women in India with a sustained sBP ⩾160 mmHg or dBP ⩾110 mmHg were assigned sequentially to receive oral nifedipine (10 mg up to 3 total doses in 6 h) ( n = 10), oral labetalol (200 mg up to 3 total doses in 6 h) ( n = 10), or a single dose of oral methyldopa 1000 mg ( n = 10) until the target blood pressure of 130–150 mmHg systolic and 80–100 mmHg diastolic was achieved. The primary endpoint of the study was achievement of the targeted blood pressure within 6 h without an adverse outcome. Secondary outcomes were use of additional antihypertensives, adverse maternal and neonatal effects, and side effect profile. Results Most women achieved the target blood pressure within 6 h without use of additional agents or adverse outcomes (nifedipine: 8/10; labetalol: 9/10; methyldopa: 5/10). Five in the methyldopa arm received additional medication for hypertension; 2 with successful control and 3 unsuccessful. One in the nifedipine arm received additional medication for tachycardia. Most women in the nifedipine arm (9/10) became tachycardic (pulse > 105) at one or more monitoring visits. No serious adverse maternal or perinatal side effects occurred. Conclusions Oral regimens of nifedipine, labetalol and methyldopa are potentially effective justifying a randomized trial of all three medications with the current dosing regimens. Findings were used to adjust operational design of the trial. Disclosures T. Easterling: None. H. Bracken: None. S. Mundle: None. L. Magee: None. P. vonDadelszen: None. B. Winikoff: None.

Introduction To increase access to safe abortion in rural India, the feasibility and acceptability of mifepristone–misoprostol abortion was assessed in a typical government run primary health center (PHC) in Nagpur district, Maharashtra State, that does not offer surgical abortion services and must refer off-site for emergency and backup services. Materials and Methods Consenting pregnant women (n=149) with ≤56 days amenorrhea seeking terminations received 200 mg mifepristone, and returned 48 h later for 400-μg sublingual misoprostol and 12 days later for abortion confirmation. Surgical backup was conducted at a nearby community health center (CHC). Results Nearly all women (98.6%) with known outcomes had successful medical abortions, and those who did not (1.4%) were successfully referred to the CHC for surgical backup. Women reported the method's ease and simplicity as the best features. Conclusion Medical abortion provision is feasible and acceptable in an Indian rural PHC that does not offer surgical abortion services. This study suggests that introduction of medical abortion at lower levels of the health-care system could increase access to safe abortion in rural India.

Introduction Magnesium sulfate is the agent of choice for the treatment and prevention of eclampsia. Optimal loading and maintenance dosing has not been determined. Objectives To compare the pharmacokinetic parameters if IM vs. IV magnesium sulfate. Methods A pharmacokinetic study was performed as part of a randomized trial that enrolled 300 women comparing IM and IV regimens of magnesium dosing in two low resource sites in India. Data from 258 enrolled women were analyzed in the pharmacokinetic study. Due to infrastructure available at the sites, a single sample was drawn per subject with the expectation of utilizing samples in a pooled data analysis. Results Magnesium clearance was estimated via pharmacokinetic modeling to be 48.1 dL/h, volume of distribution 156 dL and IM bioavailability 86.2%. The IM regimen produced higher initial serum concentrations, consistent with a substantially larger loading dose. At steady state, Mg concentrations in the IM and IV Groups were comparable. With either regimen, a substantial number of subjects would be expected to have serum concentrations lower than those generally expected to be therapeutic. Conclusion A larger loading dose for the IV regimen should be considered. Where feasible, individualized higher doses of magnesium sulfate would yield a greater number of treated women with clinically effective magnesium concentrations.