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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.

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).

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.

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.

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).

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.

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.