Search

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.

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.

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.

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.