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Objective: To assess whether, in those requiring continuing uterine stimulation after cervical ripening with oral misoprostol and membrane rupture, augmentation with low‐dose oral misoprostol is superior to intravenous oxytocin. Design: Open‐label, superiority randomised trial. Setting: Government hospitals in India. Population: Women who were induced for hypertensive disease in pregnancy and had undergone cervical ripening with oral misoprostol, but required continuing stimulation after artificial membrane rupture. Methods: Participants received misoprostol (25 micrograms, orally, 2‐hourly) or titrated oxytocin through an infusion pump. All women had one‐to‐one care; fetal monitoring was conducted using a mixture of intermittent and continuous electronic fetal monitoring. Main outcome measures: Caesarean birth. Results: A total of 520 women were randomised and the baseline characteristics were comparable between the groups. The caesarean section rate was not reduced with the use of misoprostol (misoprostol, 84/260, 32.3%, vs oxytocin, 71/260, 27.3%; aOR 1.23; 95% CI 0.81–1.85; P = 0.33). The interval from randomisation to birth was somewhat longer with misoprostol (225 min, 207–244 min, vs 194 min, 179–210 min; aOR 1.137; 95% CI 1.023–1.264; P = 0.017). There were no cases of hyperstimulation in either arm. The rates of fetal heart rate abnormalities and maternal side effects were similar. Fewer babies in the misoprostol arm were admitted to the special care unit (10 vs 21 in the oxytocin group; aOR 0.463; 95% CI 0.203–1.058; P = 0.068) and there were no neonatal deaths in the misoprostol group, compared with three neonatal deaths in the oxytocin arm. Women's acceptability ratings were high in both study groups. Conclusions: Following cervical preparation with oral misoprostol and membrane rupture, the use of continuing oral misoprostol for augmentation did not significantly reduce caesarean rates, compared with the use of oxytocin. There were no hyperstimulation or significant adverse events in either arm of the trial. [ABSTRACT FROM AUTHOR]

Background: Medical abortion with mifepristone and misoprostol can be provided up to 63 days' gestation in India. This accounts for 67.5 percent of all abortions in the country. We conducted an assessment to determine the availability of medical abortion medicines, specifically the combi-pack, in India. Methods: We applied the World Health Organization landscape assessment protocol at the national level. The assessment protocol included a five-step adaptation of an existing availability framework, including online data collection, desk review, country-level key informant interviews, and an analysis to identify barriers and opportunities to improve medical abortion availability. The assessment was conducted between August and March 2021. Results: Medicines for medical abortion are included in the national essential drug list and available with prescription in India. The assessment identified 42 combi-pack products developed by 35 manufacturers. The quality of medical abortion medicines is regulated by national authorities; but as health is devolved to states, there are significant inter-state variations. This is seen across financing, procurement, manufacturing, and monitoring mechanisms for quality assurance of medical abortion medicines prior to distribution. There is a need to strengthen supply chain systems, ensure consistent availability of trained providers and build community awareness on use of medical abortion medicines for early abortions, at the time of the assessment. Conclusion: Opportunities to improve availability and quality of medical abortion medicines exist. For example, uniform implementation of regulatory standards, greater emphasis on quality-assurance during manufacturing, and standardizing of procurement and supply chain systems across states. Regular in-service training of providers on medical abortion is required. Finally, innovations in evidence dissemination and community engagement about the recently amended abortion law are needed. Plain language summary: Medical abortion is popular in India and benefits from a liberal legal context. It is important to understand the availability of quality abortion medicines in the country. Using the World Health Organization country assessment protocol and availability framework for medical abortion medicines we examined the availability of these medicines from supply to demand. We used this information to identify opportunities for increasing availability of quality-assured medical abortion medicines. We found that the context for medical abortion varies across states. Strengthening procurement and supply chain management, with a greater emphasis on quality-assurance and regulation of manufacturing should be instituted at the state-level. Training is also needed to increase provider knowledge of the latest national guidelines and laws to ensure respectful and person-centered services. Finally, the public should be informed about medical abortion as a safe and effective choice, especially for early abortions. [ABSTRACT FROM AUTHOR]

Background: Medical abortion is safer than surgical abortion. Several studies have shown that combination of antiprogesterone drug mifepristone and prostaglandin misoprostol can increase complete abortion rate in medical management of first-trimester miscarriage compared to misoprostol alone. Letrozole, an aromatase inhibitor, has emerged as an alternative to mifepristone for induction of medical abortion as mifepristone is expensive and not registered in many countries. Aims and Objectives: The aim of the present study was to evaluate the safety and efficacy of combined regimen of letrozole and misoprostol in first-trimester medical abortion compared to misoprostol alone. Materials and Methods: It was a comparative observational study conducted at R. G. Kar Medical College, a tertiary care hospital in West Bengal, India. The study population was the antenatal mothers booked at antenatal clinic willing for termination of pregnancy at <12 weeks of gestational age. Participants were allocated, 39 in each group in a nonrandomized manner. Patients in one group (Group A) were posted for medical abortion with combination regimen of tablet letrozole (10 mg) once daily for 3 days followed by application of tablet misoprostol 800 mcg sublingually on day 4. In other group (Group B), patients were on misoprostol-only regimen with the application of tablet misoprostol 800 mcg sublingually. Results: Induction-abortion time was significantly less in the letrozole group (11±0.79 h) than the misoprostol group (13.23±0.81 h), P=0.0001. Complete abortion rate was significantly higher in the letrozole group compared to misoprostol group (84.62% and 64.10%, respectively, P=0.03). 15.38% patients in the letrozole group and 35.90% patients in the misoprostol group had excessive vaginal bleeding and the difference was statistically significant, P=0.03. The duration of vaginal bleeding was also significantly less in the letrozole group (2.45±0.29 days) than the misoprostol group (2.82±0.37 days), P<0.0001. Incidence of side-effects was comparable and the severity of side-effects was not significantly different between the groups. Conclusion: Letrozole and misoprostol combination regimen leads to significant increase in complete abortion rate and also significant reduction of the duration of vaginal bleeding, induction-abortion time, and need for surgical intervention when compared to misoprostol regimen. [ABSTRACT FROM AUTHOR]

Introduction: In the first trimester, almost one in five identified pregnancies end in spontaneous miscarriage, and another 22% result in induced abortion. After a spontaneous and/or induced abortion, there may be retained products of conception (POC). Because of its relatively poor efficacy and the unpredictability of the time interval until spontaneous evacuation, expectant treatment is not often chosen by healthcare professionals. In view of these facts, the current study's objective was to weigh the effectiveness of MVA and oral misoprostol 600 mg in managing incomplete abortion. Materials and Procedures: The investigation was conducted at the tertiary care center in India. The survey was conducted for one year. Subjects were selected from those attending the department for either spontaneous or induced abortions. A total of 230 women were randomly assigned to receive the interventions of a single dose of oral misoprostol 600 mcg or MVA. They were equally distributed to two groups and observed for the various parameters of success, signs and symptoms, satisfaction, and complications. The obtained values were compared statistically for the significance at <0.05 of P values. Results: Of the 200 subjects (30 lost to follow-up), there was no significant variance in the demographics, clinical outcomes, and complications between the groups. However, the pain, fever, shivering, and satisfaction parameters were statistically variant between the groups. Fever, shivering, and pain were lower for the MISO subjects while satisfaction was reported higher from subjects in MISO group. Conclusion: MISO and MVA are acceptable, safe, and efficient therapies for first-trimester un-complicated incomplete abortion. Nonetheless, misoprostol appears to be a marginally superior option to MVA in terms of accessibility, low therapy costs, reduced pain, and reduced demand for specialized personnel or equipment. [ABSTRACT FROM AUTHOR]

Purpose: To examine the association between self-managed abortion and the self-reported experience of abortion complications in India, a country with a high incidence of self-managed abortion.Patients and Methods: The study used a cross-sectional multivariable logistic regression analysis of data from the National Family Health Survey (NFHS-4) of 2015– 2016 to compare the odds of self-reported complications experienced during abortion between self-managed and clinician-managed abortions in India.Results: On average, self-managed abortions occurred earlier in gestation than clinician-managed abortions, 7.8 weeks and 11.3 weeks, respectively (p < 0.001). Self-managed abortion was associated with fewer self-reported abortion-related complications than clinician-managed abortions when adjusted for covariates not including gestational age (Adjusted Odds Ratio (aOR) 0.82, 95% confidence interval (CI) 0.69, 0.97). However, once adjusted for gestational age, there was no longer a clinically meaningful or statistically significant difference in the odds of self-reported complications between self-managed and clinician-managed abortions (aOR = 0.98, 95% CI 0.81, 1.18).Conclusion: These findings suggest that people in India are using safe methods to self-manage abortions and support the hypothesis that self-managed abortion can improve access to abortion and reproductive choice without increasing risk. [ABSTRACT FROM AUTHOR]

Introduction: Both, surgical and medicinal techniques can be used vaginally to treat incomplete abortions. Although, Manual Vacuum Aspiration (MVA) is a safe and efficient surgical treatment for the management of incomplete abortion, it is not frequently offered and is not very cost effective in rural areas, especially in low resource settings. Misoprostol is an alternative to MVA for the treatment of incomplete abortion. Aim: To assess the effectiveness and acceptability of using vaginal misoprostol for the management of first trimester spontaneous incomplete abortion as an alternative to MVA. Materials and Methods: A randomised clinical trial was conducted between February 2020 to July 2021 in the Department of Obstetrics and Gynaecology, at RG Kar Medical College and Hospital, Kolkata, West Bengal, India. A total of 144 participants were randomised into two groups with 72 women in each group, to treatment with either MVA or 400 mcg vaginal at 3 hour intervals. The main outcome measures assessed at 24 hour follow-up were complete uterine evacuation confirmed by transvaginal sonography, and client acceptability and satisfaction were assessed from entry in data form by participants. Chi-square (χ²) tests were used for categorical data, and the Student's paired t-test was used for continuous data. Statistical significance in all calculations was defined as p<0.05 and the study would follow the Intention To Treat (ITT) analysis while computing the results. Results: The mean ages were 27.44 years (6.8) and 28.47 years (6.6) for the misoprostol and MVA groups respectively. For the gestational age, the mean gestational ages were 8.88 (2.01) and 8.90 (2.17) weeks for the misoprostol and MVA groups, respectively. A higher failure rate in terms of incomplete abortion was encountered in the misoprostol arm compared to the MVA arm. Although this difference in complete uterine evacuation rate did not reach statistical significance (RR=4, 95% Confidence Interval (CI) 0.879-18.192, p=0.0728). Pyrexia appeared to be a significant complication in the misoprostol group compared to MVA group (p=0.038). There was no significant difference in satisfaction in both groups (p=0.659) and no significant difference in acceptability. Conclusion: As an alternative to surgical intervention, three 400 mcg misoprostol pills could be administered vaginally over the course of three hours to treat spontaneous first trimester uncomplicated incomplete abortion. [ABSTRACT FROM AUTHOR]

Objective: To compare the efficacy of using a combination of transcervical Foley catheter and sublingual misoprostol with sublingual misoprostol alone for induction of labor (IOL) in women with pre‐eclampsia between 28 and 34 weeks of pregnancy. Methods: This randomized controlled trial was conducted on women with pre‐eclampsia at 28–34 weeks of pregnancy, with unfavorable cervix, admitted to a tertiary hospital in south India. They were randomized to receive either a combination of transcervical Foley catheter and sublingual misoprostol, or sublingual misoprostol alone. Vaginal birth within 24 h of induction, induction to delivery interval, and neonatal morbidity/mortality were the main outcome measures. Results: Vaginal birth within 24 h was higher with the combination of Foley catheter and sublingual misoprostol compared with sublingual misoprostol alone (60% versus 41.4%, P = 0.028). Overall vaginal delivery rates were comparable between the groups (90% versus 80%, P = 0.051). There was no difference in number of doses of misoprostol, and induction to delivery interval between groups. After excluding those with lower likelihood of neonatal survival, live birth rates, mean birth weight, and neonatal intensive care unit admission rates were similar in both groups. Conclusions: Combination of transcervical Foley catheter and sublingual misoprostol was found to be more effective in achieving vaginal birth within 24 h compared with sublingual misoprostol for IOL in pre‐eclampsia between 28 and 34 weeks of pregnancy. Trial Registration Number: CTRI/2018/09/015766; http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=27984. Synopsis: Combination of Foley catheter and sublingual misoprostol appears to be more effective than sublingual misoprostol alone for induction of labor in pre‐eclampsia.T [ABSTRACT FROM AUTHOR]

Introduction: Low- and middle-income countries (LMICs) are committed to achieving the Sustainable Development Goal 3.1 to reduce maternal mortality. The Ministry of Health and Family Welfare of India recommends prophylactic uterotonic administration to every woman following delivery to reduce the risk of postpartum hemorrhage (PPH), as PPH is the leading cause of maternal mortality in LMICs, including India. In 2018, the World Health Organization first recognized heat-stable carbetocin for PPH prevention. Governments are now considering its introduction into their public health systems. Methods: A decision-tree model was developed from the public healthcare system perspective to compare the value of heat-stable carbetocin versus oxytocin and misoprostol among women giving birth in public sector healthcare facilities in India. The model accounted for differences in PPH risk and costs based on mode of delivery and healthcare setting, as well as provider behavior to mitigate quality concerns of oxytocin. Model outcomes for each prophylactic uterotonic included the number of PPH events, DALYs due to PPH, deaths due to PPH, and direct medical care costs. The budget impact was estimated based on projected uterotonic uptake between 2022–2026. Results: Compared to oxytocin, heat-stable carbetocin avoided 5,468 additional PPH events, 5 deaths, and 244 DALYs per 100,000 births. Projected direct medical costs to the public healthcare system were lowered by US $171,700 (₹12.8 million; exchange rate of ₹74.65 = US$1 from 2 Feb 2022) per 100,000 births. Benefits were even greater when compared to misoprostol (7,032 fewer PPH events, 10 fewer deaths, 470 fewer DALYs, and $230,248 saved per 100,000 births). In the budget impact analysis, India's public health system is projected to save US$11.4 million (₹849 million) over the next five years if the market share for heat-stable carbetocin grows to 19% of prophylactic uterotonics administered. Conclusions: Heat-stable carbetocin is expected to reduce the number of PPH events and deaths, avoid more DALYs, and reduce costs to the public healthcare system of India. Greater adoption of heat-stable carbetocin for the prevention of PPH could advance India's efforts to achieve its maternal health goals and increase efficiency of its public health spending. [ABSTRACT FROM AUTHOR]

Background: Over-the-counter (OTC) sale of medical abortion (MA) inducing drugs is a common practice. Exploring its impact on women's health and the barriers to avail free MA services at hospital by these women is essential to improve upon policy decision. Methods: A prospective observational study included 112 women following ingestion of MA drugs from nonformal providers. Demography, clinical details, and reasons for not availing free abortion services at hospital were recorded. Results: Among 112 women, mean age was 28.63 (SD 4.7) years. Seventy one (63.39%) women were from rural region; 70.54% were educated below high school; 44 (39.28%) had prior induced abortion; 62.5% had never used any contraception. Majority (101; 90%) took two drugs (Mifepristone and Misoprostol), 28 (25%) used correct dosage. Drugs were consumed beyond 9 weeks of gestation by 25 (22.4%) women. Abnormal vaginal bleeding was commonest 105 (93.75%) presentation. Haemorrhagic shock was noted in 21 (18.75%) women, while 21 (18.7%) women required blood transfusion. "Easy and quick availability of these drugs OTC" was the commonest statement for not attending hospital. Conclusion: Easy and quick availability of OTC drugs, distance to hospital were major barriers. Incorrect dosage and lack of gestational age calculation were two most common errors in the risk assessment protocol. Expanding provider base, by training midlevel providers, can overcome these and unmask the full potential of MA to make abortion safer. [ABSTRACT FROM AUTHOR]

Objective: To examine the simultaneous effect of high-volume Foley catheter (HVFC) (60 ml) and vaginal misoprostol on labor induction in nulliparous women. Methods: A randomized, double- blind, controlled trial was conducted among nulliparous post-date (>40 weeks) pregnant women between June and December 2019. At enrollment 100 women were randomized into each group (either HVFC and vaginal misoprostol or low-volume Foley catheter [LVFC] [30 ml] and vaginal misoprostol), for labor induction. Demographic and clinical data were collected at enrollment and delivery. Results: Women in the HVFC group had statistically significantly shorter induction to delivery interval (median 860 min, interquartile range [IQR] 840-940 min vs. 1160 min, IQR 1080-1320 min, P < 0.001) and duration of labor (median 615 min, IQR 600-680 min vs. 750, IQR 692.5-800 min, P < 0.001). Mode of vaginal delivery (n = 94 vs. n = 78, P = 0.002), number of doses of misoprostol required (median 2, IQR 1-2 vs. 2, IQR 1-3), and need of oxytocin augmentation (n = 22 vs. n = 39, P = 0.014 and P < 0.001), was significantly better in the HVFC group. However, there was no significant difference with respect to other maternal or neonatal outcomes. Conclusion: Simultaneous use of HVFC and vaginal misoprostol for labor induction significantly shortens the induction to delivery interval and duration of labor in nulliparous women. Trial Registration: Clinical Trial Registry of India CTRI/2019/05/019394 (http://ctri. nic.in/Clini caltr ials/pmain det2.php?trial id=31554 &EncHi d=&userN ame=Foley %20cat heter). [ABSTRACT FROM AUTHOR]

Background:Early pregnancy failure has been a major health problem throughout the world. An estimated 15% of all pregnancies end in spontaneous miscarriage, apart from 46 million manually induced abortions. Of these, at least 20 millions are expected to be unsafe, with an approximate 67000 deaths occurring annually due to illegal abortions performed under unsafe conditions. India is no exception and the death following to these unsafe and illegal abortions is on the rise at an alarming rate. This could also be attributed to the limited availability of medically safe and legal abortion procedures, especially in rural India. Thus, there is a requirement for a safe, inexpensive, feasible and widely accepted modes of abortion techniques to prevent maternal deaths associated with unsafe abortion techniques. Aims and Objectives- EFFICACY- Complete evacuation of products of conception from the uterine cavity, SAFETY- Amount of bleeding per vaginum during hospital stay, ACCEPTABILITYDuration of hospital stay. Material and Methods:A comparative interventional study was designed and conducted at the Department of Obstetrics and Gynaecology in Government Maternity Hospital, Sultan Bazar, Koti, Hyderabad affiliated to Osmania Medical College, Hyderabadwhich is a tertiary care teaching hospital over a period of 1 year i.e., from February 2021 to January 2022 on 160 clinically diagnosed incomplete and missed abortion patients with gestational age less than or equal to 12 weeks, who were classified into 2 groups based upon the kind of interventions they opted; as Group-A, who opted for medical intervention with Tab. Misoprostol. and Group-B, who opted for Manual Vaccum Aspiration (MVA). Results:The mean age of Group A was 23.7 years while that of Group B was 26.5 years. Most of the subjects enrolled (124 of 160) were multigravida which increases the efficacy of abortion as compared to primigravida. Additionally, many of the subjects were multipara (108) which in turn has better efficacy as compared to the primipara individuals. Conclusion:The obtained results have led to the conclusion that the MVA group has higher safety index when compared to medical intervention with misoprostol regimen by the means of reduced bleeding. Also, a higher satisfaction and feasibility levels were observed with MVA since there were minimal Against Medical Advice (AMA) or absconded subjects. These observations suggest that MVA could be a promising method of abortion with higher efficacy, acceptability and safety as compared to medical management. [ABSTRACT FROM AUTHOR]

We compared two combined methods for cervical ripening before induction of labour (IOL) Women (n = 150) were randomised into Foley's-misoprostol (n = 75) and Foley's-dinoprostone (n = 75) groups. A single dose of vaginal misoprostol tablet (25 µg) or intracervical dinoprostone gel (0.5 mg) were used alongwith intracervical Foley's. The primary outcome was induction-delivery interval (IDI) and secondary outcomes were change in Bishop's score, oxytocin requirement, caesarean section (CS) rate, chorioamnionitis and neonatal outcome. The mean parity, gestation and indications for IOL were similar in the two groups. The IDI (19 h 37 min and 19 h 20 min; p =.683), cervical ripening time, oxytocin requirement, CS rate (18.7 and 25.4%, p =.322) and neonatal outcome were similar. Hyperstimulation developed in 2.7% women with Foley's-misoprostol and in 1.3% with Foley's-dinoprostone (p =.55). No woman had chorioamnionitis. Thus, these two combined methods of cervical ripening and IOL were observed to be similarly efficacious. A low incidence of hyperstimulation and no chorioamnionitis may be attributed to using a single dose of prostaglandins. Misoprostol may be substituted for dinoprostone in resource limited countries. What is already known on this subject? Combined methods for cervical ripening (intracervical Foley's plus prostaglandins) before induction of labour (IOL) may be similarly or more efficacious than individual methods. Most studies comparing various combined methods have used repeated doses of prostaglandins. A combined method using repetitive doses of prostaglandins may increase the risk of hyperstimulation and also of infection consequent to repeated vaginal examination to administer prostaglandins. These two concerns may be offset by combining a single dose of prostaglandin with intracervical Foley's catheter. What do the results of this study add? Two combined methods for cervical ripening using a single dose of vaginal misoprostol (25 µg) or intracervical dinoprostone gel (0.5 mg) co-administered with intracervical Foley's catheter were found to be similarly efficacious. The IDI (19 h 37 min and 19 h 20 min; p =.683), cervical ripening time, oxytocin requirement, CS rate (18.7 and 25.4%, p =.322) and neonatal outcome were similar. The incidence of hyperstimulation was low (2.7 and 1.3% with Foley's-misoprostol and Foley's-dinoprostone, respectively) and no woman had chorioamnionitis. What are the implications of these findings for clinical practice and/or further research? Combined methods for cervical ripening using a single dose of prostaglandins (misoprostol or dinoprostone) were observed to be similarly efficacious. Misoprostol is a cheaper alternative to dinoprostone and may be utilised in resource limited countries. These methods may be compared with each other in more number of women in order to identify which combined method is more efficient and safe. Clinical Trials Registry of India: CTRI/2017/12/010738 [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Introduction: In India, the routine Active Management of Third-Stage of Labour (AMTSL) with conventional intramuscular oxytocin, at the rural, resource-constrained areas, is often compromised due to lack of trained healthcare personnel and proper maintenance of cold chain system, causing maternal mortality and morbidity from Postpartum Haemorrhage (PPH). In these scenarios, tablet misoprostol, can be efficacious and convenient alternative. Aim: This Randomised Controlled Trial (RCT) was designed to evaluate efficacy and safety of misoprostol administered per rectum with respect to intramuscular oxytocin for effective control of PPH. Materials and Methods: In this RCT, conducted in Sambhunath Pandit Hospital, kolkata, West Bengal, India from September 2015 to August 2016, total 80 eligible pregnant mothers in normal labour with prior consent and fulfilled criteria, were allocated to two separated groups (n=40) by computer generated randomisation table. Control group received 10 IU injection oxytocin and case group received 600 µg misoprostol tablet per rectally within one minute of cord clamping and cutting. The primary outcome measures were mean thirdstage and mean postpartum blood loss up to eight hours after delivery. Secondary outcome variables were Mean Arterial Pressure (MAP) after eight hours postdelivery, haemoglobin and haematocrit after 24 hours of delivery and reported side effects. Data was entered into a Microsoft excel spreadsheet and statistical analysis was done by Statistical Package for the Social Sciences (SPSS) version 20.0.1 and Graph Pad Prism version 5.0. Results: Total sample size was 80 equally divided into two groups, with a mean age of 23.20±3.1558 years and 23.7750±3.8927 years in case and control group respectively. The mean third-stage blood loss (332.4105±72.6632 mL versus {vs} 329.0088±59.4503 mL, p=0.8193) and mean total blood loss (426.5575±80.0215 mL vs 424.8783±61.5808 mL, p=0.9165) were statistically indifferent between misoprostol and oxytocin groups by two-sample t-tests. The mean for eight hours postpartum MAP (p=0.0894), 24 hours postpartum haemoglobin (p=0.4534) and haematocrit (p=0.1325) were statistically insignificant between the two groups by two-sample t-tests. Incidence of adverse effects like shivering, diarrhoea, compared by Pearson's Chi-square test, were found to be more but non significant in misoprostol group. Conclusion: This study concludes that per-rectal misoprostol is equally effective as intramuscular oxytocin to control PPH without significant adverse effects. [ABSTRACT FROM AUTHOR]

Objective: Previous studies have demonstrated quality concerns with misoprostol. Mifepristone, however, has not been extensively assessed for quality. Between 2020 and 2021, Concept Foundation and the International Planned Parenthood Federation conducted a study to determine the quality of these medical abortion drugs in low- and middle-income countries (LMIC)., Methods: The collection of batch samples of misoprostol and mifepristone was carried out by trained sampling agents in selected LMIC. Single drug packs and combipacks were sampled. A World Health Organization prequalified laboratory conducted testing method verifications and subsequent sample analysis. Tests included identification, assay, related substances, and content uniformity for misoprostol, and identification, assay, related substances, and dissolution for mifepristone., Results: Samples were collected from Burkina Faso, Cambodia, Democratic Republic of Congo, India, Kyrgyzstan, Moldova, Nepal, Nigeria, Pakistan, Uganda and Vietnam. Sixty-four pooled batch samples were tested, consisting of 31 combipacks, 26 misoprostol-only and seven mifepristone-only products. Overall, 54.7% of samples were non-compliant with one or more of the specifications, representing 51.6% of combipack products, 57.1% of misoprostol tablets analyzed and 23.7% of mifepristone tablets. One falsified misoprostol-only product was found., Conclusion: The present study confirms that a significant problem still exists in relation to the quality of medical abortion drugs in LMIC. For misoprostol, our findings suggest that historical concerns around primary packaging may have been largely resolved but that manufacturing processes for both finished product and active pharmaceutical ingredient need to be improved. The present study also provides evidence of mifepristone quality issues., (© 2023 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)

In the article, the authors discuss the legal issues over the use of medication abortion (MA) that determine the access of women to quality and affordable abortifacient drugs. Also cited are the safety and effectiveness of pregnancy termination at home using MA, the ability of women to self-care after abortion, and the practices of women in using MA in countries like India and Mexico.

The use of misoprostol in the second trimester by a woman with a uterine scar may lead to severe contractions and uterine rupture. We report a 24-year-old pregnant female patient who presented at the Emergency Department at a tertiary care hospital in Puducherry, India, in 2020 with haemorrhagic shock. She was at 16 weeks of gestation and had taken over the counter misoprostol for inducing an abortion. A quick initial resuscitation and urgent laparotomy were performed. An irreparable circumferentially avulsed uterus suspended only by round ligaments was noted. Haemostasis required internal artery ligation and immediate total hysterectomy. The patient was doing well upon follow-up six months after the surgery. Proper and supervised use of misoprostol in the appropriate dosage can avoid life-threatening consequences of uterine rupture. [ABSTRACT FROM AUTHOR]

Objective: To determine the effectiveness and economic impact of two methods for induction of labour in hypertensive women, in low-resource settings.Design: Cost-consequence analysis of a previously reported multicentre, parallel, open-label randomised trial.Setting& Population: A total of 602 women with a live fetus, aged ≥18 years requiring delivery for pre-eclampsia or hypertension, in two public hospitals in Nagpur, India.Methods: We performed a formal economic evaluation alongside the INFORM clinical trial. Women were randomised to receive transcervical Foley catheterisation or oral misoprostol 25 mcg. Healthcare expenditure was calculated using a provider-side microcosting approach.Main Outcome Measures: Rates of vaginal this delivery within 24 hours of induction, healthcare expenditure per completed treatment episode.Results: Induction with oral misoprostol resulted in a (mean difference) $20.6USD reduction in healthcare expenditure [95% CI (-) $123.59 (-) $72.49], and improved achievement of vaginal delivery within 24 hours of induction, mean difference 10% [95% CI (-2 to 17.9%), P = 0.016]. Oxytocin administration time was reduced by 135.3 minutes [95% CI (84.4-186.2 minutes), P < 0.01] and caesarean sections by 9.1% [95% CI (1.1-17%), P = 0.025] for those receiving oral misoprostol. Following probabilistic sensitivity analysis, oral misoprostol was cost-saving in 63% of 5,000 bootstrap replications and achieved superior rates of vaginal delivery, delivery within 24 hours of induction and vaginal delivery within 24 hours of induction in 98.7%, 90.7%, and 99.4% of bootstrap simulations. Based on univariate threshold analysis, the unit price of oral misoprostol 25 mcg could feasibly increase 31-fold from $0.24 to $7.50 per 25 mcg tablet and remain cost-saving.Conclusion: Compared to Foley catheterisation for the induction of high-risk hypertensive women, oral misoprostol improves rates of vaginal delivery within 24 hours of induction and may also reduce costs. Additional research performed in other low-resource settings is required to determine their relative cost-effectiveness.Tweetable Abstract: Oral misoprostol less costly and more effective than Foley catheter for labour induction in hypertension. [ABSTRACT FROM AUTHOR]

Background: Pregnancy loss is a distressing problem and retention of dead fetus in utero has its own ill effects on physical, psychological, and social aspects, and hence, it is better to recommend medical induction, provided this can be safely undertaken. Aims: The aim of this study is to compare the efficacy, tolerability, induction-delivery interval, and perceived stress scores between induction methods in late intrauterine fetal death (IUFD) with misoprostol alone and mifepristone with misoprostol combination in a rural population of Eastern India. Materials and Methods: This pilot study was conducted on 125 patients after taking institutional ethical clearance and informed consent of the patients in a time span of 1 year. Group 2 patients received 200 mg of mifepristone per orally and observed for 48 h, followed by 50 μg misoprostol administered in the posterior vaginal fornix, and repeated 6th hourly up to a maximum of four doses. Group 1 received 50 μg misoprostol per vaginally 6 hourly for four doses. Induction-delivery interval was calculated. Perceived stress level was calculated on admission and before discharge. Results: Significantly lower induction-delivery interval was observed in Group 2 as compared to Group 1 with P < 0.001. There was no significant difference of Cohen's perceived stress scores on admission, but the difference was significantly lower in Group 2 on discharge with the value of P = 0.03. Group 1 had significantly lower hospital stay in days as compared to Group 2 of patients with P < 0.001. Conclusions: Patients with IUFD administered misoprostol per vaginally only may require shorter hospital stay as compared to patients administered with oral mifepristone followed by misoprostol vaginally but the delivery induction time increases significantly and may increase perceived stress levels which may have short- and long-term negative psychological impact. [ABSTRACT FROM AUTHOR]

A comparison of induction of labour (IOL) using three doses of 25 µg vaginal misoprostol inserted at intervals of 4 h or more with a stepwise oral regime starting with 50 µg followed by two doses of 100 µg was studied in a double-blind placebo-controlled trial in a tertiary centre in South India. Primary outcome was vaginal delivery in 24 h. Significantly more women in the first group required oxytocin augmentation and a third dose of the drug than women in the second group. Uterine tachysystole and other maternal and neonatal complications were similar. Thus it is concluded that women induced with oral, as compared to vaginal misoprostol are more likely to labour without oxytocin. [ABSTRACT FROM AUTHOR]

Objective: To assess whether a combination of misoprostol and oxytocin is more beneficial than oxytocin alone in reducing blood loss after vaginal delivery among women with known risk factors for postpartum hemorrhage (PPH).Methods: A randomized, double-blind trial was conducted in a medical college in eastern India among women aged at least 18 years who had known high-risk factors for PPH. Using a computer-generated random number sequence (block size 6-8), participants were randomly assigned to receive 400 μg misoprostol or matched placebo tablets sublingually, in addition to 10 units of oxytocin, after vaginal delivery. The primary outcomes were postpartum blood loss at 1 hour and frequency of PPH. Analyses were by intention to treat.Results: Both groups contained 144 participants. Postpartum blood loss at 1 hour after delivery was significantly lower among women who received misoprostol than among those who received placebo (225.8±156.7 mL vs 302.4±230.3 mL; P<0.001). The frequency of moderate PPH (500-999 mL) was significantly lower in the group receiving misoprostol than in the placebo group (5 [3.5%] vs 15 [10.4%] participants; P=0.03).Conclusion: As compared with oxytocin alone, misoprostol with oxytocin more effectively reduced blood loss after vaginal delivery among women at risk of PPH. Clinical Trial Registry India:CTRI/2014/03/004491. [ABSTRACT FROM AUTHOR]

Introduction: Although home use of misoprostol for early medical abortion is considered to be safe, effective and feasible, it has not become standard service delivery practice. The aim of this study was to compare the efficacy, safety, and acceptability of home use of misoprostol with clinic misoprostol in a low-resource setting.Material and Methods: This was a secondary analysis of a randomized controlled trial conducted in six primary care clinics in India. Women seeking medical abortion within up to nine gestational weeks (n = 731) received mifepristone in the clinic and were allocated either to home or clinic administration of misoprostol. Follow-up contact was after 10-15 days.Results: Of 731 participants, 73% were from rural areas and 55% had no formal education. Complete abortion rates in the home and clinic misoprostol groups were 94.2 and 94.4%, respectively. The rate of adverse events was similar in both groups (0.3%). A greater proportion of home users (90.2%) said that they would opt for misoprostol at home in the event of a future abortion compared with clinic users (79.7%) who would opt for misoprostol at the clinic in a similar situation (p = 0.0002). Ninety-six percent women using misoprostol at home or in the clinic were satisfied with their abortion experience.Conclusions: Home-use of misoprostol for early medical abortion is as effective and acceptable as clinic use, in low resource settings. Women should be offered a choice of this option regardless of distance of their residence from the clinic and communication facilities. [ABSTRACT FROM AUTHOR]

Objective: To assess whether secondary prevention, which preemptively treats women with above-average postpartum bleeding, is non-inferior to universal prophylaxis.Design: A cluster-randomised non-inferiority community trial.Setting: Health sub-centres and home deliveries in the Bijapur district of Karnataka, India.Population: Women with low-risk pregnancies who were eligible for delivery with an Auxiliary Nurse Midwife at home or sub-centre and who consented to be part of the study.Methods: Auxiliary Nurse Midwifes were randomised to secondary prevention using 800 mcg sublingual misoprostol administered to women with postpartum blood loss ≥350 ml or to universal prophylaxis using 600 mcg oral misoprostol administered to all women during the third stage of labour.Main Outcome Measures: Postpartum haemoglobin ≤7.8 g/dl, mean postpartum blood loss and postpartum haemoglobin, postpartum haemorrhage rate, transfer to higher-level facilities, acceptability and feasibility of the intervention.Results: Misoprostol was administered to 99.7% of women as primary prevention. In secondary prevention, 92 (4.7%) women had postpartum bleeding ≥350 ml, of which 90 (97.8%) received misoprostol. The proportion of women with postpartum haemoglobin ≤7.8 g/dl was 5.9 and 8.8% in secondary and primary prevention clusters, respectively [difference -2.9%, one-sided 95% confidence interval (CI) <1.3%]. Postpartum transfer and haemorrhage rates were low (<1%) in both groups. Shivering was more common in primary prevention clusters (P = 0.013).Conclusion: Secondary prevention of postpartum haemorrhage with misoprostol is non-inferior to universal prophylaxis based on the primary outcome of postpartum haemoglobin. Secondary prevention could be a good alternative to universal prophylaxis as it medicates fewer women and is an acceptable and feasible strategy at the community level.Tweetable Abstract: Secondary prevention of postpartum haemorrhage with misoprostol is non-inferior to universal prophylaxis. [ABSTRACT FROM AUTHOR]

Purpose: In India, two third of maternal deaths occur in rural areas where there is lack of transportation facilities, lack of refrigeration to store the injectable uterotonic drug such as oxytocin, lack of skilled personnel to administer them and lack of sterile syringes and needles. Hence, this study was conceived to evaluate misoprostol as a safe, effective, easily administered non-parenteral drug in the prevention of postpartum hemorrhage.Methods: This study was conducted during the period from August 2012 to July 2014. Low risk women with singleton pregnancy at term admitted for vaginal delivery were eligible for the study. A total of 500 women were randomized to two groups, 250 in each group, either to receive 400 mcg misoprostol sublingually or 10 units oxytocin intramuscularly at the delivery of anterior shoulder. Patient factors, labor parameters, blood loss and side effects were noted.Results: The women in both the groups were well matched with respect to age, parity, gestational age and labor parameters. There was statistical significance in the blood loss (p = 0.04) between the two groups. The average blood loss was 70 ml in misoprostol group and 75 ml in oxytocin group. Shivering was the statistically significant side effect (p = 0.004) in the misoprostol group and nausea was the statistically significant side effect (p = 0.003) in the oxytocin group.Conclusions: Sublingual misoprostol is as effective as intramuscular oxytocin as a prophylactic oxytocic in the active management of third stage of labor for prevention of postpartum hemorrhage. [ABSTRACT FROM AUTHOR]

Objective To describe intrapartum uterotonic drug use and related behaviors in public health facility-based deliveries and to describe drug storage conditions in associated pharmacies. Methods A descriptive study was conducted between August and November 2011 to document practices related to uterotonic administration and storage based on direct observation of deliveries at public health facilities in four Indian districts (n = 97, n = 89, n = 91, and n = 89) with contrasting maternal health and socioeconomic indicators. Results Uterotonic drug use before and after delivery was common among the 366 study participants. Labor augmentation rates ranged from 53.5%–93.0% of deliveries across districts, with many receiving multiple uterotonics and administration via intramuscular injection or intravenous push. Uterotonic use following delivery ranged from 78.6%–99.1% across districts, with correct use of uterotonics for postpartum hemorrhage prevention varying from 6.0%–8.8% in Uttar Pradesh and 41.2%–76.4% in Karnataka. Active management of the third stage of labor following Indian guidelines was less than 10% in all districts. Storage of uterotonics at room temperature was common. Conclusion Given that labor augmentation is nearly routine and at odds with Indian guideline recommendations, rigorous research is needed to assess maternal and fetal outcomes of current versus guidelines-based practice. Active management of the third stage of labor as per Indian guidelines was minimal. [ABSTRACT FROM AUTHOR]

Aim With the increasing rate of cesarean delivery ( CD) worldwide, there is a need for a revision of practices to prevent post-partum hemorrhage ( PPH) after CD. In search of a safe, cheap and effective alternative to oxytocin for prevention of PPH during the postoperative period of CD, the present study aimed to compare rectally administrated misoprostol with i.v. oxytocin infusion. Methods A randomized, placebo-controlled, double-blind prospective trial was undertaken on 192 women who did not have risk factors for PPH and who had an uneventful emergency CD under spinal anesthesia. They were randomly allocated to receive either 800 mg of rectal misoprostol or an i.v. infusion of oxytocin at the end of operation. Primary outcome measures were the amount of postoperative (24 h) blood loss and incidence of PPH during the postoperative period. The secondary outcome measures were the postoperative drop in hemoglobin concentration after 24 h, need for additional uterotonic and blood transfusion, and side-effects/complications during the 24-h observation period. Results There was a significant reduction of blood loss in the misoprostol group compared with the oxytocin group (144.5 ± 100.1 vs 191.7 ± 117.1, P < 0.0001). The two groups were similar in terms of the secondary outcome parameters. Conclusion Rectally administrated 800-mg misoprostol may be an effective alternative to oxytocin infusion to prevent PPH after CD. [ABSTRACT FROM AUTHOR]

CONTEXT: The availability of trained abortion providers is limited in India. Allowing ayurvedic physicians and nurses to perform medication abortions may improve women's access to the procedure, but it is unclear whether these clinicians can provide these services safely and effectively. METHODS: Allopathic physicians, ayurvedic physicians and nurses (10 of each), none of whom had experience in abortion provision, were trained to perform medication abortions. In 2008-2010, these providers performed medication abortions in five clinics in Bihar and Jharkhand for 1,225 women with a pregnancy of up to eight weeks' gestation.A two-sided equivalence design was used to test whether providers'assessments of client eligibility and completeness of abortion matched those of an experienced physician "verifier," and whether medication abortions performed by nurses and ayurvedic physicians were as safe and effective as those done by allopathic physicians. RESULTS: Failure rates were low (5-6%), and those for nurses and ayurvedic physicians were statistically equivalent to those for allopathic physicians. Provider assessments of client eligibility and completeness of abortion differed from those of the verifier in only a small proportion of cases (3-4% for eligibility and 4-5% for completeness); these proportions, and rates of loss to follow-up, were statistically equivalent among provider types. No serious complications were observed, and services by all three groups of providers were acceptable to women. CONCLUSION: Findings support amending existing laws to improve women's access to medication abortion by expanding the provider base to include ayurvedic physicians and nurses. [ABSTRACT FROM AUTHOR]

Please cite this paper as: Bellad M, Tara D, Ganachari M, Mallapur M, Goudar S, Kodkany B, Sloan N, Derman R. Prevention of postpartum haemorrhage with sublingual misoprostol or oxytocin: a double-blind randomised controlled trial. BJOG 2012;119:975-986. Objective Sublingual misoprostol produces a rapid peak concentration, and is more effective than oral administration. We compared the postpartum measured blood loss with 400 μg powdered sublingual misoprostol and after standard care using 10 iu intramuscular (IM) oxytocin. Design Double-blind randomised controlled trial. Setting A teaching hospital: J N Medical College, Belgaum, India. Sample A cohort of 652 consenting eligible pregnant women admitted to the labour room. Methods Subjects were assigned to receive the study medications and placebos within 1 minute of clamping and cutting the cord by computer-generated randomisation. Chi-square and bootstrapped Student's t-tests were used to test categorical and continuous outcomes, respectively. Main outcome measures Measured mean postpartum blood loss and haemorrhage (PPH, loss ≥500 ml), >10% pre- to post-partum decline in haemoglobin, and reported side effects. Results The mean blood loss with sublingual misoprostol was 192 ± 124 ml ( n = 321) and 366 ± 136 ml with oxytocin IM ( n = 331, P ≤ 0.001). The incidence of PPH was 3.1% with misoprostol and 9.1% with oxytocin ( P = 0.002). No woman lost ≥1000 ml of blood. We observed that 9.7% and 45.6% of women experienced a haemoglobin decline of >10% after receiving misoprostol and oxytocin, respectively ( P ≤ 0.001). Side effects were significantly greater in the misoprostol group than in the oxytocin group. Conclusion Unlike other studies, this trial found sublingual misoprostol more effective than intramuscular oxytocin in reducing PPH, with only transient side effects being greater in the misoprostol group. The sublingual mode and/or powdered formulation may increase the effectiveness of misoprostol, and render it superior to injectable oxytocin for the prevention of PPH. Further research is needed to confirm these results. [ABSTRACT FROM AUTHOR]

Objectives To study the safety of second trimester abortion in women with previous uterine scar. Methods We screened the records of 518 women who underwent an abortion between 12 and 20 weeks' gestation at the Postgraduate Institute of Medical Education and Research, Chandigarh, India, from January 2000 to December 2010. Methods used for abortion were: (i) vaginal misoprostol with or without pre-treatment with mifepristone, and (ii) intracervical dinoprostol gel or vaginal misoprostol ± extra-amniotic saline ± oxytocin infusion. Seventeen women, aborted by means of a hysterotomy, were excluded from further analysis. Results Of the remaining 501 women, 44 had a uterine scar (Group 1) and 457 had none (Group 2). In Group 1, 40/44 (91%) and in Group 2, 452/457 (99%) women aborted successfully. The mean induction-abortion interval (IAI) was similar in the two groups (15.03 ± 10.69 hours and 12.52 ± 9.0 hours in Groups 1 and 2, respectively; p == 0.083). There were three uterine ruptures, 1/44 (2%) in group 1 and 2/457 (0.4%) in group 2 ( p == 0.132, NS); all three women had received mifepristone followed by vaginal misoprostol. Conclusion In women with a scarred uterus, midtrimester abortion may be successfully achieved using any of the aforementioned regimens. [ABSTRACT FROM AUTHOR]

Objective: To compare the cost-effectiveness of community-based distribution of misoprostol for prevention with misoprostol for treatment of postpartum hemorrhage (PPH).Methods: A Monte Carlo simulation depicted mortality and anemia-related morbidity attributable to PPH among 3 scenarios of 10,000 women delivering at home in rural India: (1) standard management; (2) standard management plus 800microg of sublingual misoprostol for PPH treatment; and (3) standard management plus 600microg of prophylactic oral misoprostol. The model included costs of drugs, birth attendant training, and transport for women who did not respond to misoprostol.Results: Misoprostol lowered mortality by 70% and 81% in scenarios 2 and 3, respectively. Scenarios 2 and 3 raise costs by 6% and 35%, respectively. Incremental cost per disability-adjusted life year (DALY) saved is estimated at $6 and $170, respectively.Conclusion: Both interventions were more effective at decreasing mortality and anemia than standard management. The most efficient scale-up plan would focus initially on increasing coverage with the treatment strategy ($6 per DALY). [ABSTRACT FROM AUTHOR]

Objective: To assess the efficacy and acceptability of home administration of misoprostol for early medical abortion in Indian family planning clinics.Methods: In this prospective cohort study, consenting pregnant women (n=599) with amenorrhea of 8 weeks or less seeking termination of pregnancy received 200mg of oral mifepristone followed 48 hours later with 400microg of oral misoprostol, administered either at home or at the clinic.Results: Almost all women (88.4%) chose to take misoprostol home. There was no statistical difference in success rates between home and clinic users (89.0% vs 92.4%, Pearson chi(2)=0.7; P=0.395). Most women in both the home (90.7%) and clinic (92.3%) groups were satisfied or very satisfied with the procedure.Conclusion: Home administration of misoprostol is safe and feasible for introduction into medical abortion services in India. [ABSTRACT FROM AUTHOR]

Objective: To determine the cost-effectiveness of prenatal iron supplementation and misoprostol use as interventions to prevent maternal mortality in home births in rural India.Methods: A cost-effectiveness analysis depicted three hypothetical cohorts of 10,000 pregnant women delivering at home in rural India: one with no intervention, one receiving standard prenatal iron supplements, and 1 receiving 600 microg of misoprostol in the third stage of labor.Results: Misoprostol used to prevent postpartum hemorrhage resulted in a 38% (95% CI, 5%-73%) decrease in maternal deaths, while prenatal iron supplementation resulted in a 5% (95% CI, 0%-47%) decrease. Misoprostol cost a median US $1401 (IQR US $1008-$1848) prenatal iron supplementation cost a median US $2241 (IQR No Lives Saved-$3882) per life saved compared with the standard care outcome.Conclusion: Misoprostol is a cost-effective maternal mortality intervention for home births. Iron supplementation may be worthwhile to improve women's health, but it is uncertain whether it can prevent mortality after hemorrhage. [ABSTRACT FROM AUTHOR]

Objective. The main objective of this study was to identify factors associated with variation in the rate of acute postpartum hemorrhage (PPH), defined as blood loss ≥ 500 mL within 2 hours of delivery, observed in a randomized clinical trial of misoprostol for the prevention of PPH, conducted in rural India. Although the women in the misoprostol group had a significantly lower probability of having a PPH, we also noted a reduction in the rate of PPH in the placebo group over the course of the study. We hypothesized that this was due to the changing skills of the auxiliary nurse midwives (ANMs) over the course of the study. Methods. We conducted a post-hoc analysis examining variation in PPH rates over the duration of the trial among the women randomized to the placebo arm (n = 808). Descriptive, correlation analysis and generalized estimating equations (GEE) were used to predict PPH rates. With no direct measure of ANM skills, we used proxy measures, including: (1) the ANM's point of entry into the study (original ANMs at the initiation of the trial were less skilled than replacement ANMs); (2) the study duration, representing exposure of the ANM to ongoing training and monitoring; and (3) duration of the second stage of labor as a measure of improved delivery practices. Results. As the study duration increased, the duration of the second stage of labor decreased (-0.12, p = 0.001) and as the duration of the second stage of labor decreased, the rate of PPH decreased (0.0282; 95% CI 0.0201-0.0363). For each 10-minute increase in the duration of second stage labor increased PPH odds by 7.1% and each 30-day duration of the trial decreased PPH odds by 3.4%. Additionally, a patient delivered by an original ANM was 3.14 times more likely to have a PPH compared to a patient delivered by a replacement ANM. Conclusions. Declining PPH rates were associated with improved skills and delivery practices that decreased duration of the second stage of labor. These improvements appeared to be consistent with the introduction of the more skilled replacement ANMs as well as ongoing training and monitoring for all ANMs over the duration of the trial. [ABSTRACT FROM AUTHOR]

Objective: Postpartum hemorrhage (PPH), a major cause of maternal mortality and morbidity in low-income countries, can occur unpredictably. This study examined the sociodemographic, clinical, and perinatal characteristics of low-risk women who experienced PPH.Methods: This analysis was conducted using data on 1620 women from a randomized trial testing oral misoprostol for prevention of PPH in rural India.Results: Of the women, 9.2% experienced PPH. No maternal or sociodemographic factors and few perinatal factors differed between women with PPH and those without, other than treatment with misoprostol. Having fewer than 4 prenatal visits and lack of iron supplementation increased the risk for PPH (P<0.001 and P=0.037, respectively). Several factors unknown until the second stage of labor (perineal tear and birth weight) were also associated (P=0.003).Conclusions: Among women at low risk for PPH, there were few factors associated with further risk. Given that PPH can occur without warning, rural communities should consider ways to increase both primary prevention (iron supplementation, AMTSL) and secondary prevention of PPH (availability of obstetric first aid, availability of transport, and availability of emergency obstetric care). [ABSTRACT FROM AUTHOR]

Objective The objective of this study was to determine if a repeat dose of misoprostol following mifepristone or a single dose of misoprostol increases the efficacy of medical termination of pregnancy. Design Randomised, placebo controlled trial. Setting K.E.M. Hospital, Pune, India, and the Health Centre, Larsen and Toubro Limited, Mumbai, India. Sample A total of 300 women seeking an abortion with amenorrhoea of 8 weeks or less. Methods Women were randomised to receive one or two doses of 400 microgram oral misoprostol at the clinic 48 hours after administration of 200 mg mifepristone. Main outcome measure Complete abortion without surgical intervention. Results The repeat administration of misoprostol 400 microgram improved the complete abortion rate from 86 to 92% and significantly reduced the rate of continuing pregnancy from 7 to 1%. Almost all the women who were administered the additional dose of misoprostol were either very satisfied (58%) or satisfied (37%) with the method. Conclusion While an additional oral dose of 400 microgram misoprostol did not significantly increase the rate of complete abortion without surgical intervention, the additional dose did significantly reduce the rate of continuing pregnancies without compromising the acceptability and ease of use of the method. [ABSTRACT FROM AUTHOR]

Objective: To study whether paramedical workers from rural primary health centers in India are able to administer oral misoprostol and actively manage the third stage of labor to prevent postpartum hemorrhage (PPH).Method: Cluster randomization was used to enroll 1200 women at 30 peripheral health centers from 5 states in India, 600 forming the study's intervention group (active management of the third stage of labor with 600 mug of oral misoprostol) and 600 forming the comparison group (in which the current government guidelines for the prevention of PPH were followed). The primary outcome was blood loss after delivery, which was measured using a calibrated blood collection drape.Results: Age, literacy level, occupation, and gravidity were similar in the 2 groups. More than 70% of women in both groups had moderate anemia (hemoglobin level <10 g/dL). Paramedical workers followed instructions in almost all deliveries in the intervention group (99%). There was a significant reduction in duration of the third stage of labor (7.9 +/- 4.2 min vs. 10.9 +/- 4.3 min; p < .001) and median blood loss after delivery (100 mL vs. 200 mL; p < .001) in the intervention group. Overall, a low incidence of PPH was observed (<1%) in both groups. A greater number of women had moderate to severe shivering (12.7% vs. 0.5%) and a temperature higher than 38 degrees C (9.7% vs. 4.3%) in the intervention group, which was statistically significant.Conclusion: Simple interventions can be easily implemented in rural health care settings to reduce the blood loss during labor. This finding has significant implications for developing countries, in which the prevalence of anemia is high. [ABSTRACT FROM AUTHOR]

Objective: To determine the complications rate of termination of pregnancy (TOP) and the risk factors for complications following TOP.Methods: Retrospective observational study of the records of 1287 women who underwent TOP in the Department of Obstetrics and Gynaecology of the Postgraduate Institute of Medical Education and Research, Chandigarh, India, between 1997 and 2001. First-trimester abortion was performed in 1088 women (85%) and second-trimester abortion in 199 women (15%). Most women (76%) were aged between 26 and 30 years; they were educated and requested TOP primarily to limit the number of their children or to space their births. A malformed fetus was the indication for TOP in 5.9% cases, and 16% of the women had medical disorders associated with the pregnancy. Suction evacuation was the method of choice for first-trimester abortion (88%); dinoprostone gel and extra-amniotic saline solution plus oxytocin infusion were the primary methods (71%) for second-trimester abortion.Results: Uterine perforation occurred in 1 patient (0.09%) after a first-trimester abortion. The total rate of complications was 3.79% after first-trimester and 4.0% after second-trimester abortions. Excessive hemorrhage and retained placenta were chief complications associated with second-trimester abortion. Incomplete abortion (1.5%) and minor infection were seen in 2.3% patients. The rate of complications was higher among parous women. Postabortion insertion of a CuT intrauterine device increased the need for a second course of antibiotics.Conclusion: Termination of pregnancy is safe if adequate care is taken while performing the procedure. [ABSTRACT FROM AUTHOR]

Abstract: International research partnerships bring together some of the best and the brightest in an effort to tackle global health problems. Such collaborations also pose complex challenges, such as maintaining ethical principles in the conduct of research in developing nations. In implementing a randomized clinical trial to reduce postpartum hemorrhage (PPH) during childbirth in rural India, U.S. and Indian collaborators addressed three such issues: the appropriateness of an ethical randomized controlled trial in the developing world, the inclusion of a placebo arm, and the relevance of informed consent in a semiliterate rural population. [Copyright &y& Elsevier]

As several important policy questions remain regarding the use of medical abortion in developing countries, we investigated the safety, efficacy, and acceptability of mifepristone-misoprostol abortion in the outpatient family planning departments of two urban hospitals and one rural hospital in India. Nine-hundred women (with gestations of ≤63 days in the urban sites and ≤56 days in the rural site) received 600 mg mifepristone followed 48 h later by 400 μg oral misoprostol in the clinic. Four point four percent or fewer urban women and 1.0% rural women were lost to follow-up. Perfect and typical-use failure rates were low at all sites. While rural women reported fewer side effects at all sites, the vast majority of women were satisfied with their medical abortions. Medical abortion can be offered safely, effectively, and acceptably in the outpatient family planning departments of urban and rural hospitals in India. [Copyright &y& Elsevier]

Abortion, under certain circumstances, is legal in India. It can be done for a variety of reasons for up to 20 weeks of gestation. In exceptional cases, the court, there is a possibility to end after 24 weeks. At the time of 2017, safety, there is a binary classification of unsafe Abortion. India has a law of liberal Abortion. The World Health Organization (WHO), in the death of 76,000 women with complications and treatment of unprocessed, mainly developing countries, has been estimated to be incomplete Abortion every year. Care of post-abortion, all reproductive health and international, and general terms used in the walk of life associated with implementing a particular service, all-natural and artificial Abortion, refer to the experienced woman. The maternal mortality rate must be the provision of health services to increase after Abortion. Misoprostol, women, must easily access women to carry out post-abortion health management is not access otherwise. Adequately trained, as long as safety is a nurse, supported, including the outpatient clinic, it can provide post-abortion care services in the first row. Tablets of contraception and safe abortion services misoprostol, to prevent unsafe Abortion, are connected to reduce the need for abortion aftercare. The health of the woman is the better treatment method to solve the complications. [ABSTRACT FROM AUTHOR]

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 21 st Nov 2018., (© 2021. The Author(s).)

Objective: To evaluate the efficacy and safety of PGE1 analogue, misoprostol, for inducing abortion or labour during mid-trimester in women who have had a prior Caesarean section (one or more). Study design: Women who had to undergo termination of pregnancy between 13 and 26 weeks of gestation for various indications and who had at least one previous Caesarean section were studied over a period of two and a half years. The standard regimen for misoprostol in all the cases was 400 µg up to 20 weeks of gestation and 200 µg for pregnancies longer than 20 weeks, either vaginally or sublingually every six hours (up to maximum 24 h). A contemporaneous cohort of women undergoing the same procedure for similar indications but without scarred uteri served as control. Results: Eighty women in the study group underwent termination procedures for unwanted pregnancy, missed abortion, fetal anomaly or fetal death. The median induction–abortion interval was 16.4 h (10–21 h) and did not differ much from that in women without previous Caesarean delivery (median: 15.6 h; range 9.6–20 h), P > 0.05. Misoprostol was found to be safe in our cohort of post-Caesarean women and there was no case of scar rupture or dehiscence. No significant differences in rates of incomplete abortions, blood loss or sepsis were detected in the study group compared to the control group. Conclusion: The use of misoprostol for mid-trimester pregnancy termination is not contraindicated in women with Caesarean scar and is effective and comparable with those in women without scarred uteri. [ABSTRACT FROM AUTHOR]

This prospective study was carried out at a tertiary care hospital on 50 women with missed abortion up to 13 weeks who were given 600 μg misoprostol sublingually every 3 h for a maximum of three doses. Success rate was 86% (up to 72 h), and the acceptability of the method was 69.7%. Sublingual misoprostol is a non-invasive, effective and safe medical method for completion of abortion in missed abortion. [ABSTRACT FROM AUTHOR]

Objective: Understanding the price components of the mifepristone/misoprostol (combi-pack) for medical abortion to improve access is critical for identifying strategies to reduce product costs for quality-assured formulations and expanding its availability and use. Methods: We constructed a cost of goods sold analysis using data collected from manufacturing companies in Bangladesh, China and India supported by publicly available information related to the product formulation, active pharmaceutical ingredients (API), manufacturing location, manufacturer profiles and other individual model components. Key model components were the active pharmaceutical ingredients (quality-assured or not), excipients, labour cost, operating cost and packaging. Results: Combi-pack direct production cost ranges from US$1.08 for finished products which are not quality assured to US$3.05 for products containing quality assured active pharmaceutical ingredients, which means that with a 30% administrative fee applied to those prices, it could be made available between US$1.40 and US$3.97 depending on location, manufacturer's profile, optimal market situation and the quality of the active pharmaceutical ingredients. The main model component impacting on the cost range is the purchase price of mifepristone active pharmaceutical ingredient and the current differential between quality-assured material supported by adequate documentation and API for which quality assurance cannot be demonstrated. Compared to India cost of goods sold is lower in Bangladesh primarily due to lower operating costs, including the cost of labour. Conclusions: It is feasible to lower the cost of quality-assured combi-packs, through reducing mifepristone API cost and selection of the manufacturing location. However, manufacturers need to be incentivised to achieve WHO pre-qualification with a carefully built business case and require support in identifying and sourcing competitively priced material and manufacturing products to the necessary standard. [ABSTRACT FROM AUTHOR]

A review of an article by S. Leigh and colleagues on costs of labour induction using oral misoprostol and Foley catheter is presented.

Background: Postpartum Hemorrhage remains the leading cause of maternal mortality. To prevent PPH, Misoprostol tablet in a dose of 600 micrograms is recommended for use immediately after childbirth in home deliveries wherein the use of oxytocin is difficult. The current article describes an implementation of "community based advance distribution of Misoprostol program" in India which aimed to design an operational framework for implementing this program., Methods: The intervention was carried out in Janjheli block in Mandi district of the state of Himachal Pradesh which is a mountainous terrain with limited geographical access and reported 90% home deliveries in the year 2014-15. An operational framework to implement program activities was designed which was based on WHO HSS building blocks. Key implementing steps included- Ensuring local ownership through program leadership, forecasting and procurement of 600 mcg misoprostol tablets, training, branding and communication, community engagement and counselling, recording and reporting, monitoring, supportive supervision and feedback mechanisms., Results: Over the one year of implementation, 512 home deliveries were reported, out of which 89% received the tablets and 84% consumed the tablet within one minute of delivery. No incidence of PPH in tablet consuming mothers was reported. On account of periodic counselling and effective community engagement the intervention also contributed to better tracking of pregnancies till delivery and institutional delivery rates which increased to 93% from 45% and 57% from 11% respectively as compared to the preceding year., Conclusions: The model has successfully shown the use of single misoprostol tablets of 600 mcg, first time in this program. We also demonstrated a HSS based operational framework, based on which the program is being scaled to additional blocks in Himachal Pradesh as well as to other states of India.

Objective: To compare 25μg of vaginal misoprostol with a Foley catheter for induction of labor (IOL) for fetal growth restriction., Methods: A randomized controlled trial was conducted in a tertiary center in South India. Women with fetal growth restriction (n=100) were randomized to be induced with three doses of vaginal misoprostol (25μg) every 6hours or with an intracervical Foley catheter, inserted 12hours before rupture of membranes, and oxytocin if needed. The primary outcome was uterine tachysystole with fetal cardiotocography abnormalities. Secondary outcomes pertained to effectiveness, complications, and patient satisfaction., Results: One woman in the misoprostol group and none in the Foley catheter group had uterine tachysystole. The duration of labor from IOL to delivery was similar in both groups (P=0.416). More women in the misoprostol group had a vaginal delivery within 12hours (26.1% versus 5.6%; P=0.005). Women induced with misoprostol were less likely to deliver by lower-segment cesarean delivery (15.2% versus 29.6%; P=0.168) and to require oxytocin augmentation (60.9% versus 85.2%; P=0.007). Complications were few in both group., Conclusion: Few women had uterine tachysystole with cardiotocography abnormalities. Vaginal misoprostol at 25μg was more effective than a Foley catheter for IOL in fetal growth restriction. Clinical Trials Registry India:CTRI/2014/02/004411., (Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.)

Abstract: Objective: To explore Indian abortion providers’ knowledge of medical abortion (MA), their personal experiences and practices of providing medical abortion, and their attitudes toward providing MA to eligible women who were poor, uneducated, and/or from rural areas. Methods: In selected districts of India''s Bihar and Maharashtra states, interviews were conducted with 270 physicians who were certified as abortion providers, using a structured questionnaire. Results: The providers’ knowledge of the gestational limit, the recommended doses of mifepristone and misoprostol, and other aspects of the approved protocol was far from universal. Only about two-thirds of these physicians authorized to perform MA actually performed it. Although they all counseled women about the procedure before they took mifepristone, the matters discussed were often limited to pain management and possible complications. Contraception was usually not discussed until the follow-up visit. Most providers thus missed the opportunity to provide sustained counseling to their MA patients, and did not counsel them about the need to protect themselves in the 2weeks following the administration of mifepristone. Moreover, many providers were reluctant to offer MA to poor, uneducated, and/or rural women. Conclusions: These findings shed light on the need to raise awareness and dispel misgivings about MA among certified providers of abortion services. By placing emphasis on the method''s safety and effectiveness, additional training to these would increase their confidence about offering MA to eligible women. [Copyright &y& Elsevier]