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IntroductionCaesarean use in India continues to rise and significant disparities exist. However, women and clinicians’ views are under-researched. This paper aims to explore women and clinicians’ views and preferences for mode of birth in two government hospitals in urban central India.MethodsThis qualitative study involved 53 semistructured interviews with high-risk women before and after induction of labour and eight focus groups with clinicians and researchers in two government hospitals in Maharashtra state. All women were recruited to the ‘Misoprostol or Oxytocin for Labour Induction’ (MOLI) randomised controlled trial (NCT03749902) and were induced for hypertensive disorders in pregnancy. Data were analysed using the framework approach to thematic analysis.ResultsInteractions between women, clinicians and families played an important role in women’s birth experiences. Most women strongly preferred vaginal birth. While a vaginal birth was important to women for their long-term health and well-being, the safety of the baby was the priority. Both women and clinicians justified caesarean use to promote fetal safety. Contrary to clinicians’ perceptions, women clearly understood their caesarean indications. The busy clinical environment was an important factor influencing the clinician’s decision and threshold for caesarean. Three themes arose from the data: (1) women’s preference for vaginal birth: a matter of ‘Trouble for two hours or trouble for two months’; (2) clinicians’ perspectives about caesarean use: ‘Don’t take a risk’; and (3) knowledge through experiences and interactions: ‘The pain didn’t come’.ConclusionWomen strongly preferred ‘normal delivery’ but accepted caesarean birth to promote fetal safety. Clinicians felt labour and vaginal birth were often risky and prioritised fetal safety in this under-resourced context. Women who had a caesarean birth understood their indication for caesarean but, compared with vaginal birth, reported that caesarean caused them additional short- and long-term anxiety, health and social concerns.Trial registration numberNCT04037683.

Background Although induction of labour is becoming more common worldwide, there are few studies that assess women’s satisfaction with it. The newly developed Participant Generated Experience and Satisfaction (PaGES) Index collects brief qualitative data and quantifies it, allowing detailed satisfaction data to be collected on large populations. The PaGES data has never previously been compared to other methods of assessing study participants’ satisfaction. We aimed to triangulate PaGES Index, Likert questionnaire and interview data from a large, randomised trial of labour induction to fully understand women’s priorities, experience and satisfaction and to compare the findings of the three instruments. Methods A convergent parallel multi-methods research design was used. Participants in the Misoprostol or Oxytocin for Labour Induction (MOLI) trial ( n  = 520) completed the PaGES Index before and after birth, listing priorities and allocating spending points to demonstrate their relative importance. Postpartum, participants scored their satisfaction with each item. Quantitative data was collected following birth on the acceptability of augmentation, delivery time, pain and anxiety using a Likert scale. Semi-structured interviews were also conducted, and thematic analysis was carried out using a framework approach. The data from 20 participants who had completed all three outcome measures were integrated and compared. Results Although common themes, such as pain, emerged from participants’ responses to the three instruments, each provided different insights. The Likert responses demonstrated overall satisfaction with the induction process but with high levels of pain and anxiety. Semi-structured interviews highlighted that safety and health of the baby was a key priority. The PaGES Index confirmed that the baby’s wellbeing was most important to women, but women also expressed a strong preference for vaginal delivery. Conclusions The PaGES Index, Likert questionnaire and semi-structured interview data provide varied but complimentary insights on women’s birth experiences and their satisfaction with their induction process. The outputs of the three methods align, but the PaGES index was unique in capturing both detailed qualitative and quantitative information for all study participants. Trial registration The MOLI study is registered in ClinicalTrials.gov (NCT03749902, Registration date: 21st Nov 2018) and Clinical Trial Registry, India (CTRI/2019/04/018827).

Background Patient-Reported Outcomes or Experience Measures (PROMS / PREMS) are routinely used in clinical studies to assess participants’ views and experiences of trial interventions and related quality of life. Purely quantitative approaches lack the necessary detail and flexibility to understand the real-world impact of study interventions on participants, according to their own priorities. Conversely, purely qualitative assessments are time consuming and usually restricted to a small, possibly unrepresentative, sub-sample. This paper, which reports a pilot study within a randomised controlled trial of induction of labour, reports the feasibility, and acceptability of the Participant-Generated Experience and Satisfaction (PaGES) Index, a new mixed qualitative / quantitative PREM tool. Methods The single-sheet PaGES Index was completed by hypertensive pregnant women in two hospitals in Nagpur, India before and after taking part in the ‘Misoprostol or Oxytocin for Labour Induction’ (MOLI) randomised controlled trial. Participants recorded aspects of the impending birth they considered most important, and then ranked them. After the birth, participants completed the PaGES Index again, this time also scoring their satisfaction with each item. Forms were completed on paper in the local language or in English, supported by Research Assistants. Following translation (when needed), responses were uploaded to a REDCap database, coded in Excel and analysed thematically. A formal qualitative evaluation (qMOLI) was also conducted to obtain stakeholder perspectives of the PaGES Index and the wider trial. Semi-structured interviews were conducted with participants, and focus groups with researchers and clinicians. Data were managed using NVivo 12 software and analysed using the framework approach. Results Participants and researchers found the PaGES Index easy to complete and administer; mothers valued the opportunity to speak about their experience. Qualitative analysis of the initial 68 PaGES Index responses identified areas of commonality and difference among participants and also when comparing antenatal and postnatal responses. Theme citations and associated comments scores were fairly stable before and after the birth. The qMOLI phase, comprising 53 one-to-one interviews with participants and eight focus groups involving 83 researchers and clinicians, provided support that the PaGES Index was an acceptable and even helpful means of capturing participant perspectives. Conclusions Subjective participant experiences are an important aspect of clinical trials. The PaGES Index was found to be a feasible and acceptable measure that unites qualitative research’s explanatory power with the comparative power of quantitative designs. It also offers the opportunity to conduct a before-and-after evaluation, allowing researchers to examine the expectations and actual experiences of all clinical trial participants, not just a small sub-sample. This study also shows that, with appropriate research assistant input, the PaGES Index can be used in different languages by participants with varying literacy levels. Trial registration Clinical Trials.gov (21/11/2018) (NCT03749902).

Background Abnormal uterine bleeding constitutes a vexing issue among female patients, substantially impacting their quality of life. Surgical interventions, particularly hysterectomy, contribute to the psychological, physical, and financial burden on families and, by extension, the healthcare system. Levonorgestrel-releasing intrauterine system (LNG-IUS) represents a conservative management approach and emerges as a beneficial option for affected patients. The present study aims to elucidate color Doppler changes in the uterine artery pre- and post-LNG-IUS insertion. Objective The primary objectives encompass an investigation into the variations in Doppler indices (resistance index (RI) and pulsatility index (PI)) within the arcuate and radial branches of the uterine artery, as well as the assessment of endometrial thickness before LNG-IUD insertion, at three months, and six months post-insertion. Secondary outcomes include evaluating changes in pictorial blood assessment chart (PBAC) scores before insertion, at three months, and at six months after LNG-IUS insertion. Methods A cross-sectional study was conducted at the Department of Obstetrics and Gynecology at All India Institute Of Medical Sciences (AIIMS), Nagpur. A cohort of 25 women underwent LNG-IUS insertion. The endometrial cavity, RI, and PI of both arcuate and radial arteries were assessed before LNG-IUS insertion and at three and six months after insertion. Results The PI of the arcuate artery exhibited minimal alteration over the six-month duration, with a p-value of 0.43. Conversely, the RI demonstrated a statistically significant increase over the same period (p = 0.03). Conversely, the radial artery exhibited no statistically significant changes in either PI or RI (p = 0.39 or 0.13, respectively). Conclusion Following six months of LNG-IUS utilization, a substantial reduction in endometrial thickness and menstrual flow was observed, concomitant with an improvement in hemoglobin levels. Notably, the PI of both the arcuate and radial arteries demonstrated no significant change. Although the RI of the arcuate artery increased, its clinical relevance may be limited. Consequently, the observed reduction in menstrual bleeding cannot conclusively be ascribed to diminished blood flow in uterine arteries.

Menstrual hygiene management poses significant challenges globally, with widespread reliance on disposable sanitary pads contributing to health risks and environmental degradation. Sustainable alternatives like menstrual cups offer promising solutions but face barriers to adoption, including myths and misconceptions. Educational interventions are crucial in promoting eco-friendly menstrual hygiene practices. A descriptive cross-sectional survey was conducted at All India Institute of Medical Sciences (AIIMS), Nagpur (Central India) among nursing officers from January to February 2022. A structured questionnaire assessed the demographic characteristics, menstrual hygiene practices, knowledge of menstrual cups, and attitude toward their use. Of the 101 participants, the majority were between the age group of 25 and 40 years (71, 70.3%) and were educated up to a Bachelor of Science degree in nursing (79, 78.21%). Overwhelmingly, 97 (96.03%) of the nursing officers used non-biodegradable sanitary pads. Frequent need to change and staining were cited as common difficulties. Although 97 (96.04%) of the participants had heard of menstrual cups, knowledge gaps existed regarding suitability for nulliparous women, material composition, cost, and lifespan. Despite expressing a desire for better alternatives by 56 (55.4%) participants, only one (0.99%) reported current menstrual cup usage, with 60 (59.4%) participants indicating future readiness to use. Discovering nurses' menstrual hygiene habits, this study sheds light on their reliance on disposable pads over menstrual cups. Improving the acceptability of menstrual cups hinges on addressing current knowledge gaps such as their feasibility for use by nulliparous women, ease of insertion, cost, and environmental sustainability. Despite hurdles like misinformation, participants show openness to embracing new options with the right guidance and education.

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.

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.

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. 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. 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 (<1%) woman in the labetalol group had an intrapartum seizure and six (1%) neonates (one [<1%] neonate in the nifedipine group, two [1%] neonates in the labetalol group, and three [1%] neonates in the methyldopa group) were stillborn. No birth had more than one adverse event. 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. PREEMPT (University of British Columbia, Vancouver, BC, Canada; grantee of Bill & Melinda Gates Foundation).

Unsafe abortion remains a critical public health issue, particularly in regions with limited access to safe and legal abortion services. This case report highlights the rare use of an abortion stick—a hazardous method involving the insertion of foreign objects into the uterus and its associated complications. A newly married woman in her 20s presented with lower abdominal pain, foul-smelling vaginal discharge and infertility following an unsafe abortion facilitated by a traditional birth attendant. Hysteroscopic evaluation revealed a 9 cm wooden stick within the uterine cavity, which was successfully removed. This case underscores the severe consequences of unsafe abortion practices, including chronic infection, uterine trauma and infertility. It also demonstrates the indispensable role of hysteroscopy in diagnosing and managing complications from unsafe abortions, preventing the need for more invasive surgical interventions. The report emphasises the need for improved access to safe reproductive healthcare.