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Background: Induction of labor (IOL) is an increasingly common intervention, but experiences and preferences of induction methods are under-researched particularly in low -and middle-income countries. Understanding these perspectives is important to improve the childbirth experience. Objective: To explore the experiences and preferences of IOL methods for women, clinicians, and researchers in the “Misoprostol or Oxytocin for Labour Induction” (MOLI) study. Study Design: This qualitative study was based in two government hospitals in the city of Nagpur, India—one tertiary referral hospital and one women's hospital. Fifty-three semi-structured interviews with women before and after induction (between days 1 and 5 postnatal), with women recruited to the “Misoprostol or Oxytocin for Labour Induction (MOLI)” randomized controlled trial (NCT03749902). Eight focus group discussions with doctors, nurses, and trial research assistants before and during trial delivery were conducted. Thematic analysis was conducted using the Framework approach. Results: Four themes emerged: (1) IOL methods, (2) impact of the study, (3) IOL and childbirth as one small part of the wider experiences in life, and (4) key moments in the childbirth experience. For women, the safety of their baby was more important than any IOL method. Clinicians had apprehensions over misoprostol use which could affect protocol implementation; they reported that changing perception is difficult as usual practice feels “comfortable.” Women wanted to share their experiences and reported key moments during childbirth including vaginal examinations, “trying for normal,” bearing the pain, waiting, and relationships with staff. Conclusion: Women did not have a strong preference for the IOL method and viewed childbirth positively when maternal and neonatal outcomes were good. Labor pain, vaginal examinations, a normal birth, and interactions with staff impacted women's experiences.

Abstract 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).

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

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