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. 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. 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. 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. The MOLI study is registered in ClinicalTrials.gov (NCT03749902, Registration date: 21st Nov 2018) and Clinical Trial Registry, India (CTRI/2019/04/018827).

Introduction Caesarean 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.Methods This 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.Results Interactions 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’.Conclusion Women 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 number NCT04037683.

Objective: To assess whether, in those requiring ongoing 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 induced with oral misoprostol for hypertensive disease in pregnancy and requiring ongoing induction after membrane rupture Methods: Participants received misoprostol (25mcg orally two hourly) or titrated oxytocin through an infusion pump. Main Outcome Measure: Caesarean birth Results: 520 women were randomised and the baseline characteristics were comparable between the groups. The caesarean section rate was not reduced by the use of misoprostol (misoprostol 32.3% vs oxytocin 27.3%; adjusted odds ratio 1.226 (95% CI 0.81-1.85, p=0.33)). There were no differences in rates of hyperstimulation, fetal heart rate abnormalities, or maternal side effects, although the geometric mean time from randomisation to birth was 31 minutes longer with misoprostol. Fewer babies in the misoprostol arm were admitted to the special care unit (10 vs 21 in the oxytocin group) and there were no neonatal deaths in the misoprostol group, compared to 3 in the oxytocin arm. Women’s acceptability ratings were high in both study groups. Conclusion: Following cervical preparation with oral misoprostol and membrane rupture, the use of ongoing oral misoprostol for augmentation did not significantly reduce caesarean rates compared to oxytocin. The method, however, was safe for both mother and baby.

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.

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).

Increasingly, births around the world are started artificially using medications or other methods. This process is known as induction of labour. As it becomes more common, methods are needed to meet the different clinical needs and birth preferences of women. Induction of labour typically includes a combination of the medication dinoprostone inserted into the vagina, artificial rupture of membranes ('releasing the waters'), and synthetic oxytocin (hormone given via a drip). This paper reviews some of the methods less commonly used for induction in the UK, namely a drug called misoprostol, which can be given orally or vaginally, and 'mechanical' methods, where labour is started by stretching the cervix (neck of the womb), most commonly with a soft silicone tube with a balloon near the tip, filled with water. Low-dose oral misoprostol tablets are now commercially available in the UK. Other methods for labour induction are not reviewed in detail in this paper. The evidence suggests mechanical induction of labour (using a balloon catheter) and misoprostol are both at least as safe and effective as using the standard drug, dinoprostone. There is evidence to suggest a balloon catheter may reduce the chance of serious negative outcomes for babies when compared with dinoprostone, and that giving low-dose oral misoprostol results in fewer caesarean births. Where possible and after informed consent, the method of induction of labour should be personalised to suit the individual woman, her clinical condition, and the setting in which she is giving birth. Local contexts and resources also need to be taken into account. To date, research into women's perspectives and experiences of induction of labour have been significantly lacking.

Plain language summaryIncreasingly, births around the world are started artificially using medications or other methods. This process is known as induction of labour. As it becomes more common, methods are needed to meet the different clinical needs and birth preferences of women.Induction of labour typically includes a combination of the medication dinoprostone inserted into the vagina, artificial rupture of membranes (‘releasing the waters’), and synthetic oxytocin (hormone given via a drip). This paper reviews some of the methods less commonly used for induction in the UK, namely a drug called misoprostol, which can be given orally or vaginally, and ‘mechanical’ methods, where labour is started by stretching the cervix (neck of the womb), most commonly with a soft silicone tube with a balloon near the tip, filled with water. Low‐dose oral misoprostol tablets are now commercially available in the UK. Other methods for labour induction are not reviewed in detail in this paper.The evidence suggests mechanical induction of labour (using a balloon catheter) and misoprostol are both at least as safe and effective as using the standard drug, dinoprostone. There is evidence to suggest a balloon catheter may reduce the chance of serious negative outcomes for babies when compared with dinoprostone, and that giving low‐dose oral misoprostol results in fewer caesarean births.Where possible and after informed consent, the method of induction of labour should be personalised to suit the individual woman, her clinical condition, and the setting in which she is giving birth. Local contexts and resources also need to be taken into account. To date, research into women's perspectives and experiences of induction of labour have been significantly lacking.

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.

de Jonge A. Induction of labour should be offered to all women at term: AGAINST: Induction of labour should not be offered to all women at term: first, do no harm. BJOG 2019;126:1599. 3 Middleton P, Shepherd E, Crowther CA. Induction of labour for improving birth outcomes for women at or beyond term. Cochrane Database Syst Rev 2018;(5): CD004945. 4 Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM,Mallett G, et al. Labor induction versus expectant management in low-risk nulliparous women. N Engl J Med. 2018;379:513–23. 5 Walker KF, Dritsaki M, Bugg G, Macpherson M, McCormick C, Grace N, et al. Labour induction near term for women aged 35 or over: an economic evaluation. BJOG 2017;124:929–34.

BackgroundEvery 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.MethodsThis 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.DiscussionAvoiding 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 registrationClinical Trials.gov, NCT03749902, registered on 21(st) Nov 2018.