An Alongside Qualitative Study Exploring Patients' and Health Care Professionals' Expectations and Experiences of Labour Induction With Misoprostol and Oxytocin for Hypertension in Pregnancy in India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Clinicians' views on various induction protocols.
研究概览
简要总结
Q MOLI is an alongside qualitative study, for the 'Misoprostol or Oxytocin for Labour Induction' (MOLI) pragmatic, open-label, randomised controlled trial, comparing a misoprostol/misoprostol regime vs the standard misoprostol/oxytocin induction of labour regime.1000 patients with hypertensive disease in pregnancy will be recruited, over 24 months, in Nagpur, India.
详细描述
Qualitative study involving semi-structured interviews, with participants (pregnant women with hypertension/pre-eclampsia participating in the 'Misoprostol or Oxytocin for Labour Induction' (MOLI) study who consent to enter the qualitative study) in a randomised trial, pre and post induction of labour and focus group discussions with healthcare professionals involved in the study (MOLI study staff; practitioners who are involved in screening, recruiting, randomising and consenting participants to the MOLI study).
The investigators aim to assess the priorities, experiences and acceptability of women being induced for hypertension in pregnancy in India, and clinician's views on the feasibility, usability, acceptability and barriers to implementation of various induction protocols.
- Explore patients' perceptions, expectations, priorities, understanding of and concerns around induction of labour, prior to induction.
- To explore the experiences, acceptability and satisfaction of patients post induction and any differences between the two RCT groups; misoprostol/misoprostol vs misoprostol/oxytocin regimes.
- To better understand the feasibility, usability and acceptability of the different induction regimes to health care professionals. To explore potential barriers for implementing research findings into clinical practice and potential solutions.
- To explore patients' and staff perspectives of the fetal monitoring regimens during the induction process.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MOLI participants post IOL (misoprostol/misoprostol)
Semi-structured interviews with MOLI participants - estimated 12 patients (until data saturation) 12 women post IOL with misoprostol/misoprostol Semi-structured interviews with MOLI participants - estimated 12 patients (until data saturation) 12 women post IOL with misoprostol/oxytocin
干预措施: Misoprostol Oral Tablet (Drug)
MOLI participants post IOL (misoprostol/oxytocin)
Semi-structured interviews with MOLI participants - estimated 12 patients (until data saturation) 12 women post IOL with misoprostol/oxytocin
干预措施: Misoprostol Oral Tablet (Drug)
MOLI participants post IOL (misoprostol/oxytocin)
Semi-structured interviews with MOLI participants - estimated 12 patients (until data saturation) 12 women post IOL with misoprostol/oxytocin
干预措施: Oxytocin (Drug)
结局指标
主要结局
Clinicians' views on various induction protocols.
时间窗: 6 months
To better understand the acceptability of the different induction regimes to health care professionals. To explore potential barriers for implementing research findings into clinical practice and potential solutions.
Patients' views on induction of labour, prior to induction.
时间窗: 6 months
Explore patients' perceptions of induction of labour, prior to induction.
Staff's views on the fetal monitoring regimens during the induction process.
时间窗: 6 months
To explore staff perspectives of the fetal monitoring regimens during the induction process.
Patients' views on the fetal monitoring regimens during the induction process.
时间窗: 6 months
To explore patients' perspectives of the fetal monitoring regimens during the induction process.
Patients' views on induction of labour, post induction.
时间窗: 6 months
To explore the experiences of patients post induction and any differences between the two RCT groups; misoprostol/misoprostol vs misoprostol/oxytocin regimes.
次要结局
未报告次要终点
研究者
Andrew D Weeks
Professor of International Maternal Health
University of Liverpool