NCT04037683

qMOLI- A Qualitative Assessment of Misoprostol or Oxytocin for Labour Induction

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 136 (actual)
• Sponsor: University of Liverpool · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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. 1. Explore patients' perceptions, expectations, priorities, understanding of and concerns around induction of labour, prior to induction. 2. 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. 3. 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. 4. To explore patients' and staff perspectives of the fetal monitoring regimens during the induction process.

Conditions

• Pre-Eclampsia

Interventions

Type	Name	Description
DRUG	Misoprostol Oral Tablet	Misoprostol 25mcg orally given 2-hourly
DRUG	Oxytocin	Oxytocin infusion

Timeline

• Start date: 2019-10-18
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2019-07-30
• Last updated: 2022-02-11

Locations

1 site across 1 country: India