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

Completed

• Conditions: Pre-Eclampsia
• Interventions: Drug: Misoprostol Oral Tablet; Drug: Oxytocin

• Registration Number: NCT04037683
• Lead Sponsor: University of Liverpool

Brief 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.

Study Timeline

• Study First Submitted: 2019-07-26
• Study First Submitted QC: 2019-07-27
• Study First Posted: 2019-07-30
• Study Start: 2019-10-18
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-09
• Last Update Posted: 2022-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MOLI participants post IOL (misoprostol/misoprostol)	Misoprostol Oral Tablet	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
MOLI participants post IOL (misoprostol/oxytocin)	Misoprostol Oral Tablet	Semi-structured interviews with MOLI participants - estimated 12 patients (until data saturation) 12 women post IOL with misoprostol/oxytocin
MOLI participants post IOL (misoprostol/oxytocin)	Oxytocin	Semi-structured interviews with MOLI participants - estimated 12 patients (until data saturation) 12 women post IOL with misoprostol/oxytocin

Primary Outcome Measures

Name	Time	Method
Clinicians' views on various induction protocols.	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.	6 months	Explore patients' perceptions of induction of labour, prior to induction.
Staff's views on the fetal monitoring regimens during the induction process.	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.	6 months	To explore patients' perspectives of the fetal monitoring regimens during the induction process.
Patients' views on induction of labour, post induction.	6 months	To explore the experiences of patients post induction and any differences between the two RCT groups; misoprostol/misoprostol vs misoprostol/oxytocin regimes.

Trial Locations

Locations (1)

Government Medical College; 🇮🇳 Nagpur, Maharashtra, India