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

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

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.

Study Overview

• Status: Completed
• Conditions: Pre-Eclampsia
• Intervention / Treatment: Drug: Misoprostol Oral Tablet; Drug: Oxytocin

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 Type: Observational
• Enrollment (Actual): 136

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Nagpur, Maharashtra, India, 440003
      • Government Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pregnant or postnatal women with hypertension/pre-eclampsia participating in the 'Misoprostol or Oxytocin for Labour Induction' (MOLI) study who consent to enter the qualitative study.

MOLI study staff. Practitioners who are involved in screening, recruiting, randomising and consenting participants to the MOLI study.

Description

MOLI RCT participants (women being induced)

Inclusion criteria

• Women who are recruited to the MOLI RCT and are either antenatal, or post-induction and meet all of the eligibility criteria:
• Women who consent to join the qualitative study

Exclusion criteria

• Women who are not recruited to the MOLI RCT
• Women who lack the capacity to make an informed decision
• Women under the age of 16
• Women who have had a stillbirth in this pregnancy
• Women who are distressed/in pain
• Women too unwell to take part in interviews, or who need urgent intervention (in less than 2 hours)
• Where delay in starting the IOL process due to time of interview could cause harm to the patient
• Women who do not give consent to be in the study

MOLI practitioners

Inclusion criteria

• Practitioners who are involved in screening, recruiting, randomising and consenting participants to MOLI RCT

Exclusion criteria

• Staff who do not wish to be included
• Staff who do not give their consent to participate

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MOLI participants pre IOL; Semi-structured interviews with MOLI participants - estimated 12 patients (until data saturation) after recruitment to MOLI RCT but prior to the start of the induction of labour (IOL) process
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	Drug: Misoprostol Oral Tablet; Misoprostol 25mcg orally given 2-hourly
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	Drug: Misoprostol Oral Tablet; Misoprostol 25mcg orally given 2-hourly; Drug: Oxytocin; Oxytocin infusion
Staff focus group pre and during MOLI recruitment; A focus group in each of the 2 recruitment sites before the start of the MOLI trial (n=2) A focus group in each of the 2 recruitment sites and with each cadre of staff during the MOLI trial (n=8); Research assistants; Residents; Consultants; Midwives

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Liverpool
• Collaborators: Gynuity Health Projects; Government Medical College, Nagpur

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: July 26, 2019
• First Submitted That Met QC Criteria: July 27, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): February 11, 2022
• Last Update Submitted That Met QC Criteria: February 9, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: induction of labour; qualitative; semi-structured interview; intrapartum fetal monitoring; focus groups
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Oxytocin; Misoprostol
• Other Study ID Numbers: 4791

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No