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

NCT ID: NCT04037683

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 136 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-18
• Study Completion Date: 2021-12-31

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.

Conditions

Pre-Eclampsia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

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

No interventions assigned to this group

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

Misoprostol Oral Tablet

Intervention Type: DRUG

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

Misoprostol Oral Tablet

Intervention Type: DRUG

Misoprostol 25mcg orally given 2-hourly

Oxytocin

Intervention Type: DRUG

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

No interventions assigned to this group

Interventions

Misoprostol Oral Tablet

Misoprostol 25mcg orally given 2-hourly

Intervention Type: DRUG

Oxytocin

Oxytocin infusion

Intervention Type: DRUG

Eligibility Criteria

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

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

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

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Government Medical College, Nagpur

INDUSTRY

Sponsor Role: collaborator

Gynuity Health Projects

OTHER

Sponsor Role: collaborator

University of Liverpool

OTHER

Sponsor Role: lead

Responsible Party

Andrew D Weeks

Professor of International Maternal Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew Weeks, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Liverpool

Kate Lightly, Dr

Role: STUDY_DIRECTOR

University of Liverpool

Locations

Government Medical College

Nagpur, Maharashtra, India

Countries

India

References

Lightly K, Mundle S, Tripathy J, Deshmukh P, Winikoff B, Weeks A, Kingdon C. Women and clinicians' views, preferences and experiences of caesarean section and vaginal birth in India: a qualitative substudy of the 'Misoprostol or Oxytocin for Labour Induction' (MOLI) trial. BMJ Glob Health. 2025 Sep 5;10(9):e018393. doi: 10.1136/bmjgh-2024-018393.

Reference Type: DERIVED

PMID: 40912733 (View on PubMed)

Other Identifiers

4791

Identifier Type: -

Identifier Source: org_study_id