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

NCT04037683 | Completed

• 1 other identifier: 4791
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Eclampsia

Keywords

induction of labour; intrapartum fetal monitoring; qualitative; semi-structured interview; focus groups

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (4)

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

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; Drug: Oxytocin

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

Interventions

Misoprostol Oral Tablet DRUG

Misoprostol 25mcg orally given 2-hourly

MOLI participants post IOL (misoprostol/misoprostol); MOLI participants post IOL (misoprostol/oxytocin)

Oxytocin DRUG

Oxytocin infusion

MOLI participants post IOL (misoprostol/oxytocin)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• Practitioners who are involved in screening, recruiting, randomising and consenting participants to MOLI RCT
• Staff who do not wish to be included
• Staff who do not give their consent to participate

Sponsors & Collaborators

• University of Liverpool: lead
• Government Medical College, Nagpur: collaborator
• Gynuity Health Projects: collaborator

Study Sites (1)

Government Medical College

Nagpur, Maharashtra, 440003, India

Location

Related Publications (1)

• 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.

  PMID: 40912733 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Misoprostol; Oxytocin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Andrew Weeks, Professor

  University of Liverpool

  PRINCIPAL INVESTIGATOR

• Kate Lightly, Dr

  University of Liverpool

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of International Maternal Health

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: July 30, 2019
• Study Start: October 18, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 11, 2022

Record last verified: 2022-02

Locations

IN (1)