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NCT Number: NCT04037683

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

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Government Medical College

Nagpur, Maharashtra, 440003, India

About this study

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.

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol Oral Tablet

Drug

Misoprostol 25mcg orally given 2-hourly

Oxytocin

Drug

Oxytocin infusion

Primary outcomes

  1. Patients' views on induction of labour, prior to induction.

    Time frame: 6 months

    Explore patients' perceptions of induction of labour, prior to induction.

  2. Patients' views on induction of labour, post induction.

    Time frame: 6 months

    To explore the experiences of patients post induction and any differences between the two RCT groups; misoprostol/misoprostol vs misoprostol/oxytocin regimes.

  3. Clinicians' views on various induction protocols.

    Time frame: 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.

  4. Patients' views on the fetal monitoring regimens during the induction process.

    Time frame: 6 months

    To explore patients' perspectives of the fetal monitoring regimens during the induction process.

  5. Staff's views on the fetal monitoring regimens during the induction process.

    Time frame: 6 months

    To explore staff perspectives of the fetal monitoring regimens during the induction process.

Sponsors and collaborators

Lead sponsor

University of Liverpool

Other

Collaborators

  • Government Medical College, Nagpur
  • Gynuity Health Projects

Registry information

Official study title

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

Acronym: qMOLI

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 30, 2019
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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