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

Pre-Eclampsia Clinical Trial

— qMOLI  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04037683
• Other study ID #: 4791
• Status: Completed
• Start date: October 18, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: University of Liverpool
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

Drug:
• Misoprostol Oral Tablet
Misoprostol 25mcg orally given 2-hourly
• Oxytocin
Oxytocin infusion

Locations

Country	Name	City	State
India	Government Medical College	Nagpur	Maharashtra

Sponsors (3)

Lead Sponsor	Collaborator
University of Liverpool	Government Medical College, Nagpur, Gynuity Health Projects

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients' views on induction of labour, prior to induction.	Explore patients' perceptions of induction of labour, prior to induction.	6 months
Primary	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
Primary	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
Primary	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
Primary	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