Clinical trial NCT04037683: qMOLI- A Qualitative Assessment of Misoprostol or Oxytocin for Labour Induction
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pre-Eclampsia
Keywords: induction of labour
intrapartum fetal monitoring
qualitative
semi-structured interview
focus groups
Lead sponsor: University of Liverpool
Sponsor class: OTHER
Collaborators: name: Government Medical College, Nagpur
name: Gynuity Health Projects
First posted: 2019-07-30
Enrollment: 136
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patients' views on induction of labour, prior to induction.
timeFrame: 6 months
measure: Patients' views on induction of labour, post induction.
timeFrame: 6 months
measure: Clinicians' views on various induction protocols.
timeFrame: 6 months
measure: Patients' views on the fetal monitoring regimens during the induction process.
timeFrame: 6 months
measure: Staff's views on the fetal monitoring regimens during the induction process.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nagpur
country: India
facility: Government Medical College
state: Maharashtra
Study officials:
affiliation: University of Liverpool
name: Andrew Weeks, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Liverpool
name: Kate Lightly, Dr
role: STUDY_DIRECTOR
References: