qMOLI- A Qualitative Assessment of Misoprostol or Oxytocin for Labour Induction (NCT04037683) | Clinical Trial Compass
CompletedNot Applicable
qMOLI- A Qualitative Assessment of Misoprostol or Oxytocin for Labour Induction
India136 participantsStarted 2019-10-18
Plain-language 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.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patients' views on induction of labour, prior to induction.
Timeframe: 6 months
2
Patients' views on induction of labour, post induction.
Timeframe: 6 months
3
Clinicians' views on various induction protocols.
Timeframe: 6 months
4
Patients' views on the fetal monitoring regimens during the induction process.
Timeframe: 6 months
5
Staff's views on the fetal monitoring regimens during the induction process.