An observational study in Pre-Eclampsia, sponsored by University of Liverpool. Completed at 1 site in India. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-11.
Sponsored by University of Liverpool · Observational
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.
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.
328 studies on the registry are indexed under Eclampsia; 48 are open to participants now.
This study's enrollment of 136 is below the median of 158 across 146 observational studies indexed under Eclampsia.
Browse Eclampsia studies →University of Liverpool is the lead sponsor of 99 studies on the registry; 10 are open to participants now.
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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.
MOLI RCT participants (women being induced)
Inclusion criteria
Exclusion criteria
MOLI practitioners
Inclusion criteria
Exclusion criteria
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
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
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
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
Misoprostol 25mcg orally given 2-hourly
Oxytocin infusion
Patients' views on induction of labour, prior to induction.
Explore patients' perceptions of induction of labour, prior to induction.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Plan to share: Undecided
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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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