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| Name | Class |
|---|---|
| Government Medical College, Nagpur | INDUSTRY |
| Gynuity Health Projects | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MOLI participants pre IOL | 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 | ||
| MOLI participants post IOL (misoprostol/misoprostol) | 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 |
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| MOLI participants post IOL (misoprostol/oxytocin) | Semi-structured interviews with MOLI participants - estimated 12 patients (until data saturation) 12 women post IOL with misoprostol/oxytocin |
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| Staff focus group pre and during MOLI recruitment | 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)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol Oral Tablet | Drug | Misoprostol 25mcg orally given 2-hourly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients' views on induction of labour, prior to induction. | Explore patients' perceptions of induction of labour, prior to induction. | 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. | 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. | 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. | 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. | 6 months |
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MOLI RCT participants (women being induced)
Inclusion criteria
Exclusion criteria
MOLI practitioners
Inclusion criteria
• Practitioners who are involved in screening, recruiting, randomising and consenting participants to MOLI RCT
Exclusion criteria
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Weeks, Professor | University of Liverpool | Principal Investigator |
| Kate Lightly, Dr | University of Liverpool | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Government Medical College | Nagpur | Maharashtra | 440003 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40912733 | Derived | Lightly K, Mundle S, Tripathy J, Deshmukh P, Winikoff B, Weeks A, Kingdon C. Women and clinicians' views, preferences and experiences of caesarean section and vaginal birth in India: a qualitative substudy of the 'Misoprostol or Oxytocin for Labour Induction' (MOLI) trial. BMJ Glob Health. 2025 Sep 5;10(9):e018393. doi: 10.1136/bmjgh-2024-018393. |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Oxytocin | Drug | Oxytocin infusion |
|
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |