Pre-EclampsiaqMOLINCT04037683
qMOLI- A Qualitative Assessment of Misoprostol or Oxytocin for Labour Induction
An observational study of Pre-Eclampsia, run by University of Liverpool at 1 site in India.
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… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- Misoprostol Oral Tablet and Oxytocin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 136 participants
- Where
- 1 siteIndia
- Study dates
- 18 Oct 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
- Practitioners who are involved in screening, recruiting, randomising and consenting participants to MOLI RCT
Who cannot join
- 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)
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- 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
- Staff who do not wish to be included
- Staff who do not give their consent to participate
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Explore patients' perceptions, expectations, priorities, understanding of and concerns around induction of labour, prior to induction.
- 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.
- 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.
- To explore patients' and staff perspectives of the fetal monitoring regimens during the induction process.
- Conditions
- Pre-Eclampsia
- Being tested
- Misoprostol Oral Tablet, Oxytocin
- Keywords
- induction of labour, intrapartum fetal monitoring, qualitative, semi-structured interview, focus groups
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol Oral TabletDrug
Misoprostol 25mcg orally given 2-hourly
OxytocinDrug
Oxytocin infusion
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Misoprostol Oral Tablet | |
| 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 Receives: Drug: Misoprostol Oral Tablet; Drug: Oxytocin | |
| 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) * Research assistants * Residents * Consultants * Midwives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' views on induction of labour, prior to induction.
Explore patients' perceptions of induction of labour, prior to induction.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start18 Oct 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- Government Medical College, Nagpur, Gynuity Health Projects
- Responsible party
- Principal investigator, Andrew D Weeks, University of Liverpool
- Investigators
- Andrew Weeks, Professor, Principal investigator, University of LiverpoolKate Lightly, Dr, Study director, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037683
- Sponsor's protocol ID
- 4791
- Acronym
- qMOLI
- Status last verified
- Feb 2022
- First submitted
- 26 Jul 2019
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40912733
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04037683
- Acronym / sponsor ID
- qMOLI / 4791
- Conditions
- Pre-Eclampsia
- Keywords
- induction of labour, intrapartum fetal monitoring, qualitative, semi-structured interview, focus groups
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- Government Medical College, Nagpur, Gynuity Health Projects
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Explore patients' perceptions, expectations, priorities, understanding of and concerns around induction of labour, prior to induction.
- 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.
- 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.
- To explore patients' and staff perspectives of the fetal monitoring regimens during the induction process.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) | – | Drug: Misoprostol Oral TabletSemi-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 |
| MOLI participants post IOL (misoprostol/oxytocin) | – | Drug: Misoprostol Oral Tablet, Drug: OxytocinSemi-structured interviews with MOLI participants - estimated 12 patients (until data saturation) 12 women post IOL with misoprostol/oxytocin |
| 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) * Research assistants * Residents * Consultants * Midwives |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
- Practitioners who are involved in screening, recruiting, randomising and consenting participants to MOLI RCT
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Misoprostol Oral TabletMisoprostol 25mcg orally given 2-hourly | Drug | MOLI participants post IOL (misoprostol/misoprostol), MOLI participants post IOL (misoprostol/oxytocin) |
| OxytocinOxytocin infusion | Drug | MOLI participants post IOL (misoprostol/oxytocin) |
Primary outcome
Patients' views on induction of labour, prior to induction.
Time frame: 6 months
Explore patients' perceptions of induction of labour, prior to induction.
Patients' views on induction of labour, post induction.
Time frame: 6 months
To explore the experiences of patients post induction and any differences between the two RCT groups; misoprostol/misoprostol vs misoprostol/oxytocin regimes.
Clinicians' views on various induction protocols.
Time frame: 6 months
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.
Patients' views on the fetal monitoring regimens during the induction process.
Time frame: 6 months
To explore patients' perspectives of the fetal monitoring regimens during the induction process.
Staff's views on the fetal monitoring regimens during the induction process.
Time frame: 6 months
To explore staff perspectives of the fetal monitoring regimens during the induction process.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Derived from this study: PubMed 40912733Lightly 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Weeks, Professor principal investigator
University of Liverpool
Kate Lightly, Dr study director
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Eclampsia, run by University of Liverpool at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' views on induction of labour, prior to induction. (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04037683, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2022.