Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

qMOLI- A Qualitative Assessment of Misoprostol or Oxytocin for Labour Induction (qMOLI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04037683
Recruitment Status : Active, not recruiting
First Posted : July 30, 2019
Last Update Posted : April 10, 2020
Sponsor:
Collaborators:
Government Medical College, Nagpur, India
Gynuity Health Projects
Information provided by (Responsible Party):
Andrew D Weeks, University of Liverpool

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.

Condition or disease Intervention/treatment
Pre-Eclampsia Drug: Misoprostol Oral Tablet Drug: Oxytocin

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 86 participants
Observational Model: Other
Time Perspective: Other
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
Actual Study Start Date : October 18, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Drug: Misoprostol Oral Tablet
Misoprostol 25mcg orally given 2-hourly

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
Drug: Misoprostol Oral Tablet
Misoprostol 25mcg orally given 2-hourly

Drug: Oxytocin
Oxytocin infusion

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



Primary Outcome Measures :
  1. Patients' views on induction of labour, prior to induction. [ Time Frame: 6 months ]
    Explore patients' perceptions of induction of labour, prior to induction.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04037683


Locations
Layout table for location information
United Kingdom
Government Medical College
Nagpur, Maharastra, United Kingdom, 440003
Sponsors and Collaborators
University of Liverpool
Government Medical College, Nagpur, India
Gynuity Health Projects
Investigators
Layout table for investigator information
Principal Investigator: Andrew Weeks, Professor University of Liverpool
Study Director: Kate Lightly, Dr University of Liverpool
Layout table for additonal information
Responsible Party: Andrew D Weeks, Professor of International Maternal Health, University of Liverpool
ClinicalTrials.gov Identifier: NCT04037683    
Other Study ID Numbers: 4791
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrew D Weeks, University of Liverpool:
induction of labour
intrapartum fetal monitoring
qualitative
semi-structured interview
focus groups
Additional relevant MeSH terms:
Layout table for MeSH terms
Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Misoprostol
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents