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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Pre-Eclampsia

Intervention / Treatment
-----------------
* Drug: Misoprostol Oral Tablet
* Drug: Oxytocin


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MOLI participants pre IOL<br>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)<br>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<br>* Misoprostol 25mcg orally given 2-hourly<br>|
| MOLI participants post IOL (misoprostol/oxytocin)<br>Semi-structured interviews with MOLI participants - estimated 12 patients (until data saturation) 12 women post IOL with misoprostol/oxytocin | Drug: Misoprostol Oral Tablet<br>* Misoprostol 25mcg orally given 2-hourly<br>Drug: Oxytocin<br>* Oxytocin infusion<br>|
| Staff focus group pre and during MOLI recruitment<br>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 the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
induction of labour, intrapartum fetal monitoring, qualitative, semi-structured interview, focus groups