Mifepristone Outpatient Labour Induction (MOLI)

The number of women having an induction of labour is increasing and is currently used in 33% of pregnancies for a range of medical reasons. The majority of women are admitted to hospital to have their labour induced, using methods which are protracted and associated with a poor birth experience, making them both costly and unpopular. Further, current methods of outpatient induction are unsuitable, unsafe and/or have a poor acceptability. The COVID-19 pandemic has driven a reduction in the number of face-to-face interactions taking place across all areas of medicine. Proving the efficacy and safety of Mifepristone would significantly reduce pre-labour admission rates and hospital length of stay for pregnant women, who are at particularly higher risk of COVID-19, and reduce delivery costs.

Study Overview

• Status: Recruiting
• Conditions: Labor, Induced
• Intervention / Treatment: Drug: Placebo; Drug: Mifepristone

Detailed Description

The study is a double blinded, two arms, multi-centre randomised controlled clinical trial to investigate the clinical effectiveness, safety and resource utilisation of intervention for the induction of labour in low-risk women admitted to the hospital. Subjects will be randomised 1:1 to one of the two arms to receive:

Arm 1: Mifepristone + standard of care Arm 2: Placebo + standard of care

The study treatment will commence from the administration of the Mifepristone or placebo. The participants will be assessed 48 hours after treatment regimen will be completed as an in-patient.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Tess Cheetham; Phone Number: 020 331 56825; Email: tess.cheetham@nhs.net
• Study Contact Backup: Name: Arnold Xhikola; Phone Number: 020 331 56825; Email: arnold.xhikola@nhs.net

Study Locations

• United Kingdom
  • Isleworth, United Kingdom
    • Not yet recruiting
    • West Middlesex University Hospital
    • Contact: Sophie Hopkins; Phone Number: 020 8321 5427
    • Contact: Lauren Trepte; Phone Number: 020 8321 5427
    • Principal Investigator: Samantha Steele
  • London, United Kingdom
    • Recruiting
    • Chelsea and Westminster Hospital
    • Contact: Shohreh Ghazali; Phone Number: 07436 855 864
    • Contact: Joanna Chilvers; Phone Number: 07436 855 864
    • Principal Investigator: Angela Yulia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Low risk women (nulliparous and multiparous).
• Pregnant women between 39 and 41+5 weeks of gestation.
• Singleton pregnancy.
• Aged 18 years or older.
• Intact fetal membranes at the time of recruitment.
• Unfavourable cervix (Bishop Score <6)
• The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements.

Exclusion Criteria:

• Multiple pregnancy;
• Breech presentation;
• Contraindication to vaginal birth placenta praevia, transverse lie, known or suspected cephalo-pelvic disproportion;
• Rupture of membranes;
• Parity >3;
• Clinical evidence of fetal growth restriction,
• Fetal macrosomia (>95th centile or absolute weight >4.5kg);
• Presence of reduced fetal movements, abnormal CTG or recent antepartum haemorrhage.
• Medical conditions: (anaemia [<100g/l], liver disease, diabetes, preeclampsia, obstetric cholestasis, renal disease, cardiac disease, sexually transmitted infections, bleeding disorders, on anticoagulants, steroid or aspirin therapy); prior uterine operations (Caesarean Section or myomectomy)
• Lives alone, >30 minutes from hospital, no personal transport to hospital.
• Contra-indications to mifepristone including chronic adrenal, hepatic, renal failure,
• Hypersensitivity to mifepristone or to any excipients, malnutrition severe asthma uncontrolled by therapy and inherited porphyria.
• Severe asthma uncontrolled by therapy and inherited porphyria
• Any investigational drug within 30 days prior to the trial drug administration.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mifepristone and standard of care; Mifepristone 300mg once only and standard of care	Drug: Mifepristone; Progestin Antagonist
Placebo Comparator: Placebo; Placebo 300mg once only and standard of care	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of women in labour or delivered within 48 hours of intervention	To determine proportion of women in established labour (contracting >2/10 minutes with progressive cervical change) or delivered within 48 hours of intervention with Mifepristone (superiority).	up to 48 hours after administration of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in clinical outcomes	Occurrence of changes in clinical outcomes such as cervical ripening, interval to labour onset and interval to delivery.	up to 6 weeks after delivery
Determine whether intervention reduces resource utilisation and patient experience	Patient reported outcomes will be collected following administration of questionnaires after delivery and up to 6 weeks after delivery	after delivery and up to 6 weeks after delivery
To assess the efficacy and safety of Mifepristone for the outpatient induction of labour	Incidence and severity of adverse events in maternal and neonatal	up to 6 weeks after delivery

Collaborators and Investigators

• Sponsor: Chelsea and Westminster NHS Foundation Trust
• Investigators: Study Chair: Mark Johnson, Chelsea and Westminster NHS Foundation Trust; Study Director: Damon Foster, Chelsea and Westminster NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2023
• Primary Completion (Estimated): October 9, 2025
• Study Completion (Estimated): October 9, 2026

Study Registration Dates

• First Submitted: November 17, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Abortifacient Agents; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Mifepristone
• Other Study ID Numbers: CW003; 2021-004860-93 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Research team wishes to enable any meta-analyses of such trials making appropriate requests. No plan to share IPD has been made at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No