Mifepristone Outpatient Labour Induction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-25

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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 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 2 days after treatment regimen will be completed as an in-patient.

Conditions

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Labor, Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blinded parallel group randomised control trial. Intervention arm Mifepristone plus standard care, comparator arm placebo plus standard of care .

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

This is a double parallel group randomised control trial

Study Groups

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Placebo

Placebo 300mg once only and standard of care

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Mifepristone and standard of care

Mifepristone 300mg once only and standard of care

Group Type EXPERIMENTAL

Mifepristone

Intervention Type DRUG

Progestin Antagonist

Interventions

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Mifepristone

Progestin Antagonist

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Pregnant women between 36+5 and 41+5 weeks of gestation
2. Singleton pregnancy
3. Aged 18 years or older
4. Unfavourable cervix (Bishop Score less than or equal to 6)
5. 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

1. Breech presentation
2. Early labour
3. Contraindication to vaginal birth (placenta praevia, transverse lie, known or suspected cephalo-pelvic disproportion or other factor contraindicated to vaginal birth in the opinion of the investigator)
4. Fetal growth restriction with oligohydramnios and/or abnormal Dopplers
5. Presence of reduced fetal movements requiring urgent delivery, abnormal CTG or recent antepartum haemorrhage requiring immediate delivery
6. Medical conditions:

i. sexually transmitted infections (active infections only) ii. bleeding disorders, on anticoagulants, steroid or aspirin therapy iii. prior uterine operations (Caesarean Section or myomectomy)
7. Contra-indications to mifepristone including chronic adrenal, hepatic, renal failure
8. Hypersensitivity to mifepristone or to any excipients, or malnutrition
9. Severe asthma uncontrolled by therapy and inherited porphyria
10. Any investigational drug with an expected interaction with mifepristone which has been administered within 30 days prior to the trial drug administration.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No