Mifepristone and Misoprostol Versus Misoprostol Alone in the Medical Management of Missed Miscarriage

Summary

Miscarriage is the most common complication of pregnancy. As many as 15-25% of pregnancies end in miscarriage, and the number of miscarriages in England is estimated to be approximately 125,000 per year. Miscarriage often brings not only physical pain, bleeding and risks of infection, but also psychological impacts on women and their families. This study will focus on women whose pregnancy sac remains inside the womb (known as a missed miscarriage) and opt for medical management of their miscarriage up to 13+6 weeks of pregnancy. NICE currently recommends that a drug called misoprostol (a vaginal pessary or oral tablet that makes the womb contract) should be used in the medical treatment of miscarriage. However, there is evidence to suggest that combining this drug with mifepristone (an oral tablet that reduces pregnancy hormones) may be more effective in treating miscarriage. Therefore, to test this in a clinical trial, participants will be allocated at random to receive either mifepristone followed by misoprostol, or a dummy drug (placebo) followed by misoprostol. Neither the participants nor the researchers will know what allocation is decided, which is necessary to test the treatments fairly. The main outcome of interest will be whether miscarriage is complete within 7 days of randomisation. If miscarriage is not complete then further treatment (more tablets or surgery) will be offered. A number of other key outcomes, such as the need for an operation, will also be assessed. We will also study the views and experience of the participants regarding the tablet treatment.

We anticipate that 710 women will be required to take part in the study to answer this question with confidence. We estimate that we would be able to recruit this many women in two years.

Conditions

• Missed Miscarriage

Interventions

DRUG

Mifepristone, Oral, 200 Mg

The Investigational Medicinal Product (IMP) is a single dose of 200mg mifepristone to be taken orally after confirmation of missed miscarriage by pelvic ultrasound scan.

DRUG

Placebo Oral Tablet

The placebo will be an oral tablet in the same form as the IMP, and identical in appearance.

Sponsors & Collaborators

• Birmingham Women's NHS Foundation Trust

  collaborator OTHER_GOV

• Royal Infirmary of Edinburgh

  collaborator OTHER

• Royal Victoria Infirmary

  collaborator OTHER

• City Hospitals Sunderland NHS Foundation Trust

  collaborator OTHER

• Liverpool Women's NHS Foundation Trust

  collaborator OTHER

• The Leeds Teaching Hospitals NHS Trust

  collaborator OTHER

• Barts & The London NHS Trust

  collaborator OTHER

• Queen's Medical Center

  collaborator OTHER

• Heart of England NHS Trust

  collaborator OTHER

• University Hospitals Coventry and Warwickshire NHS Trust

  collaborator OTHER

• Oxford University Hospitals NHS Trust

  collaborator OTHER

• St Mary's Hospital, London

  collaborator OTHER

• University College London Hospitals

  collaborator OTHER

• University Hospital Southampton NHS Foundation Trust

  collaborator OTHER

• King's College Hospital NHS Trust

  collaborator OTHER

• University of Edinburgh

  collaborator OTHER

• University of Nottingham

  collaborator OTHER

• Queen Mary University of London

  collaborator OTHER

• University of Warwick

  collaborator OTHER

• University of Southampton

  collaborator OTHER

• University of Birmingham

  lead OTHER

Principal Investigators

• Arri Coomarasamy · University of Birmingham

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-09-20

Primary Completion

2020-01-09

Completion

2020-01-09

Countries

• United Kingdom

Study Locations