Study information
Promise trial
PROgesterone in recurrent MIScarriagE
Objective
To assess improvement in live birth rate after progesterone supplementation.
In the absence of properly randomized controlled trials that assessed the efficacy of progesterone in women with RM, a clinical trial with adequate randomization is necessary. In clinical practice, women with RM are frequently seeking advice about the indication for progesterone treatment. Therefore, we have designed a randomized clinical trial to assess the efficacy of progesterone, as compared with placebo, on the live birth rate in women with at least 3 preceding miscarriages.
Study design
Randomized, double-blind, placebo controlled multicentre study
Study population
Women with recurrent miscarriage, i.e. at least 3 miscarriages, aged 18-39 years, conceiving spontaneously
Intervention
One group receives vaginal progesterone pessaries 2x 200 mg twice daily (Utrogestan®) and the other group receives placebo pessaries of identical appearance twice daily.
Outcome measures
Primary: Live birth rate.
Secondary: Miscarriage rate, gestational age at delivery, adverse events, serum progesterone luteal phase.
Project leaders
Dr Arri Coomarasamy, MBChB, MD, MRCOG
Senior lecturer and Consultant
Gynaecologist
Birmingham Women’s Hospital
Metchley park Road
B15 2TG Birmingham, UK
arricoomar@blueyonder.co.uk
Dr. M. Goddijn
AMC (H4-205)
Meibergdreef 9
1105 AZ Amsterdam ZO