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Promise trial


PROgesterone in recurrent MIScarriagE


Go to the Promise website



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



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
Birmingham Women’s Hospital
Metchley park Road
B15 2TG Birmingham, UK


Dr. M. Goddijn

AMC (H4-205)

Meibergdreef 9

1105 AZ Amsterdam ZO