PROgesterone in recurrent MIScarriagE
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.
Randomized, double-blind, placebo controlled multicentre study
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.
Primary: Live birth rate.
Secondary: Miscarriage rate, gestational age at delivery, adverse events, serum progesterone luteal phase.
Dr Arri Coomarasamy, MBChB, MD, MRCOG
Dr. M. Goddijn
1105 AZ Amsterdam ZO