PROgesterone in recurrent MIScarriagE
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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