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Open trials

The PROMISE: PROgesterone in early MIScarriage

PromiseLogoChief Investigator:  Dr Rajendra Rai
Principal Investigator: Dr Yacoub Khaliff
Sponsor: Imperial College London and Imperial College Healthcare NHS Trust

Background

Miscarriage is the commonest complication of pregnancy – affecting 1 in 6 clinically recognised pregnancies.

Recurrent miscarriage is a distinct clinical entity. The incidence of 1% is significantly higher than that expected by chance alone (0.4%) and, in contrast to women with sporadic miscarriage, those with RM tend to lose genetically normal pregnancies. Even after comprehensive investigations, a cause for RM is identified in less than 50% of couples. The evidence regarding treatment with progesterone to prevent pregnancy loss in women with recurrent miscarriage is inconclusive and contradictory. In many cases this is due to small sample size or poorly conducted studies.

Trial aims

To test the hypothesis that in women with unexplained recurrent miscarriages, progesterone (400mg pessaries, twice daily), started as soon as possible after a positive pregnancy test (at < 6 weeks gestation) and continued to 12 weeks of gestation, compared to placebo, increases live births beyond 24 completed weeks of pregnancy by at least 10%.

Secondary aims
  1. To test the hypothesis that progesterone improves various pregnancy and neonatal outcomes.
  2. To test the hypothesis that progesterone, compared to placebo, does not incur substantial adverse effects to the mother or the neonate.
  3. To explore differential or subgroup effects of progesterone in various prognostic subgroups.
  4. To perform an economic evaluation for cost-effectiveness.

Trial design

Multicentre double blind randomised controlled trial 

Participating centres

  • Imperial College Healthcare NHS Trust St Mary’s 
  • Birmingham Women’s NHS Trust
  • Liverpool Women’s NHS Foundation Trust
  • Guy’s and St Thomas’ NHS Foundation Trust
  • Sheffield Royal Teaching Hospitals NHS Trust. Royal Hallamshire Hospital
  • Southampton University Hospitals NHS Trust
  • NHS Ayrshire and Arran: Crosshouse Hospital
  • Academic Medical Center, Amsterdam, Holland

Website

www.medscinet.net/promise

Trial Identification Numbers

MREC: 
UKCRN Portfolio: 
ISRCTN: 92644181 
EudraCT: 2009-011208-42
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