PROMISE: first-trimester progesterone therapy in women with a history of unexplained recurrent miscarriages - a randomised, double-blind, placebo-controlled, international multicentre trial and economic evaluation

Coomarasamy A, Williams H, Truchanowicz E, Seed PT, Small R, Quenby S, Gupta P, Dawood F, Koot YE, Bender Atik R, Bloemenkamp KWM, Brady R, Briley A, Cavallaro R, Cheong YC, Chu J, Eapen A, Essex H, Ewies A, Hoek A, Kaaijk EM, Koks CA, Li T-C, MacLean M, Mol BW, Moore J, Parrott S, Ross JA, Sharpe L, Stewart J, Trépel D, Vaithilingam N, Farquharson RG, Kilby MD, Khalaf Y, Goddijn M, Regan L, Rai R
Record ID 32010000362
English
Authors' objectives: Progesterone is essential to maintain a healthy pregnancy. Guidance from the Royal College of Obstetricians and Gynaecologists and a Cochrane review called for a definitive trial to test whether or not progesterone therapy in the first trimester could reduce the risk of miscarriage in women with a history of unexplained recurrent miscarriage (RM). The PROMISE trial was conducted to answer this question. A concurrent cost-effectiveness analysis was conducted.
Authors' recommendations: There is no evidence that first-trimester progesterone therapy improves outcomes in women with a history of unexplained RM.
Details
Project Status: Completed
URL for project: http://www.nets.nihr.ac.uk/projects/hta/083801
Year Published: 2016
URL for published report: http://www.journalslibrary.nihr.ac.uk/hta/hta20410/#/abstract
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: England, United Kingdom
MeSH Terms
  • Abortion, Habitual
  • Luteal Phase
  • Pregnancy
  • Pregnancy Outcome
  • Progesterone
Contact
Organisation Name: NIHR Health Technology Assessment programme
Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
Contact Name: journals.library@nihr.ac.uk
Contact Email: journals.library@nihr.ac.uk
Copyright: <p>2010 Queen's Printer and Controller of HMSO</p>
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