Progesterone in Recurrent Miscarriages (PROMISE) Study

• Research type

  Research Study

• Full title

  First trimester progesterone therapy in women with a history of unexplained recurrent miscarriages: A randomised, double-blind, placebo-controlled, multi-centre trial [The PROMISE (PROgesterone in recurrent MIScarriagE) Trial] Funded by NIHR-HTA(UK) 08/38/01 for £1.2million

• IRAS ID

  15825

• Eudract number

  2009-011208-42

• ISRCTN Number

  ISRCTN92644181

• Research summary

  Title: Progesterone in Recurrent Miscarriages - A Randomised Trial (PROMISE). Objectives: This study will randomly assign women to either progesterone or placebo pessaries if they have had 3 or more previous miscarriages (of unexplained cause) and have now become pregnant. The primary objective is to evaluate if progesterone therapy results in more live born babies (over the gestation of 24 weeks). We will also report on various other pregnancy, safety, and health economic outcomes. Design: Participants will receive either progesterone or placebo pessaries twice a day, and neither the participants nor the carers will know which of the two preparations is being given (This is necessary to produce a scientifically valid answer). Participation: Eligible women will be invited via any of the recruitment centres to have a consultation with a research nurse or doctor to discuss the study, who will also check for eligibility in the study. If eligible, then the participant's expected to try to become pregnant for up to 1 year, and if pregnancy is achieved, then the research nurse will send the necessary medication via couriers with instructions and telephone support. Funding: The trial has received funding from the government of UK (NIHR-HTA for œ1.2m). Importance of this study: recurrent miscarriages affect over 6000 couples in the UK every year, causing substantial physical and psychological impact; for instance, studies have shown that the level of distress and the bereavement reaction associated with miscarriages are no less when compared to women who had suffered a stillbirth of a term baby. If the benefit shown in the existing studies is confirmed in our study, we expect the uptake of this treatment to be rapid and widespread given the low cost of progesterone, its well known safety profile and convenience (outpatient use, taken as pessaries). Progesterone is already in clinical use for the prevention of preterm births.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  09/H1208/44

• Date of REC Opinion

  19 Oct 2009

• REC opinion

  Further Information Favourable Opinion