Is progesterone a cost-effective way to prevent preterm birth? (The OPPTIMUM trial)

Professor Jane Norman (Edinburgh), Professor Andrew Shennan (London), Professor Dame Tina Lavender (Manchester). Jane Brewin (Tommy’s Chief Executive) sits on the trial steering committee.

Research carried out in Tommy’s centres has shown that progesterone doesn’t lower the risk of premature birth.

This research study is now complete

Around 60,000 babies are born too early every year in the UK. The OPPTIMUM trial was a double-blind randomised control trial that aimed to lower this number. It looked at whether giving progesterone to women at high risk of premature labour might prevent preterm births. Women took progesterone – a hormone that is naturally made by the body and helps maintain pregnancy – vaginally, every day between 22 and 34 weeks of pregnancy.

OPPTIMUM involved researchers from three of Tommy’s centres, and around 1,300 women from over 60 centres around the UK took part.

Results

The study, which finished in 2015, showed that progesterone didn’t have any significant effect on decreasing the number of premature births. There was also no longer-term benefit to children after 2 years. 

Timing

2013-2015

Research paper

Norman JE, Marlow N, Messow CM et al. Does progesterone prophylaxis to prevent preterm labour improve outcome? A randomised double-blind placebo-controlled trial (OPPTIMUM). Health Technol Assess. 2018 Jun;22(35):1-304. doi: 10.3310/hta22350.

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Funding

This study took place in three of Tommy's centres and was funded by the Medical Research Council

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