Preterm birth is the leading cause of infant death and long-term disability. Although well-studied in clinical trials and systematic reviews, there remains considerable uncertainty and controversy regarding the specific conditions in which progesterone may be effective in preventing or delaying preterm birth: to whom it should be offered and in what form. Resolving this uncertainty could help pregnant women at risk of preterm birth make more personalized and better informed care choices. Given the lifelong consequences, even a small change in the rate of preterm births could yield significant benefits. An IPD meta-analysis (MA) of randomized controlled trials offers a robust methodology for evaluating conditions under which progesterone may be effective in preventing preterm birth and associated outcomes in women at risk of early delivery.
- Assess the benefits and harms of progesterone (in different forms, doses, routes of administration, and timing) when used for the prevention of preterm birth;
- Investigate whether there are any particular therapeutic approaches that are more effective than others; and
- Explore whether there are particular types of women who derive greater benefit (or harm) from progesterone.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.