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Background

Preterm birth is the leading cause of infant death and long-term disability worldwide. Despite completion of many trials and several systematic reviews and meta-analyses, there remains significant uncertainty regarding the specific conditions in which progesterone may be effective in preventing or delaying preterm birth - to whom should it be offered and in what form. Resolving this uncertainty could have important impact, providing robust evidence to help pregnant women at risk of preterm birth make informed choices. Given the lifelong consequences, even a small change in the rate of preterm births could yield significant benefit.

The EPPPIC IPD meta-analysis aims to provide a comprehensive evaluation of the effectiveness of progestogens in preventing preterm birth, considering both benefits and potential harms.

Scope

EPPPIC will evaluate

1. Effectiveness of any progestogen versus no active intervention (co-treatment is permitted)
2. Effectiveness of vaginally administered progesterone versus 17-OHPC versus oral medroxyprogesterone acetate (co-treatment is permitted)

Exploring potential differences in effectiveness according to type of progestogen and route of administration

Considering impact on preterm birth (<37 weeks, <34 weeks, <28 weeks), fetal/neonatal death, serious neonatal complications, infant disability and important maternal morbidity.

In asymptomatic women considered at high risk of preterm birth, but not at immediate risk of preterm birth, and not those for whom progestogen is administered to prevent miscarriage and does not continue beyond 16 weeks of gestation.

Separate evaluation of singleton and of multiple gestation pregnancies exploring:

Whether effectiveness differs according to key risk factors at trial entry (previous spontaneous preterm birth, multiple gestation pregnancy, cervical length, positive fetal fibronectin test) and additional trial and patient-level characteristics to investigate whether there are particular types of woman or pregnancy that derive greater benefit (or harm) from intervention.

Methods

EPPPIC will follow the approach and methods set out in a registered protocol, will adhere to international standards for systematic review and be reported in accordance with PRISMA-IPD.

Organisation

EPPPIC will be an international partnership comprising trial investigators who contribute data for analysis, members of the Secretariat which includes stakeholder representatives, and the IPD-MA research team. We will work together to provide a definitive evaluation of the existing evidence. The project will be carried out on behalf of, and published by, the EPPPIC Group.