Abstract
BackgroundPreterm birth (PTB) is estimated to affect 14.9 million babies globally every year. Global rates of PTB continue to increase from 9.8 to 10.6% over a 15-year period from 2000 to 2014. Vaginal progesterone is commonly used by clinicians as a prevention strategy, with recent evidence affirming the benefit of vaginal (micronised) progesterone to prevent PTB in women with a shortened cervix (< 25 mm). Given the low incidence of a short cervix at mid-gestation in high-risk populations further evidence is required. The objective of this review is to determine if vaginal progesterone reduces spontaneous preterm birth (sPTB) before 37 weeks in asymptomatic high-risk women with a singleton pregnancy with a normal mid-gestation cervical length.MethodsStudies will be sourced from MEDLINE, Embase and Cochrane Register of Trials (CENTRAL) from their inception onwards with the search terms ‘progesterone’ and ‘preterm birth’. Studies will be screened and included if they assess vaginal progesterone compared to placebo in women with a normal cervical length. The primary outcome will be sPTB < 37 weeks, with secondary outcomes of sPTB < 34 weeks.Two independent reviewers will conduct study screening at abstract and full text level, data extraction and risk of bias assessment with disagreements resolved by an experienced researcher. The Mantel-Haenszel statistical method and random effects analysis model will be used to produce treatment effect odds ratios and corresponding 95% confidence intervals.DiscussionThis review will assess the current body of evidence and provide clarity regarding the potential benefits and best practice of use of vaginal progesterone in asymptomatic women with high-risk singleton pregnancies and normal cervical length.Trial registrationPROSPERO CRD42020152051
Highlights
Preterm birth (PTB) is estimated to affect 14.9 million babies worldwide every year [1], with a higher burden in low- and middle-income countries [2]
Despite approximately 80% of these preterm births occurring in disadvantaged countries in sub-Saharan Africa and Asia, data suggests that rates of PTB are steadily increasing in high-income countries [2]
A recent individual patient data (IPD) meta-analysis affirmed the benefit of vaginal progesterone in prevention of spontaneous preterm birth (sPTB) in women with a short cervix (< 25 mm) with a 20% reduction in sPTB before 36 weeks, and a greater reduction of 35% before 34 weeks [8]
Summary
Preterm birth (PTB) is estimated to affect 14.9 million babies worldwide every year [1], with a higher burden in low- and middle-income countries [2]. Despite approximately 80% of these preterm births occurring in disadvantaged countries in sub-Saharan Africa and Asia, data suggests that rates of PTB are steadily increasing in high-income countries [2]. This is a worrying trend as PTB remains the leading cause of death for children under the age of five [4]. The objective of this review is to determine if vaginal progesterone reduces spontaneous preterm birth (sPTB) before 37 weeks in asymptomatic high-risk women with a singleton pregnancy with a normal mid-gestation cervical length
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