Abstract
Objective 17-α-hydroxyprogesterone caproate (17-OHP) has been recommended by professional societies
for the prevention of recurrent preterm birth, but subsequent clinical studies have
reported conflicting efficacy results. This study aimed to contribute to the evidence
base regarding the effectiveness of 17-OHP in clinical practice using real-world data.
Study Design A total of 4,422 individuals meeting inclusion criteria representing recurrent spontaneous
preterm birth (sPTB) were identified in a database of insurance claims, and 568 (12.8%)
received 17-OHP. Crude and propensity score-matched recurrence rates and risk ratios
(RRs) for the association of receiving 17-OHP on recurrent sPTB were calculated.
Results Raw sPTB recurrence rates were higher among those treated versus not treated; after
propensity score matching, no association was detected (26.3 vs. 23.8%, RR = 1.1,
95% CI: 0.9–1.4).
Conclusion We failed to identify a beneficial effect of 17-OHP for the prevention of spontaneous
recurrent preterm birth in our observational, U.S. based cohort.
Key Points
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We observed higher risk for sPTB in the group receiving 17-OHP in the unmatched analysis
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After propensity-score matching, we still failed to identify a beneficial effect of
17-OHP on sPTB
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Sensitivity analyses demonstrated robustness to the inclusion criteria and modeling
assumptions.
Keywords
progesterone - obstetrics - observational data - propensity score - premature rupture
of membranes - spontaneous preterm delivery
