Effectiveness of 17-OHP for Prevention of Recurrent Preterm Birth: A Retrospective Cohort Study

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

• We observed higher risk for sPTB in the group receiving 17-OHP in the unmatched analysis

• After propensity-score matching, we still failed to identify a beneficial effect of 17-OHP on sPTB

• 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

Authors' Contributions

J.B.H. was responsible for designing the study, acquiring the data, writing the code for the analyses, and preparing the manuscript. A.Z. was responsible for acquiring the data, writing the code for the analyses, and preparing the manuscript. S.H.-D. was responsible for preparing the manuscript, and designing the statistical analyses used to debias the observational data. J.M.H. was responsible for preparing the manuscript, and identifying relevant covariates usable to adjust for treatment assignment and outcome differences in the treated and untreated group. B.J.W. was responsible for preparing the manuscript, and identifying relevant covariates usable to adjust for treatment assignment and outcome differences in the treated and untreated group. A.L.B. was responsible for designing the study, designing the statistical analyses used to debias the observational data, and preparing the manuscript.

^* These authors contributed equally to this work.

We observe that some of the modeling approaches result in effect estimates bounded away from zero, with a higher risk in the treated population.

Publikationsverlauf

Eingereicht: 21. Juni 2021

Angenommen: 24. Oktober 2021

Artikel online veröffentlicht:
31. Dezember 2021

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