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218: Does adjunctive use of progesterone in women with cerclage improve prevention of preterm birth?

      Objective

      Preterm birth (PTB) is the leading cause of neonatal morbidity and mortality. Some patients have clear indications for cerclage (C), intramuscular progesterone (17-OHP), or vaginal progesterone (Vag P). However, in patients with an unclear clinical picture, providers may combine interventions. The objective of this study is to evaluate outcomes in women with C compared to women with C and adjunctive progesterone (P).

      Study Design

      A retrospective cohort study was performed from 10/2011 - 6/2014. Women with C placement during the study period were identified through a query of the computerized surgery database. Exclusion criteria included multiple gestations, patients simultaneously on 17-OHP and Vag P, and patients lost to follow-up. The primary outcome was prevention of PTB <35 weeks. Statistical analysis including parametric and non-parametric tests were employed as indicated. Logistic regression was performed to calculate odds ratios and 95% confidence intervals and to adjust for confounders (including indication for C or P). Kaplan-Meier (KM) estimates were created for each subgroup from time of C placement to delivery with statistical significance determined using log rank test p-value of <0.05.

      Results

      Of 144 women meeting inclusion criteria, 81 had C only, 53 had C + 17-OHP, and 10 had C + Vag P. Compared to C only, women with either type of P delivered at similar gestational ages (GA): 34.9 ± 5.89 vs. 33.8 ± 6.09 weeks, respectively; p = 0.27. There was no significant difference in GA at delivery between those with C only versus cerclage + 17-OHP: 34.9 ± 5.9 vs 34.4± 6.03 weeks, respectively; p=0.63. However, women with C + Vag P delivered earlier than women with C only: 30.59 ± 5.58 vs. 34.84 ± 5.91 weeks, respectively; p = 0.044. Women with C + Vag P had an adjusted OR for delivery < 35 weeks compared with C only of 5.09 (95% CI: 1.12 - 23.09). The KM plot demonstrates that women with C + Vag P are significantly more likely to deliver sooner than the other groups (Figure 1). Neonatal outcomes were not improved by C + any P (data not shown).

      Conclusion

      The study found that the use of C only or combined with any P did not prevent PTB <35 weeks or adverse neonatal outcomes. Women receiving C and Vag P are significantly more likely to deliver earlier possibly indicating a higher risk group that could benefit from further studies.
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