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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).
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.
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).
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.