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To determine whether perioperative antibiotics and indomethacin administration at the time of exam-indicated second-trimester cerclage placement significantly prolongs gestation.
This is a randomized controlled trial performed at a single tertiary care hospital between March 2010 and November 2012. Women older than 18 years of age with a singleton pregnancy between 16+0 and 23+6 weeks gestation who were undergoing an exam-indicated cerclage were eligible. Women were randomly assigned to receive either perioperative antibiotics (either cefazolin 1-2mg based on weight or 600mg clindamycin IV pre-operatively followed by 2 additional doses q8 hours) and indomethacin (50mg PO immediately post-operatively followed by 2 additional doses q8 hours) or no peri-operative prophylactic medications. The primary outcome was gestational latency after cerclage placement. Using 80% power and an alpha of 0.05, we needed 50 women to show a 28 day improvement in latency assuming a baseline latency without intervention of 50 ± 35 days.
Fifty-three subjects were enrolled in the study, with three lost to follow-up. There was no difference between groups in demographic characteristics, obstetric history, or pre-operative cervical exam. A significantly greater proportion of pregnancies were prolonged by at least 28 days among women who received perioperative antibiotics and indomethicin [24 (92.3%) vs 15 (62.5%), p=0.01]. However, median latency, gestational age at delivery, and neonatal outcomes were statistically similar between groups.
Among women receiving an exam-indicated cerclage in the second trimester, gestation was significantly more likely to be prolonged by 4 weeks among women who received perioperative indomethacin and antibiotics. Larger studies will be necessary to determine whether this pregnancy prolongation can translate into improvements in neonatal outcomes.
1Obstetric and neonatal outcomes
NICU, neonatal intensive care unit; PPROM, preterm premature rupture of membranes.