Emily S Miller1, William A Grobman, Linda Fonseca, Barrett K Robinson. 1. Departments of Obstetrics and Gynecology, Northwestern University, Feinberg School of Medicine, Chicago, Illinois, University of Texas Southwestern-Austin, Austin, Texas, Indiana University School of Medicine, Indianapolis, Indiana.
Abstract
OBJECTIVE: To evaluate whether perioperative indomethacin and antibiotic administration at the time of examination-indicated cerclage placement prolongs gestation. METHODS: 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 0/7 and 23 6/7 weeks of gestation undergoing an examination-indicated cerclage were eligible. Women were randomly assigned to receive either perioperative indomethacin and antibiotics or no perioperative prophylactic medications. The primary outcome was gestational latency after cerclage placement. Fifty women were required to be randomized to show, with 80% power, a 28-day improvement in latency assuming a latency without intervention of 50±35 days. RESULTS:Fifty-three patients were enrolled with three lost to follow-up. A greater proportion of pregnancies were prolonged by at least 28 days among women who received indomethacin and perioperative antibiotics (24 [92.3%] compared with 15 [62.5%], P=.01). However, gestational age at delivery and neonatal outcomes were statistically similar between groups. CONCLUSIONS: Among women receiving an examination-indicated cerclage in the second trimester, gestation was significantly more likely to be prolonged by 28 days among women who received perioperative indomethacin and antibiotics. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01114516. LEVEL OF EVIDENCE: I.
RCT Entities:
OBJECTIVE: To evaluate whether perioperative indomethacin and antibiotic administration at the time of examination-indicated cerclage placement prolongs gestation. METHODS: 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 0/7 and 23 6/7 weeks of gestation undergoing an examination-indicated cerclage were eligible. Women were randomly assigned to receive either perioperative indomethacin and antibiotics or no perioperative prophylactic medications. The primary outcome was gestational latency after cerclage placement. Fifty women were required to be randomized to show, with 80% power, a 28-day improvement in latency assuming a latency without intervention of 50±35 days. RESULTS: Fifty-three patients were enrolled with three lost to follow-up. A greater proportion of pregnancies were prolonged by at least 28 days among women who received indomethacin and perioperative antibiotics (24 [92.3%] compared with 15 [62.5%], P=.01). However, gestational age at delivery and neonatal outcomes were statistically similar between groups. CONCLUSIONS: Among women receiving an examination-indicated cerclage in the second trimester, gestation was significantly more likely to be prolonged by 28 days among women who received perioperative indomethacin and antibiotics. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01114516. LEVEL OF EVIDENCE: I.
Authors: George U Eleje; Ahizechukwu C Eke; Joseph I Ikechebelu; Ifeanyichukwu U Ezebialu; Princeston C Okam; Chito P Ilika Journal: Cochrane Database Syst Rev Date: 2020-09-24