Multifactorial Approach to Emergent Cerclage

Summary

Though cervical insufficiency is a common cause of second trimester pregnancy loss, the placement of an emergent cerclage in these patients is thought to improve perinatal outcomes. It is unknown whether the use of tocolytics and antibiotics prolongs pregnancies complicated by need for emergent cerclage. The objective is to determine whether administration of peri-operative antibiotics and indomethacin to patients receiving emergent cerclages for cervical insufficiency increases latency period to delivery compared with patients receiving emergent cerclage alone.

Timeline

Start

2010-03

Primary completion

2013-03

Completion

2014-03

Outcome

Met primary endpoint

registry MEDIAN Indomethacin and Antibiotics: 97 (57 to 125) days NCT01114516 ↗

registry Control vs Indomethacin and Antibiotics; p = 0.018; Log Rank NCT01114516 ↗

paper A greater proportion of pregnancies were prolonged by at least 28 days among women who received indomethacin and perioperative antibiotics PMID 24807330 ↗

Publications

• Results Miller ES, Grobman WA, Fonseca L, Robinson BK. Indomethacin and antibiotics in examination-indicated cerclage: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1311-1316. doi: 10.1097/AOG.0000000000000228.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cefazolin	Small molecule	1 g	Intravenous
Subject	Clindamycin	Unknown	600 mg	Intravenous
Subject	Indomethacin	Small molecule	50 mg	Oral

Indications