CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 53 enrolled
Drug / intervention
Indomethacin and antibiotics (cefazolin or clindamycin)drug
Likely dose
Indomethacin and antibiotics (cefazolin or clindamycin) 50mgfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01114516
NCT01114516N/ACompleted

Role in Emergent Cerclage of Indomethacin and Antibiotics

Northwestern University·interventional·Posted May 3, 2010·Updated Nov 7, 2014

In Brief

A clinical study evaluating Indomethacin and antibiotics (cefazolin or clindamycin) for Cervical Insufficiency. Completed, enrolled 53 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 3, 2010
Enrollment StartMar 1, 2010
Primary CompletionMar 1, 2013
Study CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 16.2 years ago

Interventions

Indomethacin and antibiotics (cefazolin or clindamycin)drug

q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin