NCT01114516

Multifactorial Approach to Emergent Cerclage

Role in Emergent Cerclage of Indomethacin and Antibiotics

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Insufficiency

Interventions

Type	Name	Description
DRUG	Indomethacin and antibiotics (cefazolin or clindamycin)	q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin

Timeline

• Start date: 2010-03-01
• Primary completion: 2013-03-01
• Completion: 2014-03-01
• First posted: 2010-05-03
• Last updated: 2014-11-07
• Results posted: 2014-10-10

Locations

1 site across 1 country: United States