Multifactorial Approach to Emergent Cerclage

Not Applicable

Completed

• Conditions: Cervical Insufficiency
• Interventions: Drug: Indomethacin and antibiotics (cefazolin or clindamycin)

• Registration Number: NCT01114516
• Lead Sponsor: Northwestern University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-29
• Study First Submitted QC: 2010-04-30
• Study First Posted: 2010-05-03
• Primary Completion: 2013-03
• Study Completion: 2014-03
• Results First Submitted: 2014-09-08
• Results First Submitted QC: 2014-10-05
• Results First Posted: 2014-10-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-05
• Last Update Posted: 2014-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 53

Inclusion Criteria

• GA 16+0 to 23+6 weeks
• Singleton gestation
• Presence of cervical dilation as diagnosed on digital examination
• Intact membranes

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Exclusion Criteria

• Age <18 years
• Allergy to NSAIDs
• Renal disease
• Allergy to penicillins AND clindamycin
• Currently on antibiotics or indomethacin for any reason
• HIV positive
• Pregnancies complicated by fetal congenital anomalies
• Preterm premature rupture of membranes
• Fever of 100.4 degrees Fahrenheit or higher
• Any patient having received a therapeutic cerclage during the current pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
indomethacin and antibiotics	Indomethacin and antibiotics (cefazolin or clindamycin)	perioperative antibiotics and indomethacin

Primary Outcome Measures

Name	Time	Method
Gestational Latency Achieved Between Cerclage Placement and Time of Delivery	24 weeks	Median gestational latency achieved Between Cerclage Placement and Time of Delivery

Secondary Outcome Measures

Name	Time	Method
Neonatal Morbidity and Mortality	1 year	Days spent in the neonatal intensive care unit
Gestational Latency of More Than 28 Days	28 days postpartum	The frequency of achieving a gestational latency of more than 28 days
Gestational Age at Delivery	24 weeks	Median gestational age at delivery
Birthweight	24 weeks	Median birthweight

Trial Locations

Locations (1)

Prentice Women's Hospital; 🇺🇸 Chicago, Illinois, United States