Multifactorial Approach to Emergent Cerclage

Completed · Not applicable

Conditions studied: Cervical Insufficiency

In brief

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.

Key facts

Study ID

NCT01114516

Run by

Northwestern University

People needed

53

Starts

2010-03-01

Expected to finish

2014-03-01

Last updated by the study team

2014-11-07

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Prentice Women's Hospital — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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