Multifactorial Approach to Emergent Cerclage

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Cefazolin; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Indomethacin

Criteria

Inclusion Criteria:

• GA 16+0 to 23+6 weeks

• Singleton gestation

• Presence of cervical dilation as diagnosed on digital examination

• Intact membranes

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