Multifactorial Approach to Emergent Cerclage (RECIA)

Northwestern University

Status: Completed

Conditions: Cervical Insufficiency

Treatments: Drug: Indomethacin and antibiotics (cefazolin or clindamycin)

Study type: Interventional

Funder types: Other

Identifiers

NCT01114516

STU00019610

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

control

No Intervention group

Description:

emergent cerclage with no peri-operative antibiotics or indomethacin

indomethacin and antibiotics

Experimental group

Description:

perioperative antibiotics and indomethacin

Treatment:

Drug: Indomethacin and antibiotics (cefazolin or clindamycin)