Conditions: Cervical Insufficiency
Keywords: cervical insufficiency
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 53
Healthy volunteers: no

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:

Arms:
arm 1: emergent cerclage with no peri-operative antibiotics or indomethacin arm 2: perioperative antibiotics and indomethacin

Interventions: intervention 1: Indomethacin and antibiotics (cefazolin or clindamycin)
Intervention descriptions: intervention 1: q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin

Protocol document: