Ibuprofen Versus Indomethacin Following Emergent Cerclage Placement

Woman's11 enrolled

Overview

Cervical insufficiency is defined as painless cervical dilation in the second trimester. Cervical insufficiency can ultimately lead to second trimester loss of pregnancy. Cerclages are utilized in pregnancies affected by cervical insufficiency in order to prolong gestational latency. There have been several studies investigating the efficacy of perioperative medications for cerclage placement and the effects they have on gestational latency. Some such studies have found that perioperative indomethacin in combination with antibiotics have significantly increased gestational latency when compared to placebo. Indomethacin has traditionally been the tocolytic of choice with cerclage placement. At our hospital, ibuprofen has been the tocolytic of choice for cerclage placement secondary to pharmacy availability. Our study aims to evaluate whether gestational latency differs among patients undergoing emergent cerclage whether they receive perioperative ibuprofen or indomethacin.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Preterm Labor

Interventions

Patients will be randomized to either received perioperative indomethacin or ibuprofen at the time of their emergent cerclage placement for 24 hours following surgery. Patient will be followed up through our electronic medical record system to determine gestational latency to evaluate if ibuprofen is inferior to indomethacin.

Ibuprofen 2400mgDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Viable, singleton pregnancy * ≥ 18 years old * Gestational age 16 weeks 0/7 days - 23 week 6/7 days (inclusive) * Intact membranes at time of enrollment * Planning to deliver at Woman's Hospital * Exam or ultrasound indicated cerclage placement Exclusion Criteria: * Contraindication to treatments (i.e. ibuprofen or indomethacin) * Unwilling to be randomized to treatment * Prophylactic cerclage placement * Temperature greater than 100.4 * Known major fetal congenital anomaly * Prior cerclage placement during the current pregnancy * Recent (within 7 days) receipt of ibuprofen or indomethacin

Outcomes

Primary Outcomes

Gestational latency

Days from cerclage placement to delivery, assessed up to 26 weeks

Time frame: From cerclage placement to delivery

Secondary Outcomes

Preterm birth

Birth before 37 weeks gestation

Time frame: At delivery