Ibuprofen Versus Indomethacin Following Emergent Cerclage Placement

Not Applicable

• Conditions: Preterm Labor
• Interventions: Drug: Ibuprofen 2400mg; Drug: Indomethacin 150mg

• Registration Number: NCT04726085
• Lead Sponsor: Woman's

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-22
• Study First Posted: 2021-01-27
• Study Start: 2021-02-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-05
• Primary Completion: 2025-01-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen	Ibuprofen 2400mg	Ibuprofen 600 mg q6 hours for 24 hours- total dose of 2400mg- after emergent cerclage placement
Indomethacin	Indomethacin 150mg	Indomethacin 50 mg q8 hours for 24 hours- total dose of 150mg- after emergent cerclage placement

Primary Outcome Measures

Name	Time	Method
Gestational latency	From cerclage placement to delivery	Days from cerclage placement to delivery, assessed up to 26 weeks

Secondary Outcome Measures

Name	Time	Method
Preterm birth	At delivery	Birth before 37 weeks gestation

Trial Locations

Locations (1)

Woman's Hospital; 🇺🇸 Baton Rouge, Louisiana, United States