Ibuprofen Versus Indomethacin Following Emergent Cerclage Placement

Stopped early · Not applicable

Conditions studied: Preterm Labor

In brief

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.

Key facts

Study ID

NCT04726085

Run by

Woman's

People needed

11

Starts

2021-02-01

Expected to finish

2023-11-06

Last updated by the study team

2025-08-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Woman's Hospital — Baton Rouge, Louisiana, United States

Full record on ClinicalTrials.gov

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