drugset / Trial / NCT04726085

Ibuprofen Versus Indomethacin Following Emergent Cerclage Placement

NCT04726085 ↗

Terminated 11 enrolled Woman's
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-02-01
Primary completion
2023-11-06
Completion
2023-11-06

Outcome

Outcome not reported

Stopped: “Investigative team moved institutions”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ibuprofen Small molecule 600 mg —
Comparator Indomethacin Small molecule 50 mg —

Indications

No indication recorded.