Ibuprofen Versus Indomethacin Following Emergent Cerclage Placement

Preterm Labor Clinical Trial

— TOCO  

Official title:

Efficacy of Ibuprofen Versus Indomethacin as Perioperative Prophylactic Treatment Following Emergent Cerclage Placement for Pregnancy Prolongation: A Randomized Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04726085
• Other study ID #: RP-20-028
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: June 1, 2025

Study information

• Verified date: December 2023
• Source: Woman's
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: June 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Preterm Labor

Intervention

Drug:
• Indomethacin 150mg
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 2400mg
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.

Locations

Country	Name	City	State
United States	Woman's Hospital	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Woman's

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational latency	Days from cerclage placement to delivery, assessed up to 26 weeks	From cerclage placement to delivery
Secondary	Preterm birth	Birth before 37 weeks gestation	At delivery