Status:
TERMINATED
Ibuprofen Versus Indomethacin Following Emergent Cerclage Placement
Lead Sponsor:
Woman's
Conditions:
Preterm Labor
Eligibility:
FEMALE
18+ years
Phase:
NA
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 pre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2023
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04726085
Start Date
February 1 2021
End Date
November 6 2023
Last Update
August 6 2025
Active Locations (1)
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1
Woman's Hospital
Baton Rouge, Louisiana, United States, 70817