Clinical trial

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

Name

RP-20-028

Description

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.

Trial arms

Trial start

2021-02-01

Estimated PCD

2025-01-01

Trial end

2025-06-01

Treatment

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.

Arms:

Indomethacin

Ibuprofen 2400mg

Arms:

Ibuprofen

Size

100

Primary endpoint

Gestational latency

From cerclage placement to delivery

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2023-12-05

1 organization

2 products

1 indication

Organization

Product

Indication

Product