Ibuprofen Versus Indomethacin Following Emergent Cerclage Placement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2023-11-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Preterm Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ibuprofen

Ibuprofen 600 mg q6 hours for 24 hours- total dose of 2400mg- after emergent cerclage placement

Group Type ACTIVE_COMPARATOR

Ibuprofen 2400mg

Intervention Type DRUG

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.

Indomethacin

Indomethacin 50 mg q8 hours for 24 hours- total dose of 150mg- after emergent cerclage placement

Group Type ACTIVE_COMPARATOR

Indomethacin 150mg

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes