Ibuprofen Versus Indomethacin Following Emergent Cerclage Placement

Study Overview
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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.

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

Conditions
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Preterm Labor

Intervention / Treatment
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* Drug: Indomethacin 150mg
* Drug: Ibuprofen 2400mg


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ibuprofen<br>Ibuprofen 600 mg q6 hours for 24 hours- total dose of 2400mg- after emergent cerclage placement | Drug: Ibuprofen 2400mg<br>* 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.<br>|
| Active Comparator: Indomethacin<br>Indomethacin 50 mg q8 hours for 24 hours- total dose of 150mg- after emergent cerclage placement | Drug: Indomethacin 150mg<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational latency | Days from cerclage placement to delivery, assessed up to 26 weeks | From cerclage placement to delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm birth | Birth before 37 weeks gestation | At delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerclage