Ibuprofen Versus Indomethacin Following Emergent Cerclage Placement (TOCO)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Preterm Labor
• Intervention / Treatment: Drug: Ibuprofen 2400mg; Drug: Indomethacin 150mg

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ericka Seidemann; Phone Number: 225-231-5296; Email: ericka.Seidemann@womans.org
• Study Contact Backup: Name: Pamela Simmons, DO; Phone Number: 225-924-8464; Email: pamela.simmons@womans.org

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70817
      • Woman's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Woman's
• Investigators: Principal Investigator: Pamela Simmons, DO, Woman's Hospital, Louisiana

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: cerclage
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor, Premature; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Reproductive Control Agents; Gout Suppressants; Tocolytic Agents; Ibuprofen; Indomethacin
• Other Study ID Numbers: RP-20-028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No