Ibuprofen Versus Indomethacin Following Emergent Cerclage Placement (TOCO)
Primary Purpose
Preterm Labor
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Indomethacin 150mg
Ibuprofen 2400mg
Sponsored by
About this trial
This is an interventional treatment trial for Preterm Labor focused on measuring cerclage
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
Sites / Locations
- Woman's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ibuprofen
Indomethacin
Arm Description
Ibuprofen 600 mg q6 hours for 24 hours- total dose of 2400mg- after emergent cerclage placement
Indomethacin 50 mg q8 hours for 24 hours- total dose of 150mg- after emergent cerclage placement
Outcomes
Primary Outcome Measures
Gestational latency
Days from cerclage placement to delivery, assessed up to 26 weeks
Secondary Outcome Measures
Preterm birth
Birth before 37 weeks gestation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04726085
Brief Title
Ibuprofen Versus Indomethacin Following Emergent Cerclage Placement
Acronym
TOCO
Official Title
Efficacy of Ibuprofen Versus Indomethacin as Perioperative Prophylactic Treatment Following Emergent Cerclage Placement for Pregnancy Prolongation: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Woman's
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor
Keywords
cerclage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ibuprofen
Arm Type
Active Comparator
Arm Description
Ibuprofen 600 mg q6 hours for 24 hours- total dose of 2400mg- after emergent cerclage placement
Arm Title
Indomethacin
Arm Type
Active Comparator
Arm Description
Indomethacin 50 mg q8 hours for 24 hours- total dose of 150mg- after emergent cerclage placement
Intervention Type
Drug
Intervention Name(s)
Indomethacin 150mg
Intervention Description
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
Intervention Name(s)
Ibuprofen 2400mg
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gestational latency
Description
Days from cerclage placement to delivery, assessed up to 26 weeks
Time Frame
From cerclage placement to delivery
Secondary Outcome Measure Information:
Title
Preterm birth
Description
Birth before 37 weeks gestation
Time Frame
At delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pamela Simmons, DO
Phone
225-924-8464
Email
pamela.simmons@womans.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ericka Seidemann
Phone
225-231-5296
Email
ericka.Seidemann@womans.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Simmons, DO
Organizational Affiliation
Woman's Hospital, Louisiana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Woman's Hospital
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Simmons, DO
Phone
225-924-8464
Email
pamela.simmons@womans.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ibuprofen Versus Indomethacin Following Emergent Cerclage Placement
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