TOCO: Ibuprofen Versus Indomethacin Following Emergent Cerclage Placement

Sponsor

Woman's (Other)

Overall Status

Recruiting

CT.gov ID

NCT04726085

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Labor	Drug: Indomethacin 150mg Drug: Ibuprofen 2400mg	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Gestational latency [From cerclage placement to delivery]
Days from cerclage placement to delivery, assessed up to 26 weeks

Secondary Outcome Measures

Preterm birth [At delivery]
Birth before 37 weeks gestation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Woman's Hospital	Baton Rouge	Louisiana	United States	70817

Sponsors and Collaborators

Woman's

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Woman's

ClinicalTrials.gov Identifier:

NCT04726085

Other Study ID Numbers:

RP-20-028

First Posted:

Jan 27, 2021

Last Update Posted:

May 4, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Woman's

cerclage

Additional relevant MeSH terms:

Obstetric Labor, Premature

Ibuprofen

Indomethacin

Study Results

No Results Posted as of May 4, 2022