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Nonsteroidal Anti-inflammatory Drug

Indomethacin vs Ibuprofen for Preterm Labor (TOCO Trial)

N/A

Waitlist Available

Led By Pamela Simmons, DO

Research Sponsored by Woman's

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥ 18 years old

Exam or ultrasound indicated cerclage placement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from cerclage placement to delivery

Awards & highlights

TOCO Trial Summary

This trial is investigating whether the drug indomethacin, which is traditionally used to treat cervical insufficiency, is more effective than the drug ibuprofen in prolonging pregnancy.

Who is the study for?

This trial is for pregnant women between 16 and nearly 24 weeks along, with a single baby and intact membranes needing emergency cerclage to prevent early labor. They must be over 18, planning to deliver at Woman's Hospital, and not have used ibuprofen or indomethacin recently.Check my eligibility

What is being tested?

The study compares two drugs—ibuprofen (2400mg) and indomethacin (150mg)—to see which one better prolongs pregnancy after an emergency stitch (cerclage) is placed in the cervix due to premature dilation.See study design

What are the potential side effects?

Possible side effects of both medications include digestive issues like stomach pain or ulcers, kidney problems, increased blood pressure, and potential risks to fetal health.

TOCO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

My exam or ultrasound showed I need a cerclage.

TOCO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and at delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Gestational latency

Secondary outcome measures

Preterm birth

TOCO Trial Design

2Treatment groups

Active Control

Group I: IbuprofenActive Control1 Intervention

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

Group II: IndomethacinActive Control1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Woman'sLead Sponsor

17 Previous Clinical Trials

1,354 Total Patients Enrolled

Pamela Simmons, DOPrincipal InvestigatorWoman's Hospital, Louisiana

Media Library

Ibuprofen (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT04726085 — N/A

Preterm Labor Research Study Groups: Ibuprofen, Indomethacin

Preterm Labor Clinical Trial 2023: Ibuprofen Highlights & Side Effects. Trial Name: NCT04726085 — N/A

Ibuprofen (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04726085 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have there been any additional investigations regarding the efficacy of Ibuprofen?

"At this moment, 56 Ibuprofen clinical trials have been launched. Of those, 14 are in the third phase of development. Sacramento, California is a hub for these studies; however there are 151 sites across the country conducting research on Ibuprofen."

Answered by AI

What maladies is Ibuprofen generally administered to address?

"Ibuprofen is commonly used as a supplemental treatment for those that have not responded to more traditional remedies. It can be employed to alleviate symptoms like catarrh and muscle spasms, as well as degenerative polyarthritis."

Answered by AI

What is the target enrollment for this trial?

"Affirmative. The clinical trial's details, which were initially posted on February 1st 2021, are available to view on the website clinicaltrials.gov and confirm that recruitment is currently ongoing. This study requires a total of 100 volunteers who will be based at one site."

Answered by AI

Are any participants being enlisted in this trial at the moment?

"Yes, clinicaltrials.gov indicates that this medical research trial is actively recruiting volunteers with the original posting date of February 1st 2021 and a recent update on May 3rd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ibuprofen Versus Indomethacin Following Emergent Cerclage Placement

2021. "Ibuprofen Versus Indomethacin Following Emergent Cerclage Placement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04726085.