What side effects are associated with this type of intervention?

Indomethacin and Ibuprofen, both tocolytic agents that inhibit prostaglandin synthesis, are commonly used to manage preterm labor. Known maternal side effects include gastrointestinal disturbances such as nausea, vomiting, and gastritis, as well as potential renal impairment. Fetal side effects can include oligohydramnios (reduced amniotic fluid) and premature closure of the ductus arteriosus, which can lead to pulmonary hypertension. These risks necessitate careful monitoring and consideration of the duration of therapy.

What prior FDA approvals exist?

Indomethacin and ibuprofen are nonsteroidal anti-inflammatory drugs (NSAIDs) that have been used off-label as tocolytic agents to inhibit prostaglandin synthesis, thereby reducing uterine contractions and prolonging pregnancy. While indomethacin has been traditionally used for this purpose, ibuprofen is also utilized in some settings due to its similar mechanism of action. Both drugs aim to delay preterm labor, although their use is typically limited to short-term management due to potential fetal and maternal side effects. The FDA has not specifically approved these NSAIDs for the treatment of preterm labor, but they are commonly employed in clinical practice based on their efficacy in reducing uterine activity.

What other types of research exist?

One promising novel alternative to Indomethacin and Ibuprofen for preterm labor is the Phosphodiesterase 4B inhibitor (BI 1015550). This agent has shown antifibrotic and immunomodulatory effects, which could potentially be beneficial in reducing uterine contractions. Another potential alternative is Pentraxin 2, which inhibits monocyte differentiation into profibrotic fibrocytes or proinflammatory macrophages and reduces the production of transforming growth factor (TGF)-beta1. Both agents have shown promising results in clinical trials for other conditions and may offer new avenues for tocolytic therapy in preterm labor.

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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

Must not have

Prophylactic cerclage placement

Contraindication to treatments (i.e. ibuprofen or indomethacin)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from cerclage placement to delivery

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing ibuprofen and indomethacin to see which one is better at helping pregnant women with cervical insufficiency keep their pregnancy longer when a stitch is placed in the cervix. Indomethacin and ibuprofen are both used to help prevent early labor, but ibuprofen has fewer side effects.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My exam or ultrasound showed I need a cerclage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a stitch placed in my cervix to prevent early labor.

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I cannot take certain medications like ibuprofen.

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I am not willing to be assigned to a treatment by chance.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Gestational latency

Secondary study objectives

Preterm birth

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for preterm labor include tocolytic agents such as Indomethacin and Ibuprofen. These medications work by inhibiting the synthesis of prostaglandins, which are compounds that play a key role in initiating uterine contractions. By reducing prostaglandin production, these drugs help to decrease the frequency and intensity of contractions, thereby prolonging pregnancy. This is crucial for preterm labor patients as it provides additional time for fetal development, potentially reducing the risks and complications associated with premature birth.