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Reduced Oxytocin for Fetal Bradycardia

Phase 4

Recruiting

Research Sponsored by Unyime Ituk

Eligibility Criteria Checklist

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

Must have

Oxytocin used for induction of labor or augmentation of labor per institutional protocols

Healthy nulliparous or multiparous women at term (37 > weeks' gestation)

Must not have

Contraindication to neuraxial analgesia

Category 3 fetal heart rate tracing prior to the initiation of combined spinal epidural analgesia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial is testing whether reducing the rate of an oxytocin infusion before starting combined spinal epidural analgesia will decrease the incidence of adverse fetal heart rate changes.

Who is the study for?

This trial is for healthy pregnant women with a single baby at term (37 weeks or more), who want neuraxial analgesia for pain relief during labor and are already receiving oxytocin as per hospital guidelines. It's not open to those on chronic pain meds, who've had systemic opioid labor analgesia, have a baby in non-head-down position, or can't have an epidural due to other risks.

What is being tested?

The study is testing if reducing the rate of oxytocin infusion by half before starting combined spinal epidural analgesia lowers the risk of adverse changes in the baby's heart rate during birth.

What are the potential side effects?

While specific side effects aren't listed here, generally speaking, changing oxytocin levels could potentially affect both mother and baby's well-being including alterations in fetal heart rate or maternal contractions.

Eligibility Criteria

Inclusion Criteria

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

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I received oxytocin to help start or speed up my labor as per hospital guidelines.

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I am a healthy woman at or past 37 weeks of pregnancy.

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I am asking for spinal or epidural pain relief.

Exclusion Criteria

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

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I cannot have spinal or epidural pain relief.

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My baby's heart rate was category 3 before starting epidural pain relief.

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I have received opioid pain relief during labor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of non-reassuring fetal heart rate tracings

Secondary study objectives

Effect of oxytocin dose on duration of 1st and 2nd stage of labor

Mode of delivery

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Half Dose OxytocinExperimental Treatment1 Intervention

Patients randomized to the half dose oxytocin will have their oxytocin infusion reduced by 50 % prior to placement of a combined spinal epidural for labor analgesia.

Group II: Standard Dose OxytocinActive Control1 Intervention

Patients randomized to the standard dose oxytocin will have their oxytocin infusion maintained at the standard of care protocol prior to placement of a combined spinal epidural for labor analgesia

0 / 6Eligibility criteria met