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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of non-reassuring fetal heart rate tracings
Secondary outcome measures
Effect of oxytocin dose on duration of 1st and 2nd stage of labor
Mode of delivery

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

Find a Location

Who is running the clinical trial?

Unyime ItukLead Sponsor

Media Library

Half dose Oxytocin Clinical Trial Eligibility Overview. Trial Name: NCT03232918 — Phase 4
Fetal Bradycardia Research Study Groups: Standard Dose Oxytocin, Half Dose Oxytocin
Fetal Bradycardia Clinical Trial 2023: Half dose Oxytocin Highlights & Side Effects. Trial Name: NCT03232918 — Phase 4
Half dose Oxytocin 2023 Treatment Timeline for Medical Study. Trial Name: NCT03232918 — Phase 4
~160 spots leftby Dec 2025
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