Oxytocin and Fetal Heart Rate Changes
Recruiting
Phase 4
Interventional Study
Fetal Bradycardia Complicating Labor and Delivery
Fetal Bradycardia During Labor
Fetal Heart Rate or Rhythm Abnormality Affecting Fetus
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 55
- Sex
- Female
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 730 (estimated)
- Sponsor
- Unyime Ituk · Other
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About This Trial
The reported risk of nonreassuring fetal heart trace following neuraxial analgesia is 3-23%. This variability may be due to fluid and oxytocin management prior to and during the initiation of neuraxial analgesia. The study hypothesis is that decreasing the oxytocin infusion rate by 50 % prior to initiation of combined spinal epidural analgesia will cause a reduction in the incidence of adverse fet…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Healthy nulliparous or multiparous women at term (37 \> weeks' gestation)
* Singleton pregnancy
* Request for neuraxial analgesia
* Oxytocin used for induction of labor or augmentation of labor per institutional protocols
Exclusion Criteria:
* Use of chronic analgesic medica…
Contacts