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NCT03232918 · ClinicalTrials.gov registry record · Phase 4
Oxytocin and Fetal Heart Rate Changes
A Phase 4 study of Fetal Bradycardia Complicating Labor and Delivery and Fetal Bradycardia During Labor, sponsored by Unyime Ituk.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 730
- Enrollment target
- 2
- Study locations
NCT03232918: Recruiting Phase 4 study of Fetal Bradycardia Complicating Labor and Delivery and Fetal Bradycardia During Labor, sponsored by Unyime Ituk.
NCT03232918 is a Phase 4 study of Fetal Bradycardia Complicating Labor and Delivery and Fetal Bradycardia During Labor that is actively recruiting participants, run by Unyime Ituk. The registered enrollment target is 730 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (41% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03232918, a Phase 4 study of Fetal Bradycardia Complicating Labor and Delivery and Fetal Bradycardia During Labor, is actively recruiting participants, sponsored by Unyime Ituk.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 730 participants
- Enrollment target
- 2
- Study locations
Study Summary
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 fetal heart rate changes.
Primary Outcome
Fetal heart rate tracings will be examined for 30 minutes before and 60 minutes after the initiation of combined spinal epidural analgesia
Conditions Studied
Interventions
- DRUG Half dose Oxytocin
Study Locations (2)
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 730 participants |
| Start Date | 2019-02-20 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 4 |
What NCT03232918 shows while recruiting
NCT03232918 is an interventional study that assigns participants to a tested intervention. The registered 730 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (41% higher).
The record links to 3 conditions, with Fetal Bradycardia Complicating Labor and Delivery appearing as the primary indexed condition, and to 1 intervention - of which Half dose Oxytocin is the first listed.
NCT03232918 reports a single indexed study location in Iowa, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT03232918 about?
NCT03232918 is a clinical study titled "Oxytocin and Fetal Heart Rate Changes". 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 ini...
What is the current status of trial NCT03232918?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 730 participants. The study started on 2019-02-20. Estimated completion is 2025-12-31.
What conditions does trial NCT03232918 study?
This clinical trial studies the following conditions: Fetal Bradycardia Complicating Labor and Delivery, Fetal Bradycardia During Labor, Fetal Heart Rate or Rhythm Abnormality Affecting Fetus.
What interventions are being tested in trial NCT03232918?
The interventions under investigation include: Half dose Oxytocin (DRUG).
Who is sponsoring clinical trial NCT03232918?
This trial is sponsored by Unyime Ituk, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03232918 being conducted?
This trial has 2 study locations across Iowa, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03232918's enrollment target sits among peer trials
730 112th of 2000 higher than 1,888 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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