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NCT03232918
Oxytocin and Fetal Heart Rate Changes
Phase 4 trial testing Half dose Oxytocin in Fetal Bradycardia Complicating Labor and Delivery in 730 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Unyime Ituk |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 730 |
| Start date | 20 February 2019 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Half dose Oxytocin — full drug profile →
Conditions studied
- Fetal Bradycardia Complicating Labor and Delivery — all drugs for Fetal Bradycardia Complicating Labor and Delivery →
- Fetal Bradycardia During Labor — all drugs for Fetal Bradycardia During Labor →
- Fetal Heart Rate or Rhythm Abnormality Affecting Fetus — all drugs for Fetal Heart Rate or Rhythm Abnormality Affecting Fetus →
Sponsor
Unyime Ituk — full company profile →
Who can join
Adults 18 to 55, female only, with Fetal Bradycardia Complicating Labor and Delivery or Fetal Bradycardia During Labor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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- PubMed search for NCT03232918
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Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03232918 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Unyime Ituk
- Last refreshed: 4 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03232918.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing