MedTrace Logo

Oxytocin and Fetal Heart Rate Changes

NCT03232918 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 730

Last updated 2025-06-04

No results posted yet for this 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.

Conditions

  • Fetal Bradycardia Complicating Labor and Delivery
  • Fetal Bradycardia During Labor
  • Fetal Heart Rate or Rhythm Abnormality Affecting Fetus

Interventions

DRUG

Half dose Oxytocin

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

Sponsors & Collaborators

  • Unyime Ituk

    lead OTHER

Principal Investigators

  • Unyime Ituk · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-20
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03232918 on ClinicalTrials.gov