Oxytocin and Fetal Heart Rate Changes

NCT03232918 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 201609722
• Study Type: interventional
• Target: 730
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of non-reassuring fetal heart rate tracings

  Fetal heart rate tracings will be examined for 30 minutes before and 60 minutes after the initiation of combined spinal epidural analgesia

  1.5 hours

Secondary Outcomes (2)

• Effect of oxytocin dose on duration of 1st and 2nd stage of labor

  24 hours

• Mode of delivery

  24 hours

Study Arms (2)

Standard Dose Oxytocin

NO 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

Half Dose Oxytocin

EXPERIMENTAL

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.

Drug: Half dose Oxytocin

Interventions

Half dose Oxytocin DRUG

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

Half Dose Oxytocin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Use of chronic analgesic medications
• Prior administration of systemic opioid labor analgesia
• Non-vertex presentation
• Contraindication to neuraxial analgesia
• Category 3 fetal heart rate tracing prior to the initiation of combined spinal epidural analgesia

Sponsors & Collaborators

• Unyime Ituk: lead

Study Sites (2)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52245, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

NOT YET RECRUITING

Related Publications (5)

• Mardirosoff C, Dumont L, Boulvain M, Tramer MR. Fetal bradycardia due to intrathecal opioids for labour analgesia: a systematic review. BJOG. 2002 Mar;109(3):274-81. doi: 10.1111/j.1471-0528.2002.01380.x.

  PMID: 11950182 BACKGROUND

• Abrao KC, Francisco RPV, Miyadahira S, Cicarelli DD, Zugaib M. Elevation of uterine basal tone and fetal heart rate abnormalities after labor analgesia: a randomized controlled trial. Obstet Gynecol. 2009 Jan;113(1):41-47. doi: 10.1097/AOG.0b013e31818f5eb6.

  PMID: 19104358 BACKGROUND

• Clarke VT, Smiley RM, Finster M. Uterine hyperactivity after intrathecal injection of fentanyl for analgesia during labor: a cause of fetal bradycardia? Anesthesiology. 1994 Oct;81(4):1083. doi: 10.1097/00000542-199410000-00041. No abstract available.

  PMID: 7943823 BACKGROUND

• Satin AJ, Leveno KJ, Sherman ML, Brewster DS, Cunningham FG. High- versus low-dose oxytocin for labor stimulation. Obstet Gynecol. 1992 Jul;80(1):111-6.

  PMID: 1603479 BACKGROUND

• Budden A, Chen LJ, Henry A. High-dose versus low-dose oxytocin infusion regimens for induction of labour at term. Cochrane Database Syst Rev. 2014 Oct 9;2014(10):CD009701. doi: 10.1002/14651858.CD009701.pub2.

  PMID: 25300173 BACKGROUND

Study Officials

• Unyime Ituk

  University of Iowa

  STUDY DIRECTOR

Central Study Contacts

Unyime Ituk

CONTACT

319-356-2633; unyime-ituk@uiowa.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The labor room nurse will be aware of the patient group assignment and will adjust the dose of the drug based on group assignment. The Investigator, Physician Provider and Outcome Assessor will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: July 28, 2017
• Study Start: February 20, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: IPD will be available for sharing immediately after publication and ending 5 years following article publication.
• Access Criteria: IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal

Locations

US (2)