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Trial · Interventional

RecruitingPhase 4Registry data

Oxytocin and Fetal Heart Rate Changes

NCTNCT03232918 (opens ClinicalTrials.gov in a new tab)Other id201609722
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 4
Enrollment
730 participants (estimated)
Sponsor
Unyime Ituk · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
20 Feb 2019
Primary completion
31 Dec 2025 (estimated)
Completion
31 Dec 2025 (estimated)
First posted
28 Jul 2017
Last update posted
4 Jun 2025
Conditions
Fetal Bradycardia Complicating Labor and Delivery · Fetal Bradycardia During Labor · Fetal Heart Rate or Rhythm Abnormality Affecting Fetus

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2020202220242026
  1. Ph 4

    Oxytocin and Fetal Heart Rate Changes

    NCT03232918

    20 Feb 2019 to est. 31 Dec 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Half dose OxytocinDrug

Arms2

  • No intervention

    Standard Dose Oxytocin

    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

  • Experimental

    Half Dose Oxytocin

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Incidence of non-reassuring fetal heart rate tracings

    Time frame · 1.5 hours

    Registry description

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

Secondary outcomes(2)

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

    Time frame · 24 hours

    Registry description

    The effect of the intervention on the duration of labor

  2. Mode of delivery

    Time frame · 24 hours

    Registry description

    The effect of the intervention on the rate of spontaneous vaginal delivery, instrumental vaginal delivery and cesarean delivery

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

0 studies on this page

Indexing hint: Meta-analysis (pooled) · 2014

High-dose versus low-dose oxytocin infusion regimens for induction of labour at term.

Budden et al. 2014The Cochrane database of systematic reviewscited by 45

PMID 25300173PMC8932234DOI 10.1002/14651858.cd009701.pub2PUB-25300173

Rights unknown
Source link

More studies

2 studies on this page

Indexing hint: Randomized controlled trial · 2009

Elevation of uterine basal tone and fetal heart rate abnormalities after labor analgesia: a randomized controlled trial.

Abrão et al. 2009Obstetrics and gynecologycited by 68

PMID 19104358DOI 10.1097/aog.0b013e31818f5eb6PUB-19104358

Full text at the publisher
Publisher page

Indexing hint: Clinical trial · 1992

High- versus low-dose oxytocin for labor stimulation.

Satin et al. 1992Obstetrics and gynecologycited by 56

PMID 1603479PUB-01603479

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 55 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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 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

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