Oxytocin and Fetal Heart Rate Changes

May 30, 2025 updated by: Unyime Ituk

A Randomized Controlled Trial Evaluating the Effect of the Oxytocin Infusion Rate on Fetal Heart Rate Changes and Maternal-Fetal Outcomes During the Initiation of Combined Spinal-Epidural Labor Analgesia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Oxytocin is used in labor and delivery to increase the frequency of contractions and augment uterine contractile strength, thereby establishing a regular pattern of labor. However, the administration of exogenous oxytocin in the presence of an uncoordinated labor pattern confers a risk for an increase in uterine contraction frequency, resulting in inadequate relaxation periods. This leads to an increase in the basal tone of the uterus, which may lead to a tetanic contraction with the risk of decreased uteroplacental blood flow and fetal hypoxemia. Previous studies investigating low- versus high-dose oxytocin for induction or augmentation of labor have had conflicting results on the effect on fetal heart rate abnormalities. One of the limitations of these studies is that the labor analgesia was not standardized. The combination of low-dose combined spinal epidural analgesia and the high/low dose oxytocin have not been evaluated. One of the proposed mechanisms for nonreassuring fetal heart a tracing after initiation of analgesia is that the pain relief from neuraxial analgesia causes a decrease in catecholamine release by the sympathetic nervous system. The subsequent decrease in the circulating epinephrine concentration contributes to an increase in uterine tone, as epinephrine is a potent tocolytic agent. The increased tone, in turn, leads to a decrease in placental blood flow, and eventually fetal bradycardia. The primary outcome of this study is the incidence of non-reassuring fetal heart rate tracings within the first 60 minutes after the placement of combined spinal epidural analgesia

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
730

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52245
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Not yet recruiting
        • Medical College of Wisconsin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of non-reassuring fetal heart rate tracings
Time Frame: 1.5 hours
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effect of oxytocin dose on duration of 1st and 2nd stage of labor
Time Frame: 24 hours
The effect of the intervention on the duration of labor
24 hours
Mode of delivery
Time Frame: 24 hours
The effect of the intervention on the rate of spontaneous vaginal delivery, instrumental vaginal delivery and cesarean delivery
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Unyime Ituk

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Unyime Ituk, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201609722

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial, after de-identification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. IPD will be available for sharing immediately after publication and ending 5 years following article publication.

IPD Sharing Time Frame

IPD will be available for sharing immediately after publication and ending 5 years following article publication.

IPD Sharing Access Criteria

IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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