RECRUITING

Oxytocin and Fetal Heart Rate Changes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2019-02-20
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03232918

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.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy nulliparous or multiparous women at term (37 \> weeks' gestation)
  2. * Singleton pregnancy
  3. * Request for neuraxial analgesia
  4. * Oxytocin used for induction of labor or augmentation of labor per institutional protocols
  1. * Use of chronic analgesic medications
  2. * Prior administration of systemic opioid labor analgesia
  3. * Non-vertex presentation
  4. * Contraindication to neuraxial analgesia
  5. * Category 3 fetal heart rate tracing prior to the initiation of combined spinal epidural analgesia

Contacts and Locations

Study Contact

Unyime Ituk
CONTACT
319-356-2633
unyime-ituk@uiowa.edu

Principal Investigator

Unyime Ituk
STUDY_DIRECTOR
University of Iowa

Study Locations (Sites)

University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52245
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Unyime Ituk

  • Unyime Ituk, STUDY_DIRECTOR, University of Iowa

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 Registration Dates

Study Start Date2019-02-20
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2019-02-20
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

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