RECRUITING

Oxytocin Rest to Reduce Cesarean Delivery

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

Prolonged labor is usually managed with continuous oxytocin infusion. "Oxytocin rest" has been proposed as a strategy to resolve protracted labor in patients who have received continuous oxytocin without progress. This strategy involves discontinuing oxytocin then restarting infusion after a period of time, under the theory that washout of the oxytocin receptor will strengthen uterine contractions to improve labor progress. "Oxytocin rest" is performed on labor and delivery units across the United States. Yet, there is no randomized or prospective data to support the practice. The purpose of this study is to assess whether oxytocin rest of 60 minutes in patients with prolonged labor reduces risk for cesarean delivery.

Official Title

Oxytocin Rest to Reduce Cesarean Delivery in Prolonged Labor: An Open-Label, Randomized Controlled Trial

Quick Facts

Study Start:2024-03-19
Study Completion:2026-03-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06268431

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:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥18 years of age
  2. * Singleton gestation in vertex presentation
  3. * ≥36 weeks gestation
  4. * Prolonged latent labor, defined as cervical dilation \<6cm after ≥8 hours since rupture of membranes and on continuous oxytocin
  1. * Not meeting the above criteria
  2. * Any contraindication to continuous oxytocin at time of randomization
  3. * Cesarean section anticipated by the clinical team at time of randomization (for any reason excepting labor dystocia)
  4. * \>18 hours between rupture of membranes and randomization
  5. * Known intraamniotic infection at randomization
  6. * Fetal demise
  7. * Any contraindication to vaginal delivery
  8. * Maternal eclampsia

Contacts and Locations

Study Contact

Teresa C Logue
CONTACT
(302)-733-6563
teresa.logue@christianacare.org

Principal Investigator

Teresa C Logue
PRINCIPAL_INVESTIGATOR
Christiana Care Health Services
Matthew K Hoffman
PRINCIPAL_INVESTIGATOR
Christiana Care Health Services

Study Locations (Sites)

ChristianaCare Health System
Newark, Delaware, 19718
United States

Collaborators and Investigators

Sponsor: Christiana Care Health Services

  • Teresa C Logue, PRINCIPAL_INVESTIGATOR, Christiana Care Health Services
  • Matthew K Hoffman, PRINCIPAL_INVESTIGATOR, Christiana Care Health Services

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 Date2024-03-19
Study Completion Date2026-03-15

Study Record Updates

Study Start Date2024-03-19
Study Completion Date2026-03-15

Terms related to this study

Additional Relevant MeSH Terms

  • Prolonged Labor
  • Failed Induction
  • Labor Dystocia