Recruiting

Oxytocin

Sponsor:

Christiana Care Health Services

Code:

NCT06268431

Conditions

Prolonged Labor

Failed Induction

Labor Dystocia

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Oxytocin rest

Study Details

Brief summary:

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.

Conditions

Prolonged Labor

Failed Induction

Labor Dystocia

Study ID

NCT06268431

Start date

Mar 19, 2024

Status verified date

Oct, 2024

Completion date

Mar 15, 2026

Anticipated

Primary completion date

Feb 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ≥18 years of age
  • Singleton gestation in vertex presentation
  • ≥36 weeks gestation
  • Prolonged latent labor, defined as cervical dilation <6cm after ≥8 hours since rupture of membranes and on continuous oxytocin

Exclusion Criteria:

  • Not meeting the above criteria
  • Any contraindication to continuous oxytocin at time of randomization
  • Cesarean section anticipated by the clinical team at time of randomization (for any reason excepting labor dystocia)
  • >18 hours between rupture of membranes and randomization
  • Known intraamniotic infection at randomization
  • Fetal demise
  • Any contraindication to vaginal delivery
  • Maternal eclampsia

Study Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 60-minute oxytocin rest

no intervention: Usual care with continuous oxytocin infusion

Interventions

Oxytocin rest

60-minute oxytocin rest

Primary outcome measure

  • Cesarean rate [ Time Frame: At time of delivery ]

Central Contacts and Locations

Central contacts

Teresa C Logue

(302)-733-6563teresa.logue@christianacare.org

Locations

ChristianaCare Health System

Recruiting

Newark, Delaware, United States, 19718

Contacts

Teresa C Logue

302-733-6563teresa.logue@christianacare.org

More Information

Sponsor

Christiana Care Health Services

Last update posted

Oct 17, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Christiana Care Health Services on 2024-10-17.