Oxytocin Rest to Reduce Cesarean Delivery

NCT ID: NCT06268431

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-19
• Study Completion Date: 2026-03-15

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.

Detailed Description

This open-label randomized trial of consenting pregnant people with prolonged latent labor aims to determine whether 60-minute oxytocin rest reduces risk for cesarean when compared to continuous oxytocin infusion. As secondary aims, this trial will also assess the impact of 60-minute oxytocin rest on: measures of the length of labor, risk for adverse maternal and neonatal outcomes, and measures of patient autonomy and sense of control.

The investigators will enroll 350 patients with singleton pregnancies at ≥36 weeks gestation with prolonged labor in the latent phase, defined as cervical dilation <6cm after ≥8 hours since rupture of membranes and on continuous oxytocin. Both nulliparous and multiparous individuals undergoing induction or augmentation of labor will be included. Patients with any contraindication to continuous oxytocin at randomization, or for whom cesarean section is anticipated at randomization will be excluded. Patients with prolonged rupture of membranes and patients with intraamniotic infection prior to randomization will also be excluded.

Using blocked randomization via computer-generated randomization scheme, subjects will be randomized with equal probability to 60-minute oxytocin rest or usual care with continuous oxytocin. Trial participants and their health care team will be aware of their assignment. Participants in the intervention group will undergo 60-minute oxytocin rest. With the permission of the clinical team, they will be able to break from continuous fetal monitoring to rest, shower, walk, or eat during this time. After 60 minutes, oxytocin will be restarted at 2 mU/min and subsequently increased by 2 mU/min every 30 minutes to a maximum dose of 30 mU/min or until adequate contractions are seen. Subjects in the control group will receive continuous oxytocin infusion, increased by 2 mU/min every 30 minutes to a maximum dose of 30 mU/min or until adequate contractions are noted.

The remainder of labor care will be at the discretion of the clinical team. Prior to hospital discharge, demographic and clinical data from each participant and their infant will be obtained via chart review.

The primary site for the trial will be ChristianaCare Health System.

Conditions

Prolonged Labor; Failed Induction; Labor Dystocia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

60-minute oxytocin rest

Group Type: EXPERIMENTAL

Oxytocin rest

Intervention Type: OTHER

60-minute oxytocin rest

Usual care with continuous oxytocin infusion

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Oxytocin rest

60-minute oxytocin rest

Intervention Type: OTHER

Other Intervention Names

pit rest

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Christiana Care Health Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teresa C Logue

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Services

Matthew K Hoffman

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Services

Locations

ChristianaCare Health System

Newark, Delaware, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Teresa C Logue

Role: CONTACT

teresa.logue@christianacare.org

(302)-733-6563

Facility Contacts

Teresa C Logue

Role: primary

teresa.logue@christianacare.org

302-733-6563

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

43084

Identifier Type: -

Identifier Source: org_study_id