Actively Recruiting

Phase Not Applicable
Age: 18Years - 55Years
FEMALE
ID06268431

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

Led by Christiana Care Health Services · Updated on 2024-10-17

350

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether a 60-minute break from oxytocin infusion, called "oxytocin rest," can reduce the chance of cesarean delivery in pregnant people experiencing prolonged latent labor. Prolonged labor is usually managed by continuous oxytocin, but this study aims to see if pausing the infusion strengthens contractions and helps labor progress. This open-label randomized trial focuses on patients with singleton pregnancies at 36 weeks or more who have slow labor progress despite continuous oxytocin. Participants will be randomly assigned to either a 60-minute oxytocin rest or continued continuous oxytocin infusion. Those in the oxytocin rest group will pause oxytocin for an hour, during which they may take breaks from monitoring to rest, shower, walk, or eat. After this, oxytocin is restarted at a low dose and gradually increased. The control group will receive continuous oxytocin, with doses increased similarly. Labor care aside from this is managed by the clinical team as usual. Throughout the study, researchers will collect clinical and demographic data, focusing on the rate of cesarean delivery as the primary outcome. Secondary outcomes include labor duration, maternal and newborn complications, and patient feelings of control during labor. Data will be gathered from hospital records until discharge. The trial will enroll 350 participants and monitor outcomes up to delivery and hospital discharge, with neonatal follow-up up to 28 days.

CONDITIONS

Brief Title

Oxytocin Rest to Reduce Cesarean Delivery

Who Can Participate

Age: 18Years - 55Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Pregnant with a single baby in head-down position
  • At least 36 weeks gestation
  • Experiencing prolonged latent labor defined as less than 6 cm cervical dilation after 8 or more hours since rupture of membranes while on continuous oxytocin
Not Eligible

You will not qualify if you...

  • Not meeting the inclusion criteria
  • Any contraindication to continuous oxytocin at randomization
  • Cesarean section anticipated at randomization for reasons other than labor dystocia
  • More than 18 hours between rupture of membranes and randomization
  • Known intraamniotic infection at randomization
  • Fetal demise
  • Any contraindication to vaginal delivery
  • Maternal eclampsia

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - From randomization until delivery (variable, depending on labor duration)

Participants receive either a 60-minute oxytocin rest or continuous oxytocin infusion during prolonged latent labor to assess effects on cesarean delivery risk and labor outcomes.

Care and monitoring during labor at the hospital

Follow-up

Duration - From delivery to hospital discharge (expected average of 3 days)

Participants and their infants are observed until hospital discharge to assess maternal and neonatal outcomes.

Data collected via chart review during hospital stay

Trial Site Locations

Total: 1 location

1

ChristianaCare Health System

Newark, Delaware, United States, 19718

Actively Recruiting

Loading map...

Research Team

T

Teresa C Logue

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

Anticholinergics for Cervical Edema in Labor (ACCEL)

Labor Dystocia

Actively Recruiting

1 location

Calcium Carbonate to Augment Labor Contractions

Labor Dystocia

Actively Recruiting

1 location

Early Diagnosis and Intervention for Fetal Malposition in Ac...

Cesarean Delivery Affecting Fetus

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here