Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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
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