Oxytocin Rest to Reduce Cesarean Delivery
ORCA
1 other identifier
interventional
350
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2024
CompletedFirst Posted
Study publicly available on registry
February 20, 2024
CompletedStudy Start
First participant enrolled
March 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2026
CompletedOctober 17, 2024
October 1, 2024
1.9 years
February 13, 2024
October 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Cesarean rate
Number of participants delivered by cesarean
At time of delivery
Secondary Outcomes (10)
Time to delivery (hours)
From randomization to delivery
Time to vaginal delivery (hours)
From randomization to delivery
Time to active labor (hours)
From randomization to delivery
Duration of active labor (hours)
From randomization to delivery
Composite maternal adverse outcome
From date of delivery to date of hospital discharge for mother, expected average of 3 days
- +5 more secondary outcomes
Study Arms (2)
60-minute oxytocin rest
EXPERIMENTALUsual care with continuous oxytocin infusion
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- ≥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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ChristianaCare Health System
Newark, Delaware, 19718, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Teresa C Logue
Christiana Care Health Services
- PRINCIPAL INVESTIGATOR
Matthew K Hoffman
Christiana Care Health Services
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2024
First Posted
February 20, 2024
Study Start
March 19, 2024
Primary Completion
February 15, 2026
Study Completion
March 15, 2026
Last Updated
October 17, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share