Clinical trial
Association Between Time of Oxytocin Initiation at 2nd Stage of Labor and Adverse Outcomes
Name
0061-22-RMB
Description
Early oxytocin administration at the 2nd stage of labor is associated with a higher rate of vaginal delivery, shorter second stage duration, and fewer adverse maternal and neonatal outcomes.
Trial arms
Trial start
2023-10-01
Estimated PCD
2025-10-01
Trial end
2026-10-01
Status
Recruiting
Treatment
Oxytocin
Native oxytocin analog
Arms:
Delayed oxytocin, Immediate oxytocin
Other names:
Pitocin
Size
120
Primary endpoint
Mode of delivery
Delivery
Eligibility criteria
Inclusion Criteria:
1. Singleton pregnancy
2. Maternal age ≥ 18 years' old
3. Oxytocin administration initiated or renewed during second stage of labor
Exclusion Criteria:
1. Maternal age \< 18 years' old
2. Multiple gestation pregnancy
3. Known fetal malformations
4. Uterine scar
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized controlled trial of singleton gestations receiving oxytocin during the second stage of labor at a single tertiary medical center. Women will be randomly allocated to one of two groups - immediate initiation of oxytocin at full dilation versus delayed oxytocin initiation following one hour of full dilation.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}
Updated at
2023-12-26
1 organization
1 product
2 indications
Organization
Rambam Health Care CampusProduct
OxytocinIndication
Complication of deliveryIndication
Cesarean Delivery