Actively Recruiting
Association Between Time of Oxytocin Initiation at 2nd Stage of Labor and Adverse Outcomes
Led by Rambam Health Care Campus · Updated on 2023-12-26
120
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the best timing to start oxytocin during the second stage of labor and how it relates to delivery outcomes and maternal or newborn complications. Cesarean delivery rates have risen globally, leading to more risks for mothers compared to vaginal delivery. The study aims to determine whether early oxytocin use at full dilation improves delivery type and reduces adverse effects for mother and baby. Participants will be randomly assigned to receive oxytocin either immediately upon entering the second stage of labor (full dilation) or one hour after entering this stage. Oxytocin, a common drug used to strengthen contractions and support labor progress, is being evaluated for how its timing affects delivery mode and outcomes. During the study, researchers will monitor delivery mode, length of the second labor stage, and complications such as fever, meconium staining, postpartum hemorrhage, fetal heart rate changes, newborn pH levels, Apgar scores, and neonatal intensive care admissions. The study includes all care from oxytocin administration through the immediate postpartum period, lasting up to five days for newborn monitoring.
CONDITIONS
Brief Title
Time of Oxytocin Initiation at 2nd Stage of Labor and Adverse Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Singleton pregnancy
- Maternal age 18 years or older
- Oxytocin administration started or renewed during the second stage of labor
You will not qualify if you...
- Maternal age under 18 years
- Multiple gestation pregnancy
- Known fetal malformations
- Uterine scar
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.
Duration - Duration of the 2nd stage of labor
Participants receive oxytocin during the 2nd stage of labor either immediately upon full dilation or after a one-hour delay to assess the optimal timing of oxytocin initiation.
1 labor and delivery visit (in-person)
Duration - Up to 5 days postpartum
Participants and their newborns are monitored for maternal and neonatal outcomes including delivery mode, postpartum hemorrhage, and neonatal intensive care unit admission.
Approximately 1 to 2 post-delivery visits
Trial Site Locations
Total: 1 location
1
Rambam medical health campus
Haifa, Israel, 31999
Actively Recruiting
Research Team
G
Gal Bachar, MD
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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