Actively Recruiting
Role of Oxytocin in the Second Stage of Labor: a Randomized Controlled Trial (The ROSSoL Trial)
Led by Washington University School of Medicine · Updated on 2026-01-05
400
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
U
University of Michigan
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the use of oxytocin during the second stage of labor, a critical time when the cervix is fully dilated and the baby is pushed out. Although oxytocin is commonly used during the first stage of labor to help with contractions and cervical dilation, its benefits and risks in the second stage are not well established. This trial aims to better understand the effects of continuing oxytocin during this stage, especially considering potential risks like uterine tachysystole, postpartum hemorrhage, and maternal hyponatremia. Participants in this randomized controlled trial will be assigned to either continue or discontinue oxytocin during the second stage of labor. For those continuing oxytocin, the drug will be administered intravenously according to hospital protocols, starting at 2 milliunits per minute and adjusted every 20 minutes to achieve adequate contractions, with a maximum of 40 milliunits per minute. Those discontinuing oxytocin will receive routine maintenance IV fluids instead. The study uses standard intravenous pumps and follows established oxytocin dosing procedures. Throughout labor and delivery admission, researchers will monitor the duration of the second stage of labor as the primary outcome. Secondary outcomes include rates of operative delivery, postpartum hemorrhage, estimated blood loss, chorioamnionitis, endometritis, severe perineal laceration, and neonatal morbidity. These assessments will help determine the impact and safety of oxytocin use during this labor stage. Participants will be observed closely during their hospital stay for all related outcomes and safety measures.
CONDITIONS
Brief Title
The Role of Oxytocin in the Second Stage of Labor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Nulliparous pregnant women at or beyond 37 weeks gestation
- Singleton pregnancies
- Admission for induction of labor or spontaneous labor
You will not qualify if you...
- Multiple gestations
- Multiparous patients
- Patients with major fetal anomalies
- Not on oxytocin at the time of complete cervical dilation
- Patients with fetal head visible at the perineum on diagnosis of complete cervical dilation
- Maternal medical condition that prohibits prolonged second stage
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During admission for delivery
Participants receive oxytocin administration or have oxytocin discontinued during the second stage of labor as per their randomized group.
1 hospital stay for labor and delivery
Duration - During admission for delivery
Participants are monitored for outcomes related to delivery and post-delivery complications during their hospital admission.
Approximately 1 to 2 visits during hospital stay
Trial Site Locations
Total: 1 location
1
Barnes Jewish Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
N
Nandini Raghuraman, MD MSCI
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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