Role of Oxytocin in the Second Stage of Labor: a Randomized Controlled Trial (The ROSSoL Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Second stage duration
Study Overview
Brief Summary
This is a randomized controlled trial investigating the utility of oxytocin administration in the second stage of labor.
Detailed Description
Oxytocin is widely used on Labor and Delivery units throughout the world.Laboring patients are most likely to initiate oxytocin in the first stage of labor. Among those who receive oxytocin, first stage initiation is far more common than second stage initiation. The goal of first stage administration is to increase uterine contractility and cause cervical dilation, particularly in patients who have epidural analgesia. Once complete cervical dilation has been achieved, most providers choose to continue oxytocin in the second stage of labor for the theoretic benefit of increased expulsion "power" while pushing. This practice is currently not evidence-based as the limited data thus far suggests no difference in operative deliveries with the use of oxytocin augmentation in general. The benefits and risk of oxytocin continuation in the second stage of labor is unknown. Oxytocin administration is associated with the risk of uterine tachysystole, postpartum hemorrhage,and maternal hyponatremia. These risks call for a closer look at prolonged oxytocin use past the first stage of labor. This is a randomized controlled trial investigating the utility of oxytocin administration in the second stage of labor.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Nulliparous pregnant women >/= 37 weeks gestation
- •Singleton pregnancies
- •Admission for induction of labor or spontaneous labor
Exclusion Criteria
- •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
Arms & Interventions
Discontinue Oxytocin
Intervention: Discontinue Oxytocin (Other)
Continue Oxytocin
Intervention: Continue Oxytocin (Drug)
Outcomes
Primary Outcomes
Second stage duration
Time Frame: During admission for delivery
Time interval from complete cervical dilation to delivery of fetus
Secondary Outcomes
- Rate of Postpartum hemorrhage(During admission for delivery)
- Rate of composite neonatal morbidity(During admission for delivery)
- Rate of chorioamnionitis during the second stage of labor(During admission for delivery)
- Rate of severe perineal laceration(During admission for delivery)
- Rate of operative delivery(During admision for delivery)
- Estimated blood loss(During admission for delivery)
- Rate of endometritis(During admission for delivery)
Investigators
Nandini Raghuraman
Assistant Professor
Washington University School of Medicine