Clinical trial NCT04303702: The Role of Oxytocin in the Second Stage of Labor
Official title: Role of Oxytocin in the Second Stage of Labor: a Randomized Controlled Trial (The ROSSoL Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Labor Complication
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2020-03-11
Enrollment: 400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Second stage duration
timeFrame: During admission for delivery
Secondary outcomes:
measure: Rate of operative delivery
timeFrame: During admision for delivery
measure: Rate of Postpartum hemorrhage
timeFrame: During admission for delivery
measure: Estimated blood loss
timeFrame: During admission for delivery
measure: Rate of chorioamnionitis during the second stage of labor
timeFrame: During admission for delivery
measure: Rate of endometritis
timeFrame: During admission for delivery
measure: Rate of severe perineal laceration
timeFrame: During admission for delivery
measure: Rate of composite neonatal morbidity
timeFrame: During admission for delivery
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
Study officials:
References: