The Role of Oxytocin in the Second Stage of Labor
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continue Oxytocin, Discontinue Oxytocin.
- Who it may be relevant to
- Registry conditions: Labor Complication. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Role of Oxytocin in the Second Stage of Labor: a Randomized Controlled Trial (The ROSSoL Trial)
Overview
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.
Interventions
- Drug Continue Oxytocin
The administration and titration of oxytocin for labor augmentation is per a hospital based protocol. To summarize, oxytocin is initiated intravenously at 2 milliunits/minute and increased by 2 milliunits/minute every 20 minutes until an adequate contraction pattern is attained or a maximum of 40 millunits/minute has been achieved. This protocol for titration and administration will be applied in this study to the oxytocin group. The intravenous pumps on Labor and Delivery have automated functio - Other Discontinue Oxytocin
Patients will have their oxytocin discontinued in the second stage of labor. The patient will receive routine maintenance IV fluids per the discretion of the provider.
Primary outcome measures
- Second stage duration [Time frame: During admission for delivery]
Secondary outcome measures (7)
- Rate of operative delivery [Time frame: During admision for delivery]
- Rate of Postpartum hemorrhage [Time frame: During admission for delivery]
- Estimated blood loss [Time frame: During admission for delivery]
- Rate of chorioamnionitis during the second stage of labor [Time frame: During admission for delivery]
- Rate of endometritis [Time frame: During admission for delivery]
- Rate of severe perineal laceration [Time frame: During admission for delivery]
- Rate of composite neonatal morbidity [Time frame: During admission for delivery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Barnes Jewish Hospital — St Louis
Identifiers
NCT: NCT04303702 · 201909112