Oxytocin Rest to Reduce Cesarean Delivery

This open-label randomized trial of consenting pregnant people with prolonged latent labor aims to determine whether 60-minute oxytocin rest reduces risk for cesarean when compared to continuous oxytocin infusion. As secondary aims, this trial will also assess the impact of 60-minute oxytocin rest on: measures of the length of labor, risk for adverse maternal and neonatal outcomes, and measures of patient autonomy and sense of control.

The investigators will enroll 350 patients with singleton pregnancies at ≥36 weeks gestation with prolonged labor in the latent phase, defined as cervical dilation \<6cm after ≥8 hours since rupture of membranes and on continuous oxytocin. Both nulliparous and multiparous individuals undergoing induction or augmentation of labor will be included. Patients with any contraindication to continuous oxytocin at randomization, or for whom cesarean section is anticipated at randomization will be excluded. Patients with prolonged rupture of membranes and patients with intraamniotic infection prior to randomization will also be excluded.

Using blocked randomization via computer-generated randomization scheme, subjects will be randomized with equal probability to 60-minute oxytocin rest or usual care with continuous oxytocin. Trial participants and their health care team will be aware of their assignment. Participants in the intervention group will undergo 60-minute oxytocin rest. With the permission of the clinical team, they will be able to break from continuous fetal monitoring to rest, shower, walk, or eat during this time. After 60 minutes, oxytocin will be restarted at 2 mU/min and subsequently increased by 2 mU/min every 30 minutes to a maximum dose of 30 mU/min or until adequate contractions are seen. Subjects in the control group will receive continuous oxytocin infusion, increased by 2 mU/min every 30 minutes to a maximum dose of 30 mU/min or until adequate contractions are noted.

The remainder of labor care will be at the discretion of the clinical team. Prior to hospital discharge, demographic and clinical data from each participant and their infant will be obtained via chart review.

The primary site for the trial will be ChristianaCare Health System.

• Time to delivery (hours) [Срок оценки: From randomization to delivery]
• Time to vaginal delivery (hours) [Срок оценки: From randomization to delivery]
• Time to active labor (hours) [Срок оценки: From randomization to delivery]
• Duration of active labor (hours) [Срок оценки: From randomization to delivery]
• Composite maternal adverse outcome [Срок оценки: From date of delivery to date of hospital discharge for mother, expected average of 3 days]
• Composite neonatal adverse outcome [Срок оценки: From date of delivery to date of hospital discharge for neonate (or up to 28 days of life)]
• Labor Agentry Scale score [Срок оценки: From date of delivery to date of hospital discharge for mother, expected average of 3 days]
• Rate of intraamniotic infection (IAI) [Срок оценки: From randomization to delivery]
• Rate of postpartum endometritis [Срок оценки: From date of delivery to date of hospital discharge for mother, expected average of 3 days]
• Rate of postpartum hemorrhage [Срок оценки: From date of delivery to date of hospital discharge for mother, expected average of 3 days]