Oxytocin Rest to Reduce Cesarean Delivery in Prolonged Labor: An Open-Label, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Cesarean rate
研究概览
简要总结
Prolonged labor is usually managed with continuous oxytocin infusion. "Oxytocin rest" has been proposed as a strategy to resolve protracted labor in patients who have received continuous oxytocin without progress. This strategy involves discontinuing oxytocin then restarting infusion after a period of time, under the theory that washout of the oxytocin receptor will strengthen uterine contractions to improve labor progress. "Oxytocin rest" is performed on labor and delivery units across the United States. Yet, there is no randomized or prospective data to support the practice.
The purpose of this study is to assess whether oxytocin rest of 60 minutes in patients with prolonged labor reduces risk for cesarean delivery.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •Singleton gestation in vertex presentation
- •≥36 weeks gestation
- •Prolonged latent labor, defined as cervical dilation <6cm after ≥8 hours since rupture of membranes and on continuous oxytocin
排除标准
- •Not meeting the above criteria
- •Any contraindication to continuous oxytocin at time of randomization
- •Cesarean section anticipated by the clinical team at time of randomization (for any reason excepting labor dystocia)
- •>18 hours between rupture of membranes and randomization
- •Known intraamniotic infection at randomization
- •Fetal demise
- •Any contraindication to vaginal delivery
- •Maternal eclampsia
研究组 & 干预措施
60-minute oxytocin rest
干预措施: Oxytocin rest (Other)
Usual care with continuous oxytocin infusion
结局指标
主要结局
Cesarean rate
时间窗: At time of delivery
Number of participants delivered by cesarean
次要结局
- Time to delivery (hours)(From randomization to delivery)
- Time to vaginal delivery (hours)(From randomization to delivery)
- Time to active labor (hours)(From randomization to delivery)
- Duration of active labor (hours)(From randomization to delivery)
- Composite maternal adverse outcome(From date of delivery to date of hospital discharge for mother, expected average of 3 days)
- Composite neonatal adverse outcome(From date of delivery to date of hospital discharge for neonate (or up to 28 days of life))
- Labor Agentry Scale score(From date of delivery to date of hospital discharge for mother, expected average of 3 days)
- Rate of intraamniotic infection (IAI)(From randomization to delivery)
- Rate of postpartum endometritis(From date of delivery to date of hospital discharge for mother, expected average of 3 days)
- Rate of postpartum hemorrhage(From date of delivery to date of hospital discharge for mother, expected average of 3 days)