PROphylactic Manual RotatIon in the Second stagE of Labor (PROMISE): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Number of participants in each group who undergo operative delivery
研究概览
简要总结
This is a randomized controlled trial to determine whether prophylactic manual rotation for fetuses identified to have persistent occiput posterior or occiput transverse presentation (POP/OTP) at the initiation of the second stage of labor in nulliparous individuals reduces rates of operative delivery, second stage of labor duration, and resultant adverse clinical outcomes compared to standard management of the second stage of labor.
详细描述
This is a randomized controlled trial in which nulliparous individuals with a term, singleton gestation who undergo a trial of labor with neuraxial anesthesia and have a fetus presenting with persistent occiput posterior or occiput transverse presentation (POP/OTP) confirmed by ultrasound at the initiation of the second stage of labor will be randomized to either prophylactic manual rotation or sham rotation. The study aims to evaluate whether prophylactic manual rotation reduces the incidence of operative delivery (a composite of cesarean and operative vaginal delivery), second stage of labor duration, and maternal and neonatal morbidity among nulliparous individuals with a fetus with POP/OTP at the initiation of the second stage of labor.
Individuals will be screened for eligibility upon admission to Labor and Delivery and approached for potential recruitment with informed consent obtained on enrollment. Once women achieve complete cervical dilation and within the first fifteen minutes of commencement of pushing, a bedside ultrasound will be performed to determine the fetal position. Those with POP/OTP will be randomized at that time point to either prophylactic manual rotation or sham rotation. The patient's primary obstetrician will be blinded to the randomization arm. The electronic health record will be reviewed and used to assess trial outcomes. The study will enroll 350 individuals, powered to detect a 15% reduction in operative delivery (instrumental vaginal delivery or cesarean section) with prophylactic manual rotation of POP/OTP, from a baseline risk of 50% without manual rotation to 35% with prophylactic rotation at initiation of the second stage of labor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
盲法说明
Both the study participant and her primary obstetrician will be blinded to the assigned randomization arm prior to delivery, as involvement in this research study should not change their care. Clinical management will be left to the discretion of each participant's primary obstetrician managing her labor, according to standard obstetrical care, who again will not be involved in the research-related study procedures.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or greater
- •English-speaking
- •Nulliparous
- •Singleton gestation
- •Planning a vaginal birth
- •Have neuraxial anesthesia
- •Term gestation (≥37 weeks' gestation)
- •Ruptured membranes
- •Complete cervical dilation
- •Cephalic presenting fetus
- •Fetus presenting with occiput posterior or occiput transverse position confirmed by ultrasound
排除标准
- •Pregnancies with intrauterine fetal demise
- •Pregnancies affected by major fetal anomaly
- •Maternal or fetal contraindication to vaginal delivery, including operative vaginal delivery
- •Fetal malpresentation, including brow or face presentation
- •Category III fetal heart rate tracing at time of randomization
- •Duration of pushing already exceeding 15 minutes in the second stage of labor
- •Lack of other inclusion criteria as described above
结局指标
主要结局
Number of participants in each group who undergo operative delivery
时间窗: From randomization until delivery, up to 5 hours
Number of participants in each group who undergo a cesarean section or an instrumental delivery (vacuum or forceps) as a composite outcome
次要结局
- Number of participants in each group who require blood product transfusion(From randomization until hospital discharge, an expected average of 3 days)
- Number of participants in each group who undergo operative vaginal delivery(From randomization until delivery, up to 5 hours)
- Number of participants in each group who undergo cesarean delivery(From randomization until delivery, up to 5 hours)
- Number of participants in each group with composite maternal morbidity(From randomization until hospital discharge, an expected average of 3 days)
- Number of participants in each group with postpartum endometritis(From delivery until hospital discharge, an expected average of 3 days)
- Number of participants in each group with postpartum hemorrhage(From randomization until hospital discharge, an expected average of 3 days)
- Number of minutes in the second stage of labor in each group(From randomization until delivery, up to 300 minutes)
- Number of participants in each group with maternal intrapartum chorioamnionitis diagnosed in the second stage of labor(From randomization until delivery, up to 5 hours)
- Number of participants in each group who experience obstetric anal sphincter injury (i.e. a composite of 3rd or 4th degree perineal lacerations)(From randomization until delivery, up to 5 hours)
- Number of participants in each group affected by neonatal intensive care unit (NICU) admission(From delivery until hospital discharge, up to 28 days of life)
- Number of participants in each group with composite severe neonatal morbidity(From delivery until hospital discharge, up to 28 days of life)
- Number of participants in each group who experience neonatal death(From delivery until hospital discharge, up to 28 days of life)
- Number of participants in each group with a neonate with neonatal sepsis(From delivery until hospital discharge, up to 28 days of life)
- Number of days a participant in each group has a neonate requiring neonatal intensive care unit (NICU) admission(From delivery until hospital discharge, up to 28 days of life)
- Number of participants in each group with a neonate with neonatal 5-minute Apgar score <5(From delivery up to 5 minutes of life)
- Number of participants in each group with a neonate with neonatal umbilical arterial cord pH ≤7.00 or base excess ≤-12 milliequivalents/L(At time of delivery)
- Number of participants in each group who experiences intrapartum shoulder dystocia(From randomization until delivery, up to 5 hours)
- Number of participants in each group with a neonate with neonatal hypoxic-ischemic encephalopathy requiring hypothermic therapy or neonatal subgaleal or intracranial hemorrhage(From delivery until hospital discharge, up to 28 days of life)
研究者
Stephanie Fisher
Assistant Professor of Obstetrics and Gynecology (Maternal Fetal Medicine)
Northwestern University