A Randomized Double Blind Clinical Trial Comparing Oxytocin Low-dose and High-dose Regimens for Labor Augmentation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,003
- 试验地点
- 1
- 主要终点
- Number of Participants Delivered by Cesarean
研究概览
简要总结
Oxytocin is a medication that is often used to strengthen contractions to overcome delayed labor progress. The primary aim of this study is to determine whether receiving a higher dose of oxytocin lowers the chance of needing a cesarean section when compared to a lower dose of oxytocin. Other aims include examining the relationship between dose of oxytocin regimen and length of labor, postpartum hemorrhage, intrauterine infection, umbilical cord gas, neonatal Apgar score <5 at 5 minutes, and need for neonatal intensive care.
详细描述
This randomized double blind clinical trial of consenting nulliparous women in spontaneous labor who require oxytocin for labor augmentation seeks to determine whether use of a high dose oxytocin regimen improves obstetric outcomes when compared with a low dose oxytocin regimen, in a manner that is safe for both mother and neonate.
This project will include 1002 women recruited from the obstetrical service at Prentice Women's Hospital. Women will be included if they are at least 36 weeks gestation, have a singleton pregnancy, and have been diagnosed with spontaneous labor or spontaneous rupture of membranes. Women will be exposed to oxytocin for the indication of labor augmentation at the discretion of their obstetric provider.
Women will be randomized with equal probability to intervention group using a fixed allocation procedure. To maintain a double blind design, the Prentice Women's Hospital pharmacy will carry out the randomization of oxytocin solutions according to the random assignment so that neither the women or their care providers nor the investigators will know the identity of the intervention assignment. The low-dose oxytocin regimen group will receive a starting oxytocin regimen concentration rate of 2 milliunits/minute that can be increased at increments of 2 milliunits/minute, as per the discretion of their obstetric provider. The high-dose oxytocin regimen group will receive a starting oxytocin regimen concentration rate of 6 milliunits/minute that can be increased at increments of 6 milliunits/minute, as per the discretion of their obstetric provider.
Once the women are enrolled, randomized, and in receipt of their assigned interventions, further clinical management will be left to the discretion of each woman's obstetric provider.
Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able to give informed written consent
- •Age 18-45 years
- •Nulliparous
- •Pregnant with a live singleton gestation that is equal to or greater than 36 weeks
- •Diagnosed with at least 6 regular uterine contractions in an observation period of no more than 60 minutes and at least one of the following: spontaneous rupture of membranes, OR cervix greater than or equal to 3 centimeters dilated OR cervix at least 80% effaced.
- •The participant's attending obstetric physician or midwife has determined that the participant needs administration of oxytocin infusion for labor augmentation. Labor augmentation will be defined as stimulation of uterine contractions when spontaneous contractions have failed to result in progressive cervical dilation of descent of fetus.
排除标准
- •Women not meeting the above criteria
- •History of prior cesarean section or uterine surgery
- •Fetus in non-cephalic presentation
- •Participant is undergoing labor induction (i.e. cervical ripening)
- •Non-English speaking
研究组 & 干预措施
High dose oxytocin regimen
The oxytocin solution will be prepared using 90 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 6 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 6 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
干预措施: Oxytocin (Drug)
High dose oxytocin regimen
The oxytocin solution will be prepared using 90 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 6 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 6 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
干预措施: Sodium Chloride 0.9% (Other)
Low dose oxytocin regimen
The oxytocin solution will be prepared using 30 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 2 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 2 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
干预措施: Oxytocin (Drug)
Low dose oxytocin regimen
The oxytocin solution will be prepared using 30 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 2 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 2 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
干预措施: Sodium Chloride 0.9% (Other)
结局指标
主要结局
Number of Participants Delivered by Cesarean
时间窗: At time of delivery
Number of participants delivered by cesarean section
次要结局
- Labor Augmentation Duration(Number of hours from randomization to delivery)
- Number of Participants With Postpartum Hemorrhage(From date of delivery to date of hospital discharge, an expected average of 3 days)
- Number of Participants With Intrapartum Chorioamnionitis(From time of labor admission to time of delivery, an expected average of 24 to 48 hours)
- Number of Participants With Postpartum Endometritis(From time of delivery to time of hospital discharge, an expected average of 3 days)
- Number of Participants Whose Offspring Experiences a Perinatal Death(Study enrollment to delivery (if intrapartum stillbirth) or 28 days of life (if liveborn))
- Number of Participants With Umbilical Cord Acidemia(At time of delivery)
- Neonatal Apgar Score of Less Than 3 at 5 Minutes of Life(Delivery through 5 minutes of life)
- Admission to Neonatal Intensive Care Unit(Delivery to 28 days of life)
- Number of Participants Whose Neonates Experience a Composite of Severe Neonatal Morbidity and Perinatal Mortality(Delivery to 28 days of life)
研究者
Moeun Son
Assistant Professor in Obstetrics and Gynecology - Maternal Fetal Medicine
Northwestern University