Outcomes Following Cesarean Delivery for Failure to Progress With Use of a Fetal Pillow
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Uterine incision to delivery time
研究概览
简要总结
The purpose of this study is to evaluate outcomes following cesarean delivery for failure to progress with the use of the Fetal Pillow. Our hypothesis is that time to delivery of the fetus is shorter with implementation of the Fetal Pillow.
详细描述
Women will be enrolled from the labor floor during their labor course when there is concern for cesarean section for failure to progress in the second stage of labor. These women may be approached if they have a prolonged labor course (before they reach full dilation), when they get to full dilation and start pushing, or following an unsuccessful operative delivery. All women who meet the inclusion criteria will be approached about participation in the study on labor and delivery. The process of informed consent will happen at that time on labor and delivery. All women will be enrolled by study staff or certain physicians at Brigham and Women's Hospital who have agreed to help consent patients for this study.
Once consent is obtained, the subjects will then be randomized 1:1 into two parallel groups, the Fetal Pillow Inflated (FPI) group and the Fetal Pillow Not Inflated (FPNI) group. A random number generator will allocate the groups in blocks of ten.
The Fetal Pillows used in the study have been donated by Safe Obstetrics Systems.
Each patient will have a Fetal Pillow inserted vaginally by the obstetrician after catheterization of the bladder (if it has not been previously performed). Once the Fetal Pillow is in place, the woman's legs will be placed flat on the operating table. The anesthesiologist will then inflate the Fetal Pillow if the patient has been randomized into the Fetal Pillow Inflated (FPI) group. In the Fetal Pillow Not Inflated (FPNI) group, the device will remain, not inflated, in the vagina. The obstetrician will therefore be blinded to the intervention. In the FPNI group the obstetrician will continue to be able to use conventional methods for delivery of a second stage arrest including hand from below and reverse breech extraction. The Fetal Pillow will be drained by the circulating nurse in the operating room following delivery with removal at the end of the procedure by the obstetrician.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Each patient will have a Fetal Pillow inserted vaginally by the obstetrician after catheterization of the bladder (if it has not been previously performed). Once the Fetal Pillow is in place, the woman's legs will be placed flat on the operating table. The anesthesiologist will then inflate the Fetal Pillow if the patient has been randomized into the Fetal Pillow Inflated (FPI) group. In the Fetal Pillow Not Inflated (FPNI) group, the device will remain, not inflated, in the vagina. The obstetrician will therefore be blinded to the intervention.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women age 18-50
- •term pregnancy (37- 41 6/7 weeks)
- •singleton gestation in cephalic presentation
- •fully dilated
- •both nulliparous and multiparous women
- •both spontaneous labor and labor inductions
排除标准
- •breech presentation
- •presence of contraindication to vaginal delivery
- •prior cesarean section
- •presence of congenital anomalies
研究组 & 干预措施
Fetal Pillow Inflated (FPI)
A Fetal Pillow will be inserted vaginally by the obstetrician after catheterization of the bladder (if it has not been previously performed). Once the Fetal Pillow is in place, the woman's legs will be placed flat on the operating table. The anesthesiologist will then inflate the Fetal Pillow. The obstetrician will not be aware to inflation of Fetal Pillow
Cesarean delivery will then be performed
The circulating nurse will deflate the Fetal Pillow following delivery. The obstetrician will remove the Fetal Pillow at the end of the procedure. The obstetrician will then fill out a survey regarding the delivery.
干预措施: Fetal Pillow (Device)
Fetal Pillow Not Inflated (FPNI)
A Fetal Pillow will be inserted vaginally by the obstetrician after catheterization of the bladder (if it has not been previously performed). Once the Fetal Pillow is in place, the woman's legs will be placed flat on the operating table. The Fetal Pillow will not be inflated.
Cesarean delivery will then be performed. The obstetrician will continue to be able to use conventional methods for delivery of a second stage arrest including hand from below and reverse breech extraction.
The circulating nurse will deflate the Fetal Pillow following delivery. The obstetrician will remove the Fetal Pillow at the end of the procedure. The obstetrician will then fill out a survey regarding the delivery.
结局指标
主要结局
Uterine incision to delivery time
时间窗: Assessed at time of delivery, delivery day (day 0)
Time (in seconds) from hysterotomy to delivery
次要结局
- Fetal Weight(Assessed at time of delivery, delivery day (day 0))
- 1 minute APGAR(Assessed at time of delivery, delivery day (day 0))
- Neonatal Intensive Care Unit (NICU) Length of Stay(Assessed at end of study period (week 4))
- Length of stay(Assessed at end of study period (week 4))
- Uterine extension(Assessed at time of delivery, delivery day (day 0))
- Composite Maternal Morbidity(Assessed both following delivery (day 0) and at end of study period (week 4))
- 5 minute APGAR(Assessed at time of delivery, delivery day (day 0))
- Composite Neonatal Morbidity(Assessed at end of study period (week 4))
- Difficulty of Delivery of Fetal head(Assessed at time of delivery, delivery day (day 0))
- Provider Opinions(Assessed at end of study period (week 4))
研究者
Julian N Robinson
Principal Investigator
Brigham and Women's Hospital