Dental Support Device in the Second Stage of Labor at a Major Tertiary Care Center; A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 348
- 试验地点
- 1
- 主要终点
- Dilation Duration of Second Stage of Labor Time
研究概览
简要总结
Obstetric practices now allow for prolonged second stage of labor to accomplish vaginal delivery. However, this practice may lead to either operative delivery (vacuum or forceps assisted delivery) or cesarean section with significant maternal/neonatal morbidity. Limited evidence suggests that dental support devices (DSD) may improve lead to shortened labor by allowing patients to push more effectively.
详细描述
In an effort to reduce the rate of cesarean section, obstetric practices now allow for prolonged second stage of labor to accomplish vaginal delivery. However, this practice is not without risks and may lead to either operative delivery (vacuum or forceps assisted delivery) or cesarean section with significant maternal/neonatal morbidity. Limited evidence suggests that dental support devices (DSD) may improve maternal valsalva and lead to a shortened second stage of labor by allowing them to push more effectively. Previous studies have been underpowered to find statistically significant results.
The Icahn School of Medicine at Mount Sinai has a unique and heterogeneous inner-city population of laboring mothers with marked rates of maternal obesity. The objective is to conduct a randomized controlled trial in which nulliparous patients are asked to use the LaboraideTM, a DSD designed for laboring women, while pushing with contractions in 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nulliparous women
- •Non-anomalous fetus
- •Singleton fetus
- •Vertex presentation
- •In the first phase of labor
- •Full term gestation (>=37w0d)
- •Maternal age 18-64 years
排除标准
- •Multiparity
- •History of prior uterine surgery such as cesarean section or myomectomy
- •Unexplained vaginal bleeding
- •Latex allergy
- •Contraindication to vaginal delivery
- •Pregestational or Gestational Diabetes
- •Fetal growth restriction
- •Fetus with suspected macrosomia
- •Prematurity (<37 weeks gestational age)
- •Multiple gestation
- •Refusal to participate
研究组 & 干预措施
Laboraide TM dental support device
Receive Laboraide
干预措施: Laboraide TM dental support device (Device)
Control Group
Patients will give consent in the first stage of labor. Subsequently, randomization will be performed using sealed envelopes opened at the time of pushing in the second stage of labor. Women assigned to Group B will not receive a Laboraide TM dental support device. Duration of the second stage and time spent pushing will be recorded. Obstetric management will not be altered by group assignment.
结局指标
主要结局
Dilation Duration of Second Stage of Labor Time
时间窗: Up to 3 hours
At the time of pushing in the second stage of labor, the time from full dilation to delivery during the second stage of labor in patients with vaginal delivery (spontaneous, vacuum, forceps included). Intention to treat analysis.
Delivery Time
时间窗: An average of 75 minutes
The time from initiation of pushing until delivery during the second stage of labor. Intention to treat analysis will be performed.
次要结局
- Number of Participants With Chorioamnionitis(Day 1)
- Number of NICU Admission(Day 1)
- Mode of Delivery(Day 1)
- Estimated Blood Loss(Day 1)
- Number of Participants With Post-partum Hemorrhage(Day 1)
- Neonatal Birth Weight(Day 1)
- Dental Support Device Comfort and Patient Satisfaction(Post-Op Day 1)
- Neonatal Sex(Day 1)
研究者
Angela Bianco
Director
Icahn School of Medicine at Mount Sinai