Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Cesarean Delivery Rate
研究概览
简要总结
This study aims to determine if using the peanut ball during labor reduces the cesarean delivery rate when compared to normal intrapartum management (no peanut ball) in the obese patient population.
详细描述
Currently at Geisinger Medical Center Danville, use of the peanut ball is at the discretion of attending or resident physicians, or obstetric nurses on the Labor and delivery team for the day. Despite the common use of this labor adjuvant tool, a well-designed prospective study is necessary to investigate if the peanut ball provides any benefit during the labor process for the obese gravida. If this simple tool is shown to reduce the rate of cesarean delivery, then hospital protocols could be changed to ensure its use during labor. This has the potential to decrease the rate of cesarean delivery in the most vulnerable patient population. The investigators propose a randomized controlled trial (RCT) to determine if using the peanut ball during labor provides a reduction in the cesarean delivery rate in the obese patient population. The investigators will compare cesarean delivery rates in patients using the peanut ball to patients receiving routine intrapartum management without the use of the peanut ball. Singleton pregnancies complicated by obesity, defined by pre-pregnancy BMI > 30kg/m2, will be included.
Study participants will be randomized to one of the two study arms. The peanut ball arm (also referred to as study arm 1) will be managed according to the parameters specified for use of the peanut ball. The participants in the Control arm (also referred to as study arm 2) will be managed according to the standard intrapartum management as defined by Geisinger's Labor & Delivery protocol and per the OB providers. The objective of the study is to determine if use of the peanut ball during labor reduces the cesarean delivery rate in the obese patient population. Secondary outcomes of interest include rate of cervical dilation, rate of operative deliveries, fetal position (occiput anterior vs. occiput posterior) at complete dilation (10 cm), and patient satisfaction.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Admitted for delivery
- •Pre-pregnancy BMI > 30kg/m2
- •Planned vaginal delivery at Geisinger Medical Center (GMC)
- •Gestational age > 37 weeks 0 days
- •Singleton pregnancy
- •Cephalic presentation
- •English speaking
排除标准
- •Pre-pregnancy BMI < 30kg/m2
- •Contraindication to vaginal delivery
- •Planned cesarean delivery (i.e., an elective primary or repeat cesarean delivery)
- •Gestational age < 37 weeks 0 days
- •Multifetal gestation
- •Intrauterine fetal demise
- •Non-English speaking
- •Greater than 9cm at the time of randomization
结局指标
主要结局
Cesarean Delivery Rate
时间窗: Delivery
Number of vaginal deliveries vs. Number of cesarean deliveries
次要结局
- Rate of Cervical Dilation(Randomization until complete dilation (10cm))
- Fetal Position(Complete Dilation (10cm))
- Type of Vaginal Delivery(Delivery)
研究者
Awathif Dhanya Mackeen
Division of Maternal-Fetal Medicine
Geisinger Clinic
