NCT03772886

Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball

Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball: A Randomized Control Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Geisinger Clinic · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Obesity
• Cesarean Section

Interventions

Type	Name	Description
DEVICE	Peanut Ball	A peanut shaped exercise ball.

Timeline

• Start date: 2019-09-09
• Primary completion: 2021-06-04
• Completion: 2021-06-09
• First posted: 2018-12-11
• Last updated: 2021-08-23

Locations

1 site across 1 country: United States