Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball

Not Applicable

Terminated

• Conditions: Cesarean Section; Obesity
• Interventions: Device: Peanut Ball

• Registration Number: NCT03772886
• Lead Sponsor: Geisinger Clinic

Brief 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.

Study Timeline

• Study First Submitted: 2018-12-07
• Study First Submitted QC: 2018-12-10
• Study First Posted: 2018-12-11
• Study Start: 2019-09-09
• Primary Completion: 2021-06-04
• Study Completion: 2021-06-09
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-17
• Last Update Posted: 2021-08-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 68

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peanut Ball Arm	Peanut Ball	Study participants randomized to the Peanut Ball Arm will have the peanut ball placed during labor. Study participants will be required to use the peanut ball for a minimum of 30 minutes of each hour until they reach complete dilation. Peanut ball use time will be noted in the patient's chart.

Primary Outcome Measures

Name	Time	Method
Cesarean Delivery Rate	Delivery	Number of vaginal deliveries vs. Number of cesarean deliveries

Secondary Outcome Measures

Name	Time	Method
Rate of Cervical Dilation	Randomization until complete dilation (10cm)	The average amount of cervical dilation (cm) per hour compared between the two groups (peanut ball vs. no peanut ball).
Fetal Position	Complete Dilation (10cm)	Occiput anterior versus occiput posterior versus occiput transverse
Type of Vaginal Delivery	Delivery	Number of spontaneous vaginal deliveries vs Number of forceps assisted vaginal deliveries vs Number of vacuum assisted vaginal deliveries.

Trial Locations

Locations (1)

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States