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

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.

Study Overview

• Status: Terminated
• Conditions: Obesity; Cesarean Section
• Intervention / Treatment: Device: Peanut Ball

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 Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peanut Ball Arm; 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.	Device: Peanut Ball; A peanut shaped exercise ball.
No Intervention: Control Arm; Study participants randomized to the Control Arm will labor without the peanut ball.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cesarean Delivery Rate	Number of vaginal deliveries vs. Number of cesarean deliveries	Delivery

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction Survey	Evaluating overall patient satisfaction during labor course	Postpartum Day One

Collaborators and Investigators

• Sponsor: Geisinger Clinic
• Investigators: Principal Investigator: Awathif D Mackeen, MD, Geisinger Clinic

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2019
• Primary Completion (Actual): June 4, 2021
• Study Completion (Actual): June 9, 2021

Study Registration Dates

• First Submitted: December 7, 2018
• First Submitted That Met QC Criteria: December 10, 2018
• First Posted (Actual): December 11, 2018

Study Record Updates

• Last Update Posted (Actual): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Peanut Ball
• Other Study ID Numbers: 2018-0613

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No