Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball

NCT03772886 | Terminated

• 1 other identifier: 2018-0613
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Cesarean Section

Keywords

Peanut Ball

Outcome Measures

Primary Outcomes (1)

• Cesarean Delivery Rate

  Number of vaginal deliveries vs. Number of cesarean deliveries

  Delivery

Secondary Outcomes (3)

• Rate of Cervical Dilation

  Randomization until complete dilation (10cm)

• Type of Vaginal Delivery

  Delivery

• Fetal Position

  Complete Dilation (10cm)

Other Outcomes (1)

• Patient Satisfaction Survey

  Postpartum Day One

Study Arms (2)

Peanut Ball Arm

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

Study participants randomized to the Control Arm will labor without the peanut ball.

Interventions

Peanut Ball DEVICE

A peanut shaped exercise ball.

Peanut Ball Arm

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Awathif D Mackeen, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division of Maternal-Fetal Medicine

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 11, 2018
• Study Start: September 9, 2019
• Primary Completion: June 4, 2021
• Study Completion: June 9, 2021
• Last Updated: August 23, 2021

Record last verified: 2021-08

Locations

US (1)