Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03772886
• Other study ID #: 2018-0613
• Status: Terminated
• Phase: N/A
• Start date: September 9, 2019
• Est. completion date: June 9, 2021

Study information

• Verified date: August 2021
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: June 9, 2021
• Est. primary completion date: June 4, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Obesity

Intervention

Device:
• Peanut Ball
A peanut shaped exercise ball.

Locations

Country	Name	City	State
United States	Geisinger Medical Center	Danville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Geisinger Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Satisfaction Survey	Evaluating overall patient satisfaction during labor course	Postpartum Day One
Primary	Cesarean Delivery Rate	Number of vaginal deliveries vs. Number of cesarean deliveries	Delivery
Secondary	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)
Secondary	Type of Vaginal Delivery	Number of spontaneous vaginal deliveries vs Number of forceps assisted vaginal deliveries vs Number of vacuum assisted vaginal deliveries.	Delivery
Secondary	Fetal Position	Occiput anterior versus occiput posterior versus occiput transverse	Complete Dilation (10cm)