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Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball

Sponsor
Geisinger Clinic (Other)
Overall Status
Terminated
CT.gov ID
NCT03772886
Collaborator
(none)
68
Enrollment
1
Location
2
Arms
21
Actual Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Peanut Ball
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball: A Randomized Control Trial
Actual Study Start Date :
Sep 9, 2019
Actual Primary Completion Date :
Jun 4, 2021
Actual Study Completion Date :
Jun 9, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Cesarean Delivery Rate [Delivery]

    Number of vaginal deliveries vs. Number of cesarean deliveries

Secondary Outcome Measures

  1. 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).

  2. Type of Vaginal Delivery [Delivery]

    Number of spontaneous vaginal deliveries vs Number of forceps assisted vaginal deliveries vs Number of vacuum assisted vaginal deliveries.

  3. Fetal Position [Complete Dilation (10cm)]

    Occiput anterior versus occiput posterior versus occiput transverse

Other Outcome Measures

  1. Patient Satisfaction Survey [Postpartum Day One]

    Evaluating overall patient satisfaction during labor course

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Geisinger Medical Center Danville Pennsylvania United States 17822

Sponsors and Collaborators

  • Geisinger Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Awathif Dhanya Mackeen, Division of Maternal-Fetal Medicine, Geisinger Clinic
ClinicalTrials.gov Identifier:
NCT03772886
Other Study ID Numbers:
  • 2018-0613
First Posted:
Dec 11, 2018
Last Update Posted:
Aug 23, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Awathif Dhanya Mackeen, Division of Maternal-Fetal Medicine, Geisinger Clinic
Peanut Ball

Study Results

No Results Posted as of Aug 23, 2021