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Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772886
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Awathif Dhanya Mackeen, Geisinger Clinic

Brief Summary:
This study aims to determine if using the peanut ball during the active phase of 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
Obesity Cesarean Section Device: Peanut Ball Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 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 : September 9, 2019
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : January 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: Peanut Ball Arm
Study participants randomized to the Peanut Ball Arm will have the peanut ball placed during the active phase of 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.



Primary Outcome Measures :
  1. Cesarean Delivery Rate [ Time Frame: Delivery ]
    Number of vaginal deliveries vs. Number of cesarean deliveries


Secondary Outcome Measures :
  1. Rate of Cervical Dilation [ Time Frame: 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 [ Time Frame: Delivery ]
    Number of spontaneous vaginal deliveries vs Number of forceps assisted vaginal deliveries vs Number of vacuum assisted vaginal deliveries.

  3. Fetal Position [ Time Frame: Complete Dilation (10cm) ]
    Occiput anterior versus occiput posterior versus occiput transverse


Other Outcome Measures:
  1. Patient Satisfaction Survey [ Time Frame: Postpartum Day One ]
    Evaluating overall patient satisfaction during labor course



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772886


Contacts
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Contact: Awathif D Mackeen, MD 570-714-1099 admackeen@geisinger.edu
Contact: Shantel T Quinn, MD, MS 570-271-8160 stquinn@geisinger.edu

Locations
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United States, Pennsylvania
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Contact: Awathif D Mackeen, MD    570-714-1099    admackeen@geisinger.edu   
Contact: Shantel T Quinn, MD, MS    570-271-8160    stquinn@geisinger.edu   
Principal Investigator: Awathif D Mackeen, MD         
Sub-Investigator: Shantel T Quinn, MD, MS         
Sponsors and Collaborators
Geisinger Clinic
Investigators
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Principal Investigator: Awathif D Mackeen, MD Geisinger Clinic
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Responsible Party: Awathif Dhanya Mackeen, Division of Maternal-Fetal Medicine, Geisinger Clinic
ClinicalTrials.gov Identifier: NCT03772886    
Other Study ID Numbers: 2018-0613
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Awathif Dhanya Mackeen, Geisinger Clinic:
Peanut Ball