Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
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|ClinicalTrials.gov Identifier: NCT03772886|
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : December 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Obesity Cesarean Section||Device: Peanut Ball||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||204 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Cesarean Delivery Rate [ Time Frame: Delivery ]Number of vaginal deliveries vs. Number of cesarean deliveries
- 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).
- 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.
- Fetal Position [ Time Frame: Complete Dilation (10cm) ]Occiput anterior versus occiput posterior versus occiput transverse
- Patient Satisfaction Survey [ Time Frame: Postpartum Day One ]Evaluating overall patient satisfaction during labor course
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772886
|Contact: Awathif D Mackeen, MDfirstname.lastname@example.org|
|Contact: Shantel T Quinn, MD, MSemail@example.com|
|United States, Pennsylvania|
|Geisinger Medical Center||Recruiting|
|Danville, Pennsylvania, United States, 17822|
|Contact: Awathif D Mackeen, MD 570-714-1099 firstname.lastname@example.org|
|Contact: Shantel T Quinn, MD, MS 570-271-8160 email@example.com|
|Principal Investigator: Awathif D Mackeen, MD|
|Sub-Investigator: Shantel T Quinn, MD, MS|
|Principal Investigator:||Awathif D Mackeen, MD||Geisinger Clinic|