Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/27/2019 |
| Start Date: | April 15, 2019 |
| End Date: | January 15, 2021 |
| Contact: | Alexandria Betz, DO |
| Email: | abetz3@geisinger.edu |
| Phone: | 570-271-8160 |
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball: A Randomized Control Trial
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.
reduces the cesarean delivery rate when compared to normal intrapartum management (no peanut
ball) in the obese patient population.
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.
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.
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
We found this trial at
1
site
100 North Academy Avenue
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
570-271-6211
Principal Investigator: Alexandria Betz, DO
Phone: 570-271-8160
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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