Clinical trial NCT03772886: Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
Official title: Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Cesarean Section
Keywords: Peanut Ball
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 68
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Cesarean Delivery Rate
timeFrame: Delivery
Secondary outcomes:
measure: Rate of Cervical Dilation
timeFrame: Randomization until complete dilation (10cm)
measure: Type of Vaginal Delivery
timeFrame: Delivery
measure: Fetal Position
timeFrame: Complete Dilation (10cm)
Other outcomes:
measure: Patient Satisfaction Survey
timeFrame: Postpartum Day One
Locations:
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Awathif D Mackeen, MD
role: PRINCIPAL_INVESTIGATOR
References: