Cesarean Section, Obesity
Conditions
Keywords
Peanut Ball
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.
Interventions
DEVICEPeanut Ball
A peanut shaped exercise ball.
Sponsors
Geisinger Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cesarean Delivery Rate | Delivery | Number of vaginal deliveries vs. Number of cesarean deliveries |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Type of Vaginal Delivery | Delivery | Number of spontaneous vaginal deliveries vs Number of forceps assisted vaginal deliveries vs Number of vacuum assisted vaginal deliveries. |
| Fetal Position | Complete Dilation (10cm) | Occiput anterior versus occiput posterior versus occiput transverse |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Survey | Postpartum Day One | Evaluating overall patient satisfaction during labor course |
Countries
United States
Outcome results
None listed