Quantifying the Impact of the Peanut Ball on the Duration of the Active Stage of Labor

Study Overview
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Brief Summary
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Prolonged labor is associated with adverse maternal and fetal outcomes including infection, postpartum hemorrhage and increased NICU admission. One of the most common indications for cesarean section in the US is prolonged labor. Maternal positioning through labor facilitated by birthing balls is believed to help facilitate labor. Current data is inconclusive on whether or not the use of birthing balls is advantageous in a statistically significant manner. In this prospective randomized controlled trial, participants will be randomly selected to receive either the experimental intervention (repositioning peanut ball during labor) or the control intervention (the standard therapy of traditional repositioning during labor). Primary outcome: Time of active labor to delivery with and without use of the peanut ball. Secondary outcome: Cesarean section frequency.

Official Title
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Quantifying the Impact of the Peanut Ball on the Duration of the Active Stage of Labor

Conditions
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Labor Onset and Length Abnormalities, Prolonged Labor, Labor Long, Labor; Poor

Intervention / Treatment
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* Device: Positioning with peanut ball
* Other: Traditional positioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fetus must be vertex in position at the time of admission to L&D Pregnant patients age 16 years old and above Singleton pregnancy (ie. one fetus) Patients who receive induction and augmentation of labor may be included Include both nulliparous and multiparous women Patients with HTN, diabetes, and obesity at any point in their pregnancy may be included Patients may be included in the study regardless of whether or not they received an epidural Patients who have been randomly assigned to receive a peanut ball must be placed on the peanut ball at 6cm dilation, not earlier. Patients who present to L&D dilated to 4cm may be included Exclusion Criteria: TOLACs and VBACs will be excluded Multiple gestation will be excluded Category 3 fetal tracing will be excluded Chorioamnionitis will be excluded Patients who present to L&D at 6cm cervical dilation will be excluded Patients placed on the peanut ball before 6cm cervical dilation will be excluded Patients with fetal malpresentation will be excluded

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Traditional Positioning<br>Participants who are randomly assigned to NOT receive a peanut ball will undergo placement on a wedge pillow and/or traditional positioning during their labor progression at 6cm cervical dilation. | Other: Traditional positioning<br>* If participants are randomly selected to NOT receive a peanut ball, the intent is for the patient to undergo traditional positioning/use wedge pillows during their labor progression.<br>|
| Experimental: Peanut Ball Positioning<br>Participants who are randomly assigned to receive a peanut ball will be positioned with a peanut ball at 6cm cervical dilation. | Device: Positioning with peanut ball<br>* If participants are randomly selected to receive a peanut ball, the intent is for the patient to remain on the peanut ball during their labor progression.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of active stage of labor | Length of time from progression of 6cm cervical dilation to 10cm | Expected <6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cesarean section rate | Proportion of patients who undergo delivery by cesarean section | < 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peanut ball, labor, cesarean section