Labor Long, Labor Onset and Length Abnormalities, Labor; Poor, Prolonged Labor
Conditions
Keywords
peanut ball, labor, cesarean section
Brief summary
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.
Interventions
DEVICEPositioning with peanut ball
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.
OTHERTraditional positioning
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.
Sponsors
University of Tennessee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of active stage of labor | Expected <6 hours | Length of time from progression of 6cm cervical dilation to 10cm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cesarean section rate | < 48 hours | Proportion of patients who undergo delivery by cesarean section |
Countries
United States
Contacts
Primary ContactRachel Nelson, MD, PhD
Outcome results
None listed