Clinical trial NCT02190591: Use of Peanut Labor Ball Following Epidural Anesthesia
Official title: Use of Peanut Labor Ball for Pelvic Positioning for Nulliparous Patients Following Epidural
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: epidural
pregnant
Cesarean Section
forceps
vaginal
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2014-07-15
Enrollment: 204
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to look at the impact of using the Peanut Labor Ball (PLB) after epidural anesthesia in patients who have never given birth. The study will measure the impact on the length of labor, cesarean section rate, operative vaginal delivery rate (vacuum or forceps use), and third or fourth degree laceration rates. This study will determine the impact of PLB use by comparing two cohorts of nulliparous patients: one with the PLB use and one with traditional wedge and pillow positioning. If benefits related to use of the PLB can be demonstrated, it is our intention that each labor room will be stocked with a PBL for use as standard of care.

This study will test the following hypotheses:

1. The Peanut Labor Ball (PLB) will impact the cesarean section and operative vaginal delivery rate in low risk nulliparous patients who receive epidural anesthesia compared to similar cohort using traditional wedge and pillow positioning.
2. Using the PLB will impact the amount of time from epidural placement to complete dilation and the time of second stage of labor, when compared with the control cohort.
3. Use of the PLB will impact the third and fourth degree laceration rates when compared with the control cohort.

Detailed description: See above

Eligibility criteria: Inclusion Criteria:

* Any nulliparous woman age ≥18 years presenting in labor (or for induction of labor) with:

Gestation: 37 0/7weeks- 41 6/7weeks -early, full, and late term gestations (ACOG, 2013).

* Single gestation
* Vertex presentation
* Plans to deliver with epidural anesthesia

Exclusion Criteria:

* A complication of pregnancy at the time of admission (including known fetal anomalies or placental anomalies)
* Any muscular or skeletal limitations of the patient that does not allow for positioning with the peanut labor ball (PLB)
* An inability to speak or understand English language
* Preterm gestation: \<36 6/7 weeks or Post-term \>42 0/7weeks
* A multiple gestation
* Non-vertex presentation
* Diabetes including Gestational Diabetes Mellitus (GDM)
* Order for magnesium sulfate infusion
* Plan for delivery without epidural
* Planned cesarean delivery

Primary outcomes:
measure: Delivery Rate
timeFrame: .5-72 hours
Secondary outcomes:
measure: Dilation to Second Stage Labor
timeFrame: thirty minutes after epidural given to birth of baby
Other outcomes:
measure: Third and Fourth Degree Lacerations
timeFrame: within the last 15-30 minutes of birth
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan TriHealth Hosptial
state: Ohio
Study officials:
affiliation: TriHealth Inc.
name: Sarah Evans, RN
role: PRINCIPAL_INVESTIGATOR
References: