NCT02899260

Brief Summary

This study is designed as a prospective, randomized controlled trial that will compare the use of the peanut exercise ball in laboring patients compared with no use of the exercise ball. We hypothesize that use of the peanut ball decreases the incidence of cesarean section.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
316

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 8, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2019

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

2.7 years

First QC Date

September 8, 2016

Last Update Submit

September 17, 2020

Conditions

Cesarean Section

Outcome Measures

Primary Outcomes (1)

  • Cesarean Section

    Vaginal birth versus cesarean section

    Labor outcome during hospitalization for labor (1-3 days)

Secondary Outcomes (4)

  • Fetal APGAR Scores

    Delivery to 5 minutes following delivery

  • Labor Duration

    Labor (1-3days)

  • Fetal cord Ph

    Immediately following delivery

  • Mode of vaginal delivery

    Delivery

Study Arms (2)

Control

NO INTERVENTION

Subjects who are randomized to to the control group will labor without the use of the peanut ball in labor.

Experimental/Peanut Ball

EXPERIMENTAL

Subjects randomized to the intervention (peanut ball) arm will have the peanut ball planed between their upper legs for at least 30minutes during their labor. Time on the peanut ball will be quantified by the bedside nursing staff.

Device: Peanut Exercise Ball

Interventions

Peanut Exercise BallDEVICE

A Peanut shaped exercise ball.

Experimental/Peanut Ball

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VCU Health System

Richmond, Virginia, 23298, United States

Location

Related Links

Study Officials

  • Sarah H Milton, MD

    Virginia Commonwealth University Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 14, 2016

Study Start

August 1, 2016

Primary Completion

April 10, 2019

Study Completion

April 10, 2019

Last Updated

September 22, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

Plan to make individual data available on clinical trials.gov at conclusion of study.

Locations

US(1)