Ambulation With Labor Epidural in Obese Women

Sponsor
University of Chicago (Other)
Overall Status
Recruiting
CT.gov ID
NCT04504682
Collaborator
(none)
20
1
1
27.2
0.7

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if ambulation with a labor epidural in place is associated with decreased rate of cesarean delivery in obese patients.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Ambulation
N/A

Detailed Description

Obese women are known to have increased risk of cesarean delivery and prolonged labors. Low concentration epidural analgesia can achieve pain relief and allow for ambulation. Prior investigations have not shown a benefit in cesarean delivery between those who ambulate with an epidural and those who do not. These studies were conducted in women with normal weights. It is unknown if ambulation with a labor epidural is beneficial in decreasing cesarean delivery among obese women.

Obese women at term with a singleton pregnancy will be enrolled in this pilot study. Patients will receive their epidural analgesia when they desire per standard protocol at our institution. Following epidural placement, a Modified Bromage Score and straight leg test will be performed. If the patient passes the straight leg test and has a modified Bromage score > 6, they will be allowed to ambulate. They will be encouraged to ambulate for 20 minutes per hour with another adult alongside them. Obstetric care will be standard of care.

On postpartum day one, the patient will be administered a Labor Agentry Scale. Chart review will then be conducted to review maternal and neonatal outcomes.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
The person completing analysis will be blinded to the treatment group.
Primary Purpose:
Treatment
Official Title:
Neuraxial Analgesia With and Without Ambulation in Laboring Nulliparous Obese Women
Actual Study Start Date :
Aug 25, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ambulation

Participants in this arm will be encouraged to ambulate with epidural in place.

Behavioral: Ambulation
Patients will be encouraged to ambulate for 20 minutes of every hour.

Outcome Measures

Primary Outcome Measures

  1. Cesarean Delivery Rate [At time of delivery]

    Percent of cesarean delivery

Secondary Outcome Measures

  1. Labor Duration [From labor onset to time of delivery]

    Duration (hrs)

  2. First Stage Duration [From onset of labor until complete dilation]

    Duration (hrs)

  3. Second Stage Duration [From complete dilation until delivery]

    Duration (hrs)

  4. Perceived Labor Control [Within 4 days postpartum]

    Score on Labor Agentry Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

Subjects capable of giving consent Singleton pregnancy Nulliparous (defined as no previous pregnancy beyond 20 weeks 0 days) Gestational age greater than or equal to 37 weeks BMI > = 35 at time of delivery admission Adult companion available Anticipated vaginal delivery

Exclusion Criteria:

Physical disability precluding ambulation Magnesium Administration Contraindications to neuraxial analgesia Cerclage in current pregnancy Active labor DPE Category III fetal heart tracing Fetal Demise In Utero

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Chicago Chicago Illinois United States 60637

Sponsors and Collaborators

  • University of Chicago

Investigators

  • Principal Investigator: Maritza Gonzalez, Faculty

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Chicago
ClinicalTrials.gov Identifier:
NCT04504682
Other Study ID Numbers:
  • IRB19-1600
First Posted:
Aug 7, 2020
Last Update Posted:
Jan 18, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 18, 2022