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Ambulation With Labor Epidural in Obese Women

Neuraxial Analgesia With and Without Ambulation in Laboring Nulliparous Obese Women

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04504682
Enrollment
14
Registered
2020-08-07
Start date
2020-08-25
Completion date
2022-05-31
Last updated
2023-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Onset and Length Abnormalities, Obesity

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.

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.

Interventions

BEHAVIORALAmbulation

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

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

The person completing analysis will be blinded to the treatment group.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Cesarean Delivery RateAt time of deliveryPercent of cesarean delivery

Secondary

MeasureTime frameDescription
Labor DurationFrom labor onset to time of deliveryDuration (hrs)
First Stage DurationFrom onset of labor until complete dilationDuration (hrs)
Second Stage DurationFrom complete dilation until deliveryDuration (hrs)
Perceived Labor ControlWithin 4 days postpartumScore on Labor Agentry Scale

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026