Ambulation With Labor Epidural in Obese Women

Not Applicable

Terminated

• Conditions: Labor Onset and Length Abnormalities; Obesity
• Interventions: Behavioral: Ambulation

• Registration Number: NCT04504682
• Lead Sponsor: University of Chicago

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.

Study Timeline

• Study First Submitted: 2020-08-06
• Study First Submitted QC: 2020-08-06
• Study First Posted: 2020-08-07
• Study Start: 2020-08-25
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-03
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ambulation	Ambulation	Participants in this arm will be encouraged to ambulate with epidural in place.

Primary Outcome Measures

Name	Time	Method
Cesarean Delivery Rate	At time of delivery	Percent of cesarean delivery

Secondary Outcome Measures

Name	Time	Method
First Stage Duration	From onset of labor until complete dilation	Duration (hrs)
Labor Duration	From labor onset to time of delivery	Duration (hrs)
Second Stage Duration	From complete dilation until delivery	Duration (hrs)
Perceived Labor Control	Within 4 days postpartum	Score on Labor Agentry Scale

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States