Back to resultsAmbulation With Labor Epidural in Obese Women
Primary Purpose
Obesity, Labor Onset and Length Abnormalities
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ambulation
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
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
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ambulation
Arm Description
Participants in this arm will be encouraged to ambulate with epidural in place.
Outcomes
Primary Outcome Measures
Cesarean Delivery Rate
Percent of cesarean delivery
Secondary Outcome Measures
Labor Duration
Duration (hrs)
First Stage Duration
Duration (hrs)
Second Stage Duration
Duration (hrs)
Perceived Labor Control
Score on Labor Agentry Scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04504682
Brief Title
Ambulation With Labor Epidural in Obese Women
Official Title
Neuraxial Analgesia With and Without Ambulation in Laboring Nulliparous Obese Women
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Limited recruitment
Study Start Date
August 25, 2020 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Labor Onset and Length Abnormalities
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
The person completing analysis will be blinded to the treatment group.
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ambulation
Arm Type
Experimental
Arm Description
Participants in this arm will be encouraged to ambulate with epidural in place.
Intervention Type
Behavioral
Intervention Name(s)
Ambulation
Intervention Description
Patients will be encouraged to ambulate for 20 minutes of every hour.
Primary Outcome Measure Information:
Title
Cesarean Delivery Rate
Description
Percent of cesarean delivery
Time Frame
At time of delivery
Secondary Outcome Measure Information:
Title
Labor Duration
Description
Duration (hrs)
Time Frame
From labor onset to time of delivery
Title
First Stage Duration
Description
Duration (hrs)
Time Frame
From onset of labor until complete dilation
Title
Second Stage Duration
Description
Duration (hrs)
Time Frame
From complete dilation until delivery
Title
Perceived Labor Control
Description
Score on Labor Agentry Scale
Time Frame
Within 4 days postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maritza Gonzalez
Organizational Affiliation
Faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
11605924
Citation
Vallejo MC, Firestone LL, Mandell GL, Jaime F, Makishima S, Ramanathan S. Effect of epidural analgesia with ambulation on labor duration. Anesthesiology. 2001 Oct;95(4):857-61. doi: 10.1097/00000542-200110000-00012.
Results Reference
background
PubMed Identifier
10403865
Citation
Collis RE, Harding SA, Morgan BM. Effect of maternal ambulation on labour with low-dose combined spinal-epidural analgesia. Anaesthesia. 1999 Jun;54(6):535-9. doi: 10.1046/j.1365-2044.1999.00802.x.
Results Reference
background
PubMed Identifier
12566183
Citation
Karraz MA. Ambulatory epidural anesthesia and the duration of labor. Int J Gynaecol Obstet. 2003 Feb;80(2):117-22. doi: 10.1016/s0020-7292(02)00339-9.
Results Reference
background
PubMed Identifier
15516383
Citation
Vahratian A, Zhang J, Troendle JF, Savitz DA, Siega-Riz AM. Maternal prepregnancy overweight and obesity and the pattern of labor progression in term nulliparous women. Obstet Gynecol. 2004 Nov;104(5 Pt 1):943-51. doi: 10.1097/01.AOG.0000142713.53197.91.
Results Reference
background
PubMed Identifier
14990405
Citation
Nuthalapaty FS, Rouse DJ, Owen J. The association of maternal weight with cesarean risk, labor duration, and cervical dilation rate during labor induction. Obstet Gynecol. 2004 Mar;103(3):452-6. doi: 10.1097/01.AOG.0000102706.84063.C7. Erratum In: Obstet Gynecol. 2004 May;103(5 Pt 1):1019.
Results Reference
background
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Ambulation With Labor Epidural in Obese Women
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