Ambulation With Labor Epidural in Obese Women

Neuraxial Analgesia With and Without Ambulation in Laboring Nulliparous Obese Women

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.

Study Overview

• Status: Terminated
• Conditions: Obesity; Labor Onset and Length Abnormalities
• Intervention / Treatment: Behavioral: Ambulation

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maritza Gonzalez; Phone Number: 773-702-3387; Email: mggonzalez@bsd.uchicago.edu
• Study Contact Backup: Name: Sunitha Suresh; Email: sunitha.suresh@uchospitals.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University Of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cesarean Delivery Rate	Percent of cesarean delivery	At time of delivery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Maritza Gonzalez, Faculty

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2020
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: IRB19-1600

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No