NCT04504682

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

August 25, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

1.8 years

First QC Date

August 6, 2020

Last Update Submit

May 3, 2023

Conditions

ObesityLabor Onset and Length Abnormalities

Outcome Measures

Primary Outcomes (1)

  • Cesarean Delivery Rate

    Percent of cesarean delivery

    At time of delivery

Secondary Outcomes (4)

  • Labor Duration

    From labor onset to time of delivery

  • First Stage Duration

    From onset of labor until complete dilation

  • Second Stage Duration

    From complete dilation until delivery

  • Perceived Labor Control

    Within 4 days postpartum

Study Arms (1)

Ambulation

EXPERIMENTAL

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

Behavioral: Ambulation

Interventions

AmbulationBEHAVIORAL

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

Ambulation

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (5)

  • 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.

    PMID: 11605924BACKGROUND

  • 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.

    PMID: 10403865BACKGROUND

  • 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.

    PMID: 12566183BACKGROUND

  • 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.

    PMID: 15516383BACKGROUND

  • 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.

    PMID: 14990405BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Walking

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Maritza Gonzalez

    Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The person completing analysis will be blinded to the treatment group.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2020

First Posted

August 7, 2020

Study Start

August 25, 2020

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

May 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)