Ambulation With Labor Epidural in Obese Women

Obesity Clinical Trial

Official title:

Neuraxial Analgesia With and Without Ambulation in Laboring Nulliparous Obese Women

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04504682
• Other study ID #: IRB19-1600
• Status: Terminated
• Phase: N/A
• Start date: August 25, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: May 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Labor Onset and Length Abnormalities
• Obesity

Intervention

Behavioral:
• Ambulation
Patients will be encouraged to ambulate for 20 minutes of every hour.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cesarean Delivery Rate	Percent of cesarean delivery	At time of delivery
Secondary	Labor Duration	Duration (hrs)	From labor onset to time of delivery
Secondary	First Stage Duration	Duration (hrs)	From onset of labor until complete dilation
Secondary	Second Stage Duration	Duration (hrs)	From complete dilation until delivery
Secondary	Perceived Labor Control	Score on Labor Agentry Scale	Within 4 days postpartum