Effect of Increased BMI on Efficacy of Labor Analgesia

NCT07367347 | Completed

• 1 other identifier: MRC-01-24-875
• Study Type: observational
• Target: 9,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to identify the most effective neuraxial technique for labor analgesia in Class III parturient

Conditions

Neuraxial Analgesia; Labor Analgesia

Keywords

labor analgesia; neuraxial analgesia; obesity; parturient

Outcome Measures

Primary Outcomes (1)

• Success rate of labor analgesia

  The success rate of each technique will be determined by: Number of patients requiring a physician top-up bolus Block symmetry First-attempt success rate

  onset of neuraxial analgesia to completion of labor

Secondary Outcomes (2)

• Maternal adverse events

  onset of neuraxial analgesia to completion of labor

• Fetal adverse events

  at 1 and 5 minutes after birth

Study Arms (1)

Class III obese parturient

Class III obese parturient receiving neuraxial analgesia

Procedure: Neuraxial analgesia

Interventions

Neuraxial Analgesia PROCEDURE

Combined spinal-epidural analgesia

Class III obese parturient

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Class III obese parturient receiving neuraxial analgesia (CSE, epidural or DPE) in labor rooms of Women's Wellness and Research Center between 1 January 2015 to 1 December 2024.

You may qualify if:

• Age \> or equal to 18 years
• BMI ≥ 40 kg/m²
• Gestational age ≥ 28 weeks

You may not qualify if:

• Age \< 18 years
• BMI \< 40 kg/m²
• History of venous thromboembolism or arterial disease (e.g., DVT, PE, angina, MI, or stroke)
• Severe active lung, cardiovascular, renal, or liver disorders; autoimmune disease; or hemoglobinopathies
• Hereditary or acquired thrombophilia (e.g., Factor V Leiden mutation or antithrombin deficiency)
• In utero fetal demise (IUFD)
• Failed operative vaginal delivery
• Cesarean for the second twin or multiple pregnancies (triplets or higher)
• IVF pregnancy
• Intraoperative bleeding\>1500mL
• Emergency cesarean section (Category I)
• Presence of large uterine fibroid ≥10 cm.

Sponsors & Collaborators

• Mariah Arif: lead

Study Sites (1)

Women's Wellness and Research Center

Doha, Qatar

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ayten Saracoglu

  University of Florida, UF Health, Jacksonville, FL 32209, USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 26, 2026
• Study Start: February 2, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)