Effect of Increased BMI on Efficacy of Labor Analgesia

January 25, 2026 updated by: Mariah Arif

The Effect of Increased BMI on Efficacy of Labor Analgesia: A Retrospective Cohort Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This retrospective cohort study collected data on eligible participants from the electronic medical records.

Study Type

Observational

Enrollment (Actual)

9000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Qatar
      • Doha, Qatar
        • Women's Wellness and Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Class III obese parturient
Class III obese parturient receiving neuraxial analgesia
Procedure: Neuraxial analgesia
Combined spinal-epidural analgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of labor analgesia
Time Frame: onset of neuraxial analgesia to completion of labor

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal adverse events
Time Frame: onset of neuraxial analgesia to completion of labor
Incidence of maternal hypotension, maternal bradycardia, high block (above T1), higher than T4 block, need of vasopressors, mortality, post-Dural puncture headache
onset of neuraxial analgesia to completion of labor
Fetal adverse events
Time Frame: at 1 and 5 minutes after birth
APGAR SCORE
at 1 and 5 minutes after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mariah Arif

Investigators

  • Principal Investigator: Ayten Saracoglu, University of Florida, UF Health, Jacksonville, FL 32209, USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2025

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

January 1, 2026

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 25, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRC-01-24-875

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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