- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07367386
Impact of Increasing BMI on the Success of Neuraxial Blocks in Class III Obese Parturients
January 25, 2026 updated by: Mariah Arif
Evaluating the Impact of Increasing BMI on the Success of Neuraxial Blocks in Class III Obese Parturients: A Retrospective Cohort Study
This study seeks to compare the success rates, feto-maternal outcomes, and complications associated with different neuraxial blocks in Class III obese parturient undergoing cesarean section
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This was a retrospective cohort study.
The data was obtained from electronic medical records of the eligible participants.
Study Type
Observational
Enrollment (Actual)
1917
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
-
-
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Doha, Qatar
- Women's Wellness and Research Center
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-
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 parturients undergoing C-section under neuraxial blocks in the operating rooms of Women's Wellness and Research Center from 1 January 2025 to 1 December 2024.
Description
Inclusion Criteria:
- Age > or equal to 18 years
- BMI ≥ 45 kg/m²
- Gestational age ≥ 28 weeks
Exclusion Criteria:
- Age < 18 years
- BMI < 45 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 undergoing cesarean section under neuraxial block
|
Single-shot spinal anesthesia
Epidural anesthesia
Combined spinal-epidural anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Failed neuraxial block
Time Frame: From onset of block until surgery completion
|
Determine the occurrence of the conversion to general anesthesia
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From onset of block until surgery completion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maternal adverse events
Time Frame: From onset of blockade until surgery completion
|
Determine the incidence of maternal hypotension, bradycardia, high-spinal (above T1 level), level of blockade higher than T4, post-dural puncture headache
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From onset of blockade until surgery completion
|
|
Fetal outcomes
Time Frame: At one and five minutes after birth
|
Apgar score
|
At one and five minutes after birth
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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-01-24-905
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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