Effect of Increased BMI on Efficacy of Labor Analgesia | NCT07367347

Studies
Effect of Increased BMI on Efficacy of Labor Analgesia

NCT07367347

Sponsor

Mariah Arif

Status

Completed

Last Update Posted

Jan 27, 2026Actual

Enrollment

9,000Actual

Phase

Not provided

Conditions

Neuraxial Analgesia
Labor Analgesia

Interventions

Neuraxial analgesia
Neuraxial Analgesia
Neuraxial Analgesia

Countries

Qatar

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2, 2025Actual

Primary Completion Date

Dec 31, 2025Actual

Completion Date

Jan 1, 2026Actual

First Submitted Date

Jan 16, 2026

First Submission Date that Met QC Criteria

Jan 16, 2026

First Posted Date

Jan 26, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2026

Last Update Posted Date

Jan 27, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Class III obese parturient		Class III obese parturient receiving neuraxial analgesia	Procedure: Neuraxial analgesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neuraxial analgesia	Procedure	Combined spinal-epidural analgesia	Class III obese parturient

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Maternal adverse events	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ayten Saracoglu	University of Florida, UF Health, Jacksonville, FL 32209, USA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Women's Wellness and Research Center		Doha			Qatar

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided