Neuraxial AnalgesiaNCT07367347
Effect of Increased BMI on Efficacy of Labor Analgesia
An observational study of Neuraxial Analgesia and Labor Analgesia, run by Mariah Arif at 1 site in Qatar.
Trial summary
This study seeks to identify the most effective neuraxial technique for labor analgesia in Class III parturient Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neuraxial Analgesia, Labor Analgesia
- What is being tested?
- Neuraxial analgesia
- Type of treatment
- Surgery or procedure
- How many people
- 9,000 participants
- Where
- 1 siteQatar
- Study dates
- 2 Feb 2025to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- Age > or equal to 18 years
- BMI ≥ 40 kg/m²
- Gestational age ≥ 28 weeks
Who cannot join
- 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)
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the detailed description
This retrospective cohort study collected data on eligible participants from the electronic medical records.
- Conditions
- Neuraxial Analgesia, Labor Analgesia
- Being tested
- Neuraxial analgesia
- Keywords
- labor analgesia, neuraxial analgesia, obesity, parturient
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuraxial analgesiaProcedure or surgery
Combined spinal-epidural analgesia
Neuraxial AnalgesiaProcedure or surgery
Epidural analgesia
Neuraxial AnalgesiaProcedure or surgery
Dural puncture epidural analgesia
| Study group | Role | What they receive |
|---|---|---|
| Class III obese parturient | Class III obese parturient receiving neuraxial analgesia Receives: Procedure: Neuraxial analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: onset of neuraxial analgesia to completion of labor
Secondary outcomes (2)
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
Measured: onset of neuraxial analgesia to completion of labor
Fetal adverse events
APGAR SCORE
Measured: at 1 and 5 minutes after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start2 Feb 2025
- Primary completion31 Dec 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuraxial AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 9,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mariah Arif
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Mariah Arif, Hamad General Hospital
- Investigators
- Ayten Saracoglu, Principal investigator, University of Florida, UF Health, Jacksonville, FL 32209, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367347
- Sponsor's protocol ID
- MRC-01-24-875
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Increased BMI on Efficacy of Labor Analgesia: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07367347
- Acronym / sponsor ID
- MRC-01-24-875
- Conditions
- Neuraxial Analgesia, Labor Analgesia
- Keywords
- labor analgesia, neuraxial analgesia, obesity, parturient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,000 participants (actual)
- Lead sponsor
- Mariah ArifOther government
- Study start
- 2 Feb 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Class III obese parturient | – | Procedure: Neuraxial analgesiaClass III obese parturient receiving neuraxial analgesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (3 listed)
- Age > or equal to 18 years
- BMI ≥ 40 kg/m²
- Gestational age ≥ 28 weeks
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuraxial analgesiaCombined spinal-epidural analgesia | Procedure or surgery | Class III obese parturient |
| Neuraxial AnalgesiaEpidural analgesia | Procedure or surgery | Class III obese parturient |
| Neuraxial AnalgesiaDural puncture epidural analgesia | Procedure or surgery | Class III obese parturient |
Primary outcome
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
2 secondary outcomes
Maternal adverse events
Time frame: onset of neuraxial analgesia to completion of labor
Fetal adverse events
Time frame: at 1 and 5 minutes after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayten Saracoglu principal investigator
University of Florida, UF Health, Jacksonville, FL 32209, USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuraxial Analgesia and Labor Analgesia, run by Mariah Arif at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of labor analgesia (time frame: onset of neuraxial analgesia to completion of labor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.