Cesarean SectionNCT07406373
Intra-abdominal Pressure, Abdominal Circumference, and Spinal Block Level in Cesarean Section
An observational study of Cesarean Section and Pregnancy, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Spinal anesthesia is commonly used for cesarean section and provides effective anesthesia with rapid onset. However, the spread of spinal anesthesia may vary among pregnant women due to physiological and anatomical changes during pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section, Pregnancy, Elective Cesarean Section
- How many people
- 107 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Feb 2026to 30 Apr 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: This study includes pregnant women aged 18-40 years who were scheduled for elective cesarean section under spinal anesthesia at the Department of Obstetrics and Gynecology, Kütahya City Hospital. Eligible participants belonged to ASA physical status II-III and provided informed consent. The study population represents a clinically stable obstetric cohort undergoing elective cesarean delivery, without conditions known to significantly alter intra-abdominal pressure or spinal anesthesia characteristics.
Who may be able to join
- Pregnant women aged 18-40 years
- Scheduled for elective cesarean section at Kütahya City Hospital
- Planned spinal anesthesia
- ASA physical status II-III
- Provided written informed consent
Who cannot join
- Refusal to participate in the study
- Emergency cesarean section
- Preeclampsia or other hypertensive disorders of pregnancy
- Onset of labor or premature rupture of membranes
- Clinical conditions affecting intra-abdominal pressure, including peripheral edema or ascites
- Height <140 cm or >180 cm
Show all 12Show fewer
- Body mass index > 40 kg/m²
- Spinal deformity or history of spinal surgery
- Contraindications to neuraxial anesthesia
- Known allergy to bupivacaine
- Requirement for additional surgical procedures other than cesarean section
- Conditions contraindicating or interfering with intra-abdominal pressure measurement, including active or previous postdural puncture headache, neurogenic bladder, hematuria, or incidental abdominal mass
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intra-abdominal Pressure and Abdominal Circumference on Sensory Block Level After Spinal Anesthesia in Pregnant Women Undergoing Cesarean Section
Spinal anesthesia is commonly used for cesarean section and provides effective anesthesia with rapid onset. However, the spread of spinal anesthesia may vary among pregnant women due to physiological and anatomical changes during pregnancy. Increased intra-abdominal pressure and abdominal circumference may influence cerebrospinal fluid dynamics and affect the level of sensory block achieved after spinal anesthesia.
This prospective observational study aims to evaluate the relationship between intra-abdominal pressure, abdominal circumference, and the maximum sensory block level following spinal anesthesia in pregnant women undergoing cesarean section. Intra-abdominal pressure and abdominal circumference will be measured before surgery, and sensory block levels and hemodynamic parameters will be assessed after spinal anesthesia. The findings of this study may help to better understand factors affecting spinal block spread in pregnant patients.
- Conditions
- Cesarean Section, Pregnancy, Elective Cesarean Section
- Keywords
- spinal block, obstetric anesthesia, sensory block level, spinal anesthesia, intra-abdominal pressure, abdominal circumference
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum sensory block level after spinal anesthesia
The maximum dermatomal level of sensory block assessed by loss of cold sensation after spinal anesthesia.
Measured: Within the first 30 minutes after spinal anesthesia
Secondary outcomes (4)
Intra-abdominal pressure
Intra-abdominal pressure measured in the preoperative period before spinal anesthesia and in the postoperative period following cesarean section using an intravesical measurement technique.
Measured: Baseline (preoperative, before spinal anesthesia) and early postoperative period (within 30 minutes after cesarean section)
Abdominal circumference
Abdominal circumference measured at the level of the umbilicus before spinal anesthesia and in the postoperative period following cesarean section.
Measured: Baseline (preoperative, before spinal anesthesia) and early postoperative period (within 30 minutes after cesarean section)
Incidence of hypotension after spinal anesthesia
Hypotension defined as mean arterial pressure <65 mmHg measured during the first 30 minutes after spinal anesthesia.
Measured: Within the first 30 minutes after spinal anesthesia
Vasopressor requirement
Requirement and total dose of vasopressor agents administered after spinal anesthesia.
Measured: Perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start7 Feb 2026
- Primary completion1 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan TELLİ, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406373
- Sponsor's protocol ID
- 2025/08-28
- Status last verified
- Oct 2026
- First submitted
- 23 Jan 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intra-abdominal Pressure and Abdominal Circumference on Sensory Block Level After Spinal Anesthesia in Pregnant Women Undergoing Cesarean Section
- ClinicalTrials.gov ID
- NCT07406373
- Acronym / sponsor ID
- 2025/08-28
- Conditions
- Cesarean Section, Pregnancy, Elective Cesarean Section
- Keywords
- spinal block, obstetric anesthesia, sensory block level, spinal anesthesia, intra-abdominal pressure, abdominal circumference
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 7 Feb 2026 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 12 Feb 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.
Spinal anesthesia is commonly used for cesarean section and provides effective anesthesia with rapid onset. However, the spread of spinal anesthesia may vary among pregnant women due to physiological and anatomical changes during pregnancy. Increased intra-abdominal pressure and abdominal circumference may influence cerebrospinal fluid dynamics and affect the level of sensory block achieved after spinal anesthesia.
This prospective observational study aims to evaluate the relationship between intra-abdominal pressure, abdominal circumference, and the maximum sensory block level following spinal anesthesia in pregnant women undergoing cesarean section. Intra-abdominal pressure and abdominal circumference will be measured before surgery, and sensory block levels and hemodynamic parameters will be assessed after spinal anesthesia. The findings of this study may help to better understand factors affecting spinal block spread in pregnant patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study includes pregnant women aged 18-40 years who were scheduled for elective cesarean section under spinal anesthesia at the Department of Obstetrics and Gynecology, Kütahya City Hospital. Eligible participants belonged to ASA physical status II-III and provided informed consent. The study population represents a clinically stable obstetric cohort undergoing elective cesarean delivery, without conditions known to significantly alter intra-abdominal pressure or spinal anesthesia characteristics.
Key inclusion criteria (5 listed)
- Pregnant women aged 18-40 years
- Scheduled for elective cesarean section at Kütahya City Hospital
- Planned spinal anesthesia
- ASA physical status II-III
- Provided written informed consent
Key exclusion criteria (12 listed)
- Refusal to participate in the study
- Emergency cesarean section
- Preeclampsia or other hypertensive disorders of pregnancy
- Onset of labor or premature rupture of membranes
- Clinical conditions affecting intra-abdominal pressure, including peripheral edema or ascites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maximum sensory block level after spinal anesthesia
Time frame: Within the first 30 minutes after spinal anesthesia
The maximum dermatomal level of sensory block assessed by loss of cold sensation after spinal anesthesia.
4 secondary outcomes
Intra-abdominal pressure
Time frame: Baseline (preoperative, before spinal anesthesia) and early postoperative period (within 30 minutes after cesarean section)
Abdominal circumference
Time frame: Baseline (preoperative, before spinal anesthesia) and early postoperative period (within 30 minutes after cesarean section)
Incidence of hypotension after spinal anesthesia
Time frame: Within the first 30 minutes after spinal anesthesia
Vasopressor requirement
Time frame: Perioperative period
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 13 Oct 2026.
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Cesarean Section (MeSH: D002585), Postoperative Pain After Cesarean Section
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Early Heart Rate Variability and Sleep and Quality of Recovery After Cesarean Delivery
Recovery of Function, Postoperative Period
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Virtual Reality for Anxiety and Birth Satisfaction During Elective Cesarean Section
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Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery
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Chronic Pain, Cesarean Section Complications
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cesarean Section and Pregnancy, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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 5 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 13 Oct 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 Turkey (Türkiye). 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?
Maximum sensory block level after spinal anesthesia (time frame: Within the first 30 minutes after spinal anesthesia). 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 13 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.