NCT07406373

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

February 7, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

January 23, 2026

Last Update Submit

April 30, 2026

Conditions

Keywords

spinal blockobstetric anesthesiasensory block levelspinal anesthesiaintra-abdominal pressureabdominal circumference

Outcome Measures

Primary Outcomes (1)

  • Maximum sensory block level after spinal anesthesia

    The maximum dermatomal level of sensory block assessed by loss of cold sensation after spinal anesthesia.

    Within the first 30 minutes after spinal anesthesia

Secondary Outcomes (4)

  • Intra-abdominal pressure

    Baseline (preoperative, before spinal anesthesia) and early postoperative period (within 30 minutes after cesarean section)

  • Abdominal circumference

    Baseline (preoperative, before spinal anesthesia) and early postoperative period (within 30 minutes after cesarean section)

  • Incidence of hypotension after spinal anesthesia

    Within the first 30 minutes after spinal anesthesia

  • Vasopressor requirement

    Perioperative period

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kütahya Şehir Hastanesi

Kütahya, Kütahya, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 23, 2026

First Posted

February 12, 2026

Study Start

February 7, 2026

Primary Completion

April 1, 2026

Study Completion

April 30, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations