NCT07335172

Brief Summary

Due to the physiologically delayed gastric emptying in pregnant women, the potential risk of aspiration before cesarean delivery constitutes an important source of perioperative complications, and when it occurs, it is associated with increased maternal morbidity and/or mortality. Systematic reviews and meta-analyses have demonstrated that, compared with non-pregnant women, gastric emptying is delayed particularly during the first trimester of pregnancy, and that gastric emptying does not occur in cases who have consumed solid food within the last 8 hours and in whom labor has begun. This study aims to evaluate preoperative gastric volumes by ultrasonography in ASA II pregnant women (according to the American Society of Anesthesiologists classification, healthy parturients without complications) scheduled to undergo elective cesarean delivery under general or spinal anesthesia, based on different fasting durations for solid and liquid intake, with the type of liquid. Although previous research in pregnant populations has predominantly focused on the importance of gastric ultrasonography in the presence of gestational diabetes mellitus, this thesis study aims to generate data from the general population. The findings are expected to enable individualized preventive measures to reduce aspiration-related complications during cesarean deliveries performed under general or spinal anesthesia, thereby contributing to patient safety.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Status
not yet recruiting

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

Study Start

First participant enrolled

January 1, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

January 13, 2026

Status Verified

November 1, 2025

Enrollment Period

1 month

First QC Date

January 5, 2026

Last Update Submit

January 5, 2026

Conditions

Keywords

Gastric Ultrasoundelective cesarean section

Outcome Measures

Primary Outcomes (2)

  • Obstetric Ultrasonographic Assessment: Gastric volume

    1\. Obstetric Ultrasonographic Assessment: Gastric Volume Gastric volume will be calculated by ultrasonography (with two mathematical models from the literature) before elective cesarean delivery and recorded in milliliters.

    60-90 minutes before surgery

  • Time of last solid food / liquid intake The time of the last solid food and liquid intake by the pregnant women will be recorded in hours. Liquid type will be also recorded.

    The time of the last solid food and liquid intake by the pregnant women will be recorded in hours. Liquid type will be also recorded.

    60-90 minutes before surgery

Secondary Outcomes (1)

  • Preoperative data

    60-90 minutes before surgery

Study Arms (1)

ASA II term pregnant women aged 18-45 years scheduled for elective cesarean delivery

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy term pregnant women aged 18-45 years, ASA II, scheduled for elective cesarean section

You may qualify if:

  • Aged 18-45 years
  • Term pregnant women classified as ASA II scheduled for elective cesarean section
  • Those who voluntarily agree to participate in the study

You may not qualify if:

  • Cases requiring emergency (Lucas classification based on the urgency of caesarean section, Category 1-2)
  • Multiple pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Ekin KUTLU

    Gazi University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Anesthesiology and Reanimation researcher/ Doctor

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 13, 2026

Study Start

January 1, 2026

Primary Completion

February 1, 2026

Study Completion

April 1, 2026

Last Updated

January 13, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share