Gastric Ultrasound Before Elective Cesarean Section

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorEkin Deniz KUTLU

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Multiple pregnancies

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 1 trial group
Group A: ASA II term pregnant women aged 18-45 years scheduled for elective cesarean delivery

Trial outcomes

Primary outcomes

1

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.

Time frame
60-90 minutes before surgery
2

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.

Time frame
60-90 minutes before surgery

Secondary outcomes

1

Preoperative data

In the preoperative period; the patient's age, weight (kg), body mass index (BMI, kg/m²), and gestational age (weeks + days) will be recorded.

Time frame
60-90 minutes before surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ekin Deniz KUTLU

Lead sponsor

Gazi University

Sponsor institution

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