Empty Stomach Assessment in Fasting Pregnant Women Using Ultrasound

Phase 1

Not yet recruiting

• Conditions: Pregnant women posted for elective caesarean section

• Registration Number: CTRI/2021/04/032643
• Lead Sponsor: Vijayanagar Institute of Medical Sciences

Brief Summary

Gastric ultrasound is valuable point of care ultrasonographic application for the assessment ofcontent and volume, which may alter perioperative clinical management. Gravid uterus introducesvariations ultrasound examination, the stomach tends to be displaced cephalad and right whencompared to non-pregnant subjects, which would conceivably affect volume estimation. Modelshave been developed and subsequently implemented assessing the gastric volumes and thecontents pregnant females. BN to assess the residue and gastric volume after overnight fasting inpregnant female patients admitted electively under ultrasound guidance.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-07-04
• Study Start: 2021-12-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 306

Inclusion Criteria

• 1. All pregnant women of 18-35 years of age, > 36 weeks of gestation, admitted for elective obstetric indication, with one clear overnight inpatient stay preoperatively.
• 2. ASA physical status II.

Exclusion Criteria

• 1. Patient refusal for the procedure.
• 2. Deviation from proposed fasting times or oral intake advice.
• 3. Body mass index (BMI) greater than 30 kg/m².
• 4. Uncontrolled diabetes mellitus.
• 5. Moderate to severe pre-eclampsia.
• 6. Hiatus hernia, intestinal disease, previous upper abdominal surgeries.
• 7. Patients taking H2 receptor blockers, proton pump inhibitors and prokinetic drugs or any other medication known to delay gastric emptying.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The residual gastric volume after overnight fasting in pregnant women.	At 6AM in the morning after overnight fasting.

Secondary Outcome Measures

Name	Time	Method
Antral grading and assessment for presence of solid food contents in the gastric antrum after overnight fasting.	At 6AM in the morning after overnight fasting.

Trial Locations

Locations (1)

Vijayanagar Institute of Medical Sciences; 🇮🇳 Bellary, KARNATAKA, India

Vijayanagar Institute of Medical Sciences

🇮🇳Bellary, KARNATAKA, India

Dr Girish Sharanayya Hiremath

Principal investigator

9449065507

girish.sh4042@gmail.com