Ultrasound for Comparison of Gastric Antral Volume in Pregnants and Non-pregnants

Completed

• Conditions: Pregnancy
• Interventions: Other: ultrasound

• Registration Number: NCT03380637
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief Summary

This study evaluates the effectiveness of ultrasound in term pregnant patients posted for elective lower segment cesarean sections and compared them with non pregnant females posted for elective surgeries.

Detailed Description

There is increased risk of aspiration in pregnancy due to various reasons i.e. increased progesterone levels, decreased motilin levels and distortion of gastric antrum due to gravid uterus.Ultrasound was proposed to be point of care tool, to assess risk stomach. A comparison with respect to the effectiveness of ultrasound was made in this study. The visibility of gastric antrum by ultrasound in term pregnant females posted for elective lower segment cesarean sections was compared with non-pregnant females posted for elective surgeries.

The secondary aim of the study was to compare the gastric antrum in either groups qualitatively and quantitatively.

Study Timeline

• Study Start: 2016-10-13
• Primary Completion: 2017-10-10
• Study Completion: 2017-10-10
• Status Verified: 2017-12
• Study First Submitted: 2017-12-15
• Study First Submitted QC: 2017-12-20
• Last Update Submitted: 2017-12-20
• Study First Posted: 2017-12-21
• Last Update Posted: 2017-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 63

Inclusion Criteria

Study group- Term pregnant patients, aged between 18 to 45 years, ASA II & III, having BMI between 18.5 to 30 kg/m2, scheduled for elective lower segment cesarean section.

Control group- Non-pregnant female patients, aged between 18 to 45 years, ASA I & II, having BMI between 18.5 to 30 kg/m2, scheduled for elective surgery.

Exclusion Criteria

Subjects with-

• Gastrointestinal pathology
• On any medication delaying gastric motility
• Systemic lupus erythematosis
• Diabetes mellitus
• Gestational diabetes
• Hypothyroidism Those who were not willing to give consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant and non-pregnant females	ultrasound	The pregnant females posted for elective lower segment cesarean section and non-pregnant females posted for elective surgeries are scanned by ultrasound in the pre recovery room. The visibility of the gastric antrum is assessed. The qualitative and quantitative assessment is made and is compared.

Primary Outcome Measures

Name	Time	Method
Effectiveness of ultrasound in pregnants and non-pregnants in terms of visibility	October 2016 to October 2017	The effectiveness is stated in terms of percentage visibility and compared in pregnants and non-pregnants.

Secondary Outcome Measures

Name	Time	Method
Quantitative assessment of Gastric Antrum	October 2016 to October 2017	The quantitative data is obtained from the derived formulae and is compared in pregnants and non-pregnants.
Qualitative assessment of Gastric antrum	October 2016 to October 2017	The qualitative grading is derived and is compared in the pregnants and non-pregnants.