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

Pregnancy Clinical Trial

Official title:

Ultrasound for Comparison of Gastric Volume in Pregnant Females Posted for Elective Lower Segment Cesarean Section With Non-pregnant Females Undergoing Elective Surgeries.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03380637
• Other study ID #: 10565/PG-2Trg/2015/173-74
• Status: Completed
• Phase: N/A
• First received: December 15, 2017
• Last updated: December 20, 2017
• Start date: October 13, 2016
• Est. completion date: October 10, 2017

Study information

• Verified date: December 2017
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: October 10, 2017
• Est. primary completion date: October 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• ultrasound
Sonosite ultrasound (Sonosite, FUJIFILM M-Turbo, made in USA)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

References & Publications (1)

Perlas A, Davis L, Khan M, Mitsakakis N, Chan VW. Gastric sonography in the fasted surgical patient: a prospective descriptive study. Anesth Analg. 2011 Jul;113(1):93-7. doi: 10.1213/ANE.0b013e31821b98c0. Epub 2011 May 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of ultrasound in pregnants and non-pregnants in terms of visibility	The effectiveness is stated in terms of percentage visibility and compared in pregnants and non-pregnants.	October 2016 to October 2017
Secondary	Qualitative assessment of Gastric antrum	The qualitative grading is derived and is compared in the pregnants and non-pregnants.	October 2016 to October 2017
Secondary	Quantitative assessment of Gastric Antrum	The quantitative data is obtained from the derived formulae and is compared in pregnants and non-pregnants.	October 2016 to October 2017