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

NCT ID: NCT03380637

Last Updated: 2017-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-13

Study Completion Date

2017-10-10

Brief Summary

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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

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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.

Conditions

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Pregnancy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant and non-pregnant females

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.

ultrasound

Intervention Type OTHER

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

Interventions

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ultrasound

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

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

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

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Dr Snigdha Bellapukonda

Junior resident, MD Anesthesia, Department of Anesthesia and Intensive care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Snigdha Bellapukonda, MBBS

Role: PRINCIPAL_INVESTIGATOR

Post graduate institute of medical education and researchh

References

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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.

Reference Type BACKGROUND
PMID: 21596885 (View on PubMed)

Other Identifiers

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10565/PG-2Trg/2015/173-74

Identifier Type: -

Identifier Source: org_study_id