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Completed

NCT Number: NCT03380637

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

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.

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Key information

Conditions

Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultrasound

Other

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

Primary outcomes

  1. Effectiveness of ultrasound in pregnants and non-pregnants in terms of visibility

    Time frame: October 2016 to October 2017

    The effectiveness is stated in terms of percentage visibility and compared in pregnants and non-pregnants.

Secondary outcomes

  1. Qualitative assessment of Gastric antrum

    Time frame: October 2016 to October 2017

    The qualitative grading is derived and is compared in the pregnants and non-pregnants.

  2. Quantitative assessment of Gastric Antrum

    Time frame: October 2016 to October 2017

    The quantitative data is obtained from the derived formulae and is compared in pregnants and non-pregnants.

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 21, 2017
Registry last updated
Dec 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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