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Completed

NCT Number: NCT06493110

Gastric Ultrasound in Term Pregnants

In this study, the investigators aimed to evaluate the gastric antrum with ultrasound and compare gastric volumes in diabetic and non-diabetic pregnant women in the standard fasting state before surgery. The primary aim was qualitative assessment, while secondary objectives included quantitative assessment, comparing gastric volume, aspiration risk, and the effect of preoperative anxiety on stomach contents.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

KahramanmarasSIU, Kahramanmaraş, Turkey (Türkiye)

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About this study

Food residues in the stomach of patients scheduled for surgery are a major risk factor for pulmonary aspiration, leading to significant morbidity and mortality. This risk is particularly critical in pregnant women who may require surgery without proper fasting. National guidelines recommend fasting for 6 hours for solid foods, 4 hours for breast milk, and 2 hours for clear liquids. These guidelines apply equally to adults and children. Pregnant patients scheduled for elective surgery follow the same fasting rules as non-pregnant patients.

Gastroparesis, defined as delayed gastric emptying without mechanical obstruction, affects 30-50% of diabetic (DM) patients. Ultrasound measurement of the gastric antral area can help identify whether the stomach is full in symptomatic patients. Gastric ultrasound is a valuable tool for assessing aspiration risk in pregnant women, especially during emergency surgeries, and has shown promise in fasting non-pregnant patients scheduled for elective surgery.

In this study, the investigators aimed to evaluate the gastric antrum using ultrasound and compare gastric volumes in diabetic and non-diabetic pregnant women in a standard fasting state before surgery. The primary goal was qualitative assessment, with secondary objectives including quantitative assessment, comparing gastric volume, aspiration risk, and the effect of preoperative anxiety on stomach contents.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with good mental status
  • Pregnant patients aged ≥18 years
  • Patients in ASA II-III group
  • Patients complying with preoperative fasting instructions (at least 6 hours for solids, at least 2 hours for clear liquids)
  • Term pregnant women (gestational age ≥ 36 weeks)
  • 50-120kg weight
  • 150cm height or taller
  • Written informed consent

Exclusion criteria

  • Taking any medication known to accelerate or delay gastric emptying, including (but not limited to) opioid-containing medications and antacids.
  • Gastroesophageal reflux, abnormal anatomy of the upper gastrointestinal tract, previous surgical procedures for the esophagus or upper abdomen, etc. any stomach complaints
  • Pregnant women with term labor or obstetric emergency
  • Twin pregnancy -

Treatment and study plan

Gastric Ultrasound

Procedure

To compare gastric volumes in standard fasting state before surgery in diabetic and non-diabetic pregnant women by evaluating the gastric antrum with ultrasound.

Primary outcomes

  1. Gastric Antrum Quality

    Time frame: 12 months

    Qualitative evaluation of the gastric antrum using ultrasound: For the qualitative evaluation of the gastric antrum, we used a grading scale where the gastric antrum is classified as Grade 0, 1, or 2. The grading criteria are as follows:

    Grade 0: The stomach appears empty in both supine and right lateral decubitus positions.

    Grade 1: The stomach appears empty in the supine position but shows clear fluid in the right lateral decubitus position.

    Grade 2: Clear fluid is seen in the stomach in both supine and right lateral decubitus positions.

Secondary outcomes

  1. Gastric Volume

    Time frame: 12 months

    Quantitative measurement of gastric volume in milliliters.

  2. Aspiration Risk

    Time frame: 12 months

    Number of participants with a high aspiration risk based on gastric volume.

  3. Preoperative Anxiety Effect

    Time frame: 12 moths

    Measurement of stomach content volume related to preoperative anxiety levels.

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Official study title

Comparison of Gastric Volumes With Ultrasound in Diabetic and Non-diabetic Term Pregnant Women Before Elective Cesarean Section

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 9, 2024
Registry last updated
Oct 21, 2024

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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