Comparing gastric volume in diabetic and non-diabetic pregnant women before cesarean section
Ultrasound Assessment of Gastric Volume in Diabetic Versus Non-Diabetic Term Pregnant Women Undergoing Elective Cesarean Section: A Prospective Randomized Clinical Trial
Beni-Suef University · NCT06621706
This study looks at the stomach size of pregnant women with and without diabetes before they have a cesarean section to see how it might affect their safety during anesthesia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Beni-Suef University (other) |
| Locations | 1 site (Banī Suwayf, Beni Suweif Governorate) |
| Trial ID | NCT06621706 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the estimated gastric volumes of fasting diabetic and non-diabetic pregnant women scheduled for elective cesarean sections using ultrasound. The research focuses on understanding the risks associated with gastric content aspiration during the perioperative period, particularly in pregnant women who are at increased risk due to physiological changes. By assessing gastric volumes, the study seeks to provide insights into the safety of anesthesia practices for these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18-40 years, undergoing elective cesarean sections, with a gestational age greater than 37 weeks and a BMI of less than 35 kg/m2.
Not a fit: Patients who may not benefit from this study include those undergoing emergency surgeries, those with gastrointestinal diseases, or those with conditions affecting gastrointestinal motility.
Why it matters
Potential benefit: If successful, this study could enhance the safety protocols for anesthesia in pregnant women, potentially reducing the risk of pulmonary aspiration during cesarean sections.
How similar studies have performed: While the approach of using ultrasound to assess gastric volume in pregnant women is not widely tested, similar studies in other populations have shown promise in improving anesthesia safety.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * pregnant women undergoing elective caesarean section * aged between 18-40 years * belonging to ASA II-III * gestational age greater than 37 weeks * BMI\< 35 kg/m2 Exclusion Criteria: * patients who refuse to give consent * patients taken to surgery on an emergency basis, -pregnant patients with upper gastrointestinal (GI) diseases and pathologies * patients with a history of using medications that affect gastrointestinal motility (e.g., opioids), severe organ dysfunction * pre-existing neurological deficits, intellectual disabilities and anatomical deformities.
Where this trial is running
Banī Suwayf, Beni Suweif Governorate
- Beni-Suef University hospital — Banī Suwayf, Beni Suweif Governorate, Egypt (RECRUITING)
Study contacts
- Principal investigator: Dina M Fakhry, MD — Beni-Suef University
- Study coordinator: Dina M Fakhry, MD
- Email: dina_fakhry_91@yahoo.com
- Phone: +201289998680
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pulmonary Aspiration, Gastric Content Aspiration, Diabetic, Gastric ultrasonography, Pregnant