Gastric Emptying Clinical Trial
Official title:
Gastric Emptying of Tea With Milk in Pregnancy - An Ultrasound Assessment.
Verified date | August 2019 |
Source | Coombe Women and Infants University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the study is to assess the difference in gastric emptying using ultrasound of pregnant patients following a cup of tea with milk or a similar volume of water.
Status | Completed |
Enrollment | 50 |
Est. completion date | June 27, 2019 |
Est. primary completion date | June 27, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Women with a singleton pregnancy >36 weeks. - Subjects must be female, aged 18 years or above at baseline. - Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol. Exclusion Criteria: - Allergy/sensitivity to milk/tea. - A medical or surgical condition leading to delayed gastric emptying (e.g. Diabetes Mellitus). - Not fasting for 6 hours for food or 2 hours for clear fluids. - No baseline ultrasound assessment. - Inability to visualize the gastric antrum. - Vomiting or inability to finish drink. |
Country | Name | City | State |
---|---|---|---|
Ireland | Coombe Women and Infants University Hospital | Dublin |
Lead Sponsor | Collaborator |
---|---|
Coombe Women and Infants University Hospital |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gastric emptying at 2 hours - supine. | The difference in gastric antrum cross sectional area (CSA) between groups, measured using ultrasound in a 45° semirecumbent supine position. | 120 mins | |
Secondary | Gastric antrum CSA - supine. | The difference in gastric antrum cross sectional area (CSA) between groups, measured using ultrasound in a 45° semirecumbent supine position. | 15 mins, 30 mins, 45 mins, 60 mins, 90 mins | |
Secondary | Gastric volume - supine. | The difference in gastric volume as calculated using the determined CSA in the 45° semirecumbent supine position. | 15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins | |
Secondary | Gastric antrum CSA - RLD. | The difference in gastric antrum cross sectional area (CSA) between groups, measured using ultrasound in the 45° semirecumbent RLD (Right lateral decubitus) position. | 15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins | |
Secondary | Gastric volume - RLD. | The difference in gastric volume as calculated using the determined CSA in the 45° semirecumbent RLD position. | 15 mins, 30 mins, 45 mins, 60 mins, 90 mins, 120 mins |
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