Gastric Emptying After Tea With Milk in Pregnancy.
Sponsor:
Coombe Women and Infants University Hospital
Collaborators:
Information provided by (Responsible Party):
Ruairi Irwin，Coombe Women and Infants University Hospital
| Tracking Information | |||
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| First Submitted Date ICMJE | October 1, 2018 | ||
| First Posted Date ICMJE | October 3, 2018 | ||
| Last Update Posted Date | October 4, 2018 | ||
| Actual Study Start Date ICMJE | October 3, 2018 | ||
| Estimated Primary Completion Date | February 1, 2019 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Gastric emptying at 2 hours - supine.[ Time Frame: 120 mins ] The difference in gastric antrum cross sectional area (CSA) between groups, measured using ultrasound in a 45° semirecumbent supine position. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Gastric Emptying After Tea With Milk in Pregnancy. |
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| Official Title ICMJE | Gastric Emptying of Tea With Milk in Pregnancy - An Ultrasound Assessment. |
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| Brief Summary | 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. |
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| Detailed Description | The study involves the allocation of either 300ml of water or 250ml of tea and 50ml of milk to fasted parturients, and assessment of gastric antrum CSA at intervals up to 2 hours. The study will be performed in patients with >34 weeks gestation at the antenatal clinic. The participants will be randomized into one of two groups with an internet based randomisation tool, and then allocated to either group as per the allocation in a sealed opaque envelope. The ultrasound assessor will be blinded to the group allocation. Participants will be asked to come to clinic in the morning fasting from solids for >6 hours and for 2 hours for clear fluids. Gastric ultrasound will be performed on the fasted pregnant patients in the right lateral decubitus position to establish a baseline and ensure that the gastric antrum is empty. Gastric antrum CSA will be measured. Intervention group: The intervention group will be given 250ml of black breakfast tea with 50ml of full fat milk. This should be consumed within 5 minutes. Gastric ultrasound will be performed at intervals up to 2 hours after the intervention in the right lateral decubitus position. Gastric antrum CSA will be measured. Three measurements of CSA will be taken and averaged. Placebo group: The placebo group will be given 300ml of water. This should be consumed within 5 minutes. Gastric ultrasound will be performed at intervals up to 2 hours after the intervention in the right lateral decubitus position. Gastric antrum CSA will be measured. Three measurements of CSA will be taken and averaged. | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | N/A | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Two groups - Tea with milk group and water control group. Masking: Interventional Masking Description:The ultrasound assessor will be blinded to group allocation. The statistician will be blinded to group allocation. Primary Purpose: Treatment |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Not yet recruiting | ||
| Estimated Enrollment ICMJE |
50 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | February 1, 2019 | ||
| Estimated Primary Completion Date | February 1, 2019 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | 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. | ||
| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | |||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | No | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | Ruairi Irwin，Coombe Women and Infants University Hospital | ||
| Study Sponsor ICMJE | Coombe Women and Infants University Hospital | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | Coombe Women and Infants University Hospital | ||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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