- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04515823
Flat OGTT (Oral Glucose Tolerance Test) During Pregnancy
August 16, 2020 updated by: Hillel Yaffe Medical Center
The Flat OGTT During Pregnancy -Prevalence and Risk for Adverse Outcomes
The aim of the study is to examine the relationship between "flat" sugar curve on OGTT-glucose tolerance test during pregnancy, neonatal birthweight and other perinatal outcomes.
Study Overview
Status
Completed
Conditions
Detailed Description
A retrospective cohort analysis of all women delivered in one university affiliated medical center between January 1st 2018 and December 31th 2019 with documented 100 grams OGTT results.
Study Type
Observational
Enrollment (Actual)
2085
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hadera, Israel, 38100
- Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
All women delivered in one university affiliated medical center between January 1st 2018 and December 31th 2019 with documented 100 grams OGTT results.
Description
Inclusion Criteria:
- Performing the OGTT test during the pregnancy
Exclusion Criteria:
- lack of documentation or Non-performance of OGTT test during the pregnancy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate the characteristics and perinatal outcomes of parturients with a flat glucose curve on 100 grams oral glucose tolerance test (OGTT).
Time Frame: 10 months
|
A flat OGTT curve occurs in a younger, leaner population.
Although flat OGTT can possibly reflect some degree of hyperinsulinemia, it is generally not associated with adverse maternal or neonatal outcomes.
|
10 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rinat Gabbay-Benziv, M.D, Hillel Yaffe Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 26, 2020
Primary Completion (Actual)
August 1, 2020
Study Completion (Actual)
August 1, 2020
Study Registration Dates
First Submitted
August 13, 2020
First Submitted That Met QC Criteria
August 13, 2020
First Posted (Actual)
August 17, 2020
Study Record Updates
Last Update Posted (Actual)
August 19, 2020
Last Update Submitted That Met QC Criteria
August 16, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 0052-20-HYMC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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