Back to resultsWomen With Minor Degrees of Glucose Intolerance and the Postpartum Glucose Tolerance Test
Primary Purpose
Glucose Tolerance Impaired in Pregnancy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
75g oral glucose tolerance test
75g GTT
Sponsored by
About this trial
This is an interventional diagnostic trial for Glucose Tolerance Impaired in Pregnancy
Eligibility Criteria
Inclusion Criteria:
- healthy women (without pre-existing diabetes) who underwent an OGTT during pregnancy
Exclusion Criteria:
- pre-existing diabetes, or failed to perform the OGTT
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
One abnormal value
GDM
Arm Description
Women with only one abnormal value on OGTT (Oral Glucose Tolerance Test) during pregnancy
Women with two abnormal values on OGTT during pregnancy - diagnosis=GDM
Outcomes
Primary Outcome Measures
Positive post-partum GTT results
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03623412
Brief Title
Women With Minor Degrees of Glucose Intolerance and the Postpartum Glucose Tolerance Test
Official Title
Women With Minor Degrees of Glucose Intolerance and the Postpartum Glucose
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2018 (Anticipated)
Primary Completion Date
September 15, 2019 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clalit Health Services
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study is to offer a 75g postpartum glucose tolerance test to women with minor degrees of glucose intolerance and to assess if these women are significantly different from women who were diagnosed as GDM (Gestational Diabetes Mellitus)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Tolerance Impaired in Pregnancy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Non-Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
One abnormal value
Arm Type
Experimental
Arm Description
Women with only one abnormal value on OGTT (Oral Glucose Tolerance Test) during pregnancy
Arm Title
GDM
Arm Type
Active Comparator
Arm Description
Women with two abnormal values on OGTT during pregnancy - diagnosis=GDM
Intervention Type
Diagnostic Test
Intervention Name(s)
75g oral glucose tolerance test
Intervention Description
Women with one abnormal value in the OGTT during pregnancy (minor degree of glucose intolerance) will be offered a post-partum 75g GTT (Glucose Tolerance Test), similar to that offered to women with GDM
Intervention Type
Diagnostic Test
Intervention Name(s)
75g GTT
Intervention Description
post-partum GTT
Primary Outcome Measure Information:
Title
Positive post-partum GTT results
Time Frame
6-12 weeks post partum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy women (without pre-existing diabetes) who underwent an OGTT during pregnancy
Exclusion Criteria:
pre-existing diabetes, or failed to perform the OGTT
12. IPD Sharing Statement
Learn more about this trial
Women With Minor Degrees of Glucose Intolerance and the Postpartum Glucose Tolerance Test
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