Women With Minor Degrees of Glucose Intolerance and the Postpartum Glucose Tolerance Test
August 12, 2018 updated by: Clalit Health Services
Women With Minor Degrees of Glucose Intolerance and the Postpartum Glucose
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)
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
600
Phase
- Not Applicable
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 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
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
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: One abnormal value
Women with only one abnormal value on OGTT (Oral Glucose Tolerance Test) during pregnancy
|
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
|
|
ACTIVE_COMPARATOR: GDM
Women with two abnormal values on OGTT during pregnancy - diagnosis=GDM
|
post-partum GTT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Positive post-partum GTT results
Time Frame: 6-12 weeks post partum
|
6-12 weeks post partum
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (ANTICIPATED)
August 15, 2018
Primary Completion (ANTICIPATED)
September 15, 2019
Study Completion (ANTICIPATED)
September 30, 2019
Study Registration Dates
First Submitted
August 6, 2018
First Submitted That Met QC Criteria
August 6, 2018
First Posted (ACTUAL)
August 9, 2018
Study Record Updates
Last Update Posted (ACTUAL)
August 14, 2018
Last Update Submitted That Met QC Criteria
August 12, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0068-18
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.