- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04350879
Diabetes Mellitus and Pregnancy : Knowledge Assessment (DMPKA)
Evaluation of Knowledge About Contraception and Pregnancy Planning Among Type 1 and Type 2 Diabetes Women
Diabetes, a chronic and frequent disease, is a risk factor of pregnancy complications such as preeclampsia, congenital malformations and macrosomia.
Preconception care is all methods to assess the best prognostic for a diabetic pregnancy. Among these methods, contraception is very important to plan the pregnancy on a chosen moment.
The content of the preconception care is well established. However, information of diabetic women concerning contraception and giabetic pregnancy has been little studied.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Reims, France
- Damien JOLLY
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
inclusion criteria :
- Patients Aged between 18 and 40 years old
- With type 1 or type 2 diabetes mellitus
- Consulting in the department of diabetology in Reims and Charleville Mezieres hospitals
- Accepting to participate in the study
exclusion criteria :
- Patients With secondary diabetes (endocrine, pancreatic or genetical origin)
- With postmenopausal status
- Without capacity to have a pregnancy (uterine aplasia, hysterectomy)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Diabetic patients
Women between 18 and 40 years old with type 1 and type 2 diabetes
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Data record
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Risk of unplanned pregnancy
Time Frame: Day 0
|
Knowledge concerning the risk of unplanned pregnancy in diabete women
|
Day 0
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PO20041
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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