Diabetes Mellitus and Pregnancy : Knowledge Assessment | NCT04350879

Studies
Diabetes Mellitus and Pregnancy : Knowledge Assessment

NCT04350879

Sponsor

CHU de Reims

Status

Completed

Last Update Posted

Jun 16, 2022Actual

Enrollment

122Actual

Phase

Not provided

Conditions

Diabetes Mellitus

Interventions

Data record

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 12, 2020Actual

Primary Completion Date

Jul 31, 2020Actual

Completion Date

Sep 30, 2020Actual

First Submitted Date

Apr 15, 2020

First Submission Date that Met QC Criteria

Apr 16, 2020

First Posted Date

Apr 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2022

Last Update Posted Date

Jun 16, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

The aim of the study is to describe the knowledge of the patients with diabetes concerning contraception and pregnancy planning.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

122Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diabetic patients		Women between 18 and 40 years old with type 1 and type 2 diabetes	Other: Data record

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Data record	Other	Data record	Diabetic patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Risk of unplanned pregnancy	Knowledge concerning the risk of unplanned pregnancy in diabete women	Day 0

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Women between 18 and 40 years old, consulting in diabetology department of Reims Universitary Hospital and Charleville Mézières General Hospital

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35143750	Derived	Feutry L, Barbe C, Marquet-Dupont A, Fevre A, Lukas-Croisier C, Vitellius G, Delemer B, Barraud S. Contraception use and knowledge related to pregnancy in diabetic women. Ann Endocrinol (Paris). 2022 Apr;83(2):88-94. doi: 10.1016/j.ando.2022.01.007. Epub 2022 Feb 7.

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D016347	Medical Records Systems, Computerized
D008499	Medical Records
D011996	Records
D003625	Data Collection