NCT04350879

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

June 16, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

April 15, 2020

Last Update Submit

June 15, 2022

Conditions

Keywords

Diabetes mellituspregnancycontraception

Outcome Measures

Primary Outcomes (1)

  • Risk of unplanned pregnancy

    Knowledge concerning the risk of unplanned pregnancy in diabete women

    Day 0

Study Arms (1)

Diabetic patients

Women between 18 and 40 years old with type 1 and type 2 diabetes

Other: Data record

Interventions

Data record

Diabetic patients

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Patients With secondary diabetes (endocrine, pancreatic or genetical origin)
  • With postmenopausal status
  • Without capacity to have a pregnancy (uterine aplasia, hysterectomy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damien JOLLY

Reims, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Electronic Health Records

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Medical Records Systems, ComputerizedMedical RecordsRecordsData CollectionEpidemiologic MethodsInvestigative TechniquesOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2020

First Posted

April 17, 2020

Study Start

March 12, 2020

Primary Completion

July 31, 2020

Study Completion

September 30, 2020

Last Updated

June 16, 2022

Record last verified: 2022-06

Locations