Diabetes MellitusDMPKANCT04350879
Diabetes Mellitus and Pregnancy : Knowledge Assessment
An observational study of Diabetes Mellitus, run by CHU de Reims at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Data record
- How many people
- 122 participants
- Where
- 1 siteFrance
- Study dates
- 12 Mar 2020to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Women between 18 and 40 years old, consulting in diabetology department of Reims Universitary Hospital and Charleville Mézières General Hospital
Who may be able to join
- 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
Who cannot join
- Patients With secondary diabetes (endocrine, pancreatic or genetical origin)
- With postmenopausal status
- Without capacity to have a pregnancy (uterine aplasia, hysterectomy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
The aim of the study is to describe the knowledge of the patients with diabetes concerning contraception and pregnancy planning.
- Conditions
- Diabetes Mellitus
- Being tested
- Data record
- Keywords
- Diabetes mellitus, pregnancy, contraception
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data recordOther
Data record
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients | Women between 18 and 40 years old with type 1 and type 2 diabetes Receives: Other: Data record |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of unplanned pregnancy
Knowledge concerning the risk of unplanned pregnancy in diabete women
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start12 Mar 2020
- Primary completion31 Jul 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350879
- Sponsor's protocol ID
- PO20041
- Acronym
- DMPKA
- Status last verified
- Jun 2022
- First submitted
- 15 Apr 2020
- Last updated
- 16 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35143750
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Knowledge About Contraception and Pregnancy Planning Among Type 1 and Type 2 Diabetes Women
- ClinicalTrials.gov ID
- NCT04350879
- Acronym / sponsor ID
- DMPKA / PO20041
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes mellitus, pregnancy, contraception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients | – | Other: Data recordWomen between 18 and 40 years old with type 1 and type 2 diabetes |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women between 18 and 40 years old, consulting in diabetology department of Reims Universitary Hospital and Charleville Mézières General Hospital
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients With secondary diabetes (endocrine, pancreatic or genetical origin)
- With postmenopausal status
- Without capacity to have a pregnancy (uterine aplasia, hysterectomy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data recordData record | Other | Diabetic patients |
Primary outcome
Risk of unplanned pregnancy
Time frame: Day 0
Knowledge concerning the risk of unplanned pregnancy in diabete women
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Derived from this study: PubMed 35143750Feutry 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.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of unplanned pregnancy (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04350879, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2022.