Skin AbnormalitiesNCT04813887
Skin Diseases and Pregnancy: Which Heathcare Professionals ?
An observational study of Skin Abnormalities and Pregnancy, run by Centre Hospitalier Departemental Vendee at 1 site in France.
Trial summary
Pregnancy-induced physiological dermatological changes are common. In 2016, they represented between 23% (acne) and 75% (pigmentary changes) of pregnancies in France. Some dermatological changes require medical advice to identify a possible pathological rash. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Skin Abnormalities, Pregnancy
- What is being tested?
- questionnaire
- How many people
- 317 participants
- Where
- 1 siteFrance
- Study dates
- 7 Apr 2021to 10 Aug 2021
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Prospective collection of data from a questionnaire answered by patients giving birth at the Departmental Hospital Center of Vendee during the postpartum period.
Who may be able to join
- Any woman who gives birth at Departmental Hospital Center of Vendee
Who cannot join
- Patient's refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Skin Diseases: Which Heathcare Professionals do Pregnant Women in Vendee Use?
Pregnancy-induced physiological dermatological changes are common. In 2016, they represented between 23% (acne) and 75% (pigmentary changes) of pregnancies in France. Some dermatological changes require medical advice to identify a possible pathological rash.
These pathological rashes can be dangerous for the mother or the fetus.
The aim of this study is to assess the prevalence of skin diseases during pregnancy and to evaluate the care pathway in a healthcare sector (Vendee) for these pregnant women?
Read the detailed description
Pregnancy-induced physiological dermatological changes are common. In 2016, they represented between 23% (acne) and 75% (pigmentary changes) of pregnancies in France. Some dermatological changes require medical advice to identify a possible pathological rash.
These pathological rashes can be dangerous for the mother or the fetus. It is therefore essential to recognize them for a quick specialized treatment. They include: intrahepatic cholestasis of pregnancy, pemphigoid gestationis, polymorphic eruption during pregnancy, atopic eczema, generalized pustular psoriasis in pregnancy.
In view of the demography of dermatologists in the Vendee, 18 dermatologists in 2020 in all establishments (hospitals, clinics, practices), the general practitioner is at the center of these considerations.
The aim of this study is to assess the situation of skin disease during pregnancy and to evaluate the care pathway in a healthcare sector (Vendee) for these pregnant women?
- Conditions
- Skin Abnormalities, Pregnancy
- Being tested
- questionnaire
- Medical subject headings
- Skin Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
Self-questionnaire on skin diseases reported during pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the health care provider that pregnant women consult when experiencing a skin disease
Type of health care provider seeing a pregnant woman for skin disease
Measured: after delivery during the patient's stay in the maternity (2-3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start7 Apr 2021
- Primary completion7 Apr 2021
- Study completion10 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AbnormalitiesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume DUCARME, Principal investigator, Departmental Hospital Center of Vendee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813887
- Sponsor's protocol ID
- CHD21_0020
- Status last verified
- Mar 2021
- First submitted
- 19 Mar 2021
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Diseases: Which Heathcare Professionals do Pregnant Women in Vendee Use?
- ClinicalTrials.gov ID
- NCT04813887
- Acronym / sponsor ID
- CHD21_0020
- Conditions
- Skin Abnormalities, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 7 Apr 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 24 Mar 2021 (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.
Pregnancy-induced physiological dermatological changes are common. In 2016, they represented between 23% (acne) and 75% (pigmentary changes) of pregnancies in France. Some dermatological changes require medical advice to identify a possible pathological rash.
These pathological rashes can be dangerous for the mother or the fetus.
The aim of this study is to assess the prevalence of skin diseases during pregnancy and to evaluate the care pathway in a healthcare sector (Vendee) for these pregnant women?
Detailed description
Pregnancy-induced physiological dermatological changes are common. In 2016, they represented between 23% (acne) and 75% (pigmentary changes) of pregnancies in France. Some dermatological changes require medical advice to identify a possible pathological rash.
These pathological rashes can be dangerous for the mother or the fetus. It is therefore essential to recognize them for a quick specialized treatment. They include: intrahepatic cholestasis of pregnancy, pemphigoid gestationis, polymorphic eruption during pregnancy, atopic eczema, generalized pustular psoriasis in pregnancy.
In view of the demography of dermatologists in the Vendee, 18 dermatologists in 2020 in all establishments (hospitals, clinics, practices), the general practitioner is at the center of these considerations.
The aim of this study is to assess the situation of skin disease during pregnancy and to evaluate the care pathway in a healthcare sector (Vendee) for these pregnant women?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective collection of data from a questionnaire answered by patients giving birth at the Departmental Hospital Center of Vendee during the postpartum period.
Key inclusion criteria (1 listed)
- Any woman who gives birth at Departmental Hospital Center of Vendee
Key exclusion criteria (1 listed)
- Patient's refusal to participate in the study
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 |
|---|---|---|
| questionnaireSelf-questionnaire on skin diseases reported during pregnancy | Other | – |
Primary outcome
Identify the health care provider that pregnant women consult when experiencing a skin disease
Time frame: after delivery during the patient's stay in the maternity (2-3 days)
Type of health care provider seeing a pregnant woman for skin disease
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 9 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Guillaume DUCARME principal investigator
Departmental Hospital Center of Vendee
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 Skin Abnormalities and Pregnancy, run by Centre Hospitalier Departemental Vendee 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 1 inclusion and 1 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 9 Sep 2021. 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?
Identify the health care provider that pregnant women consult when experiencing a skin disease (time frame: after delivery during the patient's stay in the maternity (2-3 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2021.