Spina Bifida or Spinal DysraphismQUALI B9NCT04195542
Vitamin B9 Supplementation Recommendations in Rennes CHU
An observational study of Spina Bifida or Spinal Dysraphism, run by Rennes University Hospital at 1 site in France.
Trial summary
The study objective is to assess the knowledge and the follow-up of vitamin B9 supplementation recommendations for women in the periconceptional period to prevent neural tube closure defects. It will be conducted with health professionnals and women who have just given birth in Rennes CHU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spina Bifida or Spinal Dysraphism
- What is being tested?
- Questionnaire
- How many people
- 1,284 participants
- Where
- 1 siteFrance
- Study dates
- 24 Sep 2019to 30 Sep 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: women in obstetric ward in Rennes CHU and All CHU professionals
Who may be able to join
- Questionnaires to women who have just given birth:
- Women >= 18 years old, hospitalized in obstretric wards in Rennes CHU
- Having given birth within 2 weeks of completing the questionnaire
- Questionnaires to hospital professionals:
- People working at the Rennes CHU
- Using a standard email address...@chu-rennes.fr
Who cannot join
- Questionnaires to women who have just given birth:
- Non-French-speaking
- Cognitive impairment preventing understanding of the questionnaire and self-reporting
- Person under legal protection
- Person subject to a measure to safeguard justice
- Refusal to participate
- Questionnaires to university hospital professionals:
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Knowledge and Follow-up of Vitamin B9 Supplementation Recommendations for Women in the Periconceptional Period to Prevent Neural Tube Closure Defects: a Study Conducted With Health Professionnals and Women Who Have Just Given Birth in Rennes CHU.
The study objective is to assess the knowledge and the follow-up of vitamin B9 supplementation recommendations for women in the periconceptional period to prevent neural tube closure defects. It will be conducted with health professionnals and women who have just given birth in Rennes CHU.
This study aimes to assess men's and women's knowledge of the need to take vitamin B9 supplementation in women in the periconceptional period and the reasons why this supplementation is carried out or not, in order to target our future prevention campaign.
This will allow comparing the results before and after the prevention campaign.
Read the detailed description
Neural tube closure defects are among the most common birth defects. They are also called Spina Bifida or spinal dysraphism. According to the latest epidemiological studies in Europe based on the EUROCAT register (1991-2011), the prevalence of neural tube closure defects (including spinal dysraphisms as well as anencephaly and encephalocele) at birth is estimated at 9.105/10000 births in Europe (95% CI 8.94 to 9.27) and 12.02/10000 births in France.
The effectiveness of vitamin B9 (or folic acid or folate) supplementation in the periconceptional period on reducing the prevalence of neural tube closure defects has been widely demonstrated.
In France, the HAS (public health agency) recommends taking vitamin B9 between 1 month before and 2 months after conception, at a dose of 0.4 mg per day (5 mg per day in case of risk factors) since 2009. However, the proportion of women taking folic acid during periconceptional period is estimated at 1%.
The spina bifida - dysraphisms centre of the University Hospital Center of Rennes wishes to implement a campaign to prevent neural tube closure defects by supplementing with vitamin B9 during periconceptional period.
This study aimes to assess men's and women's knowledge of the need to take vitamin B9 supplementation in women in the periconceptional period and the reasons why this supplementation is carried out or not, in order to target our future prevention campaign.
This will allow comparing the results before and after the prevention campaign. Finally, such a study is an awareness-raising campaign by itself. The study objective is to assess the knowledge and the follow-up of vitamin B9 supplementation recommendations for women in the periconceptional period to prevent neural tube closure defects. It will be conducted with health professionnals and women who have just given birth in Rennes CHU.
A questionnaire will be administered to each study participant, among 2 distinct populations:
- Paper questionnaire for women who have just given birth during their stay in the maternity ward at the University Hospital of Rennes.
- Electronic questionnaire (Sphinx Déclic) sent to all CHU mailbox users.
- Conditions
- Spina Bifida or Spinal Dysraphism
- Being tested
- Questionnaire
- Keywords
- Spina Bifida, Spinal dysraphism, vitamin B9 supplementation, folic acid, neural tube closure defects, folate
- Medical subject headings
- Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
questionnaire assessing knowledge of the need to take vitamin B9 supplementation in women in the periconceptional period and the reasons why this supplementation is carried out or not
| Study group | Role | What they receive |
|---|---|---|
| women in obstetric ward in Rennes CHU | women in obstetric ward in Rennes CHU Receives: Other: Questionnaire | |
| CHU professionals | All CHU professionals contacted via their email address Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the knowledge and the follow-up of vitamin B9 supplementation recommendations for women in the periconceptional period to prevent neural tube closure defects.
Proportion of people who were or had a spouse supplemented during her last pregnancy.
Measured: the inclusion day
Secondary outcomes (4)
To assess the proportion of people who are aware of the need for vitamin B9 supplementation during the periconceptional period.
Proportion of people who are aware of the need for vitamin B9 supplementation during the periconceptional period.
Measured: the inclusion day
To describe the type of B9 vitamin supplementation taken by women before and during pregnancy (alone or in a multivitamin supplement) and the modalities of intake (dosage, frequency, duration before and during pregnancy, etc.)
Dosage, frequency, duration before and during pregnancy, type of supplementation alone or in a multivitamin supplement
Measured: the inclusion day
To understand how respondents were informed of the value of this supplementation (through their studies, through a health professional, medias, their entourage…)
Source of information about supplementation (through their studies, through a health professional, medias, their entourage…)
Measured: the inclusion day
To understand why women do not take any B9 supplementation : information not known, pregnancy not planned, refusal to take it despite a medical prescription, forgetfulness.
Reasons of take any B9 supplementation : information not known, pregnancy not planned, refusal to take it despite a medical prescription, forgetfulness.
Measured: the inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start24 Sep 2019
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spina Bifida or Spinal DysraphismStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emma BAJEUX, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195542
- Sponsor's protocol ID
- 35RC19_30032_QUALI B9
- Acronym
- QUALI B9
- Status last verified
- Apr 2023
- First submitted
- 28 Nov 2019
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge and Follow-up of Vitamin B9 Supplementation Recommendations for Women in the Periconceptional Period to Prevent Neural Tube Closure Defects: a Study Conducted With Health Professionnals and Women Who Have Just Given Birth in Rennes CHU.
- ClinicalTrials.gov ID
- NCT04195542
- Acronym / sponsor ID
- QUALI B9 / 35RC19_30032_QUALI B9
- Conditions
- Spina Bifida or Spinal Dysraphism
- Keywords
- Spina Bifida, Spinal dysraphism, vitamin B9 supplementation, folic acid, neural tube closure defects, folate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,284 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 12 Dec 2019 (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.
The study objective is to assess the knowledge and the follow-up of vitamin B9 supplementation recommendations for women in the periconceptional period to prevent neural tube closure defects. It will be conducted with health professionnals and women who have just given birth in Rennes CHU.
This study aimes to assess men's and women's knowledge of the need to take vitamin B9 supplementation in women in the periconceptional period and the reasons why this supplementation is carried out or not, in order to target our future prevention campaign.
This will allow comparing the results before and after the prevention campaign.
Detailed description
Neural tube closure defects are among the most common birth defects. They are also called Spina Bifida or spinal dysraphism. According to the latest epidemiological studies in Europe based on the EUROCAT register (1991-2011), the prevalence of neural tube closure defects (including spinal dysraphisms as well as anencephaly and encephalocele) at birth is estimated at 9.105/10000 births in Europe (95% CI 8.94 to 9.27) and 12.02/10000 births in France.
The effectiveness of vitamin B9 (or folic acid or folate) supplementation in the periconceptional period on reducing the prevalence of neural tube closure defects has been widely demonstrated.
In France, the HAS (public health agency) recommends taking vitamin B9 between 1 month before and 2 months after conception, at a dose of 0.4 mg per day (5 mg per day in case of risk factors) since 2009. However, the proportion of women taking folic acid during periconceptional period is estimated at 1%.
The spina bifida - dysraphisms centre of the University Hospital Center of Rennes wishes to implement a campaign to prevent neural tube closure defects by supplementing with vitamin B9 during periconceptional period.
This study aimes to assess men's and women's knowledge of the need to take vitamin B9 supplementation in women in the periconceptional period and the reasons why this supplementation is carried out or not, in order to target our future prevention campaign.
This will allow comparing the results before and after the prevention campaign. Finally, such a study is an awareness-raising campaign by itself. The study objective is to assess the knowledge and the follow-up of vitamin B9 supplementation recommendations for women in the periconceptional period to prevent neural tube closure defects. It will be conducted with health professionnals and women who have just given birth in Rennes CHU.
A questionnaire will be administered to each study participant, among 2 distinct populations:
- Paper questionnaire for women who have just given birth during their stay in the maternity ward at the University Hospital of Rennes.
- Electronic questionnaire (Sphinx Déclic) sent to all CHU mailbox users.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women in obstetric ward in Rennes CHU | – | Other: Questionnairewomen in obstetric ward in Rennes CHU |
| CHU professionals | – | Other: QuestionnaireAll CHU professionals contacted via their email address |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women in obstetric ward in Rennes CHU and All CHU professionals
Key inclusion criteria (6 listed)
- Women >= 18 years old, hospitalized in obstretric wards in Rennes CHU
- Having given birth within 2 weeks of completing the questionnaire
- People working at the Rennes CHU
- Using a standard email address...@chu-rennes.fr
Key exclusion criteria (8 listed)
- Non-French-speaking
- Cognitive impairment preventing understanding of the questionnaire and self-reporting
- Person under legal protection
- Person subject to a measure to safeguard justice
- Refusal to participate
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 |
|---|---|---|
| Questionnairequestionnaire assessing knowledge of the need to take vitamin B9 supplementation in women in the periconceptional period and the reasons why this supplementation is carried out or not | Other | CHU professionals, women in obstetric ward in Rennes CHU |
Primary outcome
To assess the knowledge and the follow-up of vitamin B9 supplementation recommendations for women in the periconceptional period to prevent neural tube closure defects.
Time frame: the inclusion day
Proportion of people who were or had a spouse supplemented during her last pregnancy.
4 secondary outcomes
To assess the proportion of people who are aware of the need for vitamin B9 supplementation during the periconceptional period.
Time frame: the inclusion day
To describe the type of B9 vitamin supplementation taken by women before and during pregnancy (alone or in a multivitamin supplement) and the modalities of intake (dosage, frequency, duration before and during pregnancy, etc.)
Time frame: the inclusion day
To understand how respondents were informed of the value of this supplementation (through their studies, through a health professional, medias, their entourage…)
Time frame: the inclusion day
To understand why women do not take any B9 supplementation : information not known, pregnancy not planned, refusal to take it despite a medical prescription, forgetfulness.
Time frame: the inclusion day
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 12 Apr 2023.
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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.
Emma BAJEUX, MD principal investigator
Rennes University Hospital
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 Spina Bifida or Spinal Dysraphism, run by Rennes University Hospital 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 6 inclusion and 8 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 12 Apr 2023. 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?
To assess the knowledge and the follow-up of vitamin B9 supplementation recommendations for women in the periconceptional period to prevent neural tube closure defects. (time frame: the inclusion day). 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 12 Apr 2023.