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Vitamin B9 Supplementation Recommendations in Rennes CHU

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04195542
Acronym
QUALI B9
Enrollment
1284
Registered
2019-12-12
Start date
2019-09-24
Completion date
2022-09-30
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spina Bifida or Spinal Dysraphism

Keywords

Spina Bifida, Spinal dysraphism, vitamin B9 supplementation, folic acid, neural tube closure defects, folate

Brief 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. 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.

Interventions

OTHERQuestionnaire

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

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
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.the inclusion dayProportion of people who were or had a spouse supplemented during her last pregnancy.

Secondary

MeasureTime frameDescription
To assess the proportion of people who are aware of the need for vitamin B9 supplementation during the periconceptional period.the inclusion dayProportion of people who are aware of the need for vitamin B9 supplementation during the periconceptional period.
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.)the inclusion dayDosage, frequency, duration before and during pregnancy, type of supplementation alone or in a multivitamin supplement
To understand how respondents were informed of the value of this supplementation (through their studies, through a health professional, medias, their entourage…)the inclusion daySource of information about supplementation (through their studies, through a health professional, medias, their entourage…)
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.the inclusion dayReasons of take any B9 supplementation : information not known, pregnancy not planned, refusal to take it despite a medical prescription, forgetfulness.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026