Clinical trial NCT04195542: Vitamin B9 Supplementation Recommendations in Rennes CHU
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spina Bifida or Spinal Dysraphism
Keywords: Spina Bifida
Spinal dysraphism
vitamin B9 supplementation
folic acid
neural tube closure defects
folate
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 1284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women in obstetric ward in Rennes CHU and All CHU professionals

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.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: the inclusion day
Secondary outcomes:
measure: To assess the proportion of people who are aware of the need for vitamin B9 supplementation during the periconceptional period.
timeFrame: the inclusion day
measure: 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.)
timeFrame: the inclusion day
measure: To understand how respondents were informed of the value of this supplementation (through their studies, through a health professional, medias, their entourage…)
timeFrame: the inclusion day
measure: 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.
timeFrame: the inclusion day
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
affiliation: Rennes University Hospital
name: Emma BAJEUX, MD
role: PRINCIPAL_INVESTIGATOR
References: