Vitamin B9 Supplementation Recommendations in Rennes CHU

NCT ID: NCT04195542

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1284 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-24
• Study Completion Date: 2022-09-30

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.

Conditions

Spina Bifida or Spinal Dysraphism

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

women in obstetric ward in Rennes CHU

women in obstetric ward in Rennes CHU

Questionnaire

Intervention Type: OTHER

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

CHU professionals

All CHU professionals contacted via their email address

Questionnaire

Intervention Type: OTHER

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

Interventions

Questionnaire

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emma BAJEUX, MD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

CHU de Rennes

Rennes, , France

Countries

France

Other Identifiers

35RC19_30032_QUALI B9

Identifier Type: -

Identifier Source: org_study_id