Vitamin B9 Supplementation Recommendations in Rennes CHU (QUALI B9)

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.

Study Overview

• Status: Completed
• Conditions: Spina Bifida or Spinal Dysraphism
• Intervention / Treatment: Other: Questionnaire

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 Type: Observational
• Enrollment (Actual): 1284

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35033
    • Chu de Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

women in obstetric ward in Rennes CHU and All CHU professionals

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
women in obstetric ward in Rennes CHU	Other: 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
CHU professionals; All CHU professionals contacted via their email address	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	the inclusion day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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…)	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.	the inclusion day

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2019
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: November 28, 2019
• First Submitted That Met QC Criteria: December 9, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: folate; folic acid; Spina Bifida; Spinal dysraphism; vitamin B9 supplementation; neural tube closure defects
• Additional Relevant MeSH Terms: Nervous System Diseases; Congenital Abnormalities; Nervous System Malformations; Neural Tube Defects; Spinal Dysraphism
• Other Study ID Numbers: 35RC19_30032_QUALI B9

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No