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Completed

NCT Number: NCT04195542

Vitamin B9 Supplementation Recommendations 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Rennes

Rennes, 35033, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

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

Treatment and study plan

Questionnaire

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    Proportion of people who are aware of the need for vitamin B9 supplementation during the periconceptional period.

  2. 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

    Dosage, frequency, duration before and during pregnancy, type of supplementation alone or in a multivitamin supplement

  3. 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

    Source of information about supplementation (through their studies, through a health professional, medias, their entourage…)

  4. 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

    Reasons of take any B9 supplementation : information not known, pregnancy not planned, refusal to take it despite a medical prescription, forgetfulness.

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study 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.

Acronym: QUALI B9

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 12, 2019
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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