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Vitamin B9 Supplementation Recommendations in Rennes CHU (QUALI B9)

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ClinicalTrials.gov Identifier: NCT04195542
Recruitment Status : Recruiting
First Posted : December 12, 2019
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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.


Condition or disease Intervention/treatment
Spina Bifida or Spinal Dysraphism 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.

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Study Type : Observational
Estimated Enrollment : 5100 participants
Observational Model: Other
Time Perspective: Prospective
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.
Actual Study Start Date : September 23, 2019
Estimated Primary Completion Date : January 23, 2020
Estimated Study Completion Date : January 23, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
women in obstetric ward in Rennes CHU
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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
women in obstetric ward in Rennes CHU and All CHU professionals
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04195542


Contacts
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Contact: Kristell COAT 299282555 ext +33 kristell.coat@chu-rennes.fr
Contact: direction de la recherche 299282555 ext +33 drc@chu-rennes.fr

Locations
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France
CHU de Rennes Recruiting
Rennes, France, 35033
Contact: Emma Bajeux, MD         
Principal Investigator: Emma Bajeux         
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Emma BAJEUX, MD Rennes University Hospital
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT04195542    
Other Study ID Numbers: 35RC19_30032_QUALI B9
First Posted: December 12, 2019    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rennes University Hospital:
Spina Bifida
Spinal dysraphism
vitamin B9 supplementation
folic acid
neural tube closure defects
folate
Additional relevant MeSH terms:
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Spinal Dysraphism
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities