NCT04195542

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,284

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 24, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 12, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

3 years

First QC Date

November 28, 2019

Last Update Submit

April 11, 2023

Conditions

Spina Bifida or Spinal Dysraphism

Keywords

Spina BifidaSpinal dysraphismvitamin B9 supplementationfolic acidneural tube closure defectsfolate

Outcome Measures

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.

    Proportion of people who were or had a spouse supplemented during her last pregnancy.

    the inclusion day

Secondary Outcomes (4)

  • To assess the 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.)

    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…)

    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.

    the inclusion day

Study Arms (2)

women in obstetric ward in Rennes CHU

women in obstetric ward in Rennes CHU

Other: Questionnaire

CHU professionals

All CHU professionals contacted via their email address

Other: Questionnaire

Interventions

QuestionnaireOTHER

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 professionalswomen in obstetric ward in Rennes CHU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women in obstetric ward in Rennes CHU and All CHU professionals

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Rennes

Rennes, 35033, France

Location

MeSH Terms

Conditions

Spinal Dysraphism

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Emma BAJEUX, MD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2019

First Posted

December 12, 2019

Study Start

September 24, 2019

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

April 12, 2023

Record last verified: 2023-04

Locations

FR(1)