NCT05191147

Brief Summary

Primary endpoint : Prevalence estimation of the dietary supplement consumption among pregnant women during the first 20-25 weeks of pregnancy. Hypothesis of the study : The sale and consumption of dietary supplements in the general population has increased in recent years. It would be interesting to know if this is also the case for pregnant women or if they are more vigilant about their health during this period. It would also allow to identify factors associated with their consumption if it exists. The investigators hypothesize that some women may sometimes fail to mention this supplement intake to care givers and they would like to know if these omissions are voluntary or not.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 22, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2022

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

3 months

First QC Date

December 22, 2021

Last Update Submit

March 1, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • the proportion of women who report taking at least one dietary supplement during the first 20-25 weeks of pregnancy

    what is the percentage of pregnant women who take dietary supplement

    1 month

Secondary Outcomes (4)

  • Describe the dietary supplements consumed during the first 20-25 weeks of pregnancy

    1 month

  • Assess whether beliefs about medication are associated with the use of dietary supplements during pregnancy

    1 month

  • Describe the mean number of dietary supplements taken by patients in early pregnancy

    1 month

  • Describe the frequency of use for each dietary supplement

    1 month

Interventions

Dietary supplementDIETARY_SUPPLEMENT

We will study dietary supplement consumption among pregnant women

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant woman who come in the service for an ultrasound

You may qualify if:

  • Aged of 18 or older
  • Pregnant woman
  • Performing a 2nd trimester ultrasound between 20 and 25 ammenorhea week
  • Informed consent signed
  • Affiliated to social security insurance or beneficiary of social security insurance

You may not qualify if:

  • Subject participating in another study
  • Subject under administrative or legal supervision
  • Non-speaking french
  • Opposing their participation in the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Grenoble

Grenoble, France

RECRUITING

MeSH Terms

Conditions

Consumer Behavior

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2021

First Posted

January 13, 2022

Study Start

January 1, 2022

Primary Completion

April 10, 2022

Study Completion

May 10, 2022

Last Updated

March 17, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations