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Prevalence of Dietary Supplement Consumption Among Pregnant Womenweeks of Pregnancy: a Cross-sectional Telephone Interview Survey (PCAFE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05191147
Recruitment Status : Recruiting
First Posted : January 13, 2022
Last Update Posted : March 17, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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.


Condition or disease Intervention/treatment
Preference, Consumer Dietary Supplement: Dietary supplement

Detailed Description:

Dietary supplement are foodstuffs whose purpose is to supplement the normal diet, by constituting a concentrated source of nutrients or other substances with a nutritional or physiological effect, alone or in combination. There are many dietary supplement, based on plants, vitamins and minerals, or other concentrates of substances with a nutritional and physiological purpose.

Thus, the consumption of dietary supplement in pregnant women is interesting to pursue because no prevalence exists on the general consumption of food supplements in pregnant women in early pregnancy. Only studies on diet and the potential danger of supplements have been carried out. More specific studies on certain types of vitamins have also been carried out but no prevalence on general consumption has been found.

Therefore, the aim of the study is to know the extent of dietary supplementation in early pregnancy, and the associated factors in order to take it into account in the management and follow-up of patients. The investigators would also like to know the intentions and motivations of these women to consume these products.

To proceed, they will give an information sheet that will allow the collection of the telephone number, during an ultrasound (between 20 and 25 weeks of amenorrhea).Then they will call them and during the telephone interview, they will collect informations needed.

Distribution of an information sheet that will allow the collection of the telephone number of each patient coming for their second trimester ultrasound (between 20 and 25 SA). This form will be accompanied by the letter of information and non-objection which will be kept by the patient. The distribution will be done by the health professionals performing the ultrasound at the beginning or at the end of the medical appointment.

So, the primary endpoint is the proportion of women who report taking at least one dietary supplement during the first 20-25 weeks of pregnancy. This information will be collected by a phone interview.

The secondary endpoints are :

  • Describe the dietary supplements consumed during the first 20-25 weeks of pregnancy: galenic form, indication, source of information, place of purchase (pharmacy, supermarket etc.)
  • Assess whether beliefs about medication are associated with the use of dietary supplements during pregnancy, using BMQ (Belief on Medicine Questionnaire)
  • Describe the mean number of dietary supplements taken by patients in early pregnancy
  • Describe the frequency of use for each dietary supplement ('(several times a day / once a day /several times a week / once a week / once a month etc...)

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Prevalence of Dietary Supplement Consumption Among Pregnant Women During the First 20-25 Weeks of Pregnancy: a Cross-sectional Telephone Interview Survey
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : April 10, 2022
Estimated Study Completion Date : May 10, 2022



Intervention Details:
  • Dietary Supplement: Dietary supplement
    We will study dietary supplement consumption among pregnant women


Primary Outcome Measures :
  1. the proportion of women who report taking at least one dietary supplement during the first 20-25 weeks of pregnancy [ Time Frame: 1 month ]
    what is the percentage of pregnant women who take dietary supplement


Secondary Outcome Measures :
  1. Describe the dietary supplements consumed during the first 20-25 weeks of pregnancy [ Time Frame: 1 month ]
    Which galenic form, indication, source of information, place of purchase (pharmacy, supermarket etc.)

  2. Assess whether beliefs about medication are associated with the use of dietary supplements during pregnancy [ Time Frame: 1 month ]
    using BMQ (Belief on Medicine Questionnaire)

  3. Describe the mean number of dietary supplements taken by patients in early pregnancy [ Time Frame: 1 month ]
    How many dietary supplement pregnant women take on a daily basis

  4. Describe the frequency of use for each dietary supplement [ Time Frame: 1 month ]
    Several times a day / once a day /several times a week / once a week / once a month etc.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Probability Sample
Study Population
Pregnant woman who come in the service for an ultrasound
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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): NCT05191147


Locations
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France
University Hospital Grenoble Recruiting
Grenoble, France
Contact: Marie Dubsay    06 06 44 20 64    marie.dubsay@gmail.com   
Sponsors and Collaborators
University Hospital, Grenoble
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT05191147    
Other Study ID Numbers: 38RC21.0368
First Posted: January 13, 2022    Key Record Dates
Last Update Posted: March 17, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No