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

Prevalence of Dietary Supplement Consumption Among Pregnant Women During the First 20-25 Weeks of Pregnancy: a Cross-sectional Telephone Interview Survey

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.

Study Overview

• Status: Recruiting
• Conditions: Preference, Consumer
• Intervention / Treatment: 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...)

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• France
  • Grenoble, France
    • Recruiting
    • University Hospital Grenoble
    • Contact: Marie Dubsay; Phone Number: 06 06 44 20 64; Email: marie.dubsay@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Pregnant woman who come in the service for an ultrasound

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe the dietary supplements consumed during the first 20-25 weeks of pregnancy	Which galenic form, indication, source of information, place of purchase (pharmacy, supermarket etc.)	1 month
Assess whether beliefs about medication are associated with the use of dietary supplements during pregnancy	using BMQ (Belief on Medicine Questionnaire)	1 month
Describe the mean number of dietary supplements taken by patients in early pregnancy	How many dietary supplement pregnant women take on a daily basis	1 month
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.	1 month

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): April 10, 2022
• Study Completion (Anticipated): May 10, 2022

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 38RC21.0368

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No