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Completed

NCT Number: NCT03233984

Effect of an Environmental Health Education Program on Pregnant Women in Order to Reduce Endocrine Disruptor Exposition

Endocrine disruptors are known as a cancer cause. On pregnant women, it can induce major foetal pathology and impact growth.

Among those molecules, bisphenol-A (BPA) is a plasticizer that can be found on cans and water.

Through a prevention program, the investigators tried to warned pregnant women on endocrine disruptors exposition risks. The goal here is to assess the effectiveness of this program on their fresh products consumption.

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Key information

Conditions

Pregnancy Endocrine System Prevention Program

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Poitiers

Poitiers, 86000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients over 18
  • Patients living in Poitiers or city around (near the immersive environment)
  • Patients on pregnancy and who declared their pregnancy to the authority
  • Patients who planned to give birth in Poitiers's hospital, Châtellerault's hospital or Clinique Fief de Grimoire, in Poitiers.
  • Patients giving her agreement

Exclusion criteria

  • Patients planning to move during the study
  • Patients under legal protection
  • Patients expecting twins
  • Patients unable to speak french
  • Patients willing to give birth in another hospital than those mentionned before

Treatment and study plan

sensibilisation program "Ma maison, mon environnement santé"

Behavioral

The aim of this program is to spread the awarness about endocrine disruptors through workshops and presentation.

Primary outcomes

  1. program effectivness

    Time frame: During the pregnancy (second and third trimester)

    Assessing the Effectiveness of the Prevention Program "My Home, My Health Environment" (consists of a series of workshop in the second and third trimesters of pregnancy) in an immersive environment or not, to evaluate the consumption of fresh products according to exposure endocrine disruptors (cans or industrial products).

Secondary outcomes

  1. psychosocial aspects

    Time frame: During the pregnancy (second and third trimester)

    Assess if the program impact any psychosocial aspects, this outcome will be determine with a psychosocial questionary (to do before and after the intervention for compare the results)

  2. Urine concentration

    Time frame: During the pregnancy (second and third trimester)

    Assess if the program has an impact on the urinary endocrine disruptors's concentrations, this outcome will be determine with samples of urine (to do before and after the intervention for comparate the results)

  3. Milk concentration

    Time frame: After the birth of the child (first year)

    Assess the milk endocrine disruptors's concentration difference between women exposed and unexposed to the program

  4. foetal growth

    Time frame: After the birth of the child (first year)

    Study the relation between endocrine disruptors expositions and foetal growth by merging PREVED and EDDS (a previous trial) datas.

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

Effect of an Environmental Health Education Program on Pregnant Women in Order to Reduce Endocrine Disruptor Exposition : Controled Randomized Trial on Primary Prevention

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jul 31, 2017
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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