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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03233984
• Other study ID #: PREVED
• Status: Completed
• Phase: N/A
• Start date: April 19, 2017
• Est. completion date: September 28, 2020

Study information

• Verified date: January 2021
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: September 28, 2020
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endocrine System
• Pregnancy
• Prevention Program

Intervention

Behavioral:
• sensibilisation program "Ma maison, mon environnement santé"
The aim of this program is to spread the awarness about endocrine disruptors through workshops and presentation.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	program effectivness	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).	During the pregnancy (second and third trimester)
Secondary	psychosocial aspects	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)	During the pregnancy (second and third trimester)
Secondary	Urine concentration	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)	During the pregnancy (second and third trimester)
Secondary	Milk concentration	Assess the milk endocrine disruptors's concentration difference between women exposed and unexposed to the program	After the birth of the child (first year)
Secondary	foetal growth	Study the relation between endocrine disruptors expositions and foetal growth by merging PREVED and EDDS (a previous trial) datas.	After the birth of the child (first year)