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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03233984
Enrollment
267
Registered
2017-07-31
Start date
2017-04-19
Completion date
2020-09-28
Last updated
2021-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endocrine System, Pregnancy, Prevention Program

Keywords

bisphenol-A, prevention, endocrine disruptors

Brief 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.

Interventions

BEHAVIORALsensibilisation program Ma maison, mon environnement santé

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

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
program effectivnessDuring 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

MeasureTime frameDescription
psychosocial aspectsDuring 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)
Urine concentrationDuring 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)
Milk concentrationAfter the birth of the child (first year)Assess the milk endocrine disruptors's concentration difference between women exposed and unexposed to the program
foetal growthAfter 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026