The Relationship of Phthalate Exposure During Pregnancy and Preeclampsia

Sponsor
Second Affiliated Hospital of Wenzhou Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04777929
Collaborator
(none)
60
1
3
20.1

Study Details

Study Description

Brief Summary

Phthalates are a group of ubiquitous synthetic endocrine-disrupting chemicals. Fetal and neonatal periods are particularly susceptible to endocrine disorders, which prenatal exposure to phthalates causes. There is increasing evidence concerning the potential endocrine disrupting for phthalate exposure during pregnancy. Prenatal exposure phthalates would disrupt the level of sex hormone in pregnant women, which results in preeclampsia. The relationship of prenatal phthalate exposure with maternal and neonatal outcomes in human beings was often sex-specific associations. Because of the potentially harmful influence of prenatal phthalate exposure, steps should be taken to prevent or reduce phthalate exposure during pregnancy.

Condition or Disease Intervention/Treatment Phase
  • Other: test Phthalates, estrogen and progesterone

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
The Relationship of Phthalate Exposure During Pregnancy and Preeclampsia
Anticipated Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
healthy pregnant woman

pregnant woman without any disease of pregnancy

Other: test Phthalates, estrogen and progesterone
test mothers Phthalates in their urine, and test estrogen and progesterone receptor in placental tissue

pregnant woman with preeclampia

pregnant woman with preeclampia but without any other disease of pregnancy

Other: test Phthalates, estrogen and progesterone
test mothers Phthalates in their urine, and test estrogen and progesterone receptor in placental tissue

Outcome Measures

Primary Outcome Measures

  1. Phthalates in urine [37 weeks to 40 weeks gestation]

    Collect the urine of pregnant women and test the abundance of Phthalates

Secondary Outcome Measures

  1. The female progesterone [37 weeks to 40 weeks gestation]

    Collect the placenta tissue of pregnant women and test the abundance of estrogen progesterone receptor

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Singleton pregnancy

  • Term pregnancy with the gestational age of 37-40 weeks

Exclusion Criteria:
  • Maternal systemic diseases (hypertension disorders, immunological diseases) or pregnant complications (polyhydramnios, oligohydramnios, diabetes mellitus, intrahepatic cholestasis of pregnancy)

  • Delivery before 37 weeks or after 40 weeks

Contacts and Locations

Locations

Site City State Country Postal Code
1 department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang China 325027

Sponsors and Collaborators

  • Second Affiliated Hospital of Wenzhou Medical University

Investigators

  • Study Director: Ying Hua, Second Affiliated Hospital of Wenzhou Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT04777929
Other Study ID Numbers:
  • SAHoWMU-CR2020-07-210
First Posted:
Mar 2, 2021
Last Update Posted:
Mar 2, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2021