The Relationship of Phthalate Exposure During Pregnancy and Preeclampsia

Preeclampsia Clinical Trial

Official title:

The Relationship of Phthalate Exposure During Pregnancy and Preeclampsia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04777929
• Other study ID #: SAHoWMU-CR2020-07-210
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: November 2022
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Estrogen
• Phthalate Exposure
• Pre-Eclampsia
• Preeclampsia
• Progestin

Intervention

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

Locations

Country	Name	City	State
China	department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phthalates in urine	Collect the urine of pregnant women and test the abundance of Phthalates	37 weeks to 40 weeks gestation
Secondary	The female progesterone	Collect the placenta tissue of pregnant women and test the abundance of estrogen progesterone receptor	37 weeks to 40 weeks gestation