The Relationship of Phthalate Exposure During Pregnancy and Preeclampsia

November 28, 2022 updated by: Second Affiliated Hospital of Wenzhou Medical University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The participants include pregnant women meeting the inclusion criteria.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phthalates in urine
Time Frame: 37 weeks to 40 weeks gestation
Collect the urine of pregnant women and test the abundance of Phthalates
37 weeks to 40 weeks gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The female progesterone
Time Frame: 37 weeks to 40 weeks gestation
Collect the placenta tissue of pregnant women and test the abundance of estrogen progesterone receptor
37 weeks to 40 weeks gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2021

Primary Completion (ACTUAL)

September 30, 2022

Study Completion (ACTUAL)

October 31, 2022

Study Registration Dates

First Submitted

February 28, 2021

First Submitted That Met QC Criteria

February 28, 2021

First Posted (ACTUAL)

March 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 29, 2022

Last Update Submitted That Met QC Criteria

November 28, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHoWMU-CR2020-07-210

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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