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CompletedNCT04777929Updated Nov 29, 2022

The Relationship of Phthalate Exposure During Pregnancy and Preeclampsia

An observational study in Phthalate Exposure, Preeclampsia and Estrogen, sponsored by Second Affiliated Hospital of Wenzhou Medical University. Completed at 1 site in China. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-29.

Sponsored by Second Affiliated Hospital of Wenzhou Medical University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 40 Years
Sex
Female
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Study 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.

02

Conditions studied

  • Phthalate Exposure
  • Preeclampsia
  • Estrogen
  • Progestin

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03

In context

Pre-Eclampsia

882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.

This study's enrollment of 60 is below the median of 163 across 380 observational studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 133 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The participants include pregnant women meeting the inclusion criteria.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • healthy pregnant woman

    pregnant woman without any disease of pregnancy

    Other: test Phthalates, estrogen and progesterone

  • pregnant woman with preeclampia

    pregnant woman with preeclampia but without any other disease of pregnancy

    Other: test Phthalates, estrogen and progesterone

Interventions

  • Othertest Phthalates, estrogen and progesterone

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

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What researchers measure

Primary outcomes

  1. Phthalates in urine

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

    Time frame: 37 weeks to 40 weeks gestation

Secondary outcomes

  1. The female progesterone

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

    Time frame: 37 weeks to 40 weeks gestation

07

Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04777929
Lead sponsor
Second Affiliated Hospital of Wenzhou Medical University
Responsible party
Sponsor
First posted
Mar 2, 2021
Start date
Jan 1, 2021
Primary completion
Sep 30, 2022
Completion
Oct 31, 2022
Last update
Nov 29, 2022

Study contacts

Ying Hua
study director · Second Affiliated Hospital of Wenzhou Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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