The Relationship of Phthalate Exposure During Pregnancy and Preeclampsia

NCT04777929 | Completed

• 1 other identifier: SAHoWMU-CR2020-07-210
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Phthalate Exposure; Preeclampsia; Estrogen; Progestin

Outcome Measures

Primary Outcomes (1)

• Phthalates in urine

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

  37 weeks to 40 weeks gestation

Secondary Outcomes (1)

• The female progesterone

  37 weeks to 40 weeks gestation

Study Arms (2)

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

test Phthalates, estrogen and progesterone OTHER

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

healthy pregnant woman; pregnant woman with preeclampia

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Eligible participants is female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The participants include pregnant women meeting the inclusion criteria.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325027, China

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Estrogens; Progesterone

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Ying Hua

  Second Affiliated Hospital of Wenzhou Medical University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2021
• First Posted: March 2, 2021
• Study Start: January 1, 2021
• Primary Completion: September 30, 2022
• Study Completion: October 31, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

CN (1)