The Mechanism of Adverse Pregnancy Outcomes Influenced by Maternal Air Pollution Exposure

NCT04215406 | Unknown

• 1 other identifier: XJTU1AF-CRF-2019-023
• Study Type: observational
• Target: 288
• Locations: 1 country
• Sites: 1

Brief Summary

This research evaluates the effects of maternal exposure to air pollution during pregnancy on adverse pregnancy outcomes, the general demographic information, the level of maternal exposure to air pollution, pregnancy-related information, the occurrence of adverse pregnancy outcomes, and serum indicators of pregnant women during pregnancy are collected. Finally, the research explores that whether the inflammatory cytokine and hormone can mediate the occurrence of adverse pregnancy outcomes under the maternal exposure to air pollution during pregnancy.

Conditions

Adverse Pregnancy Outcomes

Keywords

pregnancy; air pollution; inflammatory cytokine; hormone; effect

Outcome Measures

Primary Outcomes (1)

• The occurrence of adverse pregnancy outcomes or delivery

  Adverse pregnancy outcomes including abortion, gestational diabetes mellitus (GDM), hypertensive disorder complicating pregnancy, preterm birth, birth defects and low birth weight(LBW).

  ①For abortion, up to 24 weeks. ②For participants without abortion will be assessed when hypertension disorders of pregnancy and GDM occur, then assessment of preterm birth, LBW and birth defects will be conducted when delivery, up to about 9 months

Study Arms (1)

The level of maternal air pollution exposure during pregnancy

The groups will be decided according to the level of maternal exposure to air pollution during pregnancy. Participants will be divided into experimental group (high level of maternal air pollution exposure) and control group (low level of maternal air pollution exposure) or other groups according to research and actual demand.

Other: The level of air pollution

Interventions

The level of air pollution OTHER

The intervention measure is the level of air pollution, it is a non-human interventional measure based on the weighted average of various air pollutants monitored by air pollution monitoring stations during different period of pregnancy.

The level of maternal air pollution exposure during pregnancy

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study participants are healthy pregnant women within 6 weeks of pregnancy from the First Affiliated Hospital of Xi'an Jiaotong University, who meet the inclusion and exclusion criteria, and sign the informed consent before the implementation of this research. All the participants will be followed up about 9 months and measured the serum concentration of inflammatory cytokine and hormone.

You may qualify if:

• The Pregnant women within 6 weeks of gestation from the First Affiliated Hospital of Xi'an Jiaotong University;
• This pregnancy is natural conception, the last menstrual period is definite and the menstrual cycle is basically regular;
• The pregnant examinations are performed in our hospital;
• The pregnant women volunteer to participate in this study and sign the informed consent.

You may not qualify if:

• The couples have chromosomal abnormalities or hereditary diseases;
• The pregnant women have trophoblastic diseases such as hydatidiform mole;
• The pregnant women with genital malformations, such as mediastinal uterus, single-horned uterus, double uterus, etc;
• The pregnant women are definitively diagnosed with uterine fibroids, ovarian cysts, polycystic ovary syndrome, gynecological inflammation and other gynecological diseases;
• The pregnant women are definitively diagnosed with hypertensive, diabetes and other chronic disease before pregnancy;
• The pregnant women are definitively diagnosed with autoimmune diseases such as systemic lupus erythematosus, multiple arteriolar inflammation, rheumatoid arthritis, etc;
• The participants have other serious diseases.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

The venous blood from pregnant women is acquired in different time point for measurement of serum concentration of inflammatory cytokine and hormone.

Study Officials

• Wenfang Yang, PHD

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY DIRECTOR

Central Study Contacts

Wenfang Yang, PHD

CONTACT

0086-029-85323223; wenfang.yang@xjtu.edu.cn

Boxing Zhang

CONTACT

0086-15029530460; 502209064@qq.com

Study Design

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

Study Record Dates

• First Submitted: December 25, 2019
• First Posted: January 2, 2020
• Study Start: January 1, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: April 29, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)