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

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ClinicalTrials.gov Identifier: NCT04215406
Recruitment Status : Recruiting
First Posted : January 2, 2020
Last Update Posted : April 29, 2022
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

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.

Condition or disease Intervention/treatment
Adverse Pregnancy Outcomes Other: The level of air pollution

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Study Type : Observational
Estimated Enrollment : 288 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effects of Maternal Exposure to Air Pollution During Pregnancy on Adverse Pregnancy Outcomes Mediated by Inflammatory Cytokine and Hormone
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. The occurrence of adverse pregnancy outcomes or delivery [ Time Frame: 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 ]
    Adverse pregnancy outcomes including abortion, gestational diabetes mellitus (GDM), hypertensive disorder complicating pregnancy, preterm birth, birth defects and low birth weight(LBW).


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.


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04215406


Contacts
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Contact: Wenfang Yang, PHD 0086-029-85323223 wenfang.yang@xjtu.edu.cn
Contact: Boxing Zhang 0086-15029530460 502209064@qq.com

Locations
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China, Shaanxi
First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710000
Contact: Wenfang Yang, PHD    0086-029-85323223    wenfang.yang@xjtu.edu.cn   
Contact: Boxing Zhang    0086-15029530460    502209064@qq.com   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
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Study Director: Wenfang Yang, PHD First Affiliated Hospital Xi'an Jiaotong University
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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT04215406    
Other Study ID Numbers: XJTU1AF-CRF-2019-023
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: April 29, 2022
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
pregnancy
air pollution
inflammatory cytokine
hormone
effect