Pulmonary Arterial HypertensionNCT07164157
The Risk of Adverse Pregnancy Outcomes for Long-term Exposure to Air Pollution in Pregnant Patients With Pulmonary Hypertension
An observational study of Pulmonary Arterial Hypertension and Air Pollution, run by Wei Huang at 1 site in China.
Trial summary
With economic development and rapid urbanization, air pollution has become an increasingly severe public health concern. The risk of adverse pregnancy outcomes is significantly elevated for pregnant women complicated by pulmonary hypertension. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pulmonary Arterial Hypertension, Air Pollution, Maternal Outcome
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2013to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women with pulmonary hypertension(PH) who attended major medical centers included in this study from January 2013 to December 2022. Our study includes all types of pregnant women with PH, primarily those who with congenital heart disease-associated PH, followed by those with left heart disease-associated PH.
Who may be able to join
- Pregnant women with pulmonary hypertension who attended major medical centers included in this study from January 2013 to December 2022.
- Complete medical records available; ② Pulmonary artery systolic pressure ≥ 35 mmHg by echocardiography or a confirmed diagnosis of pulmonary hypertension by right heart catheterization; ③ Residential address information available at the city (district, county) level or higher.
Who cannot join
- ① Unclear diagnosis and completely missing address information;
- Incomplete medical records; ③ Lost to follow-up during pregnancy or within six weeks postpartum.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
With economic development and rapid urbanization, air pollution has become an increasingly severe public health concern. The risk of adverse pregnancy outcomes is significantly elevated for pregnant women complicated by pulmonary hypertension. However, no studies to date have specifically examined the impact of environmental factors on pulmonary hypertension in pregnant women, nor their subsequent birth outcomes. Therefore, investigating the correlation between them holds substantial clinical and public health significance.
Read the detailed description
The purpose of the research is preliminary found that the correlation between air pollution and maternal outcomes in pregnant women with pulmonary arterial hypertension and provide useful information for managment of pregnant women in special ambient conditions.
- Keywords
- pulmonary hypertension, air pollution, maternal outcome, heart failure, preterm birth, low birth weight
- Medical subject headings
- Pulmonary Arterial Hypertension, Hypertension, Pulmonary, Heart Failure, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The First Affiliated Hospital of Chongqing Medical University | Not described | |
| The Second Affiliated Hospital of Chongqing Medical University | Not described | |
| Xiangya Hospital of Central South University | Not described | |
| The second Xiangya Hospital of Central South University | Not described | |
| Yan'an Hospital of Kunming City | Not described | |
| Gansu Provincial Hospital | Not described | |
| Qilu Hospital of Shandong University | Not described | |
| The second hospital of Army Military University | Not described | |
| Guizhou Provincial People's Hospital | Not described | |
| The Second Affiliated Hospital of Nanchang University | Not described | |
| Henan Provincial People's Hospital | Not described | |
| Gannan Medical University | Not described | |
| Women and Children's Hospital of Chongqing Medical University | Not described | |
| The First People's Hosipital of Yunnan Province | Not described | |
| People's Hosipital of Xinjiang Uygur Autonomous Region | Not described | |
| The First Affiliated Hospital of Anhui Medical University | Not described | |
| Yantai Yuhuangding Hospital | Not described | |
| The Third People's Hosipital of Chengdu | Not described | |
| Zhongda Hospital Southeast University | Not described | |
| The First Affiliated Hospital of Xi'an Jiao Tong University | Not described | |
| Gansu Provincial Maternity and Child-care Hospital | Not described | |
| The First Affiliated Hospital of Guangxi Medical University | Not described | |
| Xijing Hospital | Not described | |
| Shenzhen People's Hospital | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.main maternal outcome
including maternal death and heart failure
Measured: diagnosis of pregnancy to six months postpartum
Secondary outcomes (1)
Secondary maternal outcome events
including other cardiac events: arrhythmia requiring treatment, thromboembolic event, myocardial infarction, stroke, pulmonary hypertension crisis and so on.
Measured: From delivery to 42 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Jan 2013
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wei Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei Huang, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164157
- Sponsor's protocol ID
- 2025XMSB0000311
- Status last verified
- Jan 2024
- First submitted
- 12 Mar 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Risk of Adverse Pregnancy Outcomes for Long-term Exposure to Air Pollution in Pregnant Patients With Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT07164157
- Acronym / sponsor ID
- 2025XMSB0000311
- Keywords
- pulmonary hypertension, air pollution, maternal outcome, heart failure, preterm birth, low birth weight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Wei HuangUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With economic development and rapid urbanization, air pollution has become an increasingly severe public health concern. The risk of adverse pregnancy outcomes is significantly elevated for pregnant women complicated by pulmonary hypertension. However, no studies to date have specifically examined the impact of environmental factors on pulmonary hypertension in pregnant women, nor their subsequent birth outcomes. Therefore, investigating the correlation between them holds substantial clinical and public health significance.
Detailed description
The purpose of the research is preliminary found that the correlation between air pollution and maternal outcomes in pregnant women with pulmonary arterial hypertension and provide useful information for managment of pregnant women in special ambient conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 24
| Arm | Type | Receives |
|---|---|---|
| The First Affiliated Hospital of Chongqing Medical University | – | – |
| The Second Affiliated Hospital of Chongqing Medical University | – | – |
| Xiangya Hospital of Central South University | – | – |
| The second Xiangya Hospital of Central South University | – | – |
| Yan'an Hospital of Kunming City | – | – |
| Gansu Provincial Hospital | – | – |
| Qilu Hospital of Shandong University | – | – |
| The second hospital of Army Military University | – | – |
| Guizhou Provincial People's Hospital | – | – |
| The Second Affiliated Hospital of Nanchang University | – | – |
| Henan Provincial People's Hospital | – | – |
| Gannan Medical University | – | – |
| Women and Children's Hospital of Chongqing Medical University | – | – |
| The First People's Hosipital of Yunnan Province | – | – |
| People's Hosipital of Xinjiang Uygur Autonomous Region | – | – |
| The First Affiliated Hospital of Anhui Medical University | – | – |
| Yantai Yuhuangding Hospital | – | – |
| The Third People's Hosipital of Chengdu | – | – |
| Zhongda Hospital Southeast University | – | – |
| The First Affiliated Hospital of Xi'an Jiao Tong University | – | – |
| Gansu Provincial Maternity and Child-care Hospital | – | – |
| The First Affiliated Hospital of Guangxi Medical University | – | – |
| Xijing Hospital | – | – |
| Shenzhen People's Hospital | – | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women with pulmonary hypertension(PH) who attended major medical centers included in this study from January 2013 to December 2022. Our study includes all types of pregnant women with PH, primarily those who with congenital heart disease-associated PH, followed by those with left heart disease-associated PH.
Key inclusion criteria (2 listed)
- Pregnant women with pulmonary hypertension who attended major medical centers included in this study from January 2013 to December 2022.
Key exclusion criteria (2 listed)
- ① Unclear diagnosis and completely missing address information;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1.main maternal outcome
Time frame: diagnosis of pregnancy to six months postpartum
including maternal death and heart failure
1 secondary outcome
Secondary maternal outcome events
Time frame: From delivery to 42 days postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension and Air Pollution, run by Wei Huang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.main maternal outcome (time frame: diagnosis of pregnancy to six months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.