NCT07164157

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2025

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
Last Updated

September 10, 2025

Status Verified

January 1, 2024

Enrollment Period

10 years

First QC Date

March 12, 2025

Last Update Submit

September 2, 2025

Conditions

Keywords

pulmonary hypertensionair pollutionmaternal outcomeheart failurepreterm birthlow birth weight

Outcome Measures

Primary Outcomes (1)

  • 1.main maternal outcome

    including maternal death and heart failure

    diagnosis of pregnancy to six months postpartum

Secondary Outcomes (1)

  • Secondary maternal outcome events

    From delivery to 42 days postpartum

Other Outcomes (1)

  • 2.main offspring events

    From delivery to 42 days postpartum

Study Arms (24)

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

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • ① Unclear diagnosis and completely missing address information;
  • Incomplete medical records; ③ Lost to follow-up during pregnancy or within six weeks postpartum.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital, Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

MeSH Terms

Conditions

Pulmonary Arterial HypertensionHypertension, PulmonaryHeart FailurePremature Birth

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesHeart DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 12, 2025

First Posted

September 10, 2025

Study Start

January 1, 2013

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

September 10, 2025

Record last verified: 2024-01

Locations