Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-29 @ 2:29 AM
Study NCT ID:
NCT07164157
Status:
COMPLETED
Last Update Posted:
2025-09-10
First Post:
2025-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Risk of Adverse Pregnancy Outcomes for Long-term Exposure to Air Pollution in Pregnant Patients With Pulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2025-03-12', 'studyFirstSubmitQcDate': '2025-09-02', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '2.main offspring events', 'timeFrame': 'From delivery to 42 days postpartum', 'description': 'including fetal or neonatal death, prematurity, low birth weight, small for gestational age'}], 'primaryOutcomes': [{'measure': '1.main maternal outcome', 'timeFrame': 'diagnosis of pregnancy to six months postpartum', 'description': 'including maternal death and heart failure'}], 'secondaryOutcomes': [{'measure': 'Secondary maternal outcome events', 'timeFrame': 'From delivery to 42 days postpartum', 'description': 'including other cardiac events: arrhythmia requiring treatment, thromboembolic event, myocardial infarction, stroke, pulmonary hypertension crisis and so on.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pulmonary hypertension', 'air pollution', 'maternal outcome', 'heart failure', 'preterm birth', 'low birth weight'], 'conditions': ['Pulmonary Arterial Hypertension', 'Air Pollution', 'Maternal Outcome']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women with pulmonary hypertension who attended major medical centers included in this study from January 2013 to December 2022.\n\n * 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.\n\nExclusion Criteria:\n\n* ① Unclear diagnosis and completely missing address information;\n\n * Incomplete medical records; ③ Lost to follow-up during pregnancy or within six weeks postpartum.'}, 'identificationModule': {'nctId': 'NCT07164157', 'briefTitle': 'The Risk of Adverse Pregnancy Outcomes for Long-term Exposure to Air Pollution in Pregnant Patients With Pulmonary Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'The Risk of Adverse Pregnancy Outcomes for Long-term Exposure to Air Pollution in Pregnant Patients With Pulmonary Hypertension', 'orgStudyIdInfo': {'id': '2025XMSB0000311'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The First Affiliated Hospital of Chongqing Medical University'}, {'label': 'The Second Affiliated Hospital of Chongqing Medical University'}, {'label': 'Xiangya Hospital of Central South University'}, {'label': 'The second Xiangya Hospital of Central South University'}, {'label': "Yan'an Hospital of Kunming City"}, {'label': 'Gansu Provincial Hospital'}, {'label': 'Qilu Hospital of Shandong University'}, {'label': 'The second hospital of Army Military University'}, {'label': "Guizhou Provincial People's Hospital"}, {'label': 'The Second Affiliated Hospital of Nanchang University'}, {'label': "Henan Provincial People's Hospital"}, {'label': 'Gannan Medical University'}, {'label': "Women and Children's Hospital of Chongqing Medical University"}, {'label': "The First People's Hosipital of Yunnan Province"}, {'label': "People's Hosipital of Xinjiang Uygur Autonomous Region"}, {'label': 'The First Affiliated Hospital of Anhui Medical University'}, {'label': 'Yantai Yuhuangding Hospital'}, {'label': "The Third People's Hosipital of Chengdu"}, {'label': 'Zhongda Hospital Southeast University'}, {'label': "The First Affiliated Hospital of Xi'an Jiao Tong University"}, {'label': 'Gansu Provincial Maternity and Child-care Hospital'}, {'label': 'The First Affiliated Hospital of Guangxi Medical University'}, {'label': 'Xijing Hospital'}, {'label': "Shenzhen People's Hospital"}]}, 'contactsLocationsModule': {'locations': [{'zip': '400016', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'The First Affiliated Hospital, Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wei Huang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Wei Huang', 'investigatorAffiliation': 'First Affiliated Hospital of Chongqing Medical University'}}}}