Pregnant Women With Pulmonary Hypertension in China

NCT05198206 | Unknown DMC

• 1 other identifier: 2021XMSB0011013
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Little is known about the status of maternal, obstetric and neonatal complications and the potential predictors of developing heart failure (HF) in the mothers with pulmonary hypertension in China. Eligible samples were screened from January, 2012 to December, 2021. Maternal clinical characteristics and in-and-out hospital outcomes were collected and compared in women with and without pulmonary hypertension. The main aims of this study are as follows:

1. 1.To investigate the perinatal diagnosis and treatment of pregnant women with pulmonary hypertension in China over the past 10 years and the maternal and infant outcomes.
2. 2.To explore risk factors that affect the outcome of pregnant women with pulmonary hypertension in mothers and infants.
3. 3.To summarise effective risk stratification management protocols and construct standardised strategies for the management of pulmonary hypertension in pregnancy.
4. 4.To establish a clinical database, biobank and follow-up cohort for pregnant women with pulmonary hypertension across China.

Conditions

Pulmonary Hypertension; Pregnancy, High Risk

Outcome Measures

Primary Outcomes (1)

• all-cause maternal mortality

  Investigating the maternal mortality rate from the diagnosis of pregnancy to six months postpartum

  diagnosis of pregnancy to six months postpartum in 2012-2021

Secondary Outcomes (3)

• Maternal incidence of cardiovascular complications

  from diagnosis of pregnancy to six months postpartum in 2012-2021

• the incidence of obstetric events

  From delivery to 42 days postpartum

• the incidence of fetal events

  From delivery to 42 days postpartum

Study Arms (32)

The First Affiliated Hospital of Chongqing Medical University

West China Hospital

the First Affiliated Hospital of Xi'an Jiaotong University

Guangdong Provincial People's Hospital

Xiangya Hospital of Central South University

The Second Affiliated Hospital of Harbin Medical University

Yan'an Hospital of Kunming City

Zhongshan Hospital

Gansu Provincial People's Hospital

Qilu Hospital of Shandong University

Shanxi Provincial Cardiovascular Hospital

West China Second Hospital

The First Affiliated Hospital of Jilin University

Xinqiao Hospital, Army Medical University

The First Affiliated Hospital of Guangzhou Medical University

the Second Xiangya Hospital of Central South University

Shengjing Hospital of China Medical University

The Second Affiliated Hospital of Nanchang University

Henan Provincial People's Hospital

Southwest Medical University Hospital

The First Affiliated Hospital of Gannan Medical University

University-town Hospital of Chongqing Medical University

Chongqing Health Center for Women and Children

Kunhua Hospital

Changdu People's Hospital of Tibet

The Sixth People's Hospital of Chengdu

Chongqing Bishan District People's Hospital

Sichuan Guangyuan People's Hospital

Xinjiang Military Region General Hospital

Xinjiang Uygur Autonomous Region People's Hospital

The First Affiliated Hospital of Anhui Medical University

Yantai Yuhuangding Hospital

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: female
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregant women who conform to echocardiographic or right heart catheter criteria of PAH in 32 centers across China were included.

You may qualify if:

• pregnant women, regardless of age, race
• diagnosed with pulmonary hypertension(PH) before pregnancy or during pregnancy
• diagnosed with PH by right heart catheterization or echocardiography
• diagnostic criteria of right heart catheterization: mean pulmonary artery pressure (mPAP) ≥ 25 mm Hg by right heart catheterization at rest
• diagnostic criteria of echocardiography: pulmonary artery systolic pressure (PASP)≥40 mm Hg
• time: from January 1, 2012 to December 31, 2021

You may not qualify if:

• Patients with isolated exercise-induced PH (mean PAP \<25 mm Hg at rest and \>30 mm Hg at exercise) were excluded.
• pulmonary artery systolic pressure (PASP)\<40 mmHg by echocardiography
• mean pulmonary artery pressure (mPAP) \< 25 mm Hg by right heart catheterization at rest

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

the First Affiliated Hospital, Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Wei Huang, Doctor

CONTACT

86-23-89011513; weihuangcq@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Wei Huang

Study Record Dates

• First Submitted: November 13, 2021
• First Posted: January 20, 2022
• Study Start: November 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: May 31, 2022
• Last Updated: January 20, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)