Long-term Outcomes of Pregnant Women With PAH

NCT ID: NCT04053296

Last Updated: 2019-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2019-12-31

Brief Summary

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The investigators intend to explore the characteristics and outcomes of pregnant women with PAH during different pregnancies and to provide applicable evidence for clinical practice.

Detailed Description

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Pulmonary arterial hypertension (PAH) is a fatal disease with progressive vascular resistance that leads to the loss of right heart function. Avoiding pregnancy is essential for PAH women. In recent years, maternal mortality in pregnant women with PAH has decreased mostly due to emerging advanced therapies for PAH and the progress in high-risk pregnancy management. Nevertheless, the maternal death rate in parturients with PAH remains high; therefore, contraception is still recommended for women diagnosed with PAH. However, some women develop this condition during pregnancy. With the two-child policy, families in China are allowed to have a second child. As a result, the number of PAH diagnoses during pregnancy may increase with the general increase in the number of pregnant women. Additionally, some patients develop PAH only during their second pregnancy. In order to investigate the incidence and clinical characteristics of pregnant women diagnosed with PAH during different pregnancies, this observational study aimed to analyze perinatal and pregnancy clinical data, to compare the perinatal status and maternal and infant outcomes of the first and second pregnancies complicated with PAH, establishing a clinical basis for the prenatal consultation, diagnosis, and treatment of pregnant women with PAH.

Conditions

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Pulmonary Arterial Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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The first pregnancy with PAH group

Observational study

Intervention Type OTHER

We follow up the results of patients.

The second pregnancy with PAH group

Observational study

Intervention Type OTHER

We follow up the results of patients.

Interventions

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Observational study

We follow up the results of patients.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

PAH was screened by Doppler echocardiography first. Echocardiographic criteria for the diagnosis of PAH included tricuspid regurgitation velocity \>2.8 m/sec, with extra more than one additional echocardiographic sign

Exclusion Criteria

Cases of PH diagnosed before pregnancy, secondary to chronic lung disease, and left heart disease, as well as right ventricular outflow tract obstruction and congenital pulmonary stenosis.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jieyan Shen, PhD

Role: STUDY_CHAIR

Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital

Locations

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Renji Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jieyan Shen, PhD

Role: CONTACT

+8613701864819

Facility Contacts

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Menghui Yang, postgraduate

Role: primary

+8618621820681

Other Identifiers

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outcomes of PAH

Identifier Type: -

Identifier Source: org_study_id

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