Long-term Outcomes of Pregnant Women With PAH

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Other: Observational study

• Registration Number: NCT04053296
• Lead Sponsor: RenJi Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-11-01
• Status Verified: 2019-08
• Study First Submitted: 2019-08-09
• Study First Submitted QC: 2019-08-09
• Last Update Submitted: 2019-08-09
• Study First Posted: 2019-08-12
• Last Update Posted: 2019-08-12
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The first pregnancy with PAH group	Observational study	-
The second pregnancy with PAH group	Observational study	-

Primary Outcome Measures

Name	Time	Method
Death	10 year	The patient die at any time.

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, China