NCT04053296

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 12, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

August 12, 2019

Status Verified

August 1, 2019

Enrollment Period

2.2 years

First QC Date

August 9, 2019

Last Update Submit

August 9, 2019

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

  • Death

    The patient die at any time.

    10 year

Study Arms (2)

The first pregnancy with PAH group

Other: Observational study

The second pregnancy with PAH group

Other: Observational study

Interventions

Observational studyOTHER

We follow up the results of patients.

The first pregnancy with PAH groupThe second pregnancy with PAH group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The first pregnancy group was composed of patients diagnosed with PAH in their first pregnancy. Patients in the second pregnancy group were diagnosed with PAH during their second pregnancy but normal in their first pregnancy.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital

Shanghai, 200127, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Observation

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Jieyan Shen, PhD

    Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital

    STUDY CHAIR

Central Study Contacts

Jieyan Shen, PhD

CONTACT

+8613701864819dr_jyshen@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2019

First Posted

August 12, 2019

Study Start

November 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

August 12, 2019

Record last verified: 2019-08

Locations

CN(1)