Pulmonary Arterial HypertensionNCT04053296
Long-term Outcomes of Pregnant Women With PAH
An observational study of Pulmonary Arterial Hypertension, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Observational study
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, 200127
Menghui Yang, postgraduate, +8618621820681, 514396423@qq.com
About this study
Official title: Morbidity and Outcomes of Pregnant Women With Pulmonary Arterial Hypertension During Different Pregnancies
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.
Read the 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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Observational study
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
We follow up the results of patients.
| Study group | Role | What they receive |
|---|---|---|
| The first pregnancy with PAH group | Not described Receives: Other: Observational study | |
| The second pregnancy with PAH group | Not described Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
The patient die at any time.
Measured: 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start1 Nov 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jieyan Shen, PhD, Study chair, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053296
- Sponsor's protocol ID
- outcomes of PAH
- Status last verified
- Aug 2019
- First submitted
- 9 Aug 2019
- Last updated
- 12 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morbidity and Outcomes of Pregnant Women With Pulmonary Arterial Hypertension During Different Pregnancies
- ClinicalTrials.gov ID
- NCT04053296
- Acronym / sponsor ID
- outcomes of PAH
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 12 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The first pregnancy with PAH group | – | Other: Observational study |
| The second pregnancy with PAH group | – | Other: Observational study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyWe follow up the results of patients. | Other | The first pregnancy with PAH group, The second pregnancy with PAH group |
Primary outcome
Death
Time frame: 10 year
The patient die at any time.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
Related trials for Pulmonary Arterial Hypertension
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jieyan Shen, PhD study chair
Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jieyan Shen, PhD (+8613701864819, dr_jyshen@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 10 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019.