Pulmonary HypertensionNCT05198206
Pregnant Women With Pulmonary Hypertension in China
An observational study of Pulmonary Hypertension and Pregnancy, High Risk, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 50 years, women only
- Conditions the study is for
- Pulmonary Hypertension, Pregnancy, High Risk
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 31 May 2022
- 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 14 to 50 years
- Women only
- Child, Adult
Study population: Pregant women who conform to echocardiographic or right heart catheter criteria of PAH in 32 centers across China were included.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital, Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Wei Huang, Doctor, 86 13638309211, weihuangcq@gmail.com
About this study
Official title: Current Status of Diagnosis and Treatment of Pregnancy With Pulmonary Hypertension and Maternal and Infant Outcomes: a Multicentre Retrospective Study in China
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:
- 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.
- To explore risk factors that affect the outcome of pregnant women with pulmonary hypertension in mothers and infants.
- To summarise effective risk stratification management protocols and construct standardised strategies for the management of pulmonary hypertension in pregnancy.
- To establish a clinical database, biobank and follow-up cohort for pregnant women with pulmonary hypertension across China.
Read the detailed description
Pulmonary hypertension is a malignant disease with a high mortality rate, difficult to diagnose at an early stage and has posed a huge economic burden on patients and society. Pregnancy with pulmonary hypertension is associated with high maternal mortality (25% - 56% ) and a high incidence of fetal complications such as preterm birth (85% - 100%), fetal growth restriction (3% - 33%) and severe outcomes such as fetal/neonatal loss (7% - 13%). A high maternal mortality rate of 30%-56% for pregnancy-related pulmonary hypertension for women and 11-28% for infants has been reported.
However, despite national and international guidelines recommending avoidance of pregnancy, some women with pulmonary hypertension persist in their pregnancies or have unplanned pregnancies, and some pregnant women are diagnosed with pulmonary hypertension only after symptoms such as heart failure have worsened. Although with the development of pulmonary arterial hypertension(PAH)-targeted drugs, the mortality rate for pregnancy-associated PAH has declined but remains relatively high. The high maternal and infant mortality rates and complication rates make it a critical condition that seriously endangers the lives of both mother and child.
Limited data in China reported the outcome, prognosis and management measures of combined pulmonary hypertension in pregnancy, and there is a lack of overall description and analysis of pregnancy with pulmonary hypertension in a multi-centre setting. The current status of high risk factors, efficacy of multidisciplinary consultation and management of maternal and fetal mortality and complications is unclear.
Therefore, the aim of this study was to retrospectively analyse the current status of the management of pregnant women with pulmonary hypertension in a multicenter setting across China, and try to summarise effective risk stratification management protocols and construct standardised strategies for the management of pulmonary hypertension in pregnancy to reduce maternal and infant mortality and adverse events and improve the prognosis of mothers and infants.
- Conditions
- Pulmonary Hypertension, Pregnancy, High Risk
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The First Affiliated Hospital of Chongqing Medical University | Not described | |
| West China Hospital | Not described | |
| the First Affiliated Hospital of Xi'an Jiaotong University | Not described | |
| Guangdong Provincial People's Hospital | Not described | |
| Xiangya Hospital of Central South University | Not described | |
| The Second Affiliated Hospital of Harbin Medical University | Not described | |
| Yan'an Hospital of Kunming City | Not described | |
| Zhongshan Hospital | Not described | |
| Gansu Provincial People's Hospital | Not described | |
| Qilu Hospital of Shandong University | Not described | |
| Shanxi Provincial Cardiovascular Hospital | Not described | |
| West China Second Hospital | Not described | |
| The First Affiliated Hospital of Jilin University | Not described | |
| Xinqiao Hospital, Army Medical University | Not described | |
| The First Affiliated Hospital of Guangzhou Medical University | Not described | |
| the Second Xiangya Hospital of Central South University | Not described | |
| Shengjing Hospital of China Medical University | Not described | |
| The Second Affiliated Hospital of Nanchang University | Not described | |
| Henan Provincial People's Hospital | Not described | |
| Southwest Medical University Hospital | Not described | |
| The First Affiliated Hospital of Gannan Medical University | Not described | |
| University-town Hospital of Chongqing Medical University | Not described | |
| Chongqing Health Center for Women and Children | Not described | |
| Kunhua Hospital | Not described | |
| Changdu People's Hospital of Tibet | Not described | |
| The Sixth People's Hospital of Chengdu | Not described | |
| Chongqing Bishan District People's Hospital | Not described | |
| Sichuan Guangyuan People's Hospital | Not described | |
| Xinjiang Military Region General Hospital | Not described | |
| Xinjiang Uygur Autonomous Region People's Hospital | Not described | |
| The First Affiliated Hospital of Anhui Medical University | Not described | |
| Yantai Yuhuangding Hospital | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause maternal mortality
Investigating the maternal mortality rate from the diagnosis of pregnancy to six months postpartum
Measured: diagnosis of pregnancy to six months postpartum in 2012-2021
Secondary outcomes (3)
Maternal incidence of cardiovascular complications
heart failure ,arrhythmias, thrombotic events (including valve thrombosis) , aortic dissection and other cardiovascular complications during pregnancy until 6 months postpartum
Measured: from diagnosis of pregnancy to six months postpartum in 2012-2021
the incidence of obstetric events
the incidence of post-partum hemorrhage, emergency Caesarean section, pre-eclampsia, eclampsia or pregnancy-induced hypertension From delivery to 42 days postpartum
Measured: From delivery to 42 days postpartum
the incidence of fetal events
prematurity , fetal mortality, early neonatal mortality, intra-uterine growth retardation, low birth weight or low Apgar score from delivery to 42 days postpartum
Measured: From delivery to 42 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Nov 2021
- Primary completion30 Apr 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe 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
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Huang, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198206
- Sponsor's protocol ID
- 2021XMSB0011013
- Status last verified
- Jan 2022
- First submitted
- 13 Nov 2021
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Current Status of Diagnosis and Treatment of Pregnancy With Pulmonary Hypertension and Maternal and Infant Outcomes: a Multicentre Retrospective Study in China
- ClinicalTrials.gov ID
- NCT05198206
- Acronym / sponsor ID
- 2021XMSB0011013
- Conditions
- Pulmonary Hypertension, Pregnancy, High Risk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 20 Jan 2022 (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.
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:
- 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.
- To explore risk factors that affect the outcome of pregnant women with pulmonary hypertension in mothers and infants.
- To summarise effective risk stratification management protocols and construct standardised strategies for the management of pulmonary hypertension in pregnancy.
- To establish a clinical database, biobank and follow-up cohort for pregnant women with pulmonary hypertension across China.
Detailed description
Pulmonary hypertension is a malignant disease with a high mortality rate, difficult to diagnose at an early stage and has posed a huge economic burden on patients and society. Pregnancy with pulmonary hypertension is associated with high maternal mortality (25% - 56% ) and a high incidence of fetal complications such as preterm birth (85% - 100%), fetal growth restriction (3% - 33%) and severe outcomes such as fetal/neonatal loss (7% - 13%). A high maternal mortality rate of 30%-56% for pregnancy-related pulmonary hypertension for women and 11-28% for infants has been reported.
However, despite national and international guidelines recommending avoidance of pregnancy, some women with pulmonary hypertension persist in their pregnancies or have unplanned pregnancies, and some pregnant women are diagnosed with pulmonary hypertension only after symptoms such as heart failure have worsened. Although with the development of pulmonary arterial hypertension(PAH)-targeted drugs, the mortality rate for pregnancy-associated PAH has declined but remains relatively high. The high maternal and infant mortality rates and complication rates make it a critical condition that seriously endangers the lives of both mother and child.
Limited data in China reported the outcome, prognosis and management measures of combined pulmonary hypertension in pregnancy, and there is a lack of overall description and analysis of pregnancy with pulmonary hypertension in a multi-centre setting. The current status of high risk factors, efficacy of multidisciplinary consultation and management of maternal and fetal mortality and complications is unclear.
Therefore, the aim of this study was to retrospectively analyse the current status of the management of pregnant women with pulmonary hypertension in a multicenter setting across China, and try to summarise effective risk stratification management protocols and construct standardised strategies for the management of pulmonary hypertension in pregnancy to reduce maternal and infant mortality and adverse events and improve the prognosis of mothers and infants.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 32
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Pregant women who conform to echocardiographic or right heart catheter criteria of PAH in 32 centers across China were included.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
all-cause maternal mortality
Time frame: diagnosis of pregnancy to six months postpartum in 2012-2021
Investigating the maternal mortality rate from the diagnosis of pregnancy to six months postpartum
3 secondary outcomes
Maternal incidence of cardiovascular complications
Time frame: from diagnosis of pregnancy to six months postpartum in 2012-2021
the incidence of obstetric events
Time frame: From delivery to 42 days postpartum
the incidence of fetal events
Time frame: From delivery to 42 days postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Individual participant dataSharing planned: Yes
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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.
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 Hypertension and Pregnancy, High Risk, run by First Affiliated Hospital of Chongqing Medical University 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 6 inclusion and 3 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 20 Jan 2022. 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 Wei Huang, Doctor (86-23-89011513, weihuangcq@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause maternal mortality (time frame: diagnosis of pregnancy to six months postpartum in 2012-2021). 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 20 Jan 2022.