Pregnant Women With Pulmonary Hypertension in China
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.
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Wei Huang, Doctor
- 전화번호: 86-23-89011513
- 이메일: weihuangcq@gmail.com
연구 장소
-
-
Chongqing
-
Chongqing, Chongqing, 중국, 400016
- 모병
- The First Affiliated Hospital, Chongqing Medical University
-
연락하다:
- Wei Huang, Doctor
- 전화번호: 86 13638309211
- 이메일: weihuangcq@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 회고전
코호트 및 개입
그룹/코호트 |
|---|
|
충칭의과대학 제1부속병원
|
|
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
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
all-cause maternal mortality
기간: diagnosis of pregnancy to six months postpartum in 2012-2021
|
Investigating the maternal mortality rate from the diagnosis of pregnancy to six months postpartum
|
diagnosis of pregnancy to six months postpartum in 2012-2021
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Maternal incidence of cardiovascular complications
기간: from diagnosis of pregnancy to six months postpartum in 2012-2021
|
heart failure ,arrhythmias, thrombotic events (including valve thrombosis) , aortic dissection and other cardiovascular complications during pregnancy until 6 months postpartum
|
from diagnosis of pregnancy to six months postpartum in 2012-2021
|
|
the incidence of obstetric events
기간: From delivery to 42 days postpartum
|
the incidence of post-partum hemorrhage, emergency Caesarean section, pre-eclampsia, eclampsia or pregnancy-induced hypertension From delivery to 42 days postpartum
|
From delivery to 42 days postpartum
|
|
the incidence of fetal events
기간: From delivery to 42 days postpartum
|
prematurity , fetal mortality, early neonatal mortality, intra-uterine growth retardation, low birth weight or low Apgar score from delivery to 42 days postpartum
|
From delivery to 42 days postpartum
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
임신, 고위험에 대한 임상 시험
-
Alan Nichol완전한암(High-grace 신경아교종)캐나다
-
The Nazareth Hospital, Israel완전한Streptococcus B Carrier State Complicating Pregnancy이스라엘