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Pregnant Women With Pulmonary Hypertension in China

3 januari 2022 uppdaterad av: Wei Huang, First Affiliated Hospital of Chongqing Medical University

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:

  1. 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.
  2. To explore risk factors that affect the outcome of pregnant women with pulmonary hypertension in mothers and infants.
  3. To summarise effective risk stratification management protocols and construct standardised strategies for the management of pulmonary hypertension in pregnancy.
  4. To establish a clinical database, biobank and follow-up cohort for pregnant women with pulmonary hypertension across China.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Förväntat)

2000

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kina
    • Chongqing
      • Chongqing, Chongqing, Kina, 400016
        • Rekrytering
        • The First Affiliated Hospital, Chongqing Medical University
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

14 år till 50 år (Barn, Vuxen)

Tar emot friska volontärer

N/A

Kön som är behöriga för studier

Kvinna

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Pregant women who conform to echocardiographic or right heart catheter criteria of PAH in 32 centers across China were included.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Kohort
  • Tidsperspektiv: Retrospektiv

Kohorter och interventioner

Grupp / Kohort
Chongqing Medical Universitys första anslutna sjukhus
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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
all-cause maternal mortality
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Maternal incidence of cardiovascular complications
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

First Affiliated Hospital of Chongqing Medical University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 november 2021

Primärt slutförande (Förväntat)

30 april 2022

Avslutad studie (Förväntat)

31 maj 2022

Studieregistreringsdatum

Först inskickad

13 november 2021

Först inskickad som uppfyllde QC-kriterierna

3 januari 2022

Första postat (Faktisk)

20 januari 2022

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

20 januari 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 januari 2022

Senast verifierad

1 januari 2022

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2021XMSB0011013

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Ja

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