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NCT Number: NCT07672210

PregnAncy-Related Aortic DISsEction in China

A multicenter observational study on pregnancy-related aortic dissection

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Key information

Conditions

Pregnancy Complication Abnormalities, Multiple Acute Aortic Syndrome Aneurysm Aortic Aneurysm Aortic Diseases Aortic Dissection Bone Diseases Bone Diseases, Developmental Cardiovascular Abnormalities Cardiovascular Diseases Collagen Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Craniofacial Abnormalities Dissection, Blood Vessel Ehlers-Danlos Syndrome Ehlers-Danlos Syndrome, Type IV Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Heart Defects, Congenital Heart Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Loeys-Dietz Syndrome Marfan Syndrome Maternal and Neonatal Outcomes Musculoskeletal Abnormalities Musculoskeletal Diseases Pregnancy Complications Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases Urogenital Diseases Vascular Diseases Vascular Ehlers-Danlos Syndrome

Age range

16 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

DeltaHealth Hospital Shanghai, Shanghai, Shanghai Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aortic dissection is diagnosed based on symptoms and physical findings, and confirmed by computed tomographic angiography (CTA) and/or transthoracic echocardiography
  • Aortic dissection occurring during pregnancy or within 12 weeks postpartum

Exclusion criteria

  • Previous history of aortic dissection, but no new aortic dissection occurring during pregnancy or within 12 weeks postpartum

Treatment and study plan

Intervention strategies including medication or surgery

Other

Medication or surgery (delivery or surgery first, or single-stage delivery and surgery) is determined based on gestational age and the type of AD, and also in consideration of the decisions made by the patient and their relatives.

Primary outcomes

  1. Early-term mortality of mothers and fetuses (or newborns)

    Time frame: Death within 30 days after treatment.

    All-cause mortality within 30 days after treatment.

  2. Long-term mortality of mothers and children

    Time frame: Through study completion, an average of 3 years.

    All-cause mortality during the follow-up period.

Secondary outcomes

  1. The incidence of maternal adverse events

    Time frame: Through study completion, an average of 3 years.

    The reinterventions for mothers due to aortic and obstetric conditions.

  2. The incidence of neonatal developmental abnormalities

    Time frame: Through study completion, an average of 3 years.

    Adverse events occurring in newborns during follow-up, including suspected signs of heritable aortic disease and growth and developmental abnormalities (cerebral palsy, intellectual disabilities, etc.)

Study contacts

Contact information is provided by the study sponsor or research team.

Su-Wei Chen, MD, PhD

CONTACT

[email protected]

+86 15524612655

Wei-Guo Ma, MD, PhD

CONTACT

[email protected]

+12032780619

Sponsors and collaborators

Lead sponsor

DeltaHealth Hospital · Shanghai

Other

Collaborators

  • Anhui Provincial Hospital
  • Beijing Anzhen Hospital
  • Central China Fuwai Hospital of Zhengzhou University
  • Changhai Hospital
  • Chinese University of Hong Kong
  • First Affiliated Hospital Xi'an Jiaotong University
  • First Affiliated Hospital of Gannan Medical University
  • First Affiliated Hospital of Guangxi Medical University
  • First Affiliated Hospital of Harbin Medical University
  • First Affiliated Hospital of Ningbo University
  • First Affiliated Hospital of Wenzhou Medical University
  • First Affiliated Hospital, Sun Yat-Sen University
  • First Hospital of China Medical University
  • Fujian Medical University Union Hospital
  • Gansu Provincial Hospital
  • General Hospital of Ningxia Medical University
  • Guangdong Provincial People's Hospital
  • Gulou Hospital Affiliated to Medical College of Nanjing University
  • Hainan General Hospital
  • Hebei Medical University Fourth Hospital
  • Henan Provincial Chest Hospital
  • Henan Provincial People's Hospital
  • Huai'an First People's Hospital
  • Lanzhou University First Hospital
  • Liuzhou Workers' Hospital
  • Luoyang Central Hospital
  • Nanjing First Hospital, Nanjing Medical University
  • Ningbo Medical Center Lihuili Hospital
  • Peking Union Medical College Hospital
  • Peking University People's Hospital
  • People's Hospital of Xinjiang Uygur Autonomous Region
  • Qilu Hospital of Shandong University
  • Qingdao Municipal Hospital
  • Qinghai Red Cross Hospital
  • RenJi Hospital
  • Renmin Hospital of Wuhan University
  • Second Affiliated Hospital of Nanchang University
  • Second Affiliated Hospital of Zhengzhou University
  • Second Xiangya Hospital of Central South University
  • Shandong Provincial Hospital
  • Shanghai Chest Hospital of Shanghai Jiao Tong University
  • Shanghai Zhongshan Hospital
  • Shanxi Bethune Hospital
  • Shanxi Yuncheng Central Hospital
  • Shengjing Hospital
  • Shenzhen Sun Yat-sen Cardiovascular Hospital
  • Shiyan City Renmin Hospital
  • Sichuan Provincial People's Hospital
  • Southwest Hospital, China
  • Suining Central Hospital
  • Taihe Hospital affiliated to Hubei University of Medicine
  • The Affiliated Hospital Of Guizhou Medical University
  • The Affiliated Hospital of Qingdao University
  • The Central Hospital of Linfen
  • The First Affiliated Hospital of Anhui Medical University
  • The First Affiliated Hospital of Bengbu Medical University
  • The First Affiliated Hospital of Dalian Medical University
  • The First Affiliated Hospital of Guangzhou Medical University
  • The First Affiliated Hospital of Nanchang University
  • The First Affiliated Hospital of Shanxi Medical University
  • The First Affiliated Hospital of Zhengzhou University
  • The First Hospital of Hebei Medical University
  • The First Hospital of Jilin University
  • The Fourth Affiliated Hospital of Zhejiang University School of Medicine
  • The General Hospital of Southern Theater Command
  • The People's Hospital of Gaozhou
  • The Second Affiliated Hospital of Hainan Medical University
  • The Second Hospital of Nanjing Medical University
  • The Second Hospital of Shandong University
  • The Third People's Hospital of Chengdu
  • The University of Hong Kong-Shenzhen Hospital
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Wannan Medical College Yijishan Hospital
  • West China Hospital
  • Wuhan Asia Heart Hospital
  • Wuhan TongJi Hospital
  • Xiamen Cardiovascular Hospital, Xiamen University
  • Xiangya Hospital of Central South University
  • Xijing Hospital，FMMU
  • Yan'an Affiliated Hospital of Kunming Medical University
  • Yantai Yuhuangding Hospital
  • Yichang Central People's Hospital
  • Zhejiang Provincial People's Hospital
  • Zhongnan Hospital
  • Zhongshan People's Hospital, Guangdong, China
  • Zunyi Medical College

Registry information

Official study title

PregnAncy-Related Aortic DISsEction in China: A Multicenter National Registry

Acronym: PARADISE

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 26, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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