PregnAncy-Related Aortic DISsEction in China (PARADISE)

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

A multicenter observational study on pregnancy-related aortic dissection

Study Overview

• Status: Enrolling by invitation
• Conditions: Marfan Syndrome; Aortic Dissection; Vascular Ehlers-Danlos Syndrome; Loeys-Dietz Syndrome; Pregnancy Complication; Maternal and Neonatal Outcomes
• Intervention / Treatment: Other: Intervention strategies including medication or surgery

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Anzhen Hospital, Tongzhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women who sustained aortic dissection that occurred during pregnancy, labor, or within 12 weeks postpartum

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AD occurred during pregnancy, labor, and puerperium attributable to pregnancy- related conditions	Other: Intervention strategies including medication or surgery; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early-term mortality of mothers and fetuses (or newborns)	All-cause mortality within 30 days after treatment.	Death within 30 days after treatment.
Long-term mortality of mothers and children	All-cause mortality during the follow-up period.	Through study completion, an average of 3 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of maternal adverse events	The reinterventions for mothers due to aortic and obstetric conditions.	Through study completion, an average of 3 years.
The incidence of neonatal developmental abnormalities	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.)	Through study completion, an average of 3 years.

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Zhu JM, Ma WG, Peterss S, Wang LF, Qiao ZY, Ziganshin BA, Zheng J, Liu YM, Elefteriades JA, Sun LZ. Aortic Dissection in Pregnancy: Management Strategy and Outcomes. Ann Thorac Surg. 2017 Apr;103(4):1199-1206. doi: 10.1016/j.athoracsur.2016.08.089. Epub 2016 Nov 5.
• Ma WG, Zhu JM, Chen Y, Qiao ZY, Ge YP, Li CN, Zheng J, Liu YM, Sun LZ. Aortic dissection during pregnancy and postpartum in patients with Marfan syndrome: a 21-year clinical experience in 30 patients. Eur J Cardiothorac Surg. 2020 Aug 1;58(2):294-301. doi: 10.1093/ejcts/ezaa048.
• Zhu JM, Chen SW, Ma WG, Chen Y, Qiao ZY, Hu HO, Li CN, Zhang J, Sun LZ. Type A aortic dissection during pregnancy and postpartum: Experience in 60 patients over 25 years. J Thorac Cardiovasc Surg. 2026 Jun;171(6):1186-1197.e1. doi: 10.1016/j.jtcvs.2025.12.030. Epub 2026 Jan 9.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2026
• Primary Completion (Estimated): November 2, 2026
• Study Completion (Estimated): April 16, 2027

Study Registration Dates

• First Submitted: June 12, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Aortic Dissection; Loeys-Dietz syndrome; Marfan Syndrome; Maternal and Neonatal Outcomes; Pregnancy complication; Vascular Ehlers-Danlos syndrome
• Additional Relevant MeSH Terms: Urogenital Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Bone Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Heart Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Hematologic Diseases; Skin Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Abnormalities, Multiple; Hemostatic Disorders; Hemorrhagic Disorders; Skin Diseases, Genetic; Skin Abnormalities; Aortic Diseases; Bone Diseases, Developmental; Aneurysm; Collagen Diseases; Aortic Aneurysm; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Hemic and Lymphatic Diseases; Ehlers-Danlos Syndrome; Ehlers-Danlos Syndrome, Type IV; Pregnancy Complications; Aortic Dissection; Loeys-Dietz Syndrome; Marfan Syndrome; Surgical Procedures, Operative
• Other Study ID Numbers: SDH2026006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No