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RecruitingNCT07672210PARADISEUpdated Jul 17, 2026

PregnAncy-Related Aortic DISsEction in China

An observational study in Pregnancy Complication, Aortic Dissection and Marfan Syndrome, sponsored by DeltaHealth Hospital · Shanghai. Recruiting at 4 sites in China. Open to female participants aged 16 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-07-17.

Sponsored by DeltaHealth Hospital · Shanghai · Observational

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
500
Ages
16 Years to 55 Years
Sex
Female
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Study summary

A multicenter observational study on pregnancy-related aortic dissection

02

Conditions studied

  • Pregnancy Complication
  • Aortic Dissection
  • Marfan Syndrome
  • Loeys-Dietz Syndrome
  • Vascular Ehlers-Danlos Syndrome
  • Maternal and Neonatal Outcomes

Keywords

  • Aortic Dissection
  • Pregnancy complication
  • Maternal and Neonatal Outcomes
  • Marfan Syndrome
  • Loeys-Dietz syndrome
  • Vascular Ehlers-Danlos syndrome
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In context

Pregnancy Complications

411 studies on the registry are indexed under Pregnancy Complications; 113 are open to participants now.

This study's planned enrollment of 500 is above the median of 400 across 198 observational studies indexed under Pregnancy Complications.

Browse Pregnancy Complications studies →

Lead sponsor

This is the only study on the registry with DeltaHealth Hospital · Shanghai as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 55 Years
Sexes eligible
Female
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • AD occurred during pregnancy, labor, and puerperium attributable to pregnancy- related conditions

    Other: Intervention strategies including medication or surgery

Interventions

  • OtherIntervention 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.

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What researchers measure

Primary outcomes

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

    All-cause mortality within 30 days after treatment.

    Time frame: Death within 30 days after treatment.

  2. Long-term mortality of mothers and children

    All-cause mortality during the follow-up period.

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

Secondary outcomes

  1. The incidence of maternal adverse events

    The reinterventions for mothers due to aortic and obstetric conditions.

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

  2. 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.)

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

07

Study locations

4 of 4 sites recruiting
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References and documents

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. PubMed 27825688 ↗
  • 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. PubMed 32259204 ↗
  • 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. PubMed 41520724 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07672210
Lead sponsor
DeltaHealth Hospital · Shanghai
Collaborators
The Second Affiliated Hospital of Hainan Medical University, Beijing Anzhen Hospital, West China Hospital, Xiangya Hospital of Central South University, Second Xiangya Hospital of Central South University, Sichuan Provincial People's Hospital, Yantai Yuhuangding Hospital, First Hospital of China Medical University, First Affiliated Hospital Xi'an Jiaotong University, Qinghai Red Cross Hospital, Shanxi Bethune Hospital, Shandong Provincial Hospital, Shengjing Hospital, Zhejiang Provincial People's Hospital, Ningbo Medical Center Lihuili Hospital, Central China Fuwai Hospital of Zhengzhou University, Xiamen Cardiovascular Hospital, Xiamen University, Linfen Central Hospital, Shenzhen Sun Yat-sen Cardiovascular Hospital, The Affiliated Hospital Of Guizhou Medical University, The University of Hong Kong-Shenzhen Hospital, Hebei Medical University Fourth Hospital, Second Affiliated Hospital of Nanchang University, Southwest Hospital, China, Gulou Hospital Affiliated to Medical College of Nanjing University, The Second Hospital of Shandong University, First Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital of Gannan Medical University, The First Affiliated Hospital of Zhengzhou University, LanZhou University, Peking Union Medical College Hospital, First Affiliated Hospital of Harbin Medical University, The First Hospital of Jilin University, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, RenJi Hospital, Peking University People's Hospital, The First Affiliated Hospital of Guangzhou Medical University, Henan Provincial Chest Hospital, First Affiliated Hospital of Wenzhou Medical University, Shanghai Zhongshan Hospital, Qilu Hospital of Shandong University, The First Affiliated Hospital of Bengbu Medical University, Wannan Medical College Yijishan Hospital, Anhui Provincial Hospital, Shanxi Yuncheng Central Hospital, Liuzhou Workers' Hospital, The Third People's Hospital of Chengdu, Suining Central Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan TongJi Hospital, Renmin Hospital of Wuhan University, The General Hospital of Southern Theater Command, Xijing Hospital，FMMU, Zunyi Medical College, The Affiliated Hospital of Qingdao University, Shanghai Chest Hospital of Shanghai Jiao Tong University, The First Affiliated Hospital of Anhui Medical University, The People's Hospital of Gaozhou, The Second Hospital of Nanjing Medical University, Nanjing First Hospital, Nanjing Medical University, General Hospital of Ningxia Medical University, Guangdong Provincial People's Hospital, Yan'an Affiliated Hospital of Kunming Medical University, Second Affiliated Hospital of Zhengzhou University, Henan Provincial People's Hospital, Wuhan Asia Heart Hospital, Changhai Hospital, Taihe Hospital affiliated to Hubei University of Medicine, Zhongnan Hospital, Luoyang Central Hospital, People's Hospital of Xinjiang Uygur Autonomous Region, Qingdao Municipal Hospital, The First Affiliated Hospital of Nanchang University, Hainan General Hospital, The First Hospital of Hebei Medical University, Gansu Provincial Hospital, The First Affiliated Hospital of Shanxi Medical University, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital of Ningbo University, Fujian Medical University Union Hospital, Huai'an First People's Hospital, Chinese University of Hong Kong, Yichang Central People's Hospital, Zhongshan People's Hospital, Guangdong, China, Shiyan City Renmin Hospital, The First Affiliated Hospital of Dalian Medical University
Responsible party
Sponsor
First posted
Jun 26, 2026
Start date
Mar 17, 2026
Primary completion
Nov 2, 2026 (estimated)
Completion
Apr 16, 2027 (estimated)
Last update
Jul 17, 2026

Study contacts

Su-Wei Chen, MD, PhD
Contact
chensw0808@gmail.com
+86 15524612655
Wei-Guo Ma, MD, PhD
Contact
wgma@yahoo.com
+12032780619

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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