Pregnancy ComplicationPARADISENCT07672210
PregnAncy-Related Aortic DISsEction in China
An observational study of Pregnancy Complication and Aortic Dissection, run by DeltaHealth Hospital · Shanghai at 4 sites in China.
Trial summary
A multicenter observational study on pregnancy-related aortic dissection Read more about this study
- Who is it for?
- Ages 16 to 55 years, women only
- Conditions the study is for
- Pregnancy Complication, Aortic Dissection, Marfan Syndrome
- What is being tested?
- Intervention strategies including medication or surgery
- How many people
- 500 participants
- Where
- 4 sitesChina
- Study dates
- 17 Mar 2026to 16 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Women who sustained aortic dissection that occurred during pregnancy, labor, or within 12 weeks postpartum
Who may be able to join
- 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
Who cannot join
- Previous history of aortic dissection, but no new aortic dissection occurring during pregnancy or within 12 weeks postpartum
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, 101118
Su-Wei Chen, MD, PhD, +86-15524612655, chensw0808@gmail.com
- Recruiting
Guangdong Provincial Hospital
Guangzhou, 510080
Tu-Cheng Sun, MD, +8613826409699, suntucheng@126.com
- Recruiting
DeltaHealth Hospital Shanghai
Shanghai, Shanghai Municipality, 201702
Li-Zhong Sun, MD, +8618911662885, lizhongsun@outlook.com
- Recruiting
Wuhan Union Hospital
Wuhan, 430022
Xing-Jian Hu, MD, +8615827346676, peterhu9517@hust.edu.cn
About this study
Official title: PregnAncy-Related Aortic DISsEction in China: A Multicenter National Registry
A multicenter observational study on pregnancy-related aortic dissection
- Conditions
- Pregnancy Complication, Aortic Dissection, Marfan Syndrome, Loeys-Dietz Syndrome, Vascular Ehlers-Danlos Syndrome, Maternal and Neonatal Outcomes
- Being tested
- Intervention strategies including medication or surgery
- Keywords
- Aortic Dissection, Pregnancy complication, Maternal and Neonatal Outcomes, Marfan Syndrome, Loeys-Dietz syndrome, Vascular Ehlers-Danlos syndrome
- Medical subject headings
- Pregnancy Complications, Aortic Dissection, Marfan Syndrome, Loeys-Dietz Syndrome, Ehlers-Danlos Syndrome, Type IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention strategies including medication or surgeryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| AD occurred during pregnancy, labor, and puerperium attributable to pregnancy- related conditions | Not described Receives: Other: Intervention strategies including medication or surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early-term mortality of mothers and fetuses (or newborns)
All-cause mortality within 30 days after treatment.
Measured: Death within 30 days after treatment.
Long-term mortality of mothers and children
All-cause mortality during the follow-up period.
Measured: Through study completion, an average of 3 years.
Secondary outcomes (2)
The incidence of maternal adverse events
The reinterventions for mothers due to aortic and obstetric conditions.
Measured: 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.)
Measured: Through study completion, an average of 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start17 Mar 2026
- Primary completion2 Nov 2026 (estimated)
- Study completion16 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pregnancy ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DeltaHealth Hospital · Shanghai
- Sponsor type
- University, hospital or other
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672210
- Sponsor's protocol ID
- SDH2026006
- Acronym
- PARADISE
- Status last verified
- Jul 2026
- First submitted
- 12 Jun 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 27825688Ma 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 32259204Zhu 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PregnAncy-Related Aortic DISsEction in China: A Multicenter National Registry
- ClinicalTrials.gov ID
- NCT07672210
- Acronym / sponsor ID
- PARADISE / SDH2026006
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- DeltaHealth Hospital · ShanghaiUniversity, hospital or other
- 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
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- 2 Nov 2026 (estimated)
- Study completion
- 16 Apr 2027 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter observational study on pregnancy-related aortic dissection
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AD occurred during pregnancy, labor, and puerperium attributable to pregnancy- related conditions | – | Other: Intervention strategies including medication or surgery |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Women who sustained aortic dissection that occurred during pregnancy, labor, or within 12 weeks postpartum
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Previous history of aortic dissection, but no new aortic dissection occurring during pregnancy or within 12 weeks postpartum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention strategies including medication or surgeryMedication 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. | Other | AD occurred during pregnancy, labor, and puerperium attributable to pregnancy- related conditions |
Primary outcome
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.
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.
2 secondary outcomes
The incidence of maternal adverse events
Time frame: Through study completion, an average of 3 years.
The incidence of neonatal developmental abnormalities
Time frame: Through study completion, an average of 3 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Background: PubMed 27825688Zhu 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.
- Background: PubMed 32259204Ma 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.
- Background: PubMed 41520724Zhu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Complication and Aortic Dissection, run by DeltaHealth Hospital · Shanghai at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Su-Wei Chen, MD, PhD (+86 15524612655, chensw0808@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early-term mortality of mothers and fetuses (or newborns) (time frame: Death within 30 days after treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07672210, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.