Aortic DissectionNCT05501145
Clinical Features, Outcomes, and Therapeutics of Pregnancy-Related Aortic Dissection
An observational study of Aortic Dissection and Pregnancy Related, run by Nanjing Medical University at 4 sites in China.
Trial summary
Aortic dissection in pregnancy represents a lethal risk to both the mother and fetus, it has yet to yield the optimal therapeutic strategy. The aim of this study was to characterize the clinical features and outcomes in women with pregnancy-related acute aortic dissection, and to suggest therapeutic guidelines. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Aortic Dissection, Pregnancy Related
- What is being tested?
- cesarean section and aortic repair
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jan 2022to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: From February 1 2012 through June 30 2022 for identification women who presented with aortic dissection during pregnancy or post partum ≤12 weeks
Who may be able to join
- Women who presented with aortic dissection during pregnancy or post partum ≤12 weeks.
Who cannot join
- Loss of surgical information.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Beijing Anzhen Hospital
Beijing, 10029
Department of Obstetrics and Gynecology, Guangdong Provincial People's Hospital
Guangzhou
Department of Cardiac Surgery, Affiliated Hospital of Qingdao University
Qingdao
Department of Obstetrics and Gynecology, Zhongshan Hospital
Shanghai
About this study
Official title: Clinical Features, Outcomes, and Therapeutics of Ppregnancy-related Aortic Dissection
Aortic dissection in pregnancy represents a lethal risk to both the mother and fetus, it has yet to yield the optimal therapeutic strategy. The aim of this study was to characterize the clinical features and outcomes in women with pregnancy-related acute aortic dissection, and to suggest therapeutic guidelines.
- Conditions
- Aortic Dissection, Pregnancy Related
- Being tested
- cesarean section and aortic repair
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cesarean section and aortic repairProcedure or surgery
The timing of aortic repair and delivery have to be determined based on the type of the dissection, the stage of pregnancy (the gestation age), and the status of the fetus, as well as the level of local neonatal service.
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start1 Jan 2022
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Anzhen Hospital, Shanghai Zhongshan Hospital, Guangdong Provincial People's Hospital
- Responsible party
- Principal investigator, Hong Liu, Nanjing Medical University
- Investigators
- Hong-jia Zhang, MD, Study chair, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501145
- Sponsor's protocol ID
- 5A Plan VII
- Status last verified
- Sep 2022
- First submitted
- 12 Aug 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu H, Yang L, Chen CY, Qian SC, Ma LY, Diao YF, Wu XY, Wu SY, Dong ZQ, Shao YF, Zhang HJ, Sun LZ, Zhu JM, Zhang JR, Li H. Management strategies and outcomes in pregnancy-related acute aortic dissection: a multicentre cohort study in China. Heart. 2024 Oct 28;110(22):1298-1306. doi: 10.1136/heartjnl-2024-324009.
PubMed 39266045
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Features, Outcomes, and Therapeutics of Ppregnancy-related Aortic Dissection
- ClinicalTrials.gov ID
- NCT05501145
- Acronym / sponsor ID
- 5A Plan VII
- Conditions
- Aortic Dissection, Pregnancy Related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing Anzhen Hospital, Shanghai Zhongshan Hospital, Guangdong Provincial People's Hospital
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 15 Aug 2022 (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.
Aortic dissection in pregnancy represents a lethal risk to both the mother and fetus, it has yet to yield the optimal therapeutic strategy. The aim of this study was to characterize the clinical features and outcomes in women with pregnancy-related acute aortic dissection, and to suggest therapeutic guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- From February 1 2012 through June 30 2022 for identification women who presented with aortic dissection during pregnancy or post partum ≤12 weeks
Key inclusion criteria (1 listed)
- Women who presented with aortic dissection during pregnancy or post partum ≤12 weeks.
Key exclusion criteria (1 listed)
- Loss of surgical information.
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 |
|---|---|---|
| cesarean section and aortic repairThe timing of aortic repair and delivery have to be determined based on the type of the dissection, the stage of pregnancy (the gestation age), and the status of the fetus, as well as the level of local neonatal service. | Procedure or surgery | – |
Primary outcome
30-day mortality
Time frame: 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Derived from this study: PubMed 39266045Liu H, Yang L, Chen CY, Qian SC, Ma LY, Diao YF, Wu XY, Wu SY, Dong ZQ, Shao YF, Zhang HJ, Sun LZ, Zhu JM, Zhang JR, Li H. Management strategies and outcomes in pregnancy-related acute aortic dissection: a multicentre cohort study in China. Heart. 2024 Oct 28;110(22):1298-1306. doi: 10.1136/heartjnl-2024-324009.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Hong-jia Zhang, MD study chair
Beijing Anzhen Hospital
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 Aortic Dissection and Pregnancy Related, run by Nanjing Medical University 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 1 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: finished, as of the sponsor's last update on 27 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day mortality (time frame: 30 days after surgery). 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 NCT05501145, which also lists 1 linked publication.
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 27 Sep 2022.