NCT07672210

Brief Summary

A multicenter observational study on pregnancy-related aortic dissection

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Mar 2026

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Mar 2026Apr 2027

Study Start

First participant enrolled

March 17, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2027

Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

8 months

First QC Date

June 12, 2026

Last Update Submit

July 16, 2026

Conditions

Pregnancy ComplicationAortic DissectionMarfan SyndromeLoeys-Dietz SyndromeVascular Ehlers-Danlos SyndromeMaternal and Neonatal Outcomes

Keywords

Aortic DissectionPregnancy complicationMaternal and Neonatal OutcomesMarfan SyndromeLoeys-Dietz syndromeVascular Ehlers-Danlos syndrome

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • The incidence of maternal adverse events

    Through study completion, an average of 3 years.

  • The incidence of neonatal developmental abnormalities

    Through study completion, an average of 3 years.

Study Arms (1)

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

Other: Intervention strategies including medication or surgery

Interventions

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.

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

Eligibility Criteria

Age16 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

DeltaHealth Hospital Shanghai

Shanghai, Shanghai Municipality, 201702, China

RECRUITING

Beijing Anzhen Hospital

Beijing, 101118, China

RECRUITING

Guangdong Provincial Hospital

Guangzhou, 510080, China

RECRUITING

Wuhan Union Hospital

Wuhan, 430022, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 27825688BACKGROUND

  • 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.

    PMID: 32259204BACKGROUND

  • 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.

    PMID: 41520724BACKGROUND

MeSH Terms

Conditions

Pregnancy ComplicationsAortic DissectionMarfan SyndromeLoeys-Dietz SyndromeEhlers-Danlos Syndrome, Type IV

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDissection, Blood VesselAneurysmVascular DiseasesCardiovascular DiseasesAcute Aortic SyndromeAortic DiseasesBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesHeart DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornConnective Tissue DiseasesSkin and Connective Tissue DiseasesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesAortic AneurysmEhlers-Danlos SyndromeHemostatic DisordersHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesSkin AbnormalitiesSkin Diseases, GeneticCollagen DiseasesSkin Diseases

Central Study Contacts

Su-Wei Chen, MD, PhD

CONTACT

+86 15524612655chensw0808@gmail.com

Wei-Guo Ma, MD, PhD

CONTACT

+12032780619wgma@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2026

First Posted

June 26, 2026

Study Start

March 17, 2026

Primary Completion (Estimated)

November 2, 2026

Study Completion (Estimated)

April 16, 2027

Last Updated

July 17, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)