NCT05501145

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

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 Start

First participant enrolled

January 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2022

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

7 months

First QC Date

August 12, 2022

Last Update Submit

September 25, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality

    30 days after surgery

Interventions

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.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Women who presented with aortic dissection during pregnancy or post partum ≤12 weeks.

You may not qualify if:

  • Loss of surgical information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Beijing Anzhen Hospital

Beijing, 10029, China

Location

Department of Obstetrics and Gynecology, Guangdong Provincial People's Hospital

Guangzhou, China

Location

Department of Cardiac Surgery, Affiliated Hospital of Qingdao University

Qingdao, China

Location

Department of Obstetrics and Gynecology, Zhongshan Hospital

Shanghai, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Aortic Dissection

Interventions

Cesarean Section

Condition Hierarchy (Ancestors)

Dissection, Blood VesselAneurysmVascular DiseasesCardiovascular DiseasesAcute Aortic SyndromeAortic Diseases

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Hong-jia Zhang, MD

    Beijing Anzhen Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator of Cardiovascular Surgery

Study Record Dates

First Submitted

August 12, 2022

First Posted

August 15, 2022

Study Start

January 1, 2022

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

September 27, 2022

Record last verified: 2022-09

Locations