PregnAncy-Related Aortic DISsEction in China

N/ARecruitingNCT07672210

DeltaHealth Hospital · Shanghai500 enrolled

Overview

A multicenter observational study on pregnancy-related aortic dissection

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

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

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.

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (4)

DeltaHealth Hospital Shanghai

Shanghai, Shanghai Municipality, China

RECRUITING

Beijing Anzhen Hospital

Beijing, China

RECRUITING

Guangdong Provincial Hospital

Guangzhou, China

RECRUITING

Outcomes

Primary Outcomes

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.

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

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.

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.

Central Contacts

Su-Wei Chen, MD, PhD

CONTACT

+86 15524612655 chensw0808@gmail.com

Wei-Guo Ma, MD, PhD

CONTACT

+12032780619 wgma@yahoo.com

Data from ClinicalTrials.gov

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