The Heart Outcomes in Pregnancy Expectations for Mom and Baby Study

Conditions

• Pregnancy Complications, Cardiovascular

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Purely observational study on the care and outcomes of participants with cardiovascular disease in pregnancy. — OTHER
  The primary exposure variable is the organization of cardio-obstetrics care which will be defined by annual site surveys and its association with outcomes will be defined by hierarchical models adjusting for patient characteristics.

Study Details

This is a prospective, observational study which is evaluating the obstetrical, neonatal, and cardiovascular outcomes of 1000 pregnant people with known heart disease to define how best to structure cardio-obstetrics care to optimize outcomes.

Key Dates

Start date

Jan 14, 2025

Status verified

Jan 2025

Primary completion

Jun 30, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

1,000 participants (estimated)

Arms

• Arm: Pregnant people with cardiovascular disease
  Any pregnant patient with acquired or congenital cardiovascular disease upon presentation to a cardio-obstetrics clinic.

Primary Outcome Measure

Rate of Adverse pregnancy outcomes [ Time Frame: up to 6 weeks postpartum ]

Central Contacts

• Karen L Florio, DO, MPH
  631-579-1030
  [email protected]
• Anna Grodzinsky, MD, MS
  816-932-2000
  [email protected]

Locations (1)

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