Pregnancy among Women with Heart Failure: A Descriptive Analysis

    Basic Details
    Date Posted
    Sunday, March 7, 2021
    Status
    Complete
    Health Outcome(s)
    pregnancy
    Description

    This request examines pregnancy among women with heart failure in the Sentinel Distribued Database (SDD). This analysis includes two reports:

    • Report 1: This report examines counts of live birth or stillbirth delivery among women with heart failure. We distributed this request to six Data Partners on October 7, 2020.
    • Report 2: This report examines the clinical characteristics in three cohorts including pregnant women with and without evidence of heart failure (HF) and non-pregnant women with HF, characterizes the use of oral HF-related therapies before, during, and after pregnancy in these cohorts, and examines maternal and fetal outcomes among pregnant women with and without HF. We distributed this request to four Data Partners on December 4, 2020.

    The study period includes data from January 1, 2010 to February 29, 2020.

    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2010 - February 29, 2020
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    Females 15 to 54 years of age
    Data Sources
    Sentinel Distributed Database (SDD)