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)