Hydroxyprogesterone Caproate and Progesterone Use During Pregnancy

Project Title Hydroxyprogesterone Caproate and Progesterone Use During Pregnancy
Date Posted
Tuesday, October 29, 2019
Project ID
cder_mpl1r_wp156
Status
Complete
Deliverables
Sentinel Modular Program Report: Hydroxyprogesterone Caproate and Progesterone Use During Pregnancy
Related Links
Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee: Makena Use During Pregnancy
Description

Our objective was to estimate use of hydroxyprogesterone caproate and progesterone during the second or third trimesters among pregnancies that ended with a live-birth delivery in the Sentinel Distributed Database (SDD). We identified live-birth deliveries occurring between January 1, 2008 to April 30, 2019. We distributed this request on August 5, 2019 to 15 Data Partners contributing to the SDD. 

Medical Product
hydroxyprogesterone caproate
progesterone
Health Outcome
exposure in pregnancy
Population / Cohort
Females 10 to 54 years of age
Time Period
January 1, 2008 - April 30, 2019
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER
Scroll to Top