NCT05803200

A Study to Describe Mothers' and Babies' Outcomes After Exposure to HyQvia During Pregnancy

Maternal and Infant Characteristics and Outcomes Following Exposure to HyQvia During Pregnancy: A Case Series Study Based on US Claims Data

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 7 (actual)
• Sponsor: Takeda · Industry
• Sex: Female
• Age: 16 Years – 44 Years
• Healthy volunteers: Not accepted

Summary

The main aim of this study is to provide further information on the safety profile of HyQvia during pregnancy. This will be done by checking the characteristics of the mother and their babies. They will also be checked for any safety outcomes that will occur when exposed to HyQvia during pregnancy.

Detailed description

This is a non-interventional, retrospective, case series of commercially insured pregnant women exposed to HyQvia during their pregnancy identified according to the MarketScan Research Database. This study will assess maternal characteristics, patterns of HyQvia utilization and pregnancy outcomes in all pregnancies exposed to HyQvia during pregnancy. This study will enroll approximately at least 7 patients based on feasibility assessment. Participants will be enrolled in the following cohort: • HyQvia This study will have a retrospective data collection from 1 January 2014 to 31 December 2020. This study would be conducted in the US. The overall time for data collection in this study will be approximately 7 years.

Conditions

• Exposure During Pregnancy

Interventions

Type	Name	Description
DRUG	No intervention	No intervention was given as this is an observational study.

Timeline

• Start date: 2023-03-15
• Primary completion: 2023-04-14
• Completion: 2023-04-14
• First posted: 2023-04-07
• Last updated: 2023-09-25

Locations

1 site across 1 country: United States