CompletedNot Applicable

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

United States7 participantsStarted 2023-03-15

Plain-language 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.

Who can participate

Age range16 Years – 44 Years

SexFEMALE

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Inclusion criteria • Exposed to HyQvia in the etiologic window defined as 90 days prior to the LMP until the end of pregnancy. Exclusion criteria • NA

What they're measuring

Number of Participants with Major Congenital Malformations in the Infant

Timeframe: Up to 7 years

Number of Participants with Spontaneous Abortion

Timeframe: Up to 7 years

Number of Participants with Stillbirth

Timeframe: Up to 7 years

Number of Participants with Preterm Birth

Timeframe: Up to 7 years

Number of Participants Being Small for Gestational Age (SGA)

Timeframe: Up to 7 years

Number of Participants with Admission to Neonatal Intensive Care Unit (NICU)

Timeframe: Up to 7 years

Number of Participants With Any Major Clinical Diagnosis or Procedures

Timeframe: Up to 7 years

Trial details

NCT IDNCT05803200

SponsorTakeda

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-04-14

View on ClinicalTrials.gov More Exposure During Pregnancy trials