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

Exposure During Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05803200
• Other study ID #: TAK-771-4004
• Secondary ID: EUPAS103800
• Status: Completed
• Start date: March 15, 2023
• Est. completion date: April 14, 2023

Study information

• Verified date: September 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: April 14, 2023
• Est. primary completion date: April 14, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Exposure During Pregnancy

Intervention

Drug:
• No intervention
No intervention was given as this is an observational study.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Major Congenital Malformations in the Infant	A major malformation is defined as a structural abnormality with surgical, medical, or cosmetic importance. Data for infants will be reviewed in the database from the date of delivery to 90 days following birth to check for any malformations. The number of infants with malformations during the database period of 1 January 2014 to 31 December 2020 (up to 7 years) will be reported.	Up to 7 years
Primary	Number of Participants with Spontaneous Abortion	Spontaneous abortion is defined as pregnancy loss before 20 weeks of gestation.	Up to 7 years
Primary	Number of Participants with Stillbirth	Stillbirth is defined as a fetal death after 20 weeks of gestation.	Up to 7 years
Primary	Number of Participants with Preterm Birth	Pre-term birth is defined as delivery before 37 weeks of gestation.	Up to 7 years
Primary	Number of Participants Being Small for Gestational Age (SGA)	SGA will be defined as weight at birth of full and preterm live-born infants in <10th percentile.	Up to 7 years
Primary	Number of Participants with Admission to Neonatal Intensive Care Unit (NICU)	NICU admissions will be identified by current procedure terminology (CPT) codes in maternal and infant claims within 30 days of delivery.	Up to 7 years
Primary	Number of Participants With Any Major Clinical Diagnosis or Procedures	Major clinical diagnoses include preeclampsia, post-partum hemorrhage, infections and thrombosis while procedures include cesarean section.	Up to 7 years

External Links

•   To obtain more information on the study, click here/on this link