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

Completed

• Conditions: Exposure During Pregnancy
• Interventions: Drug: No intervention

• Registration Number: NCT05803200
• Lead Sponsor: Takeda

Brief 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.

Study Timeline

• Study First Submitted: 2023-03-14
• Study Start: 2023-03-15
• Study First Submitted QC: 2023-04-06
• Study First Posted: 2023-04-07
• Primary Completion: 2023-04-14
• Study Completion: 2023-04-14
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HyQvia	No intervention	Pregnant female participants who have insurance coverage with full prescriptions benefits exposed to HyQvia during the period from 90 days before the last menstrual period (LMP) through 30 days after delivery will be observed retrospectively from 1 January 2014 to 31 December 2020 (up to 7 years).

Primary Outcome Measures

Name	Time	Method
Number of Participants with Stillbirth	Up to 7 years	Stillbirth is defined as a fetal death after 20 weeks of gestation.
Number of Participants with Major Congenital Malformations in the Infant	Up to 7 years	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.
Number of Participants with Spontaneous Abortion	Up to 7 years	Spontaneous abortion is defined as pregnancy loss before 20 weeks of gestation.
Number of Participants with Preterm Birth	Up to 7 years	Pre-term birth is defined as delivery before 37 weeks of gestation.
Number of Participants Being Small for Gestational Age (SGA)	Up to 7 years	SGA will be defined as weight at birth of full and preterm live-born infants in \<10th percentile.
Number of Participants with Admission to Neonatal Intensive Care Unit (NICU)	Up to 7 years	NICU admissions will be identified by current procedure terminology (CPT) codes in maternal and infant claims within 30 days of delivery.
Number of Participants With Any Major Clinical Diagnosis or Procedures	Up to 7 years	Major clinical diagnoses include preeclampsia, post-partum hemorrhage, infections and thrombosis while procedures include cesarean section.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States