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

Study Overview
=================
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.

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

Conditions
-----------------
Exposure During Pregnancy

Intervention / Treatment
-----------------
* Drug: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 44 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HyQvia<br>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). | Drug: No intervention<br>* No intervention was given as this is an observational study.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of Participants with Spontaneous Abortion | Spontaneous abortion is defined as pregnancy loss before 20 weeks of gestation. | Up to 7 years | 
| Number of Participants with Stillbirth | Stillbirth is defined as a fetal death after 20 weeks of gestation. | Up to 7 years | 
| Number of Participants with Preterm Birth | Pre-term birth is defined as delivery before 37 weeks of gestation. | Up to 7 years | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug Therapy