Exposure During Pregnancy
Conditions
Keywords
Drug Therapy
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.
Interventions
DRUGNo intervention
No intervention was given as this is an observational study.
Sponsors
Takeda
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 44 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Stillbirth | Up to 7 years | Stillbirth is defined as a fetal death after 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. |
Countries
United States
Outcome results
None listed