An observational study in Exposure During Pregnancy, sponsored by Takeda. Completed at 1 site in United States. Open to female participants aged 16 Years to 44 Years. Per ClinicalTrials.gov, last updated 2023-09-25.
Sponsored by Takeda · Observational
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.
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:
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.
Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Commercially insured US pregnant women exposed to HyQvia from 90 days before LMP to the end of pregnancy and their infants included in the MarketScan Research Database during the period 2014-2020.
Inclusion criteria • Exposed to HyQvia in the etiologic window defined as 90 days prior to the LMP until the end of pregnancy.
Exclusion criteria
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
No intervention was given as this is an observational study.
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.
Time frame: Up to 7 years
Number of Participants with Spontaneous Abortion
Spontaneous abortion is defined as pregnancy loss before 20 weeks of gestation.
Time frame: Up to 7 years
Number of Participants with Stillbirth
Stillbirth is defined as a fetal death after 20 weeks of gestation.
Time frame: Up to 7 years
Number of Participants with Preterm Birth
Pre-term birth is defined as delivery before 37 weeks of gestation.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 7 years
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Csr
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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