Maternal and Infant Characteristics and Outcomes Following Exposure to HyQvia During Pregnancy: A Case Series Study Based on US Claims Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Number of Participants with Major Congenital Malformations in the Infant
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 44 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
HyQvia
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).
干预措施: No intervention (Drug)
结局指标
主要结局
Number of Participants with Major Congenital Malformations in the Infant
时间窗: 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
时间窗: Up to 7 years
Spontaneous abortion is defined as pregnancy loss before 20 weeks of gestation.
Number of Participants with Stillbirth
时间窗: Up to 7 years
Stillbirth is defined as a fetal death after 20 weeks of gestation.
Number of Participants with Preterm Birth
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: Up to 7 years
Major clinical diagnoses include preeclampsia, post-partum hemorrhage, infections and thrombosis while procedures include cesarean section.
次要结局
未报告次要终点