An Observational Study of Hepatitis C Virus in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 772
- 试验地点
- 17
- 主要终点
- HCV infection of the offspring
研究概览
简要总结
This multi-center observational study examines risk factors for HCV transmission from mother to baby.
详细描述
This multi-center observational study examines risk factors for HCV transmission from mother to baby. The study will also assess risk factors associated with Hepatitis C Virus (HCV) infection in pregnant women. Also, the study will describe the outcomes of pregnant women with HCV as well as the outcomes of their infants to 18 months of age.
Approximately 750 HCV antibody positive pregnant women and their infants will be followed from baseline until the infant is 18 months. A randomly selected control cohort of 500 pregnant women who are HCV antibody negative will be followed until delivery.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy
- •An HCV antibody positive screen (case) measured using two FDA-approved ELISA tests, the Abbott Architect version 3.0 system and the Ortho HCV 3.
- •Gestational age at screening no later than 23 weeks and 6 days, and gestational age at enrollment no later than 27 weeks and 6 days, based on clinical information and evaluation of the earliest ultrasound as described below.
排除标准
- •Planned termination of pregnancy
- •Known major fetal anomalies or demise
- •Intention of the patient or the managing obstetricians for the delivery to be outside a MFMU Network center, unless special provisions are made to insure infant follow-up at two and 18 months of age.
- •Participation in this study in a previous pregnancy.
- •Unwilling or unable to commit to 18 months of follow-up for HCV positive infants
结局指标
主要结局
HCV infection of the offspring
时间窗: at 2 months and/or 18 months of age
The primary outcome is HCV infection of the offspring, where infection is defined by satisfying any one of the following criteria: * HCV RNA positive (i.e. presence of viral load) by polymerase chain reaction (PCR) test at 2-6 months (2 month visit) * HCV RNA positive and HCV antibody positive at the 18-24 months (18 month visit) * HCV RNA positive at 18-24 months with a negative HCV antibody at 18-24 months and negative RNA at 2-6 months. However, the positive result must be confirmed by a repeat test on the 18-month sample to qualify. * HCV antibody positive at 18-24 months with negative HCV RNA at both visits. However, the positive result must be confirmed by a repeat test on the 18-month sample to qualify. * Clinical result that is either HCV RNA positive or HCV antibody positive obtained at 18 months or older with a confirmed clinical diagnosis of HCV, if a central laboratory sample could not be obtained at 18-24 months.
次要结局
- Gestational diabetes mellitus (GDM)(during pregnancy)
- Preeclampsia(during pregnancy)
- Birth weight of infant(at birth)
- Small for gestational age(at birth)
- Vaginal bleeding during pregnancy(during pregnancy)
- Cholestasis(during pregnancy)
- HCV antibody status in infant(at 18 months of age)
- Neonatal intensive care unit (NICU) admission(at birth)
- Neonatal infections(at birth)
- Gestational age at delivery(at birth)
- Viral load in infant(at birth, 2 months, and 18 months)
- Hyperbilirubinemia(at birth)
- Preterm delivery < 37 weeks of gestation(at birth)