An Observational Study of Hepatitis C Virus in Pregnancy (HCV)

Study ID
STU 102012-033

Cancer Related
No

Healthy Volunteers
Yes

Study Sites

Contact
Lisa Moseley
214-648-2591
lisa.moseley@utsouthwestern.edu

Principal Investigator
Brian Casey

Summary

The study is a multi-center observational cohort study of women at participating MFMu network clinical centers. in addition, selected centers of the niCHD international and Domestic Pediatric and Maternal HiV Studies network will enroll patients into the HCV study. Women who have an HCV antibody positive screen, as determined by the test, before 23.6 weeks gestation will be eligible to enroll in the study. approximately 1,200 seropositive viremic and 600 seropositive non-viremic women are expected to be enrolled in the study.
approximately 50% of women in the MFMu network with an HCV antibody positive screen are expected to be identified through routine unselected screening. Two randomly selected matched controls will be followed for each of these women. it is estimated that approximately 1800 women who have an HCV antibody negative screen will be included in the control cohort. Controls will be matched to patient by clinical center and gestational age +/- two weeks.
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 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.
Maternal Secondary outcomes
1. Gestational age at delivery
2. Preterm delivery [Less Than] 37 weeks of gestation
3. Gestational diabetes mellitus (GDM)
4. Vaginal bleeding during pregnancy
5. Preeclampsia
6. Cholestasis
Fetal and neonatal Secondary outcomes
7. Viral load
8. HCV antibody status, defined as positive or negative
9. Birth weight
10. Hyperbilirubinemia. Peak total bilirubin of at least 15 mg% or the use of phototherapy
11. niCu admission
12. Small for gestational age defined as less than the 5th percentile birth weight for gestational age at birth, assessed specifically by sex and race of the infant based on united States birth certificate data
13. neonatal infections, namely sepsis and pneumonia
infant and Child Secondary outcomes
1. Viral load at 2-6 and 18-24 months of age
2. HCV antibody status, defined as positive or negative at 2-6 and 18-24 months of age

Participant Eligibility

1. Singleton pregnancy
2. An HCV antibody positive screen (case) OR a randomly selected HCV antibody negative screen (control) matched to a case patient by project gestational age (see below) +/- 2 weeks and clinical center site. HCV antibody screen will be measured using two FDA-approved ELISA tests, the Abbott Architect version 3.0 system and the Ortho HCV 3.0.
3. Gestational age at screening no later than 23.6 weeks and gestational age at enrollment no later than 27.6 weeks, based on clinical information and evaluation of the earliest ultrasound.
4. Pregnant women 16 years of age or older.