Clinical Trial:

HCV in pregnancy

Full Name

Hepatitis C in Pregnancy: An observational study of hepatitis C virus in pregnancy (1_PRO00000222)

Description

Women who have an HCV antibody positive screen, before 23.6 weeks gestation will be eligible to enroll in the study. In addition, among those women who have a HCV antibody negative screen, a randomly selected control cohort (two controls for each case participant) will be enrolled. Information will be gathered by participant interview and chart review for all participants; all will be followed until delivery. Case participants only (HCV positive) will have blood drawn at enrollment; at 2 separate study visits, approximately 4 weeks apart; and again at the time of delivery. For infants born to participants in the case cohort, blood will be drawn by heel stick, and saliva collected, at the time of newborn screening, if possible. Blood will be collected again at 2 months and 18 months of age.

Eligibility

Inclusion Criteria

o Singleton pregnancy
o Gestational age at enrollment no later than 276 weeks
o Not eligible or potentially eligible for the CMV trial
o No known major fetal anomalies
o No intent to deliver outside a Maternal Fetal Medicine Units Network center
o Must commit to 18 months of follow-up for HCV positive infants

Doctor(s) Running This Study

Specialties

  • Obstetrics
  • Maternal-Fetal Medicine (Perinatology)

Area of focus i

  • Heart disease in pregnancy
  • Medical complications in pregnancy
  • Pregnancy Loss

LVPG Cliniciani

Accepting New Patients