Screening for Hepatitis C During Pregnancy at a Toronto Inner City Prenatal Clinic
Condition: Hepatitis C; Pregnancy
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Observational

Summary: 
      The first part of this study will investigate the incidence of Hepatitis C in pregnant women
      attending an inner city health clinic in downtown Toronto. All women attending the clinic who
      give their consent to participate will be screened by a standardized questionnaire as well as
      by a blood test. Blood testing will tell us how many of these women have Hepatitis C. We will
      then be able to compare the specificities and sensitivities of targeted screening (risk
      behaviour questionnaires) versus universal screening (blood tests).

      In the second part of the study we will follow the pregnancies of those women who were
      identified as Hepatitis C positive on the screening test. Follow- up will include liver
      enzymes and viral load quantifications (amounts) in the first, second and third trimesters as
      well as during delivery and six weeks post-partum. We will also document pregnancy outcomes
      with regard to type of delivery and complications. Pregnancy outcomes will be compared to an
      age and race matched group of women who do not have Hepatitis C.

      Study Hypothesis:

      We expect a higher incidence of Hepatitis C in this inner city population compared to the
      general Canadian pregnant population (0.9%). We predict an HCV seroprevalence (rate) ranging
      between 2-6% in this population and we also predict that targeted screening by standardized
      questionnaire will fail to identify half of the Hepatitis C positive cases.

      By following this group of Hepatitis C positive women through pregnancy, we expect to lend
      further support to previous data showing significant decrease and/or normalization of serum
      transaminases as well as significant increase in HCV viral load by third trimester. We also
      expect to see no significant differences in pregnancy outcomes or obstetrical complications
      between HCV positive women and the HCV negative women.
    

Detailed description: 
      All women attending our prenatal clinic will be invited to participate in this research
      study. Participants will complete two short questionnaires during their first visit to our
      prenatal clinic and be tested for Hepatitis C. Women who test positive for Hepatitis C will
      be carefully followed during their pregnancies and will have viral load tests and liver
      function tests during each trimester, at delivery and six weeks after their babies are born.
      All women testing positive for Hepatitis C will be referred to a hepatologist (a liver
      specialist) after delivery and their babies will be referred to a pediatrician for further
      follow-up and care. Based on previous studies we are concerned that some women may never know
      that they are carriers unless their blood is checked for the virus. Currently testing for
      Hepatitis C during pregnancy is not routinely done.

      The results of this study will help us to find out how many women attending our prenatal
      clinic test positive for Hepatitis C and how many cases would have been missed if we only
      relied on one of the questionnaires to decide whether to do the blood test or not. (The
      questionnaire deals with factors that could put a person at risk for acquiring Hepatitis C).
      By following our Hepatitis C positive pregnant patients throughout their pregnancies,
      deliveries and after their babies are born we will learn more about how the virus changes
      during pregnancy. The type of deliveries, any complications and the overall state of health
      of the Hepatitis C positive mothers participating in this study will be reported. We will
      also be able to report on the number of babies who are born with the virus and the state of
      their health up to six months of age.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Females are 16 years of age and over who present to the inner city health clinic for
        antenatal care who give their informed consent to participate in this study.
      
Keywords: Screening for Hepatitis C in Pregnancy