Pregnancy Clinical Trial
Official title:
The Seroprevalence of Hepatitis C and Course of Infection Among Pregnant Women Attending a Toronto Inner City Antenatal Care Clinic
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.
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.
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