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
NCT number | NCT00348660 |
Other study ID # | 04-095 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 2005 |
Est. completion date | October 2010 |
Verified date | February 2019 |
Source | St. Michael's Hospital, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 653 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years to 45 Years |
Eligibility |
Inclusion Criteria: - 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. - Participants read and understand English or assisted by an interpreter / family member enabling fully informed consent and participation in this study Exclusion Criteria: - Females under the age of 16. - Participants who do not read and understand English for whom no interpreters are available. |
Country | Name | City | State |
---|---|---|---|
Canada | St Michael's Hospital - Women's Health Care Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
St. Michael's Hospital, Toronto |
Canada,
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