Hepatitis CNCT00348660
Screening for Hepatitis C During Pregnancy at a Toronto Inner City Prenatal Clinic
An observational study of Hepatitis C and Pregnancy, run by Unity Health Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Pregnancy
- How many people
- 653 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2005to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Females under the age of 16.
- Participants who do not read and understand English for whom no interpreters are available.
Trial locations and contacts
1 site in 1 country.
Canada1 site
St Michael's Hospital - Women's Health Care Centre
Toronto, Ontario, M5C 2T2
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Hepatitis C, Pregnancy
- Keywords
- Screening for Hepatitis C in Pregnancy
- Medical subject headings
- Hepatitis C
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startAug 2005
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 653 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark H Yudin, MD MSc, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348660
- Sponsor's protocol ID
- 04-095
- Status last verified
- Feb 2019
- First submitted
- 30 Jun 2006
- Last updated
- 22 Feb 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Seroprevalence of Hepatitis C and Course of Infection Among Pregnant Women Attending a Toronto Inner City Antenatal Care Clinic
- ClinicalTrials.gov ID
- NCT00348660
- Acronym / sponsor ID
- 04-095
- Conditions
- Hepatitis C, Pregnancy
- Keywords
- Screening for Hepatitis C in Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 653 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 4 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Females under the age of 16.
- Participants who do not read and understand English for whom no interpreters are available.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark H Yudin, MD MSc principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C and Pregnancy, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.