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Screening for Hepatitis C During Pregnancy at a Toronto Inner City Prenatal Clinic

20. Februar 2019 aktualisiert von: Unity Health Toronto

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.

Studienübersicht

Status

Abgeschlossen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

653

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Ontario
      • Toronto, Ontario, Kanada, M5C 2T2
        • St Michael's Hospital - Women's Health Care Centre

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

16 Jahre bis 45 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Weiblich

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Mark H Yudin, MD MSc, Unity Health Toronto

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. August 2005

Primärer Abschluss (Tatsächlich)

1. Oktober 2010

Studienabschluss (Tatsächlich)

1. Oktober 2010

Studienanmeldedaten

Zuerst eingereicht

30. Juni 2006

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. Juni 2006

Zuerst gepostet (Schätzen)

4. Juli 2006

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Februar 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. Februar 2019

Zuletzt verifiziert

1. Februar 2019

Mehr Informationen

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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