Birth Defects, Hepatitis C, Pregnancy Complications
Conditions
Keywords
Birth Defects, Pregnancy, Ribavirin, Hepatitis C
Brief summary
Ribavirin should be avoided during pregnancy and during the 6 months before pregnancy in both the female and the male sexual partner. If a pregnancy occurs and is reported to the Ribavirin Pregnancy Registry, the Registry will follow the pregnant woman throughout pregnancy. The Registry will also follow the infant until 1 year of age. The goal of the Registry is to learn more about the effects of ribavirin on pregnancy and the risk for birth defects. Pregnant women exposed to ribavirin, either by taking ribavirin (during pregnancy or 6 months before pregnancy) or through a male sexual partner (who took ribavirin during the female partner's pregnancy or during the 6 months before pregnancy), are encouraged to contact the Registry.
Detailed description
Ribavirin, a nucleoside analog with antiviral activity, is used in combination with interferons or pegylated interferons for the treatment of chronic hepatitis C (HCV). Extensive clinical studies have demonstrated that combination therapy with ribavirin and interferons or pegylated interferons are efficacious treatments for HCV. However, ribavirin has been assigned a FDA Pregnancy Category X classification, indicating that it should not be used in women who are pregnant or in men whose partners may become pregnant. Because the incidence of HCV is highest in the group with the highest reproductive potential, the 25 - 45 year age group, (CDC, 2001) it is likely that inadvertent pregnancy exposures will occur and should be monitored. The primary objectives of this Registry are: * To evaluate the association between ribavirin and birth defects occurring in offspring of female patients exposed to ribavirin during pregnancy or within six months after therapy has stopped. * To evaluate the association between ribavirin and birth defects occurring in offspring of females exposed to ribavirin during pregnancy or within six months after therapy has stopped, through their male sexual partners taking ribavirin.
Interventions
None listed
Sponsors
Aurobindo Pharma Ltd
Sandoz
Merck Sharp & Dohme LLC
Teva Pharmaceuticals USA
Zydus Pharmaceuticals USA, Inc.
Syneos Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Pregnancy occurring to one of the following groups while the patient or sexual partner was on ribavirin and/or within six months after therapy stopped: * Female patients who become pregnant on ribavirin therapy, or * Female patients who start ribavirin therapy while pregnant, or * Female patients who become pregnant post-ribavirin therapy (defined as the six month time period after therapy has stopped) or * Females who become pregnant while their male sexual partner is on ribavirin therapy or * Females who are pregnant when their male sexual partner starts ribavirin therapy, or * Females who become pregnant while their male sexual partner is in the post-ribavirin therapy period (defined as the six month time period after therapy has stopped). * Timing of the prenatal exposure to ribavirin, no broader than within six months prior to pregnancy or trimester during which the exposure took place. * Sufficient information to determine whether the pregnancy is prospectively registered (i.e., whether the outcome of pregnancy was known at the time of the report). * Date the pregnancy exposure report is registered. * Source of the report (health care professional, pregnant patient, or male sexual partner). * Report contact information to allow for follow-up.
Exclusion criteria
* Females who were not exposed to Ribavirin during the designated time (described above)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate association between ribavirin and birth defects | At birth outcome, infant follow-up at 6 and 12 months | To evaluate the association between ribavirin and birth defects occurring in offspring of female patients exposed to ribavirin during pregnancy or within six months after therapy has stopped. To evaluate the association between ribavirin and birth defects occurring in offspring of females exposed to ribavirin during pregnancy or within six months after therapy has stopped, through their male sexual partners taking ribavirin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimate risk of birth defects in exposed pregnancies | At birth outcome, infant follow-up at 6 and 12 months | Attempt to estimate the risk of birth defects occurring in offspring of female patients exposed to ribavirin during pregnancy or within six months after therapy has stopped, and detect any increase in the prevalence or pattern of birth defects among these pregnancies. Attempt to estimate the risk of birth defects occurring in offspring of females exposed to ribavirin during pregnancy or within six months after therapy has stopped, through their male sexual partners taking ribavirin, to detect any increase in the prevalence or pattern of birth defects among these pregnancies. |
Countries
United States
Outcome results
None listed