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The Ribavirin Pregnancy Registry (RPR)
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Purpose
| Condition |
|---|
| Birth Defects Pregnancy Complications Hepatitis C |
| Study Type: | Observational [Patient Registry] |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Target Follow-Up Duration: | 12 Months |
| Official Title: | The Ribavirin Pregnancy Registry |
- To evaluate association between ribavirin and birth defects [ Time Frame: 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.
- Estimate risk of birth defects in exposed pregnancies [ Time Frame: 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.
| Estimated Enrollment: | 600 |
| Study Start Date: | January 2004 |
| Estimated Study Completion Date: | December 2025 |
| Estimated Primary Completion Date: | December 2024 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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)
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00114712
| Contact: Earle Griffith, PMP | 800 593 2214 | pregnancyregistries@incresearch.com | |
| Contact: Stacey Stone | 800 593 2214 | pregnancyregistries@incresearch.com |
| United States, North Carolina | |
| INC Research, LLC | Recruiting |
| Wilmington, North Carolina, United States, 28405 | |
| Contact: Earle Griffith, PMP 800-593-2214 pregnancyregistries@incresearch.com | |
| Principal Investigator: | Susan Sinclair, PhD | INC Research |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | INC Research |
| ClinicalTrials.gov Identifier: | NCT00114712 History of Changes |
| Other Study ID Numbers: |
RPR-1 |
| Study First Received: | June 16, 2005 |
| Last Updated: | January 23, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | A condensed version of the annual interim report is available to healthcare providers upon request. |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by INC Research:
|
Birth Defects Pregnancy Ribavirin Hepatitis C |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis C Pregnancy Complications Congenital Abnormalities Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases |
Flaviviridae Infections RNA Virus Infections Ribavirin Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on September 21, 2017