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Clinical Trial Details

Overview

Research Study Summary

A clinical research study for the treatment of Birth Defects, Pregnancy Complications or Hepatitis C

Research Study Title

Ribavirin Pregnancy Registry

Purpose

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.

To Learn more
Phase

4

Gender

Female

Age

18 to 65 Years

Overall Status

Recruiting

Lead Sponsor

INC Research

Facility Type

N/A

Eligibility

Female ages 18 Years to 65 Years

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)

Site Locations (1)

Country State City Zip Facility and Contact
United States North Carolina Wilmington 28405 INC Research, LLC
Earle Griffith, PMP
800-593-2214
pregnancyregistries@incresearch.com

Contact

Earle Griffith, PMP
800 593 2214
E-mail:

NCT ID: NCT00114712

Date Last Changed: December 5, 2013

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