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Clinical Trial Details
Research Study Summary
A clinical research study for the treatment of Birth Defects, Pregnancy Complications or Hepatitis C
Research Study Title
Ribavirin Pregnancy Registry
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
Female ages 18 Years to 65 Years
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
Females who are pregnant when their male sexual partner starts ribavirin
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
Report contact information to allow for follow-up.
- Females who were not exposed to Ribavirin during the designated time (described
Site Locations (1)
||INC Research, LLC
Earle Griffith, PMP
NCT ID: NCT00114712
Date Last Changed: December 5, 2013
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