The Ribavirin Pregnancy Registry

Stopped early

Conditions studied: Birth Defects, Pregnancy Complications, Hepatitis C

In brief

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.

Key facts

Study ID

NCT00114712

Run by

Syneos Health

People needed

477

Starts

2004-01-01

Expected to finish

2020-11-02

Last updated by the study team

2020-12-14

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Females who were not exposed to Ribavirin during the designated time (described above)

Where it is running

• INC Research, LLC — Wilmington, North Carolina, United States

Full record on ClinicalTrials.gov

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