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NCT00114712 · ClinicalTrials.gov registry record

The Ribavirin Pregnancy Registry

A clinical trial, sponsored by Syneos Health.

Terminated
Registry status
477
Enrollment target

NCT00114712: Clinical Trial study, sponsored by Syneos Health.

NCT00114712 is a clinical trial that was terminated before completion, run by Syneos Health. The registered enrollment target is 477 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00114712 was terminated before completion, sponsored by Syneos Health.

TERMINATED
Registry status
477 participants
Enrollment target

Study 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.

Primary Outcome

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.

Trial Details

FieldValue
Enrollment Target 477 participants
Start Date 2004-01
Est. Completion 2020-11-02
Syneos Health

4 total trials

Why NCT00114712 stopped before completion

NCT00114712 is an observational study that tracks outcomes without assigning an intervention. The registered 477 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT00114712 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00114712 about?

NCT00114712 is a clinical study titled "The 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 fo...

What is the current status of trial NCT00114712?

This trial is currently terminated. The enrollment target is 477 participants. The study started on 2004-01. Estimated completion is 2020-11-02.

Who is sponsoring clinical trial NCT00114712?

This trial is sponsored by Syneos Health, which has 4 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00114712, the US trial registry maintained by the National Library of Medicine. NCT00114712 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.