About: The Ribavirin Pregnancy Registry: An Interim Analysis of Potential Teratogenicity at the Mid-Point of Enrollment

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About: The Ribavirin Pregnancy Registry: An Interim Analysis of Potential Teratogenicity at the Mid-Point of Enrollment Goto Sponge NotDistinct Permalink

An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	The Ribavirin Pregnancy Registry: An Interim Analysis of Potential Teratogenicity at the Mid-Point of Enrollment
Creator	Greene, F Jones, Judith Kwo, Y Maddrey, C Michael, • Miller, Richard Paul, • Sinclair, Susan Willis, •
Source	Medline; PMC
abstract	INTRODUCTION: Significant teratogenic effects have been demonstrated in all animal species exposed to ribavirin. Ribavirin is prescribed for chronic hepatitis C and is contraindicated in women who are pregnant and in the male sexual partners of women who are pregnant. Both sexes are advised to avoid pregnancy for 6 months after exposure. The Ribavirin Pregnancy Registry was established in 2003 to monitor pregnancy exposures to ribavirin for signals of possible human teratogenicity. METHODS: This voluntary registry enrolls pregnant women with prenatal exposure to ribavirin. Exposure is classified as direct—women taking ribavirin during pregnancy or the 6 months prior to conception—or indirect—women exposed through sexual contact, 6 months prior to or during pregnancy, with a man who is taking or has taken ribavirin in the past 6 months. Women are followed until delivery and infants for 1 year. When enrollment is complete, birth defect rates will be compared with the Metropolitan Atlanta Congenital Defects Program’s published rate of 2.67. Using data collected since inception in 2003 through February 2016, preliminary rates were calculated. RESULTS: The registry has enrolled 272 pregnant women, with 180 live births: there were seven birth defect cases among 85 directly exposed women [7/85 (8.2%) (95% confidence interval (CI) 3.4–16.2)] and four birth defect cases among 95 indirectly exposed women [4/95 (4.2%) (95% CI 1.2–10.4)]. Of the 11 infants, nine had structural defects and two had chromosomal anomalies. Patterns suggesting a common etiology or relationship with ribavirin exposure are not seen. CONCLUSION: Based on the patterns of birth defects reported, preliminary findings do not suggest a clear signal of human teratogenicity for ribavirin. However, the current sample size is insufficient for definitive conclusions, and ribavirin exposure should be avoided during pregnancy and during the 6 months prior to pregnancy, in accordance with prescribing information. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00114712.
has issue date	2017-07-08(xsd:dateTime)
bibo:doi	10.1007/s40264-017-0566-6
bibo:pmid	28689333
has license	no-cc
sha1sum (hex)	ad6dd1860c99d708129393f91b573d6a6981e300
schema:url	https://doi.org/10.1007/s40264-017-0566-6
resource representing a document's title	The Ribavirin Pregnancy Registry: An Interim Analysis of Potential Teratogenicity at the Mid-Point of Enrollment
has PubMed Central identifier	PMC7100215
has PubMed identifier	28689333
schema:publication	Drug Saf
resource representing a document's body	covid:ad6dd1860c99d708129393f91b573d6a6981e300#body_text
is schema:about of	named entity 'voluntary' named entity 'Ribavirin' named entity 'PREGNANCY' named entity 'CHRONIC HEPATITIS C' named entity 'ANIMAL SPECIES' named entity 'DURING PREGNANCY' named entity 'EXPOSED TO' named entity 'PROGRAM' named entity 'CONCEPTION' named entity 'INFANTS' named entity 'CLASSIFIED' named entity '27S' named entity 'TERATOGENIC EFFECTS' named entity 'SIGNALS' named entity 'ESTABLISHED' named entity 'SIGNIFICANT' named entity 'FOLLOWED' named entity 'MONTHS' named entity 'TAKING' named entity 'PRENATAL EXPOSURE' named entity 'HUMAN' named entity 'INDIRECT' named entity 'RATES' named entity 'WOMEN' named entity 'DIRECT' named entity 'TO AVOID' named entity 'RIBAVIRIN' named entity 'SEXUAL CONTACT' named entity 'PREGNANCY' named entity 'YEAR' named entity 'METROPOLITAN' named entity 'METHODS' named entity 'TAKEN' named entity 'SEXUAL PARTNERS' named entity 'ENROLLMENT' named entity 'POSSIBLE' named entity 'DEMONSTRATED' named entity 'EXPOSURES' named entity 'COMPARED' named entity 'MONITOR' named entity 'ENROLLMENT' named entity 'POTENTIAL' named entity 'MID' named entity 'POINT' named entity 'RIBAVIRIN' named entity 'TERATOGENICITY' named entity 'PREGNANT WOMEN' named entity 'TERATOGENICITY' named entity 'EXPOSURE' named entity 'COMPLETE' named entity 'REGISTRY' named entity 'EXPOSED' named entity 'BIRTH DEFECT' named entity 'IN THE PAST' named entity 'ATLANTA' named entity 'PREGNANT' named entity 'MALE' named entity 'PRESCRIBED' named entity 'DELIVERY' named entity 'HAVE' named entity 'INTRODUCTION' named entity 'PAST 6 MONTHS' named entity 'PRIOR TO' named entity 'MAN' named entity 'CONTRAINDICATED' named entity 'VOLUNTARY' named entity 'INTERIM ANALYSIS' named entity 'REGISTRY' covid:arg/ad6dd1860c99d708129393f91b573d6a6981e300 named entity 'EXPOSURE TO RIBAVIRIN' named entity 'teratogenicity' named entity 'Defects' named entity 'contact'

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