CompletedNot Applicable

Maternal and Neonatal Outcomes Following Exposure to Benzodiazepines During Pregnancy

South Korea3,094,227 participantsStarted 2020-12-01

Plain-language summary

This is a nationwide cohort study to assess maternal and neonatal outcomes following exposure to benzodiazepines during pregnancy.

Who can participate

Age range20 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Pregnancies with live birth, 2011-2018 * Pregnancies linked to liveborn infants * Pregnancies aged 20-45 years at delivery Exclusion Criteria: * Pregnancies with a chromosomal abnormality * Pregnancies with exposure to known teratogenic drugs (e.g. antineoplastic agent, warfarin, lithium, isotretinoin, misoprostol, thalidomide) during the first trimester * Pregnancies with no benzodiazepine prescription during the first trimester, but with at least one benzodiazepine prescription during the 3 months before the pregnancy onset

What they're measuring

Risk of congenital malformations

Timeframe: from the birth date until up to 8 years, death, or study end date (Dec 31, 2019)

Trial details

NCT IDNCT04856436

SponsorSungkyunkwan University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-06-30

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