Maternal and Neonatal Outcomes Following Exposure to Benzodiazepines During Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3094227 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2021-07-30

Brief Summary

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

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Detailed Description

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Benzodiazepines are widely used in pregnant women; however, their safety on congenital malformations in a real-world setting is still uncertain. We aimed to assess the association between benzodiazepine use in early pregnancy and the risk of congenital malformations. We will conduct a retrospective nationwide cohort study using the Health Insurance Review and Assessment (HIRA) database of South Korea, which covers the entire South Korean population.

Conditions

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Pregnancy Related Benzodiazepines Causing Adverse Effects in Therapeutic Use Congenital Anomaly

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Pregnant women with exposure to benzodiazepines

Women who gave birth during 2011-2018, were aged 20-45 years and were filled at least one benzodiazepine prescription during the first trimester (first 90 days of pregnancy).

Benzodiazepine

Intervention Type DRUG

Exposure to benzodiazepine during early pregnancy

Pregnant women without exposure to benzodiazepines

Women who gave birth during 2011-2018, were aged 20-45 years and did not fill a benzodiazepine prescription during the 3 months before the pregnancy onset through the end of the first trimester

Benzodiazepine

Intervention Type DRUG

Exposure to benzodiazepine during early pregnancy

Interventions

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Benzodiazepine

Exposure to benzodiazepine during early pregnancy

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes