Maternal and Neonatal Outcomes Following Exposure to Benzodiazepines During Pregnancy
Study Details
Study Description
Brief Summary
This is a nationwide cohort study to assess maternal and neonatal outcomes following exposure to benzodiazepines during pregnancy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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). |
Drug: Benzodiazepine
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 |
Drug: Benzodiazepine
Exposure to benzodiazepine during early pregnancy
|
Outcome Measures
Primary Outcome Measures
- Risk of congenital malformations [from the birth date until up to 8 years, death, or study end date (Dec 31, 2019)]
Overall congenital malformations and organ-specific congenital malformations in infants, which are confirmed by diagnostic records in the HIRA database. All infants were followed up for at least 1 year.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sungkyunkwan University | Suwon | Gyeonggi-do | Korea, Republic of | 16419 |
Sponsors and Collaborators
- Sungkyunkwan University
- National Research Foundation of Korea
Investigators
- Principal Investigator: Ju-Young Shin, PhD, Sungkyunkwan University
Study Documents (Full-Text)
None provided.More Information
Publications
- Bais B, Molenaar NM, Bijma HH, Hoogendijk WJG, Mulder CL, Luik AI, Lambregtse-van den Berg MP, Kamperman AM. Prevalence of benzodiazepines and benzodiazepine-related drugs exposure before, during and after pregnancy: A systematic review and meta-analysis. J Affect Disord. 2020 May 15;269:18-27. doi: 10.1016/j.jad.2020.03.014. Epub 2020 Mar 5. Review.
- Bellantuono C, Tofani S, Di Sciascio G, Santone G. Benzodiazepine exposure in pregnancy and risk of major malformations: a critical overview. Gen Hosp Psychiatry. 2013 Jan-Feb;35(1):3-8. doi: 10.1016/j.genhosppsych.2012.09.003. Epub 2012 Oct 6. Review.
- Grigoriadis S, Graves L, Peer M, Mamisashvili L, Dennis CL, Vigod SN, Steiner M, Brown C, Cheung A, Dawson H, Rector N, Guenette M, Richter M. Benzodiazepine Use During Pregnancy Alone or in Combination With an Antidepressant and Congenital Malformations: Systematic Review and Meta-Analysis. J Clin Psychiatry. 2019 Jul 9;80(4). pii: 18r12412. doi: 10.4088/JCP.18r12412.
- Iqbal MM, Sobhan T, Ryals T. Effects of commonly used benzodiazepines on the fetus, the neonate, and the nursing infant. Psychiatr Serv. 2002 Jan;53(1):39-49. Review.
- Shyken JM, Babbar S, Babbar S, Forinash A. Benzodiazepines in Pregnancy. Clin Obstet Gynecol. 2019 Mar;62(1):156-167. doi: 10.1097/GRF.0000000000000417. Review.
- SKKU-2021-PREG-BZ