Pregnancy RelatedNCT04856436
Maternal and Neonatal Outcomes Following Exposure to Benzodiazepines During Pregnancy
An observational study of Pregnancy Related and Benzodiazepines Causing Adverse Effects in Therapeutic Use, run by Sungkyunkwan University at 1 site in South Korea.
Trial summary
This is a nationwide cohort study to assess maternal and neonatal outcomes following exposure to benzodiazepines during pregnancy. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Benzodiazepines Causing Adverse Effects in Therapeutic Use, Congenital Anomaly
- What is being tested?
- Benzodiazepine
- How many people
- 3,094,227 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2020to 30 Jul 2021
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women who gave birth in South Korea between 2011 and 2018
Who may be able to join
- Pregnancies with live birth, 2011-2018
- Pregnancies linked to liveborn infants
- Pregnancies aged 20-45 years at delivery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maternal and Neonatal Outcomes Following Benzodiazepine Use During Pregnancy
This is a nationwide cohort study to assess maternal and neonatal outcomes following exposure to benzodiazepines during pregnancy.
Read the 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.
- Conditions
- Pregnancy Related, Benzodiazepines Causing Adverse Effects in Therapeutic Use, Congenital Anomaly
- Being tested
- Benzodiazepine
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenzodiazepineDrug
Exposure to benzodiazepine during early pregnancy
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Benzodiazepine | |
| 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 Receives: Drug: Benzodiazepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of congenital malformations
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.
Measured: from the birth date until up to 8 years, death, or study end date (Dec 31, 2019)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start1 Dec 2020
- Primary completion30 Jun 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,094,227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sungkyunkwan University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Principal investigator, Ju-Young Shin, Sungkyunkwan University
- Investigators
- Ju-Young Shin, PhD, Principal investigator, Sungkyunkwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856436
- Sponsor's protocol ID
- SKKU-2021-PREG-BZ
- Status last verified
- Mar 2022
- First submitted
- 19 Apr 2021
- Last updated
- 7 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23044244Grigoriadis 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):18r12412. doi: 10.4088/JCP.18r12412.
PubMed 31294935Bais 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.
PubMed 32217339Iqbal 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. doi: 10.1176/appi.ps.53.1.39.
PubMed 11773648Shyken JM, Babbar S, Babbar S, Forinash A. Benzodiazepines in Pregnancy. Clin Obstet Gynecol. 2019 Mar;62(1):156-167. doi: 10.1097/GRF.0000000000000417.
PubMed 30628916Noh Y, Lee H, Choi A, Kwon JS, Choe SA, Chae J, Kim DS, Shin JY. First-trimester exposure to benzodiazepines and risk of congenital malformations in offspring: A population-based cohort study in South Korea. PLoS Med. 2022 Mar 2;19(3):e1003945. doi: 10.1371/journal.pmed.1003945. eCollection 2022 Mar.
PubMed 35235572