Lorazepam - Medication and Pregnancy KB

Lorazepam

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Calderon-Margalit, 2009	USA 1996 - nr	Pregnant mothers who initiated prenatal care before 20 weeks’ gestation and planned to deliver at either one of the two study hospitals.	Pregnant women who used Lorazepam during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed (general population or NOS) Pregnant women who did not use psychotropic medications during pregnancy.	73 / 2493	Of the women who were taking psychotropic medications, 235 (78%) took only one medication, 51 (17%) used two medications, and 14 (5%) used three or more medications.
Meng a (Controls unexposed, sibling), 2023	Taiwan 2004 - 2018	All singleton pregnancies of females aged 15–50 years who gave birth during the study period.	Sibling with at least one Lorazepam prescription received by the mother during early pregnancy (the first 20 weeks of pregnancy).	sibling Discordant matched sibling without benzodiazepine or Z-hypnotic prescriptions from 30 days before the date of the estimated last menstrual period to the end of the 20th week of pregnancy.	-9 / -9	Number of exposures not provided (authors provided number of Exposure discordant pairs and number of Case discordant pairs).
Meng a (Controls unexposed, sick), 2023	Taiwan 2004 - 2018	All singleton pregnancies of females aged 15–50 years who gave birth during the study period.	At least one Lorazepam prescription received by a mother during early pregnancy (the first 20 weeks of pregnancy).	unexposed, sick Pregnant women with no benzodiazepine or Z-hypnotic prescriptions from 30 days before the date of the estimated last menstrual period to the end of the 20th week of pregnancy.	11182 / 2770460	Use of results obtained with PS-FSW because more exposures, with a sick control group and sensitivity analyses (sibling control study, and paternal negative control design) that obtained similar results.
Meng b, 2023	Taiwan 2004 - 2018	Women with pregnancies from both the two national health databases.	Women receiving at least 1 prescription of Lorazepam during the risk period only (1-28 days before miscarriage).	unexposed, sick Women receiving at least 1 prescription of Lorazepam during the reference period only (181-208 days before the last menstrual period).	136134 / 134864	Use of Case-Time-Control (CTC) Design OR => nb of exposures/cases/controls not applicable; and the main Reference period, i.e 181 to 208 days before the last menstrual period.
Noh, 2022	South Korea 2011 - 2018	All pregnancies in women aged 20 to 45 years at delivery resulting in live births from 1 January 2011 to 31 December 2018, in South Korea.	Pregnant women who filled at least Lorazepam prescription during the first trimester (first 90 days of pregnancy).	unexposed, sick Pregnant women who were not prescribed any benzodiazepine from 3 months before the last menstrual period to the end of the first trimester (with similar psychiatric conditions after propensity score).	2468 / 3053381	Propensity scored adjusted for indications and led to an unexposed cohort with similar psychiatric conditions => considered as unexposed, sick control groups.

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk
Bonnot, 2003	France 1976 - 1997	Infants with the studied congenital malformation.	Infants with a malformations other than this one studied.	-9 / -9	Total number of infants with a congenital malformation is 13703, but the number of cases changes according to the studied malformations. Raw data not sufficient to calculate OR (data for 'control' groups not available).
Laspro, 2024	USA 2013 - 2023	Newborns with oral clefts (ICD 10 codes Q35 or Q36 or Q37).	Newborns without oral clefts.	12098 / -9	P-values were calculated, while to account for multiple testing (693 hypotheses) Benjamini-Hochberg (BH) corrections were performed with a false discovery rate (Q) of 0.05 => use of Table 4. Bejamini Hochberg Correction when available.
Sheehy, 2019	Canada 1998 - 2015	Pregnancies ending with spontaneous abortion (pregnancy loss between between the beginning of the sixth week of gestation and the 19th completed week of gestation, excluding planned or induced abortions).	Pregnancies ending with live births (5 for each case) randomly selected at the index date and matched with the case pregnancy by gestational age and calendar year.	27149 / 134305
Tinker, 2019	USA 1997 - 2011	Live bom, stillborn, or induced terminations with at least one of the 30 different birth defects (excluding chromosomal or monogenic disorders) diagnosed prenatally, at birth, or during the first year of life.	Liveborn infants without major birth defects identified on the same catchment area and month of birth as the cases.	-9 / 11614	Total number of cases not provided by authors. For analyses of hypospadias, only male control infants were included => OR not provided and insufficient data to be calculated.

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