Temazepam - Medication and Pregnancy KB

Temazepam

Exposed non-exposed, cohort studies

Study	Country Study period Study design	Data source	Exposure definition	Non-exposure definition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias
Ban (Other indications) (Controls unexposed, disease free) 2014	United Kingdom 1990 - 2010 retrospective cohort (claims database)	The Health Improvement Network (THIN), UK.	Children born to women with prescription of Temazepam (without concurrent prescriptions of antidepressants) in women’s primary care electronic health records from four weeks before the estimated onset of the last menstrual period up to 12 weeks.	unexposed, disease free Children born to women without depression or anxiety.	1st trimester	379 / 351785	This study assessed 2 different benzodiazepines. In order to avoid redundancy of controls, only 1 was reported in the meta-analysis of class, i.e the substance with the most exposures (i.e Diazepam).
		The Health Improvement Network (THIN), UK.	Exposure was obtained from The Health Improvement Network (THIN), where anonymised children’s and mothers’ medical records from 495 general practices throughout the UK were linked. Prescriptions are automatically entered.		1st trimester	379 / 351785
Ban (Other indications) (Controls unexposed, sick) 2014	United Kingdom 1990 - 2010 retrospective cohort (claims database)	The Health Improvement Network (THIN), UK.	Children born to women with prescription of Temazepam (without concurrent prescriptions of antidepressants) in women’s primary care electronic health records from four weeks before the estimated onset of the last menstrual period up to 12 weeks.	unexposed, sick Children born to women with depression or anxiety but with no first trimester psychotropic medication.	1st trimester	379 / 19193	Unexposed sick: Depression or anxiety (including generalised anxiety disorder, panic attacks, insomnia and other anxiety related disorder) in the year before pregnancy or during pregnancy. Only Diazepam was reported in the class MA (control redundancy).
Ban (Other indications) (Controls unexposed, sick) 2014		The Health Improvement Network (THIN), UK.	Exposure was obtained from The Health Improvement Network (THIN), where anonymised children’s and mothers’ medical records from 495 general practices throughout the UK were linked. Prescriptions are automatically entered.		1st trimester	379 / 19193

Case-control studies

Study	Country Study period Study design	Data source	Case	Control	Exposition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias
Bonnot 2003	France 1976 - 1997 case control	European Institut of Genomutations (IEG), Lyon, France.	Infants with the studied congenital malformation.	Infants with a malformations other than this one studied.	The medical records are checked to obtain data on treatment intake and other exposures or risks.	1st trimester	-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).
Bonnot 2003	France 1976 - 1997 case control	European Institut of Genomutations (IEG), Lyon, France.	After having defined a population, often on geographical criteria, these networks set up birth observatories in order to exhaustively identify neonatal malformations in their reference population.			1st trimester	-9 / -9
Laspro 2024	USA 2013 - 2023 nested case control	EPIC Cosmos, a database incorporating health information of 180 million patients, throughout the United States from approximately 180 US institutions utilizing EPIC medical records.	Newborns with oral clefts (ICD 10 codes Q35 or Q36 or Q37).	Newborns without oral clefts.	Gestational medication use was identified by medications, prescribed, provider-administered, or reported use by mothers at any point during pregnancy.	during pregnancy (anytime or not specified)	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.
Laspro 2024	USA 2013 - 2023 nested case control		Oral cleft cohorts were isolated using a combination of ICD codes, from the EPIC medical records.			during pregnancy (anytime or not specified)	12098 / -9
Sheehy 2019	Canada 1998 - 2015 nested case control	A nested case-control study within the Quebec Pregnancy Cohort, Montreal, Quebec, Canada.	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.	The Quebec Public Prescription Drug Insurance Plan database (drug name, start date, dose, and duration).	early pregnancy	27149 / 134305
Sheehy 2019	Canada 1998 - 2015 nested case control		The data sources included the medical service database the Régie de l’assurance maladie du Québec (diagnoses, medical procedures, ...) and the MedEcho database (in-hospital diagnoses and procedures, including gestational age for planned abortions, spontaneous abortions, and deliveries).			early pregnancy	27149 / 134305

Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;

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