Temazepam - Medication and Pregnancy KB

Temazepam

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Ban (Other indications) (Controls unexposed, disease free), 2014	United Kingdom 1990 - 2010	All singleton live births for women aged 15–45 years included in the Health Improvement Network (THIN) (covering 5% of the total UK population).	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.	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).
Ban (Other indications) (Controls unexposed, sick), 2014	United Kingdom 1990 - 2010	All singleton live births for women aged 15–45 years included in the Health Improvement Network (THIN) (covering 5% of the total UK population).	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.	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).

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

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