Nifedipine (versus unexposed) - Medication and Pregnancy KB

Nifedipine (versus unexposed)

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Bortolus, 2000	Italy 1992 - 1994	Children born to women recruited between 12 and 34 weeks of gestation, with chronic or gestational or unclassified hypertension (diastolic pressure between 90 and 110mmHg).	Children born to women with hypertension randomly assigned to slow-release nifedipine, starting from 10 mg twice daily (increased up to 80 mg daily, if necessary).	unexposed, sick Children born to women with hypertension randomly assigned to no treatment.	130 / 130	Methods completed with the 1st publication of this clinical trial: Parazzini et al., 1998. For all malformations: overlapping between Parazzini et al., 1998 and Bortolus 2000 => use of the 1st one because it is based on a higher number of babies.
Parazzini, 1998	Italy 1992 - 1994	Pregnant women, between 12 and 34 weeks of gestation, with chronic or gestational or unclassified hypertension (diastolic pressure between 90 and 110mmHg).	Pregnant women with hypertension randomly assigned to slow-release nifedipine, starting from 10 mg twice daily (increased up to 80 mg daily, if necessary).	unexposed, sick Pregnant women with hypertension randomly assigned to no treatment.	145 / 138	For all malformations: overlapping between Parazzini et al., 1998 and Bortolus 2000 => use of the 1st one because it is based on a higher number of babies.
Weber-Schoendorfer, 2008	Finland, France, Germany, Israel, Italy, the Netherlands. 1986 - 2003	Pregnant women who or whose physician contacted a Teratology Information Service (TIS) in regard to exposure to chemicals or drugs during pregnancy.	Pregnant women with first- trimester exposure to Nifedipine.	unexposed (general population or NOS) Pregnant women who had been counseled during pregnancy about exposures known to be non-teratogenic.	76 / 806

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk
Vermes, 2015	Hungary 1980 - 1996	Newborn infants (including infant deaths and usual stillborn fetuses) with isolated Oesophageal Atresia.	Newborn infants (including infant deaths and usual stillborn fetuses) without congenital abnormalities.	221 / 356	Study design completed with other studies published on the Hungarian Case-Control Surveillance of Congenital Abnormalities (HCCSCA). Cases with multiple/syndromic Oesophageal Atresia were excluded from the study.
Zarante, 2009	Colombia 2001- 2006	All newborns and stillborns of weight >500 g that presented only one craniofacial malformation, not associated with any other congenital condition.	The next non-malformed same sex child born in the same hospital.	374 / 728	Exclusion of patients with Down syndrome, Potter sequence, VACTERL association, and other unspecified multiple malformations.

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