Nifedipine (versus unexposed) - Medication and Pregnancy KB

Nifedipine (versus unexposed)

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
Bortolus 2000	Italy 1992 - 1994 randomized controlled trial	A randomised multicentre clinical trial, in 33 obstetric and nephrology centres, Gruppo di Studio Ipertensione in Gravidanza, Italy.	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.	2nd and/or 3rd trimester	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.
Bortolus 2000	Italy 1992 - 1994 randomized controlled trial		Eligible women were randomly assigned treatment group. Group allocation was done by telephone to the Istituto Mario Negri in Bergamo. The randomisation list was generated by computer. Separate randomisation lists were used for each centre and type of hypertension.		2nd and/or 3rd trimester	130 / 130
Parazzini 1998	Italy 1992 - 1994 randomized controlled trial	A randomised multicentre clinical trial, in 33 obstetric and nephrology centres, Gruppo di Studio Ipertensione in Gravidanza, Italy.	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.	2nd and/or 3rd trimester	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.
Parazzini 1998	Italy 1992 - 1994 randomized controlled trial		Eligible women were randomly assigned treatment group. Group allocation was done by telephone to the Istituto Mario Negri in Bergamo. The randomisation list was generated by computer. Separate randomisation lists were used for each centre and type of hypertension.		2nd and/or 3rd trimester	145 / 138
Weber-Schoendorfer 2008	Finland, France, Germany, Israel, Italy, the Netherlands. 1986 - 2003 prospective cohort	A multicenter (n = 11), prospective observational study of the European Network of Teratology Information Services (ENTIS).	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.	at least 1st trimester	76 / 806
Weber-Schoendorfer 2008			A similarly structured questionnaire was used by all the centres to record the following data at the first contact during (early) pregnancy before the pregnancy outcome was known, including details of drug exposure (timing in pregnancy, dose, and duration).		at least 1st trimester	76 / 806

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
Vermes 2015	Hungary 1980 - 1996 case control	The Hungarian Case-Control Surveillance of Congenital Abnormalities (HCCSCA).	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.	Exposure data collected from 3 sources: a post-paid structured questionnaire sent to the parents requesting drugs taken during pregnancy, according to gestational months; maternal prenatal care logbook (in which obstetricians must record all prescribed drugs); nurses visited non-responding families.	1st trimester, during pregnancy (anytime or not specified)	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.
Vermes 2015	Hungary 1980 - 1996 case control		The Hungarian Congenital Abnormality Registry (HCAR), in which notification by physicians of cases with Congenital anomalies is mandatory (including infant deaths and usual stillborn fetuses). Controls were selected from the National Birth Registry of the Central Statistical Office.			1st trimester, during pregnancy (anytime or not specified)	221 / 356
Zarante 2009	Colombia 2001- 2006 case control	The Institute of Human Genetics of the Pontificia Universidad Javeriana, an active member of the Latin-American Collaborative Study of Congenital Malformations (ECLAMC) which is an international registry of congenital malformations .	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.	Information collected in 10 Colombian hospitals (NOS).	during pregnancy (anytime or not specified)	374 / 728	Exclusion of patients with Down syndrome, Potter sequence, VACTERL association, and other unspecified multiple malformations.
Zarante 2009	Colombia 2001- 2006 case control		Information collected in 10 Colombian hospitals (NOS).		Information collected in 10 Colombian hospitals (NOS).	during pregnancy (anytime or not specified)	374 / 728

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

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