Zolmitriptan - Medication and Pregnancy KB

Zolmitriptan

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
Källén (control exposed to ergots) 2011	Sweden 1995 - 2008 population based cohort propective	The Swedish Medical Birth Register	Infants born to women who had used Zolmitriptan during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Infants born to women who had used Ergots drugs for migraine during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	1st trimester	362 / 527	Exposed groups of the whole study: drugs for migraine (ergots or triptans).
Källén (control exposed to ergots) 2011	Sweden 1995 - 2008 population based cohort propective	The Swedish Medical Birth Register	Pregnant women who attend antenatal clinics in Sweden (which the vast majority do) are interviewed by a midwife and asked about drugs used since the pregnancy started. This interview is usually made before the end of the first trimester (usually between weeks 10 and 12 of pregnancy).		1st trimester	362 / 527
Källén (control unexposed, disease free) 2011	Sweden 1995 - 2008 population based cohort propective	The Swedish Medical Birth Register	Infants born to women who had used Zolmitriptan during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, disease free Infants born to women who did not use drugs for migraine.	1st trimester	362 / 1229901	Exposed groups of the whole study: drugs for migraine (ergots or triptans). 1229901= Total number of infants (n=1233228) - Number of infants whose mother used drugs for migraine in 1st trimester (n=3327)
Källén (control unexposed, disease free) 2011	Sweden 1995 - 2008 population based cohort propective	The Swedish Medical Birth Register	Pregnant women who attend antenatal clinics in Sweden (which the vast majority do) are interviewed by a midwife and asked about drugs used since the pregnancy started. This interview is usually made before the end of the first trimester (usually between weeks 10 and 12 of pregnancy).		1st trimester	362 / 1229901
Nezvalová-Henriksen (Control unexposed, disease free) 2013	Norway 2004 - 2007 population based cohort retrospective	The Medical Birth Registry of Norway (MBRN) database and The Norwegian Prescription Database (NorPD)	Zolmitriptan prescription redemption during pregnancy ('anytime' or 'during the first trimester' or 'during the second trimester' or 'during the third trimester'). (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, disease free Pregnant women did not redeem triptans during the study period (the population comparison group).	1st trimester, 2nd trimester, 3rd trimester, during pregnancy (anytime or not specified)	156 / 178565	Other triptans also studied.
Nezvalová-Henriksen (Control unexposed, disease free) 2013	Norway 2004 - 2007 population based cohort retrospective		The Norwegian Prescription Database (NorPD) was the source of information on the individual triptan prescriptions. The timing of triptan redemption, in gestational weeks, was determined by the number of weeks from the onset of pregnancy to the date the prescription was redeemed.			156 / 178565	Other triptans also studied.
Nezvalová-Henriksen (Control unexposed, sick) 2013	Norway 2004 - 2007 population based cohort retrospective	The Medical Birth Registry of Norway (MBRN) database and The Norwegian Prescription Database (NorPD)	Zolmitriptan prescription redemption during pregnancy ('anytime' or 'during the first trimester' or 'during the second trimester' or 'during the third trimester'). (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Triptan prescription redemption between 7 and 1 month prior to pregnancy only.	1st trimester, 2nd trimester, 3rd trimester, during pregnancy (anytime or not specified)	156 / 1095	Other triptans also studied.
Nezvalová-Henriksen (Control unexposed, sick) 2013	Norway 2004 - 2007 population based cohort retrospective		The Norwegian Prescription Database (NorPD) was the source of information on the individual triptan prescriptions. The timing of triptan redemption, in gestational weeks, was determined by the number of weeks from the onset of pregnancy to the date the prescription was redeemed.			156 / 1095	Other triptans also studied.
Spielmann (Control mainly exposed other treatments, sick) 2017	Germany 1999 - 2014 prospective cohort	German Embryotox system	Pregnant women with Zolmitriptan use for migraine disorder any time from conception to delivery. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Pregnant women suffering from migraine disorder but not taking triptans between their last menstrual period and delivery.	during pregnancy (anytime or not specified)	75 / 475	The majority of exposed women took triptans in the first trimester (75.2%). Sumatriptan was the most frequently used triptan. Other triptans also studied.
	Germany 1999 - 2014 prospective cohort	German Embryotox system	All data are recorded using structured questionnaires via phone interview and/or as a written form.		during pregnancy (anytime or not specified)	75 / 475
Spielmann (Control unexposed, disease free) 2017	Germany 1999 - 2014 prospective cohort	German Embryotox system	Pregnant women with Zolmitriptan use for migraine disorder any time from conception to delivery. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, disease free Pregnant women without migraine disorder who were neither exposed to triptans nor to one of the following established teratogens or fetotoxicant.	during pregnancy (anytime or not specified)	75 / 1733	The majority of exposed women took triptans in the first trimester (75.2%). Sumatriptan was the most frequently used triptan. Other triptans also studied.
Spielmann (Control unexposed, disease free) 2017	Germany 1999 - 2014 prospective cohort	German Embryotox system	All data are recorded using structured questionnaires via phone interview and/or as a written form.		during pregnancy (anytime or not specified)	75 / 1733

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

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

Empty. There are no case-control studies available for this drug.

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