Study | Country Study period |
Population source | Exposure definition | Non-exposure definition | Sample size | Rmk |
---|---|---|---|---|---|---|
Ephross (Naratriptan versus Sumatriptan), 2014 |
Worlwide 1996 - 2012 |
Women were eligible for enrollment by their health care provider if they were pregnant, exposed to sumatriptan, naratriptan, or the sumatriptan/naproxen sodium combination product at any time during pregnancy (beginning from the first day of the last menstrual period) | Pregnant women exposed to naratriptan at any time during pregnancy (beginning from the first day of the last menstrual period). |
exposed to other treatment, sick
Pregnant women exposed to sumatriptan at any time during pregnancy (beginning from the first day of the last menstrual period). |
57 / 626 | PV registry of GlaxoSmithKline. Exposure to sumatriptan and naratriptan provided and considered as separate subgroups. |
Källén (control exposed to ergots), 2011 |
Sweden 1995 - 2008 |
All deliveries in Sweden (1 211 670 women) recorded in the Medical Birth Register with data from antenatal care. | Infants born to women who had used Naratriptan 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). |
22 / 527 | Exposed groups of the whole study: drugs for migraine (ergots or triptans). |
Källén (control unexposed, disease free), 2011 |
Sweden 1995 - 2008 |
All deliveries in Sweden (1 211 670 women) recorded in the Medical Birth Register with data from antenatal care. | Infants born to women who had used Naratriptan 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. |
22 / 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) |
Spielmann (Control mainly exposed other treatments, sick), 2017 |
Germany 1999 - 2014 |
Cohort of pregnant women enrolled by the German Embryotox system for risk assessment related to pregnancy. | Pregnant women with Naratriptan 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. |
42 / 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. |
Spielmann (Control unexposed, disease free), 2017 |
Germany 1999 - 2014 |
Cohort of pregnant women enrolled by the German Embryotox system for risk assessment related to pregnancy. | Pregnant women with Naratriptan 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. |
42 / 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. |
Yusuf (Control exposed to Sumatriptan), 2018 |
The United States 1996 - 2012 |
Women with a diagnosis of migraine (International Classification of Diseases, Ninth Revision, diagnosis codes 346.xx) or prescription claims for migraine‐specific acute medications (triptans or ergotamine‐derivatives). | Pregnant women with migraine exposed to Naratriptan during pregnancy using an insurance administrative claims database. |
exposed to other treatment, sick
Pregnant women with migraine exposed to Sumatriptan during pregnancy using an insurance administrative claims database. |
230 / 4519 | This study was funded by Amgen and was conceived and conducted by Amgen employees. |
Study | Country Study period |
Case | Control | Sample size | Rmk |
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