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 Eletriptan 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 | 14 / 527 | Exposed groups of the whole study: drugs for migraine (ergots or triptans). | |
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). | ||||||||
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 Eletriptan 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 | 14 / 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) | |
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). | ||||||||
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) | Eletriptan 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) | 207 / 178565 | ||
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. | ||||||||
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) | Eletriptan 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) | 207 / 1095 | ||
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. | ||||||||
Spielmann (Control mainly exposed other treatments, sick) 2017 |
Germany 1999 - 2014 prospective cohort |
German Embryotox system | Pregnant women with Eletriptan 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) | 18 / 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. | |
All data are recorded using structured questionnaires via phone interview and/or as a written form. | ||||||||
Spielmann (Control unexposed, disease free) 2017 |
Germany 1999 - 2014 prospective cohort |
German Embryotox system | Pregnant women with Eletriptan 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) | 18 / 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. | |
All data are recorded using structured questionnaires via phone interview and/or as a written form. |
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;