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 |
---|---|---|---|---|---|---|---|---|
Ephross (Naratriptan versus Sumatriptan) 2014 |
Worlwide 1996 - 2012 prospective cohort |
The Sumatriptan, Naratriptan, and Treximet Pregnancy Registry | 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). |
1st trimester, during pregnancy (anytime or not specified) | 57 / 626 | PV registry of GlaxoSmithKline. Exposure to sumatriptan and naratriptan provided and considered as separate subgroups. | |
Shortly after the expected date of birth, registry personnel contacted the enrolling health care provider to obtain information focused on the use of sumatriptan, naratriptan, and/or the sumatriptan/naproxen sodium combination product and other headache medications during pregnancy. | ||||||||
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 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). |
1st trimester | 22 / 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 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. |
1st trimester | 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) | |
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). | ||||||||
Spielmann (Control mainly exposed other treatments, sick) 2017 |
Germany 1999 - 2014 prospective cohort |
German Embryotox system | 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. |
during pregnancy (anytime or not specified) | 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. | |
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 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. |
during pregnancy (anytime or not specified) | 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. | |
All data are recorded using structured questionnaires via phone interview and/or as a written form. | ||||||||
Yusuf (Control exposed to Sumatriptan) 2018 |
The United States 1996 - 2012 retrospective cohort (claims database) |
The Truven Health Marketscan Commercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits Databases | 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. |
1st trimester, 2nd and/or 3rd trimester | 230 / 4519 | This study was funded by Amgen and was conceived and conducted by Amgen employees. | |
Administrative claims data contained in the Truven Health Marketscan Com- mercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits Databases. |
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;