| 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 (Control exposed to Naratriptan) 2014 |
Worlwide 1996 - 2012 prospective cohort |
The Sumatriptan, Naratriptan, and Treximet Pregnancy Registry | Pregnant women exposed to sumatriptan at any time during pregnancy (beginning from the first day of the last menstrual period). |
exposed to other treatment, sick
Pregnant women exposed to naratriptan at any time during pregnancy (beginning from the first day of the last menstrual period). |
1st trimester, during pregnancy (anytime or not specified) | 626 / 57 | 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. | ||||||||
|
Kallen 2001 |
Sweden 1995 - 1999 population based cohort retrospective |
The Swedish Medical Birth Registry | Women who had reported the use of Sumatriptan in early pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). |
unexposed (general population or NOS)
All deliveries in Sweden as registered in the Medical Birth Registry. |
early pregnancy | 658 / -9 | Exposed group of the whole study: use of drugs for migraine. | |
| The register is based on information obtained by interview at the first antenatal visit (usually around 10 to 12 weeks gestation). Information on drug use is, thus, based on an interview at the first antenatal visit with a midwife. | ||||||||
|
Källén (Controls exposed to ergots) 2011 |
Sweden 1995 - 2008 population based cohort propective |
The Swedish Medical Birth Register | Infants born to women who had used Sumatriptan 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 | 2257 / 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 (Controls unexposed, disease free) 2011 |
Sweden 1995 - 2008 population based cohort propective |
The Swedish Medical Birth Register | Infants born to women who had used Sumatriptan 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 | 2257 / 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) | Sumatriptan 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) | 575 / 178565 | Other triptans also studied. | |
| 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) | Sumatriptan 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) | 575 / 1095 | Other triptans also studied. | |
| 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. | ||||||||
|
O'Quinn 1999 |
USA Not specified prospective cohort |
Data obtained by the open-label, uncontrolled clinical trial of sumatriptan injection prior to product marketing of injectable sumatriptan (Imitrex, GlaxoWell-come Inc., Research Triangle Park, NC) | Pregnant women exposed to sumatriptan after conception. |
unexposed, sick
Pregnant women exposed to sumatriptan only prior to conception. |
1st trimester | 76 / 92 | Open-label, prospective study conducted by Glaxo Wellcome Research Institute. | |
| The study was designed to include four office visits. Telephone interviews and automated prescription refilling occurred in between visits. Patients were asked to injected sumatriptan with an auto-injector. Diary cards were also used to record sumatriptan injections, concomitant drug use... | ||||||||
|
Olesen (Control unexposed, disease free) 2000 |
Denmark 1991 - 1996 population based cohort retrospective |
Pharmaco-Epidemiological Prescription Database of North Jutland county | Women who filled at least one prescription for sumatriptan during pregnancy. |
unexposed, disease free
Healthy women, who in this context are defined as women who did not redeem any prescriptions during pregnancy, |
during pregnancy (anytime or not specified) | 34 / 15995 | ||
| The North Jutland County’s prescription data base | ||||||||
|
Olesen (Control unexposed, sick) 2000 |
Denmark 1991 - 1996 population based cohort retrospective |
Pharmaco-Epidemiological Prescription Database of North Jutland county | Women who filled at least one prescription for sumatriptan during pregnancy. |
unexposed, sick
Migraine controls, who were women who redeemed at least one prescription for sumatriptan or ergotamine 52 to 12 weeks prior to conception, but not during pregnancy. |
during pregnancy (anytime or not specified) | 34 / 89 | (Table 2: Control group: Migraine patients who did not redeem prescriptions for antimigraine drugs 3 months prior to or during pregnancy.) | |
| The North Jutland County’s prescription data base | ||||||||
|
Shuhaiber (Control exposed to other treatments) 1998 |
Canada, USA prospective cohort |
Teratogen information service (TIS) | Pregnant women who used sumatriptan during pregnancy. |
exposed to other treatment, sick
Disease-matched controls (pregnant women contacting Motherisk who had migraine headache and used other drugs such as acetaminophen, nonsteroidal anti-inflammatory drugs, and narcotic analgesics). |
at least 1st trimester, during pregnancy (anytime or not specified) | 96 / 96 | A total of 96 women who were exposed to sumatriptan during pregnancy were followed up prospectively by the four participating centers: 91 in Toronto, 3 in Philadelphia, 1 in London, and 1 in Farmington. Mosterrik => main center. | |
| Pregnant women contacted a teratogen information service (TIS) during pregnancy to request counseling after sumatriptan use. | ||||||||
|
Shuhaiber (Control unexposed, disease free) 1998 |
Canada, USA prospective cohort |
Teratogen information service (TIS) | Pregnant women who used sumatriptan during pregnancy. |
unexposed, disease free
Nonteratogen controls (pregnant women who contacted Motherisk requesting counseling about medications known to be safe in the human fetus). |
at least 1st trimester, during pregnancy (anytime or not specified) | 96 / 96 | A total of 96 women who were exposed to sumatriptan during pregnancy were followed up prospectively by the four participating centers: 91 in Toronto, 3 in Philadelphia, 1 in London, and 1 in Farmington. Mosterrik => main center. | |
| Pregnant women contacted a teratogen information service (TIS) during pregnancy to request counseling after sumatriptan use. | ||||||||
|
Spielmann (Control mainly exposed other treatments, sick) 2017 |
Germany 1999 - 2014 prospective cohort |
German Embryotox system | Pregnant women with Sumatriptan 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) | 253 / 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 Sumatriptan 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) | 253 / 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 Naratriptan) 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 Sumatriptan during pregnancy using an insurance administrative claims database. |
exposed to other treatment, sick
Pregnant women with migraine exposed to Naratriptan during pregnancy using an insurance administrative claims database. |
1st trimester, 2nd and/or 3rd trimester | 4519 / 230 | 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 |
|---|---|---|---|---|---|---|---|---|---|
|
De Jonge 2013 |
The Netherlands 1998 - 2008 case control |
A population-based birth defect registry EUROCAT NNL | All malformed foetuses and children (live births, stillbirths, spontaneous abortions and terminations of pregnancy) excluding chromosomal and genetic disorders. | From the IADB, a population-based prescription database that contains prescription data from approximately 55 community pharmacies in The Netherlands, we selected the population controls. The IADB covers an estimated population of 500,000 individuals, which is considered representative of the general population. | For controls: from the IADB, a population-based prescription database. For cases: the pharmacy records for 3 months before conception until delivery were obtained and verified in a telephone interview and only the actually used medication is registered. | 1st trimester | 3212 / 29223 | 'All types of births are included in the registry: live births, stillbirths, spontaneous abortions and terminations of pregnancy.' Other drugs studied: 'Drugs acting on nervous system and Drugs considered to be safe'. | |
| Information on congenital malformations is obtained from the medical files, including pathology reports, and coded afterwards, according to the International Classification of Diseases (ICD) coding system by trained registry staff. | |||||||||
Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;
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