Triptans

Exposed non-exposed studies (cohort)

Study Country
Study period
Population source Exposure definition Non-exposure definition Sample size Rmk
Harris (Control exposed before pregnancy), 2018 Norway
1999 - 2008
All women in Norway who were pregnant between 1999 and 2008 and that accepted to participate to the MoBa (41%). Of whom, 45.7% of these women returned questionnaires at 5 years of age of their children. Children whose mothers reported migraine in pregnancy that were treated with triptans. unexposed, sick
Children whose mothers reported migraine only before pregnancy.
353 / 1922 The most commonly used triptan was sumatriptan (Table S1). Emotionality, Activity, and Shyness Temperament Questionnaire: continuous variable.
Harris (Control mainly exposed to other treatments, sick), 2018 Norway
1999 - 2008
All women in Norway who were pregnant between 1999 and 2008 and that accepted to participate to the MoBa (41%). Of whom, 45.7% of these women returned questionnaires at 5 years of age of their children. Children whose mothers reported migraine in pregnancy that were treated with triptans. exposed to other treatment, sick
Children whose mothers reported migraine in pregnancy that were not treated with triptans.
353 / 1509 The most commonly used triptan was sumatriptan (Table S1). Emotionality, Activity, and Shyness Temperament Questionnaire: continuous variable.
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 triptans 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).
2777 / 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 triptans 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.
2777 / 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)
Kallen - Sumatriptan, 2001 Sweden
1995 - 1999
Almost all births (approximately 1% are missing). 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.
658 / -9 Exposed group of the whole study: use of drugs for migraine.
Nezvalová-Henriksen (Control unexposed, disease free), 2013 Norway
2004 - 2007
All singleton deliveries (after the 12th gestational week) without chromosomal abnormalities during the study period. Triptan prescription redemption during pregnancy ('anytime' or 'during the first trimester' or 'during the second trimester' or 'during the third trimester'). unexposed, disease free
Pregnant women did not redeem triptans during the study period (the population comparison group).
1465 / 178565
Nezvalová-Henriksen (Control unexposed, sick), 2013 Norway
2004 - 2007
All singleton deliveries (after the 12th gestational week) without chromosomal abnormalities during the study period. Triptan prescription redemption during pregnancy ('anytime' or 'during the first trimester' or 'during the second trimester' or 'during the third trimester'). unexposed, sick
Triptan prescription redemption between 7 and 1 month prior to pregnancy only.
1465 / 1095
O'Quinn - Sumatriptan, 1999 USA
Not specified
Patients could be male or female, could have migraine with or without aura, and were at least 18 years of age. Ergotamine-containing drugs could not be prescribed for 24 h before or after use of sumatriptan. Pregnant women exposed to sumatriptan after conception. unexposed, sick
Pregnant women exposed to sumatriptan only prior to conception.
76 / 92 Open-label, prospective study conducted by Glaxo Wellcome Research Institute.
Olesen - Sumatriptan (Control unexposed, disease free), 2000 Denmark
1991 - 1996
Women who filled prescriptions during pregnancy in North Jutland County (approximately 10% of the total Danish population). 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,
34 / 15995
Olesen - Sumatriptan (Control unexposed, sick), 2000 Denmark
1991 - 1996
Women who filled prescriptions during pregnancy in North Jutland County (approximately 10% of the total Danish population). 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.
34 / 89 (Table 2: Control group: Migraine patients who did not redeem prescriptions for antimigraine drugs 3 months prior to or during pregnancy.)
Shuhaiber - Sumatriptan (Control exposed to other treatments), 1998 Canada, USA
Pregnant women who voluntarily contacted a 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)
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.
Shuhaiber - Sumatriptan (Control unexposed, disease free), 1998 Canada, USA
Pregnant women who voluntarily contacted a 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).
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.
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 triptan use for migraine disorder any time from conception to delivery. exposed to other treatment, sick
Pregnant women suffering from migraine disorder but not taking triptans between their last menstrual period and delivery.
432 / 475 The majority of exposed women took triptans in the first trimester (75.2%). Sumatriptan was the most frequently used triptan (59%).
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 triptan use for migraine disorder any time from conception to delivery. unexposed, disease free
Pregnant women without migraine disorder who were neither exposed to triptans nor to one of the following established teratogens or fetotoxicant.
432 / 1733 The majority of exposed women took triptans in the first trimester (75.2%). Sumatriptan was the most frequently used triptan.
Wood 2016a (Control exposed only before pregnancy), 2016 Norway
1999 - 2008
All women in Norway who were pregnant between 1999 and 2008 and that accepted to participate to the MoBa (41%). Of whom, 60.2% of these women returned questionnaires at 36 months post partum. Triptan exposure during pregnancy. unexposed, sick
Triptan exposure six months prior to pregnancy but not during pregnancy.
396 / 798 Comparisons between self-reported medication exposure in the MoBa study and exposure ascertained via prescription redemption in the Prescription Drug Registry show acceptable sensitivity and high specificity.
Wood 2016a (Control mainly exposed to other treatments, sick), 2016 Norway
1999 - 2008
All women in Norway who were pregnant between 1999 and 2008 and that accepted to participate to the MoBa (41%). Of whom, 60.2% of these women returned questionnaires at 36 months post partum. Triptan exposure during pregnancy. exposed to other treatment, sick
Pregnant women with history of migraine without triptan use.
396 / 3291 Comparisons between self-reported medication exposure in the MoBa study and exposure ascertained via prescription redemption in the Prescription Drug Registry show acceptable sensitivity and high specificity.
Wood 2016a (Control unexposed, disease free), 2016 Norway
1999 - 2008
All women in Norway who were pregnant between 1999 and 2008 and that accepted to participate to the MoBa (41%). Of whom, 60.2% of these women returned questionnaires at 36 months post partum. Triptan exposure during pregnancy. unexposed, disease free
Population comparison group in which no history of migraine or triptan use was reported.
396 / 36688 Comparisons between self-reported medication exposure in the MoBa study and exposure ascertained via prescription redemption in the Prescription Drug Registry show acceptable sensitivity and high specificity.
Wood 2016b, 2016 Norway
1999 - 2008
All women in Norway who were pregnant between 1999 and 2008 and that accepted to participate to the MoBa (41%). Of whom, 60.2% of these women returned questionnaires at 36 months post partum. Triptan exposure during pregnancy. unexposed, sick
No triptan exposure during pregnancy.
375 / 3829

Case-control studies (cohort)

Study Country
Study period
Case Control Sample size Rmk
Bérard, 2012 Canada
1998 - 2007
Four independent nested case–control analyses were performed on: (1) major congenital malformations (MCMs), (2) prematurity (<37 weeks of gestation), (3) low birth weight (LBW) (<2500 g), and (4) spontaneous abortions (occurring anytime between the first day and the 20th week of gestation). Women having delivered babies with no major or minor congenital malformations were defined as controls. 4716 / 54991 Overall, 59,707 pregnant women met the eligibility criteria and were considered for analyses (53 [0.08%] used DHE, 139 [0.23%] triptans, and 2990 [5.01%] NSAIDs).
de Jonge - Sumatriptan, 2013 The Netherlands
1998 - 2008
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. 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'.
Werler, 2009 The United States
1997 - 2003
Subjects with the diagnosis of gastroschisis either as an isolated anomaly or as a part of multiple congenital anomalies. Control subjects were infants without a known structural defect, born during the same time period, and same geographic study sites as cases. 514 / 3277 Exposure considered in the whole study: 275 vasoactive products including decongestants, anti-migraine triptans, non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, anti-hypertensives, and bronchodilators.

master protocol