Triptans

Exposed non-exposed, cohort studies

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
Harris (Control exposed before pregnancy)
2018 		Norway
1999 - 2008
prospective cohort 		Norwegian Mother and Child Cohort Study (MoBa), a prospective population-based pregnancy cohort study Children whose mothers reported migraine in pregnancy that were treated with triptans. unexposed, sick
Children whose mothers reported migraine only before pregnancy. 		during pregnancy (anytime or not specified) 353 / 1922 The most commonly used triptan was sumatriptan (Table S1). Emotionality, Activity, and Shyness Temperament Questionnaire: continuous variable.
Follow-up is conducted via questionnaires in pregnancy weeks 17, 22, and 30. Medication use in pregnancy was reported in Q1 (6 months pre- pregnancy and gestational weeks 0-13 ), Q3 (week 13-29 ), and Q4 (week 30-end of pregnancy) for specific indications.
Harris (Control mainly exposed to other treatments, sick)
2018 		Norway
1999 - 2008
prospective cohort 		Norwegian Mother and Child Cohort Study (MoBa), a prospective population-based pregnancy cohort study 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. 		during pregnancy (anytime or not specified) 353 / 1509 The most commonly used triptan was sumatriptan (Table S1). Emotionality, Activity, and Shyness Temperament Questionnaire: continuous variable.
Follow-up is conducted via questionnaires in pregnancy weeks 17, 22, and 30. Medication use in pregnancy was reported in Q1 (6 months pre- pregnancy and gestational weeks 0-13 ), Q3 (week 13-29 ), and Q4 (week 30-end of pregnancy) for specific indications.
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 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). 		1st trimester 2777 / 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 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. 		1st trimester, 2nd and/or 3rd trimester 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)
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).
Kallen - Sumatriptan
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.
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) 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). 		1st trimester, 2nd trimester, 3rd trimester, during pregnancy (anytime or not specified) 1465 / 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) 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. 		1st trimester, 2nd trimester, 3rd trimester, during pregnancy (anytime or not specified) 1465 / 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.
O'Quinn - Sumatriptan
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 - Sumatriptan (Control unexposed, disease free)
2000 		Denmark
1991 - 1996
retrospective cohort (claims database) 		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 - Sumatriptan (Control unexposed, sick)
2000 		Denmark
1991 - 1996
retrospective cohort (claims database) 		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 - Sumatriptan (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 - Sumatriptan (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 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. 		1st trimester, during pregnancy (anytime or not specified) 432 / 475 The majority of exposed women took triptans in the first trimester (75.2%). Sumatriptan was the most frequently used triptan (59%).
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 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. 		1st trimester, during pregnancy (anytime or not specified) 432 / 1733 The majority of exposed women took triptans in the first trimester (75.2%). Sumatriptan was the most frequently used triptan.
All data are recorded using structured questionnaires via phone interview and/or as a written form.
Wood 2016a (Control exposed only before pregnancy)
2016 		Norway
1999 - 2008
prospective cohort 		The Norwegian Mother and Child Cohort study (MoBa) Triptan exposure during pregnancy. unexposed, sick
Triptan exposure six months prior to pregnancy but not during pregnancy. 		during pregnancy (anytime or not specified) 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.
Medication information was gathered from two prenatal (Q1, Q3) and one postpartum questionnaire (Q4); this information was reported before the outcome was known.
Wood 2016a (Control mainly exposed to other treatments, sick)
2016 		Norway
1999 - 2008
prospective cohort 		The Norwegian Mother and Child Cohort study (MoBa) Triptan exposure during pregnancy. exposed to other treatment, sick
Pregnant women with history of migraine without triptan use. 		during pregnancy (anytime or not specified) 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.
Medication information was gathered from two prenatal (Q1, Q3) and one postpartum questionnaire (Q4); this information was reported before the outcome was known.
Wood 2016a (Control unexposed, disease free)
2016 		Norway
1999 - 2008
prospective cohort 		The Norwegian Mother and Child Cohort study (MoBa) Triptan exposure during pregnancy. unexposed, disease free
Population comparison group in which no history of migraine or triptan use was reported. 		during pregnancy (anytime or not specified) 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.
Medication information was gathered from two prenatal (Q1, Q3) and one postpartum questionnaire (Q4); this information was reported before the outcome was known.
Wood 2016b
2016 		Norway
1999 - 2008
prospective cohort 		The Norwegian Mother and Child Cohort study (MoBa) Triptan exposure during pregnancy. unexposed, sick
No triptan exposure during pregnancy. 		during pregnancy (anytime or not specified) 375 / 3829
Medication information was gathered prospectively from two prenatal (Q1, Q3) and one postpartum questionnaire (Q4).

Case-control studies

Study Country
Study period
Study design		 Data source Case Control Exposition Exposition period Sample size
(exposed/unexposed) Or (case / control)		 Remarks Risk of bias
Bérard
2012 		Canada
1998 - 2007
nested case control 		The Quebec Pregnancy Registry (QPR), built with the linkage of three databases: the Régie de l’assurance maladie du Québec (RAMQ), MED-ECHO, and the Institut de la statistique du Québec (ISQ) databases 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. From the Régie de l’assurance maladie du Québec (RAMQ), for each pregnant woman, it was obtained data on all filled prescriptions in the year preceding and during pregnancy including date of filling, name, dosage, form, quantity, and duration. during pregnancy (anytime or not specified) 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).
MED-ECHO provided data on all maternal and baby acute care hospitalizations in the year prior, during pregnancy, and in the year after pregnancy. The ISQ provided also baby characteristics (gender, birth weight, gestational age at delivery).
De Jonge - Sumatriptan
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. A population-based prescription database, the IADB was used to obtain the mother’s pharmacy records. Actual use of the prescribed medication is 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.
Werler
2009 		The United States
1997 - 2003
case control 		The National Birth Defects Prevention Study, a population-based case–control study of birth defects 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. Mothers of case- and control-infants are interviewed by telephone within 24 months after their estimated date of delivery, notably about pregnancy exposures. 1st trimester 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.
In each of the 10 states, birth defect registries identify infants with selected major structural malformations and a random sample of live born infants without major defects as a control group. Diagnoses abstracted from medical records were reviewed by a clinical geneticist.

Risk of bias: : NA;   : low;   : moderate;   : serious;   : critical;   : unclear;  

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