- Medication and Pregnancy KB

Study	Type of data	Exposure measurement	Outcome assessment	Adjustment
De Jonge, 2013	case control	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.	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.	None
Ephross (Control exposed to Naratriptan), 2014	prospective cohort	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.	Shortly after the expected date of birth, registry personnel contacted the enrolling health care provider to obtain information focused on the outcome of pregnancy. All defect reports were reviewed by two clinicians: a pediatrician and an obstetrician-gynecologist.	None
Kallen, 2001	population based cohort retrospective	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.	Outcomes were registered in the Medical Birth Registry, based on data collected at delivery and at the pediatric examination of the newborn, using standardized forms.	None
Källén (Controls exposed to ergots), 2011	population based cohort propective	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).	The outcomes were ascertained from multiple sources: the paediatric form of the Medical Birth Register, the Register of Birth Defects and the Patient Register.	No adjustment for this control group.
Källén (Controls unexposed, disease free), 2011	population based cohort propective	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).	The outcomes were ascertained from multiple sources: the paediatric form of the Medical Birth Register, the Register of Birth Defects and the Patient Register.	No adjustment for this group of exposure.
Nezvalová-Henriksen (Control unexposed, disease free), 2013	population based cohort retrospective	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.	The medical birth registry of Norway where data are collected via obligatory standardised forms by trained health personnel during medical check-ups during pregnancy and during the delivery and the subsequent hospital stay.	The confounding factors included, among others, maternal age, pregnancy complications, prescribed poten- tially teratogenic drugs during pregnancy, other co-medication during pregnancy, and for some outcomes delivery complications
Nezvalová-Henriksen (Control unexposed, sick), 2013	population based cohort retrospective	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.	The medical birth registry of Norway where data are collected via obligatory standardised forms by trained health personnel during medical check-ups during pregnancy and during the delivery and the subsequent hospital stay.	No adjustment for this control group.
O'Quinn, 1999	prospective cohort	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...	All pregnancies were followed to outcome in the perinatal period. Investigators were required to report the name of the patient’s obstetrician in order that follow-up could be accomplished.	None
Olesen (Control unexposed, disease free), 2000	population based cohort retrospective	The North Jutland County’s prescription data base	The Danish Medical Birth Registry includes data on all births since 1973, including each child’s birth- day, gestational age, birth weight, and malformations. Abortions are not recorded in the registry. The data stem from official reports filled in by the midwives at- tending deliveries.	Odds ratios were adjusted for the mother’s smoking during pregnancy (yes or no), parity (number of primiparous women), maternal age, and marital status (the number of women who lived with the child’s father).
Olesen (Control unexposed, sick), 2000	population based cohort retrospective	The North Jutland County’s prescription data base	The Danish Medical Birth Registry includes data on all births since 1973, including each child’s birth- day, gestational age, birth weight, and malformations. Abortions are not recorded in the registry. The data stem from official reports filled in by the midwives at- tending deliveries.	Odds ratios were adjusted for the mother’s smoking during pregnancy (yes or no), parity (number of primiparous women), maternal age, and marital status (the number of women who lived with the child’s father).
Shuhaiber (Control exposed to other treatments), 1998	prospective cohort	Pregnant women contacted a teratogen information service (TIS) during pregnancy to request counseling after sumatriptan use.	All patients were contacted by telephone within 2 years of the expected date of confinement and asked details about the outcome of pregnancy, birth weight, birth defects, and complications. One center (Motherisk) also requested written documentation from the child’s physician.	None
Shuhaiber (Control unexposed, disease free), 1998	prospective cohort	Pregnant women contacted a teratogen information service (TIS) during pregnancy to request counseling after sumatriptan use.	All patients were contacted by telephone within 2 years of the expected date of confinement and asked details about the outcome of pregnancy, birth weight, birth defects, and complications. One center (Motherisk) also requested written documentation from the child’s physician.	None
Spielmann (Control mainly exposed other treatments, sick), 2017	prospective cohort	All data are recorded using structured questionnaires via phone interview and/or as a written form.	Structured questionnaire administered via phone interview and/or as a written form, notably on gestational age at birth, weight, length, head circumference, Apgar score, umbilical artery pH, birth defects, postnatal disorders, pregnancy loss. Medical reports requested in cases of birth defects.	No adjustment for this group of exposure.
Spielmann (Control unexposed, disease free), 2017	prospective cohort	All data are recorded using structured questionnaires via phone interview and/or as a written form.	Structured questionnaire administered via phone interview and/or as a written form, notably on gestational age at birth, weight, length, head circumference, Apgar score, umbilical artery pH, birth defects, postnatal disorders, pregnancy loss. Medical reports requested in cases of birth defects.	No adjustment for this group of exposure.
Yusuf (Control exposed to Naratriptan), 2018	retrospective cohort (claims database)	Administrative claims data contained in the Truven Health Marketscan Com- mercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits Databases.	Administrative claims data contained in the Truven Health Marketscan Com- mercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits Databases.	None

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