Tramadol (versus unexposed) - Medication and Pregnancy KB

Tramadol (versus unexposed)

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
Bowie 2022	Canada 2013 - 2018 population based cohort retrospective	Administrative health data of the single-payer health care system in Ontario, Canada	Parent–infant pairs exposed to tramadol during at least the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed (general population or NOS) Parent–infant pairs not exposed to any opioid analgesic during pregnancy period.	at least 1st trimester	781 / 587676	Estimated date of confinement rather than delivery date to prevent overselection of preterm births and, thus, anomalies. Excluded multiple fetuses and pregnant people with opioid use disorder or opioid overdose within 2 years before delivery.
Bowie 2022	Canada 2013 - 2018 population based cohort retrospective		Records of prescribed prenatal opioid analgesics in the Narcotic Monitoring System (NMS) database. Records information on controlled drug prescriptions issued to Ontario residents.		at least 1st trimester	781 / 587676
Ferrer 2025	France 2004 - 2020 retrospective cohort (claims database)	The EFEMERIS (Évaluation chez la Femme Enceinte des MÉdicaments et de leurs RISques) database, Haute-Garonne, France.	Pregnant women who had a prescription and a dispensation for tramadol at least once during pregnancy (between the date of the last menstrual period and the date of the pregnancy outcome) without a prescription and dispensation of codeine.	unexposed (general population or NOS) Pregnant women who had no prescription and dispensation for tramadol or codeine during pregnancy (between the date of the last menstrual period and the date of the pregnancy outcome)..	at least 1st trimester, during pregnancy (anytime or not specified)	1602 / 158426
Ferrer 2025	France 2004 - 2020 retrospective cohort (claims database)		Data on reimbursed medications prescribed and dispensed to patients, as well as the dates of conception and pregnancy outcome, were obtained from the French health insurance system.			1602 / 158426
Gouraud 2010	France 1984 prospective cohort	13 French pharmacovigilance centers	Pregnancies exposed to tramadol during organogenesis (4 to 12 weeks after LMP).	unexposed (general population or NOS) Pregnancies exposed to agents known to be non teratogenic (paracetamol, amoxicillin, homeopathic drugs, hair dying…) or not exposed to any drug during organogenesis.	1st trimester	151 / 973	Additional details provided by authors. Gouraud, A. Fundam. Clin. Pharmacol. 2010 is the same abstract. Patients concomitantly exposed to more than one level II opioid during organogenesis were excluded from the study.
Gouraud 2010	France 1984 prospective cohort	13 French pharmacovigilance centers	The first contact to the pharmacovigilance center took place before week 22 after the last menstrual period then contacted by mail or phone after the expected date of delivery.		1st trimester	151 / 973
Källén 2015	Sweden 1997 - 2013 population based cohort retrospective	The Swedish Medical Birth Register	Infants born to women who had reported use of tramadol in early pregnancy.	unexposed (general population or NOS) Infants born to women who did not reported use of tramadol in early pregnancy.	early pregnancy	1776 / 1797678
Källén 2015	Sweden 1997 - 2013 population based cohort retrospective	The Swedish Medical Birth Register	Interviews made by midwives at the first antenatal care visit of the pregnant woman, in most cases during weeks 10–12.		early pregnancy	1776 / 1797678
Sørensen 2022	Denmark 1997 - 2016 population based cohort retrospective	The Danish National Patient Register and the Danish Medical Birth Register,the Danish, National Prescription Register, the Income Statistics Register, the Danish Education Register and the Danish Civil Registration System.	Pregnant women with redemption of at least one prescription of tramadol within the first trimester of pregnancy (for major malformations) or within the first 22 weeks of pregnancy (for spontaneous abortions).	unexposed (general population or NOS) Pregnant women without exposure to tramadol (no redemption of a tramadol prescription during the specific exposure period).	1st trimester, early pregnancy	7310 / 1643339	Analyses on major congenital malformations were based on pregnancies resulting in a live birth.
Sørensen 2022	Denmark 1997 - 2016 population based cohort retrospective		Gathered from the Danish National Prescription Register.		1st trimester, early pregnancy	7310 / 1643339

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

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

Empty. There are no case-control studies available for this drug.

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