Tramadol (versus unexposed) - Medication and Pregnancy KB

Tramadol (versus unexposed)

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Bowie, 2022	Canada 2013 - 2018	Parent–infant pair records for all live births and stillbirths at more than 20 weeks’ gestation delivered at Ontario hospitals with an estimated date of confinement between the study period.	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.	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.
Ferrer, 2025	France 2004 - 2020	All residents of Haute-Garonne (South-West France) covered by the general health insurance system with pregnancies between July 1, 2004 and December 31, 2020.	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)..	1602 / 158426
Gouraud, 2010	France 1984	Pregnancies for which the first contact to the pharmacovigilance center took place before week 22 after the last menstrual period (LMP).	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.	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.
Källén, 2015	Sweden 1997 - 2013	Births in the Swedish Medical Birth Register during the study period.	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.	1776 / 1797678
Sørensen, 2022	Denmark 1997 - 2016	Two separate cohorts were constructed for the analyses: all registered pregnancies (birth or abortive outcome) to analyze spontanous abortion and pregnancies resulting in a live birth to analyse major malformations.	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).	7310 / 1643339	Analyses on major congenital malformations were based on pregnancies resulting in a live birth.

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk

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

15 studies, not fulfilled eligibility criteria, were excluded. See excluded tab for the list of these studies and reason of exclusion.

master protocol