Prevalence of major malformations and small for gestational age in newborns of female transplant recipients on tacrolimus-containing regimens during pregnancy.

Publication/Presentation Date

7-22-2025

Abstract

In female transplant recipients, immunosuppressant use during pregnancy raises potential concerns about adverse maternal and fetal outcomes. This non-interventional study used prospectively- and retrospectively-reported cases from the Transplant Pregnancy Registry International from 1991 until 2020. The study used two separate cohorts to evaluate the prevalence of major malformations and small for gestational age (SGA), respectively, among livebirth infants born to female kidney or liver transplant recipients receiving tacrolimus-containing regimens (Tac) or non-tacrolimus-containing regimens (non-Tac). There were 1988 pregnancies (2056 livebirths) in the cohort used to assess the prevalence of malformations and 2172 pregnancies (2248 livebirths) in the cohort used to assess the prevalence of SGA. Prevalence of major malformations was similar in Tac and non-Tac groups: 2.0% and 1.9% in prospectively-reported, and 4.7% and 3.1% in retrospectively-reported cases, respectively (overall adjusted odds ratio (aOR): 1.10; 95% CI: 0.68, 1.81). There was a lower prevalence of SGA in the Tac group than in the non-Tac group: 17.9% and 32.2% in prospectively-reported and 18.1% and 23.5% in retrospectively-reported cases, respectively (overall OR, 0.70; 95% CI, 0.57, 0.87). The use of tacrolimus in female transplant recipients was not associated with a high risk of major malformations or SGA in livebirth infants. HMA-EMA Catalogue of RWD Studies: EUPAS37025.

ISSN

1600-6143

Disciplines

Medicine and Health Sciences

PubMedID

40706680

Department(s)

Department of Surgery

Document Type

Article

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