Open-access Safety of Pregnancy Following Solid Organ Transplantation: A Scoping Review

ABSTRACT

Objective:  To conduct a scoping review to identify the clinical monitoring of pregnancy in women who have undergone liver, kidney, heart, and lung transplantation, with the aim of assessing the safety of pregnancy in this context.

Methods:  This is a scoping review conducted through searches in the MEDLINE/PubMed, LILACS, and SciELO databases, including studies published between 2014 and 2024.

Results:  A total of 45 studies were included, selected from 1,206 records, with a predominance of publications on kidney transplantation (77.7%). Maternal age at conception ranged from 18 to 45 years. Neonatal outcomes were evaluated in 71% of the studies, which reported a wide variation in gestational age at birth, with records ranging from 24 weeks to gestational ages greater than 37 weeks. Birth weights also ranged from 554 g to 4,256 g, abortion rates between 3% and 41%, and the occurrence of congenital malformations between 3% and 21%. Regarding maternal outcomes, addressed by 84% of the studies, the data indicate a prevalence of blood pressure abnormalities, pre-eclampsia, and gestational diabetes. Immunosuppressants were addressed in 68% of the studies, with tacrolimus being widely used, while mycophenolate was systematically contraindicated due to its recognized teratogenic potential.

Conclusion:  The results demonstrated that pregnancy after transplantation is feasible and safe. According to the included studies, the main determinants of maternal–fetal safety include a minimum interval of 12 months between transplantation and conception, family planning, stable graft function and discontinuation of mycophenolate use. This review contributes to guiding evidence-based clinical practices in the context of post-transplant pregnancy.

Descriptors
Organ Transplantation; Maternal and Child Health; Scoping Review; Immunosuppressive Agents

RESUMO

Objetivo:  Realizar uma revisão de escopo para identificar o acompanhamento clínico da gestação em mulheres submetidas a transplantes de fígado, rim, coração e pulmão, com o objetivo de verificar a segurança da gestação nesse contexto.

Metodologia:  Trata-se de uma revisão de escopo realizada a partir de pesquisa nas bases de dados Medical Literature Analysis and Retrieval System Online (MEDLINE/PubMed), Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS) e Scientific Electronic Library Online (SciELO), contemplando os estudos de 2014 a 2024.

Resultados:  Foram incluídos 45 estudos, selecionados a partir de 1.206 registros, com predominância de publicações sobre transplante renal (77,7%). Observou-se que a idade materna no momento da concepção variou entre 18 e 45 anos. Os desfechos neonatais foram avaliados em 71% dos estudos, que relataram ampla variação na idade gestacional ao nascimento, com registros desde 24 semanas até idades gestacionais superiores a 37 semanas. Também foram reportados pesos ao nascer variando de 554 g a 4.256 g, taxas de aborto entre 3% e 41% e ocorrência de malformações congênitas entre 3% e 21%. Em relação aos desfechos maternos, abordados por 84%, os dados apontam para uma prevalência de alterações da pressão arterial, pré-eclâmpsia e diabetes gestacional. Os imunossupressores foram abordados em 68% dos estudos, com ampla utilização de tacrolimo, enquanto o micofenolato foi sistematicamente contraindicado devido ao seu reconhecido potencial teratogênico.

Conclusão:  Os resultados demonstraram que a gestação após a realização de um transplante é viável e segura. De acordo com os estudos incluídos, os principais fatores determinantes para a segurança materno-fetal incluem intervalo mínimo entre o transplante e a concepção de 12 meses, planejamento familiar, função estável do enxerto e ausência de uso de micofenolato. A revisão contribui para orientar condutas clínicas baseadas em evidências no contexto da gestação pós-transplante.

Descritores
Transplante de Órgãos; Saúde Materno-Infantil; Revisão de Escopo; Imunossupressores

INTRODUCTION

Solid organ transplantation is an effective treatment for several chronic diseases, providing a significant improvement in patients' quality of life1. With advances in surgical techniques and immunosuppressive management, the number of transplant recipients living for extended periods is growing, including women of childbearing age with reproductive desires2,3.

Pregnancy following solid organ transplantation, such as kidney, liver, lung, and heart transplants, is considered a high-risk obstetric condition. The main challenges in this scenario involve the continuous use of immunosuppressant medications – essential for preventing graft rejection – and their potential impacts on maternal and fetal health4,5. Although some immunosuppressants, such as tacrolimus and cyclosporine, have a relatively safe profile during pregnancy, others, such as antimetabolic agents (mycophenolate sodium/mofetil), are associated with teratogenicity and require discontinuation before conception5-7. In addition to these effects on the fetus, transplanted women who become pregnant have a higher risk of obstetric complications, such as pre-eclampsia and gestational diabetes8,2.

Despite advancements, the available evidence on the safety of pregnancy in this context remains limited. Therefore, integrating available knowledge is essential. This study aims to evaluate the safety of pregnancy after solid organ transplantation (liver, lung, heart, and kidney) through a scoping review.

METHODS

This scoping review was developed based on the methodological framework outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines9,10.

The search strategy was conducted across the following databases: Medical Literature Analysis and Retrieval System Online (MEDLINE/PubMed), Latin American and Caribbean Health Sciences Literature (Literatura Latino-Americana e do Caribe em Ciências da Saúde-LILACS) via the Virtual Health Library (Biblioteca Virtual em Saúde-BVS), and Scientific Electronic Library Online (SciELO).

Table 1 describes the term combinations used in each database. Inclusion criteria considered studies conducted from 2014 to 2024 that addressed the management of pregnancy after solid organ transplantation (liver, lung, heart, and kidney). Studies with only a published abstract, without full text available, literature reviews, case studies, letters to the editor, duplicate articles in the databases, and studies that did not address the proposed theme were excluded.

Table 1
Descriptors used for searching the different databases.

The studies were preselected by reviewing titles and abstracts and by applying the inclusion and exclusion criteria. For this stage, the Rayyan® application was used, and two reviewers independently evaluated the studies. A third reviewer assessed any discrepancies found, which were subsequently resolved by consensus. In the second stage, the preselected articles were read in full, and those that matched the research topic were included in the review. The research was conducted in June 2025.

RESULTS

The database search identified 1,206 studies. After the selection process (Fig. 1), 45 studies were included (Table 2). The temporal scope of the studies ranged from 2014 to 2024, with 46% (n = 21) published in the last 5 years analyzed. Regarding the country of origin of the studies, the data are dispersed, with the majority (17%; n = 8) conducted in the United States (USA). Brazil appears in this review with 3 publications (6.6%).

Table 2
Studies included in the scoping review (n = 45).
Figure 1
Study selection process.

Most articles addressed pregnancy after kidney transplantation, representing 77.7% (n = 35). Pregnancy after liver transplantation was addressed in 28.8% of the studies (n = 13), followed by heart transplantation (8.8%; n = 4) and lung transplantation (6.6%; n = 3). It is important to note that a single study addressed more than one organ, which justifies the overlap in the data presented.

The topics covered by the publications were classified into eleven themes, although an article could address more than one theme, namely: Maternal outcomes; Neonatal outcomes; Immunosuppression in pregnancy; Graft function; Demographic and clinical characteristics of recipients (Recipient characteristics); Breastfeeding; Guidance on family planning; Mode of delivery; Maternal perceptions; Management guidelines for the care team; and Pregnancies fathered by male transplant recipients.

The characteristics of the recipients were described in all included studies (n = 45), including age at the time of transplantation, etiology of the indication, age at conception, time interval between transplantation and pregnancy, demographic profile, and presence of comorbidities. Maternal age at conception ranged from 18 to 45 years. All studies indicated that the minimum recommended interval between transplantation and conception is 12 months.

The mode of delivery, characterized as vaginal delivery or cesarean section, was reported in 66% of cases (n = 30). Cesarean section had a prevalence of 49% to 100% across the studies analyzed. Regarding the evaluation of graft function, present in 73% (n = 33), the studies performed a comparative analysis of the functional markers of the transplanted organs before, during, and after gestation.

The theme related to guidance on family planning13,14,20,43,53, present in 11% of cases (n = 5), covers topics such as contraceptive methods and medical team counseling. The theme addressing maternal perception30,41, identified in 4.4% of the articles (n = 2), encompasses physical-psychosocial aspects, the desire for motherhood, and the role of the care team.

Neonatal outcomes were assessed in 71% of the studies (n = 32), which reported wide variation in gestational age at birth, ranging from 24 weeks to >37 weeks. Birth weights also ranged from 554 g to 4,256 g, abortion rates between 3% and 41%, and the occurrence of congenital malformations between 3% and 21%. Regarding maternal outcomes, addressed by 84% (n = 38), the data indicate a prevalence of blood pressure abnormalities, pre-eclampsia, and gestational diabetes.

In a study investigating pregnancies fathered by male transplant recipients27, the use of mycophenolate as immunosuppressive therapy was evaluated, suggesting that paternal exposure to this medication is not statistically associated with congenital malformations or other adverse outcomes when compared to pregnancies without such exposure. Regarding breastfeeding12, the study indicates that the use of tacrolimus as an immunosuppressant during pregnancy does not constitute a contraindication to breastfeeding. The study addressing clinical management guidelines for the care team36 presents recommendations for monitoring these patients, including requesting pre-pregnancy tests, preferentially selecting immunosuppressive therapy and continuous laboratory monitoring during pregnancy.

Immunosuppressants were addressed in 68% of the included studies (n = 31), with most describing the therapeutic regimens used during pregnancy. Figures 2, 3, 4, and 5 present the main reported immunosuppressive therapies, organized according to the transplanted organ. In general, the studies focused on identifying the drugs used throughout pregnancy. Widespread use of tacrolimus was observed, while mycophenolate was systematically contraindicated due to its recognized teratogenic potential.

Figure 2
Description of immunosuppressive therapies used in kidney transplantation (n = 19).
Figure 3
Description of immunosuppressive therapies used in liver transplantation (n = 7).
Figure 4
Description of immunosuppressive therapies used in lung transplantation (n = 3).
Figure 5
Description of immunosuppressive therapies used in heart transplantation (n = 2).

DISCUSSION

This scoping review enabled the mapping and analysis of available evidence regarding factors influencing pregnancy safety in women undergoing solid organ transplantation.

In Brazil, data from the Brazilian Association of Organ Transplantation (Associação Brasileira de Transplante de Órgãos - ABTO)55 show that, in 2024, 9,318 solid organ transplants were performed – including kidney, liver, heart, and lung transplants – with a predominance of kidney transplants (6,325), followed by liver (2,457), heart (443), and lung (93). These data reflect the findings observed in this review, in which pregnancy after kidney transplantation was the most frequently addressed topic.

Data related to maternal outcomes demonstrate that solid organ transplant recipients have a higher risk of developing gestational complications, such as hypertension, gestational diabetes, and pre-eclampsia, compared to the general population – a finding consistent with that reported in other studies5,7,56,57. However, publications emphasize that transplantation does not contraindicate conception.

It is known that, before transplantation, many women experience hormonal imbalances and reproductive dysfunctions due to their underlying disease, which can cause anovulation, irregular menstrual cycles, and infertility58,59. However, studies show that transplanted women can regain fertility shortly after the procedure3,60. Despite this, the findings of this review highlight the scarcity of publications addressing reproductive counseling, suggesting that many patients may not receive adequate guidance.

Tacrolimus is the most frequently used immunosuppressant during pregnancy in studies, reflecting a practice aligned with guidelines indicating its safety during this period4. Despite the essential role of immunosuppressants in graft maintenance, studies have significant limitations in monitoring doses and serum levels during pregnancy. This lack of data highlights a knowledge gap about the behavior of immunosuppressants during pregnancy.

Regarding neonatal outcomes, studies indicate an increased risk of prematurity, low birth weight, and a higher prevalence of miscarriages and malformations. Coffin et al.61 reported that newborns of transplanted women had a three times higher risk of complications. Exposure to immunosuppressants, particularly mycophenolate, known for its teratogenic effect, may contribute to an increased risk of congenital malformations and miscarriages7,8, although its use was limited or contraindicated in the included studies.

Cesarean delivery was the most frequently observed mode of delivery among transplant recipients; however, studies suggest that this high prevalence is more related to gestational complications than to the transplant procedure itself.

The results also demonstrate that maternal perceptions continue to receive little consideration, despite their relevance to family planning. Van Buren, Beck, Lely, van de Wetering and Massey41 report that women stated they had difficulty discussing pregnancy with healthcare staff, often receiving contradictory information. These findings reinforce the importance of clear clinical protocols, promoting safe and informed decision-making.

Concerning breastfeeding, the findings are consistent with the existing literature, indicating that this practice should not be contraindicated56,12. Evidence shows that the concentration of tacrolimus in breast milk is extremely low, with infants receiving less than 1% of the weight-adjusted daily maternal dose62,63.

The study27 that addressed the topic of pregnancies resulting from transplanted men demonstrated an absence of obstetric or neonatal complications among pregnancies with or without paternal exposure to mycophenolate. Despite these findings, recommendations continue to contraindicate the use of mycophenolate in men or women of childbearing age due to its teratogenicity64.

Regarding management guidelines for the healthcare team, the findings indicate that a safe pregnancy requires the fulfillment of three main criteria: (i) a minimum interval of one year post-transplantation, (ii) the absence of mycophenolate use, and (iii) a functioning graft13,14,20. Additionally, it is worth noting that planned pregnancies are more likely to result in the birth of healthy babies without compromising graft function or maternal health, compared with unplanned pregnancies43,53.

In Brazil, despite being among the countries with the highest number of transplants performed55,65, only three studies were identified3,17,22, revealing a gap in national research on the subject. This scarcity of data compromises the development of specific clinical protocols, impacting the care management of women who undergo solid organ transplants and become pregnant in the country.

This study has some limitations. Although the search was conducted across relevant databases, some studies may have been missed, especially those available in databases not included in the research. The heterogeneity across studies makes direct comparisons of results difficult.

CONCLUSION

This scoping review showed that pregnancy in women who have undergone solid organ transplantation is feasible and safe. According to studies, the main determinants of maternal-fetal safety include: an adequate interval between transplantation and conception, family planning, stable graft function, and the absence of mycophenolate use.

Despite the recent increase in publications on the subject, gaps persist in monitoring immunosuppressants during pregnancy, highlighting insufficient data on dose adjustments and immunosuppressant serum levels, which impact clinical management. In the Brazilian context, studies are scarce, highlighting the need for national research to support safe clinical protocols for the management of women who undergo transplantation and wish to become pregnant.

ACKNOWLEDGEMENT

We thank the Hospital de Clínicas de Porto Alegre and the Multiprofessional Residency Program in Surgical Clinic for supporting this research.

  • DECLARATION OF USE OF ARTIFICIAL INTELLIGENCE TOOLS
    The authors declare that no artificial intelligence tools were used in the preparation, writing, data analysis, or review of this manuscript.
  • FUNDING
    Not applicable.

DATA AVAILABILITY STATEMENT

All datasets were generated or analyzed in the current study.

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  • 64 Agência Nacional de Vigilância Sanitária. Risco de teratogenicidade - Novos aconselhamentos sobre a prevenção de gravidez para mulheres e homens em tratamento com CellCept® (micofenolato de mofetila). São Paulo; 2015. [acesso em 2025 nov 16]. Disponível em: https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/cartas-aos-profissionais-de-saude/2017/cellcept-r-micofenolato-de-mofetila-risco-de-teratogenicidade-e-orientacoes-para-a-prevencao-de-gravidez-roche-11-de-dezembro-de-2015
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  • 65 Ministério da Saúde. Brasil é o segundo maior transplantador de órgãos do mundo. Brasília; 2022. [acesso em 2025 nov 16]. Disponível em: https://www.gov.br/saude/pt-br/assuntos/noticias/2022/fevereiro/brasil-e-o-segundo-maior-transplantador-de-orgaos-do-mundo
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Edited by

Publication Dates

  • Publication in this collection
    26 June 2026
  • Date of issue
    2026

History

  • Received
    19 Jan 2026
  • Accepted
    04 May 2026
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