Solid Organ TransplantationNCT07291258
Long-term Follow-up of the Offspring Born to Mothers With a Solid Organ Transplant, Transplantlines Next Generation
An observational study of Solid Organ Transplantation and Pregnancy, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Background Pregnancy after all types of solid organ transplantation (SOT) is possible, although these have higher risk of pregnancy complications for mother and child, such as preeclampsia and preterm birth. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Solid Organ Transplantation, Pregnancy, Long-term Follow-up
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Oct 2025to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All offspring born after maternal KTx or LiTx and aged ≥16 years in the Netherlands will be eligible for inclusion. All offspring, at any age born after PTx (including pancreas islet transplantation), HTx or LuTx in the Netherlands will be eligible for inclusion. For all participants it will be emphasized that the invasive test (blood sample) is optional, participants can still participate in the study if they don't want a blood sample taken (or if they don't want to participate in another specific part of the study.) Data will be compared to reference values and/or existing birth cohorts, and if applicable, part of the data will be compared to a control group of healthy adolescents and (young) adults from existing birth cohorts or the Lifelines cohort.
Who may be able to join
- Mother with a KTx, LiTx, PTx (including pancreas islet transplantation), HTx or LuTx before pregnancy (including mothers with multiple transplantation types)
- Age ≥16 years for offspring born to mother with a KTx or LiTx
Who cannot join
- No informed consent
- Non Dutch or English speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jildau R. Meinderts, MD contact
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, Provincie Groningen, 9713GZ
Margriet F.C. de Jong, MD, PhD, MBA, +31655256391, m.f.c.de.jong@umcg.nl
About this study
Official title: Long-term Follow-up of the Offspring Born to Mothers With a Solid Organ Transplant
Background Pregnancy after all types of solid organ transplantation (SOT) is possible, although these have higher risk of pregnancy complications for mother and child, such as preeclampsia and preterm birth. Thus, the development of the unborn child seems to be affected by the transplant and its consequences such as the immunosuppressive medication use. Worldwide data regarding follow-up after birth is scarce. The very limited existing data existing only in young children are reassuring. However, the investigators hypothesize that there are health risks for the children. Given the side effects of the immunosuppressive medication on patients and limited knowledge from animal studies, the investigators particularly expect cardiovascular effects such as hypertension and kidney damage. These develop over a long time-period and lead late to symptoms.
Aims Aim of this study is to gain more insight into the overall health of offspring born after SOT. Primary aim is to assess the cardiovascular health and the presence of kidney disease, and compare these with reference values from the general population or birth cohorts. Secondary aims are the immunological status including the microbiome of the child given the maternal immunosuppressive medication use, and the overall development of the offspring, including qualitative research regarding the quality of life. Third aim is to assess if there are differences in health between offspring born to mothers with a kidney, liver, pancreas (including pancreas islet), heart and lung transplantation (KTx, LiTx, PTx, HTx, LuTx resp.). The investigators also want to establish a biobank for later follow-up research.
Read more
Study design This will be a cross-sectional monocenter cohort study. All offspring ≥16 years of age born after KTx or LiTx and all offspring born at any age after PTx, HTx and LuTx in the Netherlands will be eligible for inclusion. The investigators estimate that there will be about 150(-220) participants. Before the study visit, participants will be asked to complete a questionnaire. Participants will be invited for a one-time study visit consisting of physical tests (including ultrasound of the kidneys and a 24-hour ambulatory blood pressure measurement) and biological sample (urine, blood and feces) collection, including sample collection for biobanking. Information about the growth and development of the offspring and, if present, diseases and medication use will be collected from the medical files of the general practitioner and pharmacy (LSP) and from data from the youth healthcare check-ups. As a control group pseudoanonymized data from the Lifelines cohort will be used.
Deliverables To the best of our knowledge, this will be the first study worldwide that will gather and analyze detailed information about the cardiovascular, kidney and immunological health at a later age (≥16 years) in the offspring born to mothers after KTx, LiTx, PTx, HTx and LuTx. This information will be important for the preconceptional counseling of families with a pregnancy wish after transplantation and thereby contribute to the health of women with a SOT. Next to that, find adverse effects of the pregnancy after transplantation on the offspring are found, the investigators expect there will be modifiable factors and/or early screening/interventions that can reduce these risks and thereby contribute to the health of the offspring.
Read the detailed description
Rationale:
Studies have reported successful pregnancy outcomes with healthy newborns after all types of solid organ transplantations (SOT). A recent systematic review performed by our center focused on the longer term outcomes (>1 year) of the children born after SOT. We found that data regarding longer term follow-up is scarce, limited to younger children and predominately focused on offspring born after kidney transplantation (KTx) and liver transplantation (LiTx). Only five studies reported outcomes on offspring aged >18 years. The limited existing data in young children are reassuring, development and overall health appears to be similar to the general population. However, it is possible that the development of the fetus is affected by the transplantation and its consequences such as the use of the immunosuppressive medication and the increased incidence of the pregnancy complications, whereby important health risks only become apparent later in life. To gain more insight into the overall health of the offspring born solid organ transplantation and to identify possible pre- and perinatal risks for diseases later in life the investigators want to perform a cross-sectional cohort study. To the best of our knowledge, this will be the first study that will gather and analyze detailed information about the cardiovascular, immunological and kidney health at a later age (≥16 years) in the offspring born to mothers after KTx, LiTx, pancreas (including pancreas islet transplantation), heart and lung transplantation (PTx, HTx, LuTx resp.)
Objective:
The primary aim of this study is to assess the cardiovascular and kidney health of the offspring born after SOT in the mother. Secondary aims are the immunological status including the microbiome of the child and the overall development of the offspring. Third, the investigators want to assess if there are differences in health between offspring born to mothers with a KTx, LiTx, PTx, HTx and LuTx. For the offspring aged <16 years of age the aim is to compare their overall health to the general population.
Study design:
This will be a descriptive cross-sectional monocenter cohort study. All offspring ≥16 years of age born after KTx or LiTx and all offspring born at any age after PTx, HTx and LuTx in the Netherlands will be eligible for inclusion. Eligible participants will be identified via previous studies on pregnancy after KTx, LiTx, HTx and LuTx. Participants will be invited for a one-time study visit consisting of questionnaires, physical tests (including ultrasound of the kidneys) and biological sample (urine, blood and feces) collection. Next to that a 24-hour ambulatory blood pressure measurement will be performed in the participants ≥16 years. The biological sample collection will include sample collection for a biobank. The collection will be in line with the Transplantlines Biobank (METc 2014/077) and an amendment to the Transplantlines Biobank is made and specific informed consent for linking the data of Transplantlines and the current study will be obtained from all participants. For all participants it will be emphasized that the invasive test (blood sample) is optional, participants can still participate in the study if they don't want a blood sample taken. For the participants aged <16 years of age no blood, urine and feces sample will be taken, no ultrasound of the kidney will be performed and a dinamap blood pressure measurement instead of a 24-hour measurement will be performed. Furthermore, data on the pregnancy will be used from three recent national studies, data from the PARTOUT network (national working group on pregnancy after renal transplantation), national data collected on pregnancy after LiTx (manuscript in preparation) and national data on pregnancy after HTx and LuTx (manuscript in preparation). National data to be collected on pregnancy after PTx will be identified and collected through our national network with treating physicians. Information about the growth and development of the offspring and, if present, diseases and medication use will be collected from the medical files of the general practitioner and pharmacy (LSP) and from data from the youth healthcare check-ups. Permission to collect this data will be separately mentioned on the IC. As a control group the investigators will evaluate whether reference values and / or data from existing birth cohorts are available. If not, pseudo anonymized data from the Lifelines cohort will be used.
Study population:
The investigators want to include all offspring aged ≥16 years of age born after KTx or LTx in the mother in the Netherlands. Around 165 children after KTx and around 30 children born after LTx will be eligible for inclusion. Because of the scarcity of pregnancies after PTx, HTx and LuTx worldwide, and as a consequence the lack of information about these pregnancies, the investigators want to include all offspring, at any age, born after PTx, HTx or LuTx heart in the Netherlands. Around 5 children born after HTx and around 12 children born after LuTx will be eligible for inclusion, for children born after PTx this number is still unknown, but will be few. In these young participants the focus will be on the overall health of this group in comparison to a control group. Overall data will be compared to reference values and to a control group of healthy adolescents and (young) adults from existing birth cohorts or the Lifelines cohort.
Main study parameters/endpoints:
The primary endpoints of the study focus on the cardiovascular and kidney health which will be assessed by growth charts and developmental information retrospectively collected from the children's health care center, physical tests (weight and height, body fat and water percentage (BIA), waist-hip-ratio, blood pressure, heart rate and ultrasound of the kidneys) and with biological samples (metabolic parameters: glucose, HbA1c, cholesterol, HDL, LDL, triglycerides, as well as kidney functional parameters: albuminuria, estimated GFR, tubular function).
- Conditions
- Solid Organ Transplantation, Pregnancy, Long-term Follow-up, Kidney Transplant, Liver Transplant, Pancreas Transplant
- Keywords
- Solid organ transplantation, Pregnancy, Offspring, Long-term follow-up, kidney transplantation, liver transplantation, pancreas transplantation, pancreas islet transplantation, Heart transplantation, lung transplantation
- Medical subject headings
- Cardiovascular Abnormalities, Kidney Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth charts
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures are growth charts during childhood years.
Measured: Retrospective data on the childhood growth from birth up till 6 years of age and lenght and weight at baseline.
BMI
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures is the BMI based on height (m) and weight (kg).
Measured: Baseline
Body fat and water percentage as measured with a bio-impednace meter (BIA).
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures are the body fat and water percentage as measured with a bio-impednace meter (BIA).
Measured: Baseline
waist-hip ratio
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures are waist-hip-ratio.
Measured: Baseline
Blood pressure
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures is blood pressure, measured with a 240hour ambulatory measurement.
Measured: Baseline
Ultrasound of the kidneys
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures is an ultrasound of the kidneys.
Measured: Baseline
Glucose
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures is the glucose levels.
Measured: Baseline
HbA1c
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures is the HbA1c.
Measured: Baseline
Cholesterol
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures is cholesterol (HDL, LDL, triglycerides)
Measured: Baseline
Albuminuria
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures is albuminuria.
Measured: Baseline
eGFR
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures is estimated GFR.
Measured: Baseline
Pulse wave velocity (PWV)
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures is a 24 hour pulse wave velocity (PWV) measurement.
Measured: Baseline
Troponine
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures is troponine.
Measured: Baseline
creatine kinase
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures is creatine kinase.
Measured: Baseline
High sensitive CRP
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures is high sensitive CRP
Measured: Baseline
Secondary outcomes (10)
Antibiotic use
Secondary aim is the immunological status, assessed by antibiotic use.
Measured: Retrospective, antibiotic use from birth untill study visit (baseline). Subdivided in antibiotic use during childhood (birth untill 18 years of age) and antibiotic use during adult life (18 years of age untill study visit/baseline)
Hospital admissions due to infectious disease
Secondary aim is the immunological status assessed by hospital admissions due to infectious disease.
Measured: Retrospective, hospital admissions from birth until study visit (baseline). Subdivided in admissions during childhood (birth until 18 years of age) and admissions during adult life (18 years of age until study visit/baseline)
IgA
Secondary aim is the immunological status assessed by levels of IgA.
Measured: Baseline
IgM
Secondary aim is the immunological status assessed by levels of IgM.
Measured: Baseline
IgG
Secondary aim is the immunological status assessed by levels of IgG
Measured: Baseline
Leukocyte profiles
Secondary aim is the immunological status assessed by quantitaive analyses of leukocyte profiles
Measured: Baseline
School level
Secondary aim is the overall development of the offspring assessed by school level.
Measured: Highest education at time of study visit (baseline) and retrospective data on special education during primary school and secondary school.
Quality of life ("Positive health questionnaire")
Secondary aim is the overall development of the offspring assessed by Quality of Life questionnaire ("positive health questionnaire")
Measured: Baseline
Chronic diseases
Secondary aim is the overall development of the offspring assessed by the presence of chronic diseases
Measured: Retrospective, presence of a chronic disease from birth until study visit (baseline). Subdivided in chronic disease during childhood (birth until 18 years of age) and chronic disease during adult life (18 years of age until study visit/baseline)
Chronic medication
Secondary aim is the overall health of the offspring assessed by the use of chronic medication
Measured: Retrospective, presence of chronic medication use from birth until study visit (baseline. Subdivided in chronic medication use during childhood (birth until 18 years of age) and chronic medication use during adult life (18 years of age until study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start15 Oct 2025
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Solid Organ TransplantationStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Groningen Transplantation Fund (GTC), Dutch Transplantation Fund, Dutch Kidney Foundation, Astellas Pharma Europe B.V., Stichting Eerstelijns Diagnostiek Nederland (SEDN)
- Responsible party
- Sponsor
- Investigators
- Margriet F.C. de Jong, MD, PhD, MBA, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291258
- Sponsor's protocol ID
- METc 2023/610
- Other IDs
- 10768, NL85646.042.23
- Status last verified
- Nov 2025
- First submitted
- 3 Sep 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Transplant Pregnancy Registry International (TPRI), 2022 annual report, Gift of Life Institute, Philadelphia, PA.
Eisenga MF, Gomes-Neto AW, van Londen M, Ziengs AL, Douwes RM, Stam SP, Oste MCJ, Knobbe TJ, Hessels NR, Buunk AM, Annema C, Siebelink MJ, Racz E, Spikman JM, Bodewes FAJA, Pol RA, Berger SP, Drost G, Porte RJ, Leuvenink HGD, Damman K, Verschuuren EAM, de Meijer VE, Blokzijl H, Bakker SJL. Rationale and design of TransplantLines: a prospective cohort study and biobank of solid organ transplant recipients. BMJ Open. 2018 Dec 31;8(12):e024502. doi: 10.1136/bmjopen-2018-024502.
PubMed 30598488Slabiak-Blaz N, Adamczak M, Gut N, Grajoszek A, Nyengaard JR, Ritz E, Wiecek A. Administration of Cyclosporine A in Pregnant Rats - the Effect on Blood Pressure and on the Glomerular Number in Their Offspring. Kidney Blood Press Res. 2015;40(4):413-23. doi: 10.1159/000368515. Epub 2015 Jul 27.
PubMed 26227088Tendron-Franzin A, Gouyon JB, Guignard JP, Decramer S, Justrabo E, Gilbert T, Semama DS. Long-term effects of in utero exposure to cyclosporin A on renal function in the rabbit. J Am Soc Nephrol. 2004 Oct;15(10):2687-93. doi: 10.1097/01.ASN.0000139069.59466.D8.
PubMed 15466273Lewandowski AJ, Leeson P. Preeclampsia, prematurity and cardiovascular health in adult life. Early Hum Dev. 2014 Nov;90(11):725-9. doi: 10.1016/j.earlhumdev.2014.08.012. Epub 2014 Sep 7.
PubMed 25209092Lindstrom L, Skjaerven R, Bergman E, Lundgren M, Klungsoyr K, Cnattingius S, Wikstrom AK. Chronic Hypertension in Women after Perinatal Exposure to Preeclampsia, Being Born Small for Gestational Age or Preterm. Paediatr Perinat Epidemiol. 2017 Mar;31(2):89-98. doi: 10.1111/ppe.12346. Epub 2017 Feb 20.
PubMed 28218407Shah S, Venkatesan RL, Gupta A, Sanghavi MK, Welge J, Johansen R, Kean EB, Kaur T, Gupta A, Grant TJ, Verma P. Pregnancy outcomes in women with kidney transplant: Metaanalysis and systematic review. BMC Nephrol. 2019 Jan 23;20(1):24. doi: 10.1186/s12882-019-1213-5.
PubMed 30674290Valentin N, Guerrido I, Rozenshteyn F, Pinotti R, Wu YC, Collins K, Shah M, Hershman M, Weisberg I. Pregnancy Outcomes After Liver Transplantation: A Systematic Review and Meta-Analysis. Am J Gastroenterol. 2021 Mar 1;116(3):491-504. doi: 10.14309/ajg.0000000000001105.
PubMed 33657039Meinderts JR, Prins JR, Berger SP, De Jong MFC. Follow-Up of Offspring Born to Parents With a Solid Organ Transplantation: A Systematic Review. Transpl Int. 2022 Aug 5;35:10565. doi: 10.3389/ti.2022.10565. eCollection 2022.
PubMed 35992748Meinderts JR, Berger SP, Bakker SJL, de Jong MFC; COMPACT network group authorship. Rationale and design of a prospective cohort study and biobank of the offspring born to mothers with a solid organ transplant: protocol for the TransplantLines Next Generation study. BMJ Open. 2026 Jul 21;16(7):e115736. doi: 10.1136/bmjopen-2025-115736.
PubMed 42481191
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of the Offspring Born to Mothers With a Solid Organ Transplant
- ClinicalTrials.gov ID
- NCT07291258
- Acronym / sponsor ID
- METc 2023/610
- Conditions
- Solid Organ Transplantation, Pregnancy, Long-term Follow-up, Kidney Transplant, Liver Transplant, Pancreas Transplant
- Keywords
- Solid organ transplantation, Pregnancy, Offspring, Long-term follow-up, kidney transplantation, liver transplantation, pancreas transplantation, pancreas islet transplantation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Groningen Transplantation Fund (GTC), Dutch Transplantation Fund, Dutch Kidney Foundation, Astellas Pharma Europe B.V., Stichting Eerstelijns Diagnostiek Nederland (SEDN)
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background Pregnancy after all types of solid organ transplantation (SOT) is possible, although these have higher risk of pregnancy complications for mother and child, such as preeclampsia and preterm birth. Thus, the development of the unborn child seems to be affected by the transplant and its consequences such as the immunosuppressive medication use. Worldwide data regarding follow-up after birth is scarce. The very limited existing data existing only in young children are reassuring. However, the investigators hypothesize that there are health risks for the children. Given the side effects of the immunosuppressive medication on patients and limited knowledge from animal studies, the investigators particularly expect cardiovascular effects such as hypertension and kidney damage. These develop over a long time-period and lead late to symptoms.
Aims Aim of this study is to gain more insight into the overall health of offspring born after SOT. Primary aim is to assess the cardiovascular health and the presence of kidney disease, and compare these with reference values from the general population or birth cohorts. Secondary aims are the immunological status including the microbiome of the child given the maternal immunosuppressive medication use, and the overall development of the offspring, including qualitative research regarding the quality of life. Third aim is to assess if there are differences in health between offspring born to mothers with a kidney, liver, pancreas (including pancreas islet), heart and lung transplantation (KTx, LiTx, PTx, HTx, LuTx resp.). The investigators also want to establish a biobank for later follow-up research.
Study design This will be a cross-sectional monocenter cohort study. All offspring ≥16 years of age born after KTx or LiTx and all offspring born at any age after PTx, HTx and LuTx in the Netherlands will be eligible for inclusion. The investigators estimate that there will be about 150(-220) participants. Before the study visit, participants will be asked to complete a questionnaire. Participants will be invited for a one-time study visit consisting of physical tests (including ultrasound of the kidneys and a 24-hour ambulatory blood pressure measurement) and biological sample (urine, blood and feces) collection, including sample collection for biobanking. Information about the growth and development of the offspring and, if present, diseases and medication use will be collected from the medical files of the general practitioner and pharmacy (LSP) and from data from the youth healthcare check-ups. As a control group pseudoanonymized data from the Lifelines cohort will be used.
Deliverables To the best of our knowledge, this will be the first study worldwide that will gather and analyze detailed information about the cardiovascular, kidney and immunological health at a later age (≥16 years) in the offspring born to mothers after KTx, LiTx, PTx, HTx and LuTx. This information will be important for the preconceptional counseling of families with a pregnancy wish after transplantation and thereby contribute to the health of women with a SOT. Next to that, find adverse effects of the pregnancy after transplantation on the offspring are found, the investigators expect there will be modifiable factors and/or early screening/interventions that can reduce these risks and thereby contribute to the health of the offspring.
Detailed description
Rationale:
Studies have reported successful pregnancy outcomes with healthy newborns after all types of solid organ transplantations (SOT). A recent systematic review performed by our center focused on the longer term outcomes (>1 year) of the children born after SOT. We found that data regarding longer term follow-up is scarce, limited to younger children and predominately focused on offspring born after kidney transplantation (KTx) and liver transplantation (LiTx). Only five studies reported outcomes on offspring aged >18 years. The limited existing data in young children are reassuring, development and overall health appears to be similar to the general population. However, it is possible that the development of the fetus is affected by the transplantation and its consequences such as the use of the immunosuppressive medication and the increased incidence of the pregnancy complications, whereby important health risks only become apparent later in life. To gain more insight into the overall health of the offspring born solid organ transplantation and to identify possible pre- and perinatal risks for diseases later in life the investigators want to perform a cross-sectional cohort study. To the best of our knowledge, this will be the first study that will gather and analyze detailed information about the cardiovascular, immunological and kidney health at a later age (≥16 years) in the offspring born to mothers after KTx, LiTx, pancreas (including pancreas islet transplantation), heart and lung transplantation (PTx, HTx, LuTx resp.)
Objective:
The primary aim of this study is to assess the cardiovascular and kidney health of the offspring born after SOT in the mother. Secondary aims are the immunological status including the microbiome of the child and the overall development of the offspring. Third, the investigators want to assess if there are differences in health between offspring born to mothers with a KTx, LiTx, PTx, HTx and LuTx. For the offspring aged <16 years of age the aim is to compare their overall health to the general population.
Study design:
This will be a descriptive cross-sectional monocenter cohort study. All offspring ≥16 years of age born after KTx or LiTx and all offspring born at any age after PTx, HTx and LuTx in the Netherlands will be eligible for inclusion. Eligible participants will be identified via previous studies on pregnancy after KTx, LiTx, HTx and LuTx. Participants will be invited for a one-time study visit consisting of questionnaires, physical tests (including ultrasound of the kidneys) and biological sample (urine, blood and feces) collection. Next to that a 24-hour ambulatory blood pressure measurement will be performed in the participants ≥16 years. The biological sample collection will include sample collection for a biobank. The collection will be in line with the Transplantlines Biobank (METc 2014/077) and an amendment to the Transplantlines Biobank is made and specific informed consent for linking the data of Transplantlines and the current study will be obtained from all participants. For all participants it will be emphasized that the invasive test (blood sample) is optional, participants can still participate in the study if they don't want a blood sample taken. For the participants aged <16 years of age no blood, urine and feces sample will be taken, no ultrasound of the kidney will be performed and a dinamap blood pressure measurement instead of a 24-hour measurement will be performed. Furthermore, data on the pregnancy will be used from three recent national studies, data from the PARTOUT network (national working group on pregnancy after renal transplantation), national data collected on pregnancy after LiTx (manuscript in preparation) and national data on pregnancy after HTx and LuTx (manuscript in preparation). National data to be collected on pregnancy after PTx will be identified and collected through our national network with treating physicians. Information about the growth and development of the offspring and, if present, diseases and medication use will be collected from the medical files of the general practitioner and pharmacy (LSP) and from data from the youth healthcare check-ups. Permission to collect this data will be separately mentioned on the IC. As a control group the investigators will evaluate whether reference values and / or data from existing birth cohorts are available. If not, pseudo anonymized data from the Lifelines cohort will be used.
Study population:
The investigators want to include all offspring aged ≥16 years of age born after KTx or LTx in the mother in the Netherlands. Around 165 children after KTx and around 30 children born after LTx will be eligible for inclusion. Because of the scarcity of pregnancies after PTx, HTx and LuTx worldwide, and as a consequence the lack of information about these pregnancies, the investigators want to include all offspring, at any age, born after PTx, HTx or LuTx heart in the Netherlands. Around 5 children born after HTx and around 12 children born after LuTx will be eligible for inclusion, for children born after PTx this number is still unknown, but will be few. In these young participants the focus will be on the overall health of this group in comparison to a control group. Overall data will be compared to reference values and to a control group of healthy adolescents and (young) adults from existing birth cohorts or the Lifelines cohort.
Main study parameters/endpoints:
The primary endpoints of the study focus on the cardiovascular and kidney health which will be assessed by growth charts and developmental information retrospectively collected from the children's health care center, physical tests (weight and height, body fat and water percentage (BIA), waist-hip-ratio, blood pressure, heart rate and ultrasound of the kidneys) and with biological samples (metabolic parameters: glucose, HbA1c, cholesterol, HDL, LDL, triglycerides, as well as kidney functional parameters: albuminuria, estimated GFR, tubular function).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All offspring born after maternal KTx or LiTx and aged ≥16 years in the Netherlands will be eligible for inclusion. All offspring, at any age born after PTx (including pancreas islet transplantation), HTx or LuTx in the Netherlands will be eligible for inclusion. For all participants it will be emphasized that the invasive test (blood sample) is optional, participants can still participate in the study if they don't want a blood sample taken (or if they don't want to participate in another specific part of the study.) Data will be compared to reference values and/or existing birth cohorts, and if applicable, part of the data will be compared to a control group of healthy adolescents and (young) adults from existing birth cohorts or the Lifelines cohort.
Key inclusion criteria (2 listed)
- Mother with a KTx, LiTx, PTx (including pancreas islet transplantation), HTx or LuTx before pregnancy (including mothers with multiple transplantation types)
- Age ≥16 years for offspring born to mother with a KTx or LiTx
Key exclusion criteria (2 listed)
- No informed consent
- Non Dutch or English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Growth charts
Time frame: Retrospective data on the childhood growth from birth up till 6 years of age and lenght and weight at baseline.
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures are growth charts during childhood years.
BMI
Time frame: Baseline
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures is the BMI based on height (m) and weight (kg).
Body fat and water percentage as measured with a bio-impednace meter (BIA).
Time frame: Baseline
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures are the body fat and water percentage as measured with a bio-impednace meter (BIA).
waist-hip ratio
Time frame: Baseline
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures are waist-hip-ratio.
Blood pressure
Time frame: Baseline
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures is blood pressure, measured with a 240hour ambulatory measurement.
Ultrasound of the kidneys
Time frame: Baseline
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures is an ultrasound of the kidneys.
Glucose
Time frame: Baseline
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures is the glucose levels.
HbA1c
Time frame: Baseline
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures is the HbA1c.
Cholesterol
Time frame: Baseline
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures is cholesterol (HDL, LDL, triglycerides)
Albuminuria
Time frame: Baseline
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures is albuminuria.
eGFR
Time frame: Baseline
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures is estimated GFR.
Pulse wave velocity (PWV)
Time frame: Baseline
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures is a 24 hour pulse wave velocity (PWV) measurement.
Troponine
Time frame: Baseline
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures is troponine.
creatine kinase
Time frame: Baseline
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures is creatine kinase.
High sensitive CRP
Time frame: Baseline
The primary aim is to assess the cardiovascular and renal health of the offspring born after maternal SOT. One of the outcome measures is high sensitive CRP
10 secondary outcomes
Antibiotic use
Time frame: Retrospective, antibiotic use from birth untill study visit (baseline). Subdivided in antibiotic use during childhood (birth untill 18 years of age) and antibiotic use during adult life (18 years of age untill study visit/baseline)
Hospital admissions due to infectious disease
Time frame: Retrospective, hospital admissions from birth until study visit (baseline). Subdivided in admissions during childhood (birth until 18 years of age) and admissions during adult life (18 years of age until study visit/baseline)
IgA
Time frame: Baseline
IgM
Time frame: Baseline
IgG
Time frame: Baseline
Leukocyte profiles
Time frame: Baseline
School level
Time frame: Highest education at time of study visit (baseline) and retrospective data on special education during primary school and secondary school.
Quality of life ("Positive health questionnaire")
Time frame: Baseline
Chronic diseases
Time frame: Retrospective, presence of a chronic disease from birth until study visit (baseline). Subdivided in chronic disease during childhood (birth until 18 years of age) and chronic disease during adult life (18 years of age until study visit/baseline)
Chronic medication
Time frame: Retrospective, presence of chronic medication use from birth until study visit (baseline. Subdivided in chronic medication use during childhood (birth until 18 years of age) and chronic medication use during adult life (18 years of age until study visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Results publicationTransplant Pregnancy Registry International (TPRI), 2022 annual report, Gift of Life Institute, Philadelphia, PA.
- Results publication: PubMed 30598488Eisenga MF, Gomes-Neto AW, van Londen M, Ziengs AL, Douwes RM, Stam SP, Oste MCJ, Knobbe TJ, Hessels NR, Buunk AM, Annema C, Siebelink MJ, Racz E, Spikman JM, Bodewes FAJA, Pol RA, Berger SP, Drost G, Porte RJ, Leuvenink HGD, Damman K, Verschuuren EAM, de Meijer VE, Blokzijl H, Bakker SJL. Rationale and design of TransplantLines: a prospective cohort study and biobank of solid organ transplant recipients. BMJ Open. 2018 Dec 31;8(12):e024502. doi: 10.1136/bmjopen-2018-024502.
- Results publication: PubMed 26227088Slabiak-Blaz N, Adamczak M, Gut N, Grajoszek A, Nyengaard JR, Ritz E, Wiecek A. Administration of Cyclosporine A in Pregnant Rats - the Effect on Blood Pressure and on the Glomerular Number in Their Offspring. Kidney Blood Press Res. 2015;40(4):413-23. doi: 10.1159/000368515. Epub 2015 Jul 27.
- Results publication: PubMed 15466273Tendron-Franzin A, Gouyon JB, Guignard JP, Decramer S, Justrabo E, Gilbert T, Semama DS. Long-term effects of in utero exposure to cyclosporin A on renal function in the rabbit. J Am Soc Nephrol. 2004 Oct;15(10):2687-93. doi: 10.1097/01.ASN.0000139069.59466.D8.
- Results publication: PubMed 25209092Lewandowski AJ, Leeson P. Preeclampsia, prematurity and cardiovascular health in adult life. Early Hum Dev. 2014 Nov;90(11):725-9. doi: 10.1016/j.earlhumdev.2014.08.012. Epub 2014 Sep 7.
- Results publication: PubMed 28218407Lindstrom L, Skjaerven R, Bergman E, Lundgren M, Klungsoyr K, Cnattingius S, Wikstrom AK. Chronic Hypertension in Women after Perinatal Exposure to Preeclampsia, Being Born Small for Gestational Age or Preterm. Paediatr Perinat Epidemiol. 2017 Mar;31(2):89-98. doi: 10.1111/ppe.12346. Epub 2017 Feb 20.
- Results publication: PubMed 30674290Shah S, Venkatesan RL, Gupta A, Sanghavi MK, Welge J, Johansen R, Kean EB, Kaur T, Gupta A, Grant TJ, Verma P. Pregnancy outcomes in women with kidney transplant: Metaanalysis and systematic review. BMC Nephrol. 2019 Jan 23;20(1):24. doi: 10.1186/s12882-019-1213-5.
- Results publication: PubMed 33657039Valentin N, Guerrido I, Rozenshteyn F, Pinotti R, Wu YC, Collins K, Shah M, Hershman M, Weisberg I. Pregnancy Outcomes After Liver Transplantation: A Systematic Review and Meta-Analysis. Am J Gastroenterol. 2021 Mar 1;116(3):491-504. doi: 10.14309/ajg.0000000000001105.
- Results publication: PubMed 35992748Meinderts JR, Prins JR, Berger SP, De Jong MFC. Follow-Up of Offspring Born to Parents With a Solid Organ Transplantation: A Systematic Review. Transpl Int. 2022 Aug 5;35:10565. doi: 10.3389/ti.2022.10565. eCollection 2022.
- Derived from this study: PubMed 42481191Meinderts JR, Berger SP, Bakker SJL, de Jong MFC; COMPACT network group authorship. Rationale and design of a prospective cohort study and biobank of the offspring born to mothers with a solid organ transplant: protocol for the TransplantLines Next Generation study. BMJ Open. 2026 Jul 21;16(7):e115736. doi: 10.1136/bmjopen-2025-115736.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jildau R. Meinderts, MD contact
Margriet F.C. de Jong, MD, PhD, MBA principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Organ Transplantation and Pregnancy, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margriet F.C. de Jong, MD, PhD, MBA (+31655256391, m.f.c.de.jong@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth charts (time frame: Retrospective data on the childhood growth from birth up till 6 years of age and lenght and weight at baseline.). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07291258, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.