Actively Recruiting

All Genders
Healthy Volunteers
ID07291258

Long-term Follow-up of the Offspring Born to Mothers With a Solid Organ Transplant, Transplantlines Next Generation

Led by University Medical Center Groningen · Updated on 2025-12-18

200

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

U

University Medical Center Groningen

Lead Sponsor

G

Groningen Transplantation Fund (GTC)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the long-term health of children born to mothers who have undergone solid organ transplantation, such as kidney, liver, pancreas, heart, or lung transplants. These pregnancies may carry higher risks like preeclampsia and preterm birth, and the effects of immunosuppressive medication on the child's development are not well understood. This observational study aims to assess cardiovascular and kidney health, immune status, and overall development of these offspring, comparing them with general population data and across different transplant types. The study involves a one-time visit where participants will complete questionnaires and undergo physical tests including kidney ultrasound, body measurements, and blood pressure monitoring. Biological samples such as urine, blood, and feces will be collected for health assessment and biobanking, with blood samples being optional. For children under 16 years, less invasive tests like blood pressure via a dynamap device will be performed, and no biological samples or kidney ultrasounds will be taken. The study will also gather medical history from healthcare records and compare data with control groups from existing cohorts. Participants will provide information about their growth, development, medication use, and health conditions through questionnaires and medical records review. Researchers will measure outcomes like blood pressure, kidney function, metabolic markers, and immune parameters. Quality of life and educational attainment will also be assessed. This cross-sectional study expects to include about 150 to 220 participants and collects data to better understand health risks and guide future counseling and interventions for families after transplantation pregnancies.

CONDITIONS

Brief Title

Long-term Follow-up of the Offspring Born to Mothers With a Solid Organ Transplant, Transplantlines Next Generation

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Mother with a kidney, liver, pancreas (including pancreas islet), heart, or lung transplant before pregnancy
  • Offspring aged 16 years or older if born to a mother with a kidney or liver transplant
Not Eligible

You will not qualify if you...

  • No informed consent provided
  • Non-Dutch or non-English speaking participants

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single visit

Participants attend a one-time study visit involving questionnaires, physical tests including ultrasound of the kidneys, and optional biological sample collection such as urine, blood, and feces. Participants aged 16 years and older undergo additional 24-hour ambulatory blood pressure measurement, while younger participants have a simpler blood pressure check.

1 visit (in-person)

Long-term Monitoring

Duration - Retrospective data collection from birth to baseline

Data on participants’ growth, development, diseases, medication use, and pregnancy-related history are collected retrospectively from medical records, youth healthcare check-ups, and national pregnancy studies. This stage involves no additional visits and focuses on analyzing health outcomes over time.

No visits required

Trial Site Locations

Total: 1 location

1

University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands, 9713GZ

Actively Recruiting

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Research Team

M

Margriet F.C. de Jong, MD, PhD, MBA

J

Jildau R. Meinderts, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Frequently Asked Questions

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Published Research Related To This Trial

Rationale and design of TransplantLines: a prospective cohort study and biobank of solid organ transplant recipients.

Michele F Eisenga, Antonio W Gomes-Neto, Marco van Londen...

https://pubmed.ncbi.nlm.nih.gov/30598488

Administration of Cyclosporine A in Pregnant Rats - the Effect on Blood Pressure and on the Glomerular Number in Their Offspring.

Natalia Slabiak-Blaz, Marcin Adamczak, Nadezda Gut...

https://pubmed.ncbi.nlm.nih.gov/26227088

Chronic Hypertension in Women after Perinatal Exposure to Preeclampsia, Being Born Small for Gestational Age or Preterm.

Linda Lindström, Rolv Skjaerven, Eva Bergman...

https://pubmed.ncbi.nlm.nih.gov/28218407