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NCT Number: NCT07592806

CRISTEL Study: Monitoring of Pregnancies in Women After Solid Organ Transplantation

The objective of this research is to obtain standardized and independent data on the number of pregnancies occurring in France and their follow-up up to 1 year postpartum (or post-pregnancy termination). This study will then aim to describe the clinical characteristics and maternal and perinatal outcomes of pregnancies in this specific population. These data will enable the dissemination of clear and up-to-date information to the medical community, thus contributing to better patient counseling and, more broadly, to couples. They will also serve to issue recommendations to optimize the planning and follow-up of pregnancies in women with solid organ transplants. Finally, this initiative aims to promote clinical research on pregnancies.

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Key information

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

According to North American and Australian registries, pregnancy is both a joyful and high-risk event for women who have received a solid organ transplant. Typically, a transplanted woman has a probability comparable to that of the general population of giving birth to a live infant, but she is likely to deliver prematurely (median gestational age: 32 weeks), to have a growth-restricted baby (median birth weight around 2.3 kg), and often in a context of preeclampsia (in at least 30% of cases)(1).

Today, these are the data shared with patients planning a pregnancy, despite uncertainty as to their accuracy and applicability in France or even Europe.

Among the unknowns that remain despite these registry data, the following should be noted:

Uncertainty about the level of pregnancy planning in this specific context: What proportion of women of childbearing age have been informed of the possibility of becoming pregnant, of the associated risks, and of necessary precautions (e.g., stopping mycophenolate mofetil at least 6 weeks before conception);

Variability in the information provided from one center to another, due to the absence of a national, consensus-based document addressing fertility and contraception in the post-transplantation setting;

Monitoring frequency specific to the graft, especially regarding exposure to immunosuppressive drugs (and consequently actual exposure to calcineurin inhibitors, the cornerstone of anti-rejection therapy, whose residual blood concentration varies from the second trimester onward)(2);

The true risk of preeclampsia, at a time when diagnosis can be refined by measuring levels of placental-derived anti-angiogenic factors in maternal serum (sFlt-1/PlGF ratio)(3), and by uterine artery Doppler;

The incidence of de novo anti-HLA immunization (HLA antigens expressed by the fetus and inherited from the father), which can now be assessed using the Luminex technique(4);

Maternal morbidity: What is the impact of pregnancy on graft function? Conversely, how does renal function influence pregnancy outcomes, regardless of the transplanted organ?

Infant morbidity in the short and medium term.

To establish these data and to provide accurate information to patients, we aim to conduct a study among pregnant women who have undergone solid organ transplantation (kidney, heart, lung, liver, or pancreas). The objective of this research is to collect standardized and independent data on the number of pregnancies occurring in France and to monitor them up to one year postpartum (or after pregnancy termination).

The study will then aim to describe the clinical characteristics and maternal and perinatal outcomes of pregnancies in this specific population. These data will help disseminate clear and up-to-date information to the medical community, thus improving patient counseling and, more broadly, support for couples. They will also serve to develop recommendations to optimize the planning and management of pregnancies in women with solid organ transplants.

Finally, this initiative aims to promote clinical research on pregnancy in the context of transplantation, particularly through clinical trials and the development of biobanks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patient aged 18 years or older and of childbearing age
  • Has received a solid organ transplant, either isolated or combined (heart, liver, lung, pancreas, kidney)
  • Has a positive blood beta-hCG test result > 5 IU/L ("positive")
  • Has signed an informed consent form
  • Affiliated with a health insurance plan

Exclusion criteria

  • Patient deprived of liberty or under legal guardianship
  • Patient refuses to participate in the study

Treatment and study plan

blood sample

Other

Two optional (non-mandatory) biological samples may be collected as part of this study:

A 2 mL venous blood sample may be taken during a routine prenatal follow-up visit (around 30 weeks of gestation) in order to analyze the preeclampsia biomarker (sFlt-1/PlGF ratio), whenever preeclampsia is suspected.

A 5 mL sample from cord blood may be collected after delivery to analyze, in the newborn, the complete blood count, white blood cell differential, lymphocyte phenotyping (T CD3+, CD19+CD20+, and NK CD46+), and immunoglobulin levels (G, A, and M for humoral immunity, and E for allergy-related function).

Primary outcomes

  1. The primary outcome is the annual incidence of conception in the population of women with solid organ transplants (i.e., included in the study).

    Time frame: Annually over the 10-year study period

    The primary outcome is the annual incidence of conception in the population of women with solid organ transplants (i.e., included in the study).

Secondary outcomes

  1. Rate of preeclampsia

    Time frame: Through study completion, an average of 1 year

    Rate of preeclampsia

  2. Trajectory of estimated glomerular filtration rate (eGFR, in mL/min/1.73 m²);

    Time frame: 3 months and 12 months postopartum

    Trajectory of estimated glomerular filtration rate (eGFR, in mL/min/1.73 m²);

  3. Live birth rate among transplanted mothers from the onset of pregnancy.

    Time frame: through study completion, an average of 1 year

    Live birth rate among transplanted mothers from the onset of pregnancy.

  4. Trajectory of serum creatinine levels

    Time frame: During pregnancy (up to 40 weeks if gestation)

    Trajectory of serum creatinine levels

  5. Rate of maternal complications before delivery and in the postpartum period (infectious episodes, rejection episodes, therapeutic pregnancy termination, postpartum hemorrhage)

    Time frame: During pregnancy (up to 40 weeks of gestation) and during post partum from delivery up to about 1 year after birth

    Rate of maternal complications before delivery and in the postpartum period (infectious episodes, rejection episodes, therapeutic pregnancy termination, postpartum hemorrhage)

  6. Mode of delivery (spontaneous labor, induced labor, planned cesarean section, or emergency cesarean section); gestational age at delivery (in weeks of gestation); proportion of gestational hypertension and preeclampsia.

    Time frame: Day of delivery: Perioperative/Periprocedural

    Mode of delivery (spontaneous labor, induced labor, planned cesarean section, or emergency cesarean section); gestational age at delivery (in weeks of gestation); proportion of gestational hypertension and preeclampsia.

  7. Birth weight of the newborn (in grams)

    Time frame: day of delivery

    Birth weight of the newborn (in grams)

  8. Rate of spontaneous miscarriage

    Time frame: Through study completion, an average of 1 year

    Rate of spontaneous miscarriage

  9. Rate of cesarean section

    Time frame: Through study completion, an average of 1 year

    Rate of cesarean section

  10. Rate of prematurity

    Time frame: Through study completion, an average of 1 year

    Rate of prematurity

  11. Rate of intrauterine growth restriction

    Time frame: Through study completion, an average of 1 year

    Rate of intrauterine growth restriction

  12. the duration of hospital stay for both the mother and the newborn

    Time frame: Through study completion, an average of 1 year

    the duration of hospital stay for both the mother and the newborn

  13. incidence of biopsy-proven acute rejection up to 12 months postpartum;

    Time frame: up to 12 months postpartum;

    incidence of biopsy-proven acute rejection up to 12 months postpartum;

  14. incidence of de novo anti-HLA sensitization at 3 and 12 months postpartum.

    Time frame: 3 months and 12 months postoartum

    incidence of de novo anti-HLA sensitization at 3 and 12 months postpartum.

  15. Trajectory of proteinuria (protein-to-creatinine ratio)

    Time frame: During pregnancy (up to 40 weeks if gestation)

    Trajectory of proteinuria (protein-to-creatinine ratio)

  16. Trajectory of tacrolimus blood levels, and anti-angiogenic factors during pregnancy,

    Time frame: During pregnancy (up to 40 weeks if gestation)

    Trajectory of tacrolimus blood levels, and anti-angiogenic factors during pregnancy,

  17. Trajectory of anti-angiogenic factors during pregnancy

    Time frame: During pregnancy (up to 40 weeks if gestation)

    Trajectory of anti-angiogenic factors during pregnancy

  18. Rate of maternal complications and hospitalizations before delivery and in the postpartum period (infectious episodes, rejection episodes, therapeutic pregnancy termination, postpartum hemorrhage)

    Time frame: During pregnancy (up to 40 weeks of gestation) and during post partum from delivery up to about 1 year after birth

    Rate of maternal hospitalizations before delivery and in the postpartum period

  19. Apgar score

    Time frame: day of delivery

    Apgar score

  20. Proportion of growth-restricted

    Time frame: day of delivery and up 3 month postpartum

    Proportion of growth-restricted

  21. Incidence of neonatal complications before the third month of life

    Time frame: day of delivery and up 3 month postpartum

    Incidence of neonatal complications before the third month of life

Study contacts

Contact information is provided by the study sponsor or research team.

Sahar Pr SELLAMI JALLOULI, PhD

CONTACT

[email protected]

01 46 25 31 37

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Acronym: CRISTEL

Important dates

Study start
2026
Primary completion
2036
Study completion
2036
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.