Surgical Operation With Transplant of Whole OrganCRISTELNCT07592806
CRISTEL Study: Monitoring of Pregnancies in Women After Solid Organ Transplantation
A study testing Blood sample in people with Surgical Operation With Transplant of Whole Organ, run by Hopital Foch.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Surgical Operation With Transplant of Whole Organ
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2036
- Phase
- Interventional
- 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 18 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Patient deprived of liberty or under legal guardianship
- Patient refuses to participate in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Being tested
- Blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Adult female patients who have received a solid organ transplant | Other | Adult female patients who have received a solid organ transplant, either isolated or combined (heart, liver, lung, pancreas, kidney), and who present with a positive beta-hCG blood test result (defined by a threshold of 5 IU/L) in one of the participating centers, or who are planning a pregnancy, will initially be identified. Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the annual incidence of conception in the population of women with solid organ transplants (i.e., included in the study).
The primary outcome is the annual incidence of conception in the population of women with solid organ transplants (i.e., included in the study).
Measured: Annually over the 10-year study period
Secondary outcomes (21)
Rate of preeclampsia
Rate of preeclampsia
Measured: Through study completion, an average of 1 year
Trajectory of estimated glomerular filtration rate (eGFR, in mL/min/1.73 m²);
Trajectory of estimated glomerular filtration rate (eGFR, in mL/min/1.73 m²);
Measured: 3 months and 12 months postopartum
Live birth rate among transplanted mothers from the onset of pregnancy.
Live birth rate among transplanted mothers from the onset of pregnancy.
Measured: through study completion, an average of 1 year
Trajectory of serum creatinine levels
Trajectory of serum creatinine levels
Measured: During pregnancy (up to 40 weeks if gestation)
Rate of maternal complications before delivery and in the postpartum period (infectious episodes, rejection episodes, therapeutic pregnancy termination, postpartum hemorrhage)
Rate of maternal complications before delivery and in the postpartum period (infectious episodes, rejection episodes, therapeutic pregnancy termination, postpartum hemorrhage)
Measured: During pregnancy (up to 40 weeks of gestation) and during post partum from delivery up to about 1 year after birth
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.
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.
Measured: Day of delivery: Perioperative/Periprocedural
Birth weight of the newborn (in grams)
Birth weight of the newborn (in grams)
Measured: day of delivery
Rate of spontaneous miscarriage
Rate of spontaneous miscarriage
Measured: Through study completion, an average of 1 year
Rate of cesarean section
Rate of cesarean section
Measured: Through study completion, an average of 1 year
Rate of prematurity
Rate of prematurity
Measured: Through study completion, an average of 1 year
Rate of intrauterine growth restriction
Rate of intrauterine growth restriction
Measured: Through study completion, an average of 1 year
the duration of hospital stay for both the mother and the newborn
the duration of hospital stay for both the mother and the newborn
Measured: Through study completion, an average of 1 year
incidence of biopsy-proven acute rejection up to 12 months postpartum;
incidence of biopsy-proven acute rejection up to 12 months postpartum;
Measured: up to 12 months postpartum;
incidence of de novo anti-HLA sensitization at 3 and 12 months postpartum.
incidence of de novo anti-HLA sensitization at 3 and 12 months postpartum.
Measured: 3 months and 12 months postoartum
Trajectory of proteinuria (protein-to-creatinine ratio)
Trajectory of proteinuria (protein-to-creatinine ratio)
Measured: During pregnancy (up to 40 weeks if gestation)
Trajectory of tacrolimus blood levels, and anti-angiogenic factors during pregnancy,
Trajectory of tacrolimus blood levels, and anti-angiogenic factors during pregnancy,
Measured: During pregnancy (up to 40 weeks if gestation)
Trajectory of anti-angiogenic factors during pregnancy
Trajectory of anti-angiogenic factors during pregnancy
Measured: During pregnancy (up to 40 weeks if gestation)
Rate of maternal complications and hospitalizations before delivery and in the postpartum period (infectious episodes, rejection episodes, therapeutic pregnancy termination, postpartum hemorrhage)
Rate of maternal hospitalizations before delivery and in the postpartum period
Measured: During pregnancy (up to 40 weeks of gestation) and during post partum from delivery up to about 1 year after birth
Apgar score
Apgar score
Measured: day of delivery
Proportion of growth-restricted
Proportion of growth-restricted
Measured: day of delivery and up 3 month postpartum
Incidence of neonatal complications before the third month of life
Incidence of neonatal complications before the third month of life
Measured: day of delivery and up 3 month postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2036 (estimated)
- Study completion1 Sep 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Operation With Transplant of Whole OrganStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Pr Hertig, MED, Principal investigator, Foch Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592806
- Sponsor's protocol ID
- 2023_0004
- Acronym
- CRISTEL
- Status last verified
- May 2026
- First submitted
- 22 Sep 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRISTEL Study: Monitoring of Pregnancies in Women After Solid Organ Transplantation
- ClinicalTrials.gov ID
- NCT07592806
- Acronym / sponsor ID
- CRISTEL / 2023_0004
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2036 (estimated)
- Study completion
- 1 Sep 2036 (estimated)
- First posted
- 18 May 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult female patients who have received a solid organ transplant | Other | Other: Blood sampleAdult female patients who have received a solid organ transplant, either isolated or combined (heart, liver, lung, pancreas, kidney), and who present with a positive beta-hCG blood test result (defined by a threshold of 5 IU/L) in one of the participating centers, or who are planning a pregnancy, will initially be identified. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patient deprived of liberty or under legal guardianship
- Patient refuses to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleTwo 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). | Other | Adult female patients who have received a solid organ transplant |
Primary outcome
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).
21 secondary outcomes
Rate of preeclampsia
Time frame: Through study completion, an average of 1 year
Trajectory of estimated glomerular filtration rate (eGFR, in mL/min/1.73 m²);
Time frame: 3 months and 12 months postopartum
Live birth rate among transplanted mothers from the onset of pregnancy.
Time frame: through study completion, an average of 1 year
Trajectory of serum creatinine levels
Time frame: During pregnancy (up to 40 weeks if gestation)
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
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
Birth weight of the newborn (in grams)
Time frame: day of delivery
Rate of spontaneous miscarriage
Time frame: Through study completion, an average of 1 year
Rate of cesarean section
Time frame: Through study completion, an average of 1 year
Rate of prematurity
Time frame: Through study completion, an average of 1 year
Rate of intrauterine growth restriction
Time frame: Through study completion, an average of 1 year
the duration of hospital stay for both the mother and the newborn
Time frame: Through study completion, an average of 1 year
incidence of biopsy-proven acute rejection up to 12 months postpartum;
Time frame: up to 12 months postpartum;
incidence of de novo anti-HLA sensitization at 3 and 12 months postpartum.
Time frame: 3 months and 12 months postoartum
Trajectory of proteinuria (protein-to-creatinine ratio)
Time frame: During pregnancy (up to 40 weeks if gestation)
Trajectory of tacrolimus blood levels, and anti-angiogenic factors during pregnancy,
Time frame: During pregnancy (up to 40 weeks if gestation)
Trajectory of anti-angiogenic factors during pregnancy
Time frame: During pregnancy (up to 40 weeks if gestation)
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
Apgar score
Time frame: day of delivery
Proportion of growth-restricted
Time frame: day of delivery and up 3 month postpartum
Incidence of neonatal complications before the third month of life
Time frame: day of delivery and up 3 month postpartum
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 May 2026.
- Individual participant dataSharing planned: No
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.
Alexandre Pr Hertig, MED principal investigator
Foch Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Surgical Operation With Transplant of Whole Organ, run by Hopital Foch.
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 5 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: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Sahar Pr SELLAMI JALLOULI, PhD (01 46 25 31 37, s.sellami-jallouli@hopital-foch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2026.