CRISTEL Study: Monitoring of Pregnancies in Women After Solid Organ Transplantation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-48
SponsorHopital Foch
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patient deprived of liberty or under legal guardianship
Patient refuses to participate in the study
Trial design
Design model
Single group
Treatments tested in this trial
Blood sample
Other interventionTwo 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).
Treatment groups
2,000 Participants
are divided into 1 treatment groupGroup A: Adult female patients who have received a solid organ transplantOther 1 intervention
Trial outcomes
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).
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 periodSecondary outcomes
1
Rate of preeclampsia
Rate of preeclampsia
Time frame
Through study completion, an average of 1 year2
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);
Time frame
3 months and 12 months postopartum3
Live birth rate among transplanted mothers from the onset of pregnancy.
Live birth rate among transplanted mothers from the onset of pregnancy.
Time frame
through study completion, an average of 1 year4
Trajectory of serum creatinine levels
Trajectory of serum creatinine levels
Time frame
During pregnancy (up to 40 weeks if gestation)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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