[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637320":3},{"organization":4,"outcomesModule":7,"designInfo":67,"detailedDescription":73,"studyPopulation":66,"armGroups":74,"interventions":80,"overallOfficials":85,"centralContacts":90,"locations":66,"responsibleParty":96,"collaborators":66,"id":98,"slug":66,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":66,"studyType":110,"phases":111,"briefSummary":112,"conditions":113,"keywords":66,"overallStatus":115,"whyStopped":66,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":66},{"fullName":5,"class":6},"Hopital Foch","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":12,"otherOutcomes":66},[9],{"measure":10,"description":10,"timeFrame":11},"The primary outcome is the annual incidence of conception in the population of women with solid organ transplants (i.e., included in the study).","Annually over the 10-year study period",[13,16,19,22,25,28,31,34,36,38,40,42,44,47,50,52,54,56,59,61,64],{"measure":14,"description":14,"timeFrame":15},"Rate of preeclampsia","Through study completion, an average of 1 year",{"measure":17,"description":17,"timeFrame":18},"Trajectory of estimated glomerular filtration rate (eGFR, in mL\u002Fmin\u002F1.73 m²);","3 months and 12 months postopartum",{"measure":20,"description":20,"timeFrame":21},"Live birth rate among transplanted mothers from the onset of pregnancy.","through study completion, an average of 1 year",{"measure":23,"description":23,"timeFrame":24},"Trajectory of serum creatinine levels","During pregnancy (up to 40 weeks if gestation)",{"measure":26,"description":26,"timeFrame":27},"Rate of maternal complications before delivery and in the postpartum period (infectious episodes, rejection episodes, therapeutic pregnancy termination, postpartum hemorrhage)","During pregnancy (up to 40 weeks of gestation) and during post partum from delivery up to about 1 year after birth",{"measure":29,"description":29,"timeFrame":30},"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.","Day of delivery: Perioperative\u002FPeriprocedural",{"measure":32,"description":32,"timeFrame":33},"Birth weight of the newborn (in grams)","day of delivery",{"measure":35,"description":35,"timeFrame":15},"Rate of spontaneous miscarriage",{"measure":37,"description":37,"timeFrame":15},"Rate of cesarean section",{"measure":39,"description":39,"timeFrame":15},"Rate of prematurity",{"measure":41,"description":41,"timeFrame":15},"Rate of intrauterine growth restriction",{"measure":43,"description":43,"timeFrame":15},"the duration of hospital stay for both the mother and the newborn",{"measure":45,"description":45,"timeFrame":46},"incidence of biopsy-proven acute rejection up to 12 months postpartum;","up to 12 months postpartum;",{"measure":48,"description":48,"timeFrame":49},"incidence of de novo anti-HLA sensitization at 3 and 12 months postpartum.","3 months and 12 months postoartum",{"measure":51,"description":51,"timeFrame":24},"Trajectory of proteinuria (protein-to-creatinine ratio)",{"measure":53,"description":53,"timeFrame":24},"Trajectory of tacrolimus blood levels, and anti-angiogenic factors during pregnancy,",{"measure":55,"description":55,"timeFrame":24},"Trajectory of anti-angiogenic factors during pregnancy",{"measure":57,"description":58,"timeFrame":27},"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",{"measure":60,"description":60,"timeFrame":33},"Apgar score",{"measure":62,"description":62,"timeFrame":63},"Proportion of growth-restricted","day of delivery and up 3 month postpartum",{"measure":65,"description":65,"timeFrame":63},"Incidence of neonatal complications before the third month of life",null,{"allocation":68,"interventionModel":69,"interventionModelDescription":66,"primaryPurpose":70,"observationalModel":66,"timePerspective":66,"maskingInfo":71},"NA","SINGLE_GROUP","SCREENING",{"masking":72,"maskingDescription":66,"whoMasked":66},"NONE","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).\n\nToday, these are the data shared with patients planning a pregnancy, despite uncertainty as to their accuracy and applicability in France or even Europe.\n\nAmong the unknowns that remain despite these registry data, the following should be noted:\n\nUncertainty 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);\n\nVariability 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;\n\nMonitoring 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);\n\nThe 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\u002FPlGF ratio)(3), and by uterine artery Doppler;\n\nThe 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);\n\nMaternal morbidity: What is the impact of pregnancy on graft function? Conversely, how does renal function influence pregnancy outcomes, regardless of the transplanted organ?\n\nInfant morbidity in the short and medium term.\n\nTo 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).\n\nThe 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.\n\nFinally, this initiative aims to promote clinical research on pregnancy in the context of transplantation, particularly through clinical trials and the development of biobanks.",[75],{"label":76,"type":6,"description":77,"interventionNames":78},"Adult female patients who have received a solid organ transplant","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\u002FL) in one of the participating centers, or who are planning a pregnancy, will initially be identified.",[79],"Other: Blood sample",[81],{"type":6,"name":82,"description":83,"armGroupLabels":84,"otherNames":66},"Blood sample","Two optional (non-mandatory) biological samples may be collected as part of this study:\n\nA 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\u002FPlGF ratio), whenever preeclampsia is suspected.\n\nA 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).",[76],[86],{"name":87,"affiliation":88,"role":89},"Alexandre Pr Hertig, MED","Foch Hospital","PRINCIPAL_INVESTIGATOR",[91],{"name":92,"role":93,"phone":94,"phoneExt":66,"email":95},"Sahar Pr SELLAMI JALLOULI, PhD","CONTACT","01 46 25 31 37","s.sellami-jallouli@hopital-foch.com",{"type":97,"investigatorFullName":66,"investigatorTitle":66,"investigatorAffiliation":66,"oldNameTitle":66,"oldOrganization":66},"SPONSOR","100637320",false,"NCT07592806","CRISTEL Study: Monitoring of Pregnancies in Women After Solid Organ Transplantation","CRISTEL","Inclusion Criteria:\n\n* Female patient aged 18 years or older and of childbearing age\n* Has received a solid organ transplant, either isolated or combined (heart, liver, lung, pancreas, kidney)\n* Has a positive blood beta-hCG test result \\> 5 IU\u002FL (\"positive\")\n* Has signed an informed consent form\n* Affiliated with a health insurance plan\n\nExclusion Criteria:\n\n* Patient deprived of liberty or under legal guardianship\n* Patient refuses to participate in the study","FEMALE","18 Years","48 Years",{"count":108,"type":109},2000,"ESTIMATED","INTERVENTIONAL",[68],"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.",[114],"Surgical Operation With Transplant of Whole Organ","NOT_YET_RECRUITING","2026-05-11",{"date":118,"type":119},"2026-05-18","ACTUAL",{"date":121,"type":109},"2026-09-01",{"date":123,"type":109},"2036-09-01",{"name":5,"class":6}]