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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
2,000
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).
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 period
Rate of preeclampsia
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);
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.
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
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)
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.
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)
Birth weight of the newborn (in grams)
Time frame: day of delivery
Rate of spontaneous miscarriage
Rate of spontaneous miscarriage
Time frame: Through study completion, an average of 1 year
Rate of cesarean section
Rate of cesarean section
Time frame: Through study completion, an average of 1 year
Rate of prematurity
Rate of prematurity
Time frame: Through study completion, an average of 1 year
Rate of intrauterine growth restriction
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
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;
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.
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)
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,
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
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)
Rate of maternal hospitalizations before delivery and in the postpartum period
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
Apgar score
Time frame: day of delivery
Proportion of growth-restricted
Proportion of growth-restricted
Time frame: 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
Time frame: day of delivery and up 3 month postpartum
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