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NOT YET RECRUITING
NCT07592806
NA

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

Sponsor: Hopital Foch

View on ClinicalTrials.gov

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). 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.

Key Details

Gender

FEMALE

Age Range

18 Years - 48 Years

Study Type

INTERVENTIONAL

Enrollment

2000

Start Date

2026-09-01

Completion Date

2036-09-01

Last Updated

2026-05-18

Healthy Volunteers

No

Interventions

OTHER

Blood sample

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).