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

NCT07592806 | Not Yet Recruiting DMC

• 1 other identifier: 2023_0004
• Study Type: interventional
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Surgical Operation With Transplant of Whole Organ

Outcome Measures

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).

  Annually over the 10-year study period

Secondary Outcomes (21)

• Rate of preeclampsia

  Through study completion, an average of 1 year

• Trajectory of estimated glomerular filtration rate (eGFR, in mL/min/1.73 m²);

  3 months and 12 months postopartum

• Live birth rate among transplanted mothers from the onset of pregnancy.

  through study completion, an average of 1 year

• Trajectory of serum creatinine levels

  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)

  During pregnancy (up to 40 weeks of gestation) and during post partum from delivery up to about 1 year after birth

Study Arms (1)

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.

Other: Blood sample

Interventions

Blood sample OTHER

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).

Adult female patients who have received a solid organ transplant

Eligibility Criteria

• Age: 18 Years - 48 Years
• Gender Eligibility Details: 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 test result (defined by a threshold of 5 IU/L) in one of the study's participating centers, or who have a pregnancy plan, will initially be identified.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patient deprived of liberty or under legal guardianship
• Patient refuses to participate in the study

Sponsors & Collaborators

• Hopital Foch: lead

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Alexandre Pr Hertig, MED

  Foch Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sahar Pr SELLAMI JALLOULI, PhD

CONTACT

01 46 25 31 37; s.sellami-jallouli@hopital-foch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: May 18, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2036
• Study Completion (Estimated): September 1, 2036
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share