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Comprehensive Assessment of First Trimester Pregnancy Loss: Analyzing Its Impact and Biological Pathways to Develop Tailored Management Care Strategies (The FIRST-CARE Study)
The FIRST-CARE Study is a prospective research project conducted at Hospital de la Santa Creu i Sant Pau (Barcelona, Spain), aimed at better understanding the causes and consequences of first-trimester pregnancy loss (miscarriage). Miscarriage is a common event that affects about 15% of clinically recognized pregnancies and can have both physical and emotional consequences for women and their partners. However, many questions about its causes remain unanswered, and most women do not receive a clear explanation or personalized support after experiencing a loss. This study will include 225 women who have experienced a miscarriage during the first 14 weeks of pregnancy. Two groups will be studied: those who have had a miscarriage for the first time and those with a history of recurrent pregnancy loss (defined as two or more previous miscarriages). The aim is to investigate a wide range of possible causes - including genetic, hormonal, immune, cardiovascular, placental, and psychological factors - in order to improve diagnosis and develop more personalized care strategies. Participants will undergo a comprehensive evaluation including ultrasound, blood tests, genetic testing, and psychological assessments. In some cases, their partners will also be invited to participate. Women will be followed for one year to assess their mental well-being and reproductive outcomes, such as the chance of getting pregnant again and the outcome of future pregnancies. The study will also create a biobank of biological samples to support future research in the field of pregnancy loss. By combining clinical evaluations, laboratory tests, and personal experiences, this study aims to uncover new insights into why miscarriages happen and how to better support women and couples going through this experience. The ultimate goal is to provide better diagnostic tools, care pathways, and support systems to reduce the emotional burden of miscarriage and improve reproductive health outcomes.
Details
| Lead sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
|---|---|
| Status | RECRUITING |
| Enrolment | 225 |
| Start date | 2025-10-02 |
| Completion | 2029-06 |
Conditions
- Miscarriage in First Trimester
Primary outcomes
- Composite Prevalence Index of Biological Risk Factors in First-Trimester Pregnancy Loss — Baseline to 3 months post-miscarriage
Proportion of women with at least one biological abnormality among the following categories: 1. Genetic (e.g., pathogenic or likely pathogenic variants identified by chromosomal microarray analysis or targeted gene panels), 2. Immunologic (e.g., positive antiphospholipid antibodies, abnormal NK cell activity, ANA positivity), 3. Endocrine (e.g., abnormal TSH, HOMA index, HbA1c or fasting glucose levels), 4. Angiogenic or Cardiovascular (e.g., altered uterine artery Doppler indices, abnormal serum PlGF or sFlt-1). Abnormality is defined according to established clinical cutoffs for each parameter. The outcome is calculated as the percentage of participants with at least one abnormal result in any of the assessed categories. Comparison will be made between women with a first miscarriage and women with recurrent pregnancy loss (RPL).
Countries
Spain