Actively Recruiting
Comprehensive Assessment of First Trimester Pregnancy Loss
Led by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Updated on 2025-12-19
225
Participants Needed
2
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comprehensive Assessment of First Trimester Pregnancy Loss
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, 18 years or older
- Diagnosed with a missed miscarriage before 14 weeks of pregnancy confirmed by ultrasound
- Presence of an intrauterine pregnancy with fetal demise
- Willing and able to provide written informed consent
- Able to understand and complete study procedures
You will not qualify if you...
- Multiple pregnancy (twins or more)
- Ectopic pregnancy
- Molar pregnancy (complete or partial)
- Ongoing pregnancy with fetal cardiac activity
- Unable or unwilling to comply with study procedures or follow-up
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain, 08025
Not Yet Recruiting
2
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain, 08025
Actively Recruiting
Research Team
C
Cristina Trilla Solà, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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