Actively Recruiting
Comprehensive Assessment of First Trimester Pregnancy Loss: Analyzing Its Impact and Biological Pathways to Develop Tailored Management Care Strategies (The FIRST-CARE Study)
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
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the causes and effects of first-trimester pregnancy loss, also called miscarriage, which affects about 15% of recognized pregnancies. This study focuses on women who have experienced either their first miscarriage or recurrent pregnancy losses, aiming to better understand the biological, clinical, and emotional factors involved. The goal is to improve diagnosis and develop personalized care strategies to support women and their partners. Participants will undergo thorough evaluations including ultrasound scans, blood tests, genetic testing of pregnancy tissue, and psychological assessments. Male partners may also be involved in some assessments. The study groups include women with a first miscarriage and those with two or more previous miscarriages. Biological samples will be collected and stored in a biobank for future research. Women will be followed for one year after the miscarriage to monitor mental health recovery and reproductive outcomes such as chances of becoming pregnant again and pregnancy results. Assessments include psychological questionnaires at 1 month and 12 months, clinical tests at 6 to 12 weeks, and ongoing data collection about future pregnancies. The study measures a variety of biological risk factors and emotional impacts to inform better care and support.
CONDITIONS
Brief Title
Comprehensive Assessment of First Trimester Pregnancy Loss
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 years or older
- Diagnosis of missed miscarriage in the first trimester (before 14 weeks of gestation) confirmed by ultrasound
- Presence of an intrauterine pregnancy with fetal demise (clinical pregnancy loss)
- Willing and able to provide written informed consent
- Ability to understand and complete study procedures
You will not qualify if you...
- Multiple pregnancy (twins or more)
- Ectopic pregnancy
- Molar pregnancy (complete or partial hydatidiform mole)
- Ongoing pregnancy with fetal cardiac activity
- Inability or unwillingness to comply with study procedures or follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months after miscarriage
Participants undergo comprehensive evaluations including genetic testing of pregnancy loss, maternal health assessments, paternal evaluations, and psychological and social assessments.
1 to 2 visits depending on assessments
Duration - Up to 12 months after enrollment
Participants are followed for one year to assess psychological recovery, subsequent pregnancy outcomes, and the prevalence of biological risk factors.
Psychological assessments at 1 month and 12 months post-loss; clinical and laboratory assessments at 6 to 12 weeks post-loss; additional follow-up visits as needed
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
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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