Comprehensive assessment of first-trimester miscarriage causes and consequences
Comprehensive Assessment of First Trimester Pregnancy Loss: Analyzing Its Impact and Biological Pathways to Develop Tailored Management Care Strategies (The FIRST-CARE Study)
This project will test genetic, hormonal, immune, cardiovascular, placental, and psychological factors in women who had a miscarriage before 14 weeks to see what may have caused it and how it affects their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 225 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Academic / other |
| Locations | 2 sites (Barcelona, Barcelona and 1 other locations) |
| Trial ID | NCT07293819 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational project enrolling 225 women with a missed miscarriage before 14 weeks at Hospital de la Santa Creu i Sant Pau in Barcelona. Participants are divided into first-time miscarriage and recurrent pregnancy loss groups and will undergo clinical evaluation and biosample collection. Analyses will include genetic testing, measurement of angiogenic and hormonal markers, immune and cardiovascular assessments, placental studies, and psychological screening. The goal is to link multi-domain findings to underlying causes and inform personalized follow-up and support.
Who should consider this trial
Good fit: Women aged 18 or older with a confirmed missed miscarriage (intrauterine fetal demise) before 14 weeks who can give informed consent and complete study procedures are ideal candidates.
Not a fit: People with multiple pregnancy, ectopic or molar pregnancy, ongoing pregnancies with fetal cardiac activity, or who cannot attend follow-up visits or provide consent are not eligible and will not benefit from participation.
Why it matters
Potential benefit: If successful, the project could provide clearer explanations for many first-trimester losses and guide more personalized follow-up, counseling, or preventive strategies for future pregnancies.
How similar studies have performed: Prior work using genetic testing and select biochemical or immunologic markers has explained a portion of early losses, but a comprehensive prospective multimodal assessment like this is less commonly performed.
Eligibility criteria
Show full inclusion / exclusion criteria
Female participants: Inclusion Criteria: * Women aged 18 years or older. * Diagnosis of missed miscarriage in the first trimester (\<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. Exclusion Criteria: * 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. Male participants: no specific inclusion or exclusion criteria will apply to male partners, since the main inclusion criteria is a clinical pregnancy loss.
Where this trial is running
Barcelona, Barcelona and 1 other locations
- Hospital de la Santa Creu i Sant Pau — Barcelona, Barcelona, Spain (Not_yet_recruiting)
- Hospital de la Santa Creu i Sant Pau — Barcelona, Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Cristina Trilla Solà, MD, PhD
- Email: ctrilla@santpau.cat
- Phone: 0034935537050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.