Comprehensive assessment of first-trimester miscarriage causes and consequences
Official title: Comprehensive Assessment of First Trimester Pregnancy Loss: Analyzing Its Impact and Biological Pathways to Develop Tailored Management Care Strategies (The FIRST-CARE Study)
Run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · NCT07293819 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 225 (estimated) |
| 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) |
| Status | Recruiting |
| Started | October 2, 2025 |
| Main results expected | December 2028 |
| Study ends | June 2029 |
| Registry record updated | December 19, 2025 |
| Trial ID | NCT07293819 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain Recruiting -
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain Not yet recruiting
Study contacts
- Study coordinator: Cristina Trilla Solà, MD, PhD
- Email: ctrilla@santpau.cat
- Phone: 0034935537050
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
See if non-invasive fetal DNA testing after early miscarriage supports mental health and follow-up care
This study tests whether doing non-invasive prenatal testing from a blood sample after an early miscarriage helps with mental well-being and guides care over the next year.
-
Letrozole plus misoprostol compared with misoprostol alone for treating missed miscarriage
This trial will test whether taking letrozole for three days before misoprostol helps women up to 13 weeks with a missed miscarriage pass the pregnancy completely more often than misoprostol alone.
-
Hysteroscopic removal versus manual vacuum aspiration for early miscarriage
This trial will test whether hysteroscopic resection or ultrasound-guided manual vacuum aspiration works better to remove pregnancy tissue in women with a first-trimester miscarriage under 9 weeks who choose surgical management.
-
Monitoring miscarriage through a blood test
This study is testing a blood test that looks at DNA to see if it can help understand the genetic reasons behind miscarriages in women who have had early pregnancy loss, especially those who used fertility treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.