Clinical trial Recruiting at 1 site Observational Ages 18 and up Women only

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 typeObservational
Ages18 Years and up
SexWomen only
Enrollment225 (estimated)
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Academic / other
Locations2 sites (Barcelona, Barcelona and 1 other locations)
StatusRecruiting
StartedOctober 2, 2025
Main results expectedDecember 2028
Study endsJune 2029
Registry record updatedDecember 19, 2025
Trial IDNCT07293819 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.