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Comprehensive Assessment of First Trimester Pregnancy Loss

NCT07293819 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 225

Last updated 2025-12-19

No results posted yet for this study

Summary

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

  • Miscarriage in First Trimester

Sponsors & Collaborators

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-02
Primary Completion
2028-12-31
Completion
2029-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07293819 on ClinicalTrials.gov