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FIRST-CARE
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Instituto de Salud Carlos III
observational
225
1 country
2
Study Start
October 2, 2025
Actual (reported)Primary Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 20, 2025
Actual (reported)October 2, 2025
Actual (reported)December 19, 2025
Actual (reported)December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Composite Prevalence Index of Biological Risk Factors in First-Trimester Pregnancy Loss
Proportion of women with at least one biological abnormality among the following categories: 1. Genetic (e.g., pathogenic or likely pathogenic variants identified by chromosomal microarray analysis or targeted gene panels), 2. Immunologic (e.g., positive antiphospholipid antibodies, abnormal NK cell activity, ANA positivity), 3. Endocrine (e.g., abnormal TSH, HOMA index, HbA1c or fasting glucose levels), 4. Angiogenic or Cardiovascular (e.g., altered uterine artery Doppler indices, abnormal serum PlGF or sFlt-1). Abnormality is defined according to established clinical cutoffs for each parameter. The outcome is calculated as the percentage of participants with at least one abnormal result in any of the assessed categories. Comparison will be made between women with a first miscarriage and women with recurrent pregnancy loss (RPL).
Baseline to 3 months post-miscarriage
Prevalence of Genetic Abnormalities in Women with First-Trimester Pregnancy Loss
Baseline to 3 months post-miscarriage
Women who have experienced their first clinically confirmed first-trimester miscarriage (n=150).
Women with a history of two or more first-trimester miscarriages (n=75).
Women aged 18 years or older with a diagnosis of first-trimester missed miscarriage (gestational age \<14 weeks) will be enrolled. The study population will include two cohorts: women experiencing their first miscarriage and women with a history of recurrent pregnancy loss (defined as two or more previous first-trimester miscarriages). Participants will be recruited at the Hospital de la Santa Creu i Sant Pau (Barcelona, Spain) from outpatient and emergency gynecology services. Male partners will be invited to participate in selected assessments when applicable.
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025, Spain
Chorionic villous sampling, blood, urine
First Submitted
July 20, 2025
First Posted
December 19, 2025
Study Start
October 2, 2025
Actual (reported)Primary Completion
December 2028
Prevalence of Immunological Abnormalities in Women with First-Trimester Pregnancy Loss
Within 12 weeks after diagnosis of pregnancy loss
Prevalence of of Endocrine Abnormalities
Within 12 weeks after diagnosis of pregnancy loss
Frequency of Angiogenic and Cardiovascular Dysfunction
Within 12 weeks after diagnosis of pregnancy loss
Subsequent pregnancy rate and outcomes within 12 months
Up to 12 months after enrollment or until delivery of subsequent pregnancy
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 19, 2025
Record last verified: 2025-12
De-identified individual participant data (IPD) related to primary and secondary outcome measures may be shared with qualified researchers upon reasonable request and with appropriate data use agreements. Shared data may include clinical, laboratory, and questionnaire data, excluding any personal identifiers.
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Source: ClinicalTrials.gov.
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