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.
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.
Multiple pregnancy (twins or more).
Ectopic pregnancy.
Molar pregnancy (complete or partial hydatidiform mole).
Ongoing pregnancy with fetal cardiac activity.
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.
Cohort
Prospective
Not listed
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).
Prevalence of Genetic Abnormalities in Women with First-Trimester Pregnancy Loss
Evaluation of the proportion of women with pathogenic or likely pathogenic variants identified by chromosomal cytogenetics (karyotyping), microarray analysis (CMA) or cfDNA in the first miscarriage group versus the recurrent pregnancy loss group. Units of Measure: Percentage of participants (%)
Prevalence of Immunological Abnormalities in Women with First-Trimester Pregnancy Loss
Evaluation of the proportion of women with abnormal immunological markers (e.g., antiphospholipid antibodies, antibuclears antibodies (ANA), peripheral lymphocyte activity) using standardized immunoassays. Unit of measurement: positivity for ANA, NK cells \> 12%, positivity for anti-phospholipid syndrom
Prevalence of of Endocrine Abnormalities
Proportion of women with abnormal thyroid function tests (TSH, T4), and/or abnormal glucose metabolism (HbA1c), and/or HOMA index. Unit measurements: TSH \> 4mUI/L; HbA1c \< 5.7%; HOMA index \> 2.5
Frequency of Angiogenic and Cardiovascular Dysfunction
Presence of altered uterine artery Doppler indices \> 2.5 or abnormal levels of angiogenic markers (e.g., PlGF, sFlt-1), measured by Doppler ultrasound and immunoassays.
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