Comprehensive Assessment of First Trimester Pregnancy Loss: Analyzing Its Impact and Biological Pathways to Develop Tailored Management Care Strategies (The FIRST-CARE Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Composite Prevalence Index of Biological Risk Factors in First-Trimester Pregnancy Loss
研究概览
简要总结
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.
详细描述
Background and Rationale Miscarriage, or early pregnancy loss, is the most common complication of pregnancy, affecting approximately 15% of clinically recognized gestations. However, this percentage is likely underestimated, as many early losses occur before the pregnancy is even detected by ultrasound. Miscarriage is often considered a sporadic event, but in many cases it can be the first sign of underlying health issues that affect maternal, paternal, or embryonic health.
Despite its frequency, miscarriage remains poorly understood and inconsistently investigated. Women experiencing early pregnancy loss often receive no clear explanation, no thorough assessment, and no tailored follow-up or support. In recurrent cases (recurrent pregnancy loss, RPL), the diagnostic work-up is limited and typically reserved for women who have had at least two or three losses. This approach leaves many women without answers and without the opportunity to benefit from early intervention or support.
Miscarriage also carries significant emotional and psychological consequences, which are often underestimated. Research has shown associations between miscarriage and depression, anxiety, post-traumatic stress, and even long-term health risks, including cardiovascular disease. Addressing miscarriage as both a biological and psychosocial condition is critical to improving patient care and outcomes.
Study Aim
The FIRST-CARE Study (First Trimester Comprehensive Assessment and Reproductive Evaluation) is a prospective, single-center cohort study designed to investigate the biological, clinical, and psychological dimensions of first-trimester miscarriage. The study aims to:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Composite Prevalence Index of Biological Risk Factors in First-Trimester Pregnancy Loss
时间窗: Baseline to 3 months post-miscarriage
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).
次要结局
- Prevalence of Genetic Abnormalities in Women with First-Trimester Pregnancy Loss(Baseline to 3 months post-miscarriage)
- 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)
- Diagnostic yield of genetic testing (cfDNA vs. CVS) by gestational age and recurrence(At time of diagnosis)
- Development of multivariate models for individual miscarriage risk stratification(After data completion (12 months))
- Depression Symptoms at 1 Month and 12 Months Post-Miscarriage(1 month and 12 months after pregnancy loss)
- Anxiety and Post-Traumatic Stress Symptoms at 1 Month and 12 Months Post-Miscarriage(1 month and 12 months after pregnancy loss)
- Grief Symptoms at 1 Month and 12 Months Post-Miscarriage(1 month and 12 months after pregnancy loss)
- Health-Related Quality of Life at 1 Month and 12 Months Post-Miscarriage(1 month and 12 months after pregnancy loss)
研究者
Cristina Trilla
MD, PhD - Consultant in Obstetrics and Gynecology, Clinical Coordinator of the Pregnancy Loss Functional Unit
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau