Comprehensive Assessment of First Trimester Pregnancy Loss

NCT07293819 | Recruiting

• 2 other identifiers: IIBSP-FIR-2024-199PI24/01735
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Miscarriage; First-trimester; Genetic testing; angiogenic markers; pregnancy loss; perinatal grief; reproductive immunology; anti-phospholipid syndrom; cell-free DNA; chorionic villous sampling

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• 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

Study Arms (2)

Group 1: First Miscarriage Cohort

Women who have experienced their first clinically confirmed first-trimester miscarriage (n=150).

Group 2: Recurrent Pregnancy Loss (RPL) Cohort

Women with a history of two or more first-trimester miscarriages (n=75).

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

NOT YET RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Chorionic villous sampling, blood, urine

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Cristina Trilla Solà, MD, PhD

CONTACT

0034935537050; ctrilla@santpau.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD - Consultant in Obstetrics and Gynecology, Clinical Coordinator of the Pregnancy Loss Functional Unit

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: December 19, 2025
• Study Start: October 2, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: De-identified individual participant data (IPD), along with supporting documentation such as the study protocol, statistical analysis plan (SAP), and informed consent form (ICF), will be made available to qualified researchers upon reasonable request. Data will be shared after publication of the main study results and upon execution of a data use agreement. Data will be shared through institutional repositories or secure transfer methods in accordance with data protection regulations.
• Access Criteria: Qualified researchers affiliated with academic institutions, hospitals, or public health organizations will be eligible to request access to de-identified individual participant data (IPD) and supporting documentation, including the study protocol, statistical analysis plan (SAP), and informed consent form (ICF). Access will be granted for scientifically sound research proposals that are compatible with the original study objectives or explore related topics in reproductive health and early pregnancy loss. Interested researchers must submit a data access request to the study sponsor or principal investigator. Upon approval, data will be shared under the terms of a data use agreement, which will outline responsibilities regarding data confidentiality, use, and publication. Data will be provided in electronic format via secure transfer platforms managed by the sponsor institution.

Locations

ES (2)