Comprehensive Assessment of First Trimester Pregnancy Loss

Recruiting now

Conditions studied: Miscarriage in First Trimester

In brief

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.

Key facts

Study ID

NCT07293819

Run by

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

People needed

225

Starts

2025-10-02

Expected to finish

2029-06-01

Last updated by the study team

2025-12-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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.
• Male participants: no specific inclusion or exclusion criteria will apply to male partners, since the main inclusion criteria is a clinical pregnancy loss.

Where it is running

• Hospital de la Santa Creu i Sant Pau — Barcelona, Barcelona, Spain (enrolling)
• Hospital de la Santa Creu i Sant Pau — Barcelona, Barcelona, Spain

Full record on ClinicalTrials.gov

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