Aspirin with or without low‑molecular‑weight heparin to prevent preeclampsia in high‑risk pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, single‑center, open‑label trial at Alexandra Hospital in Athens that will enroll 100 singleton pregnancies identified as high risk for preeclampsia (>1:150 by FMF first‑trimester screening). Participants are randomized 1:1 to receive 160 mg daily aspirin alone or 160 mg aspirin plus weight‑adjusted therapeutic tinzaparin from before 16 weeks until 36 weeks gestation. The primary outcome is incidence of preeclampsia, with secondary outcomes including early preeclampsia, gestational hypertension, HELLP, preterm birth, fetal growth restriction, placental abruption, and neonatal outcomes. Blood samples at 20–24, 32–34, and 36 weeks will measure PlGF, sFlt‑1, inflammatory markers, and related biomarker ratios, and regular telephone follow‑up will monitor adherence and adverse events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Singleton pregnancy
* High risk for preeclampsia (risk \>1:150) based on FMF screening algorithm combining first-trimester ultrasound, biochemical markers, and medical history
* Gestational age \<16 weeks at enrollment
* Maternal age ≥18 years
* Willing and able to provide written informed consent
* Adequate ability for follow-up (direct telephone communication, accessible residence)

Exclusion Criteria:

* Multiple pregnancy
* Current permanent aspirin use for other medical indications
* Serious congenital fetal abnormality detected on ultrasound
* Contraindication to aspirin or low molecular weight heparin including: known hypersensitivity, active peptic ulcer disease, bleeding disorders or coagulopathy, severe thrombocytopenia (platelet count \<100,000/μL), active or recent significant bleeding, history of heparin-induced thrombocytopenia
* Pre-existing severe renal failure (creatinine clearance \<30 mL/min)
* Unable to provide informed consent
* Low probability of adequate follow-up (residence in remote areas without telephone access, accommodation in temporary structures)

Where it's running

• First Department of Obstetrics and Gynecology, Alexandra Hospital
  Athens, Attica, Greece Recruiting

Study contacts

• Study coordinator: Dimitrios Baroutis, MD, MSc, PhD(c)
• Email: dbaroutis@gmail.com
• Phone: +306978275745

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.