Recruiting PHASE4 Preeclampsia Severe

Compares treatment options for Preeclampsia Severe

Official title LDA and LMWH vs LDA Alone in High-risk Patients for Preeclampsia Prevention

ClinicalTrials.gov ID: NCT07361679

What this study is testing

What is Aspirin?

Aspirin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for preeclampsia severe.

Also referred to as ASA, Low-dose aspirin.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Preeclampsia is a major cause of maternal and perinatal morbidity and mortality worldwide. Low-dose aspirin started in the first trimester reduces the risk of preeclampsia in high-risk women.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older, women only

You may be able to join if

  • Singleton pregnancy
  • High risk for preeclampsia (risk \>1:150) based on FMF screening algorithm combining first-trimester ultrasound, biochemical markers, and medical...
  • Gestational age \<16 weeks at enrollment
  • Maternal age ≥18 years
  • Willing and able to provide written informed consent

You likely can't join if

  • 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...
  • Pre-existing severe renal failure (creatinine clearance \<30 mL/min)
  • Unable to provide informed consent
See the full eligibility criteria
Who can join
  • 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)
What rules you out
  • 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)...
  • 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)

The study team makes the final eligibility decision.

Where it's taking place

  • Athens, Attica, Greece

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Athens, Attica, Greece. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.