Low Molecular Weight Heparin Improves Endothelial Function in Pregnant Women at High Risk of Preeclampsia.
Kelsey McLaughlin, Dora Baczyk, Audrey Potts...
https://pubmed.ncbi.nlm.nih.gov/27840330Actively Recruiting
Phase 4
Age: 18Years +
FEMALE
ID07361679
Combined Administration of Low Molecular Weight Heparin and Aspirin Versus Aspirin Alone in Gravidas at High Risk for Preeclampsia: A Randomized Controlled Trial
Led by Alexandra Hospital, Athens, Greece · Updated on 2026-01-23
100
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Preeclampsia is a serious condition affecting pregnant women and their babies worldwide. Researchers are studying whether adding low molecular weight heparin (LMWH) to low-dose aspirin can better prevent preeclampsia in women at high risk compared to aspirin alone. This randomized controlled trial focuses on pregnant women with a high risk of developing preeclampsia, aiming to provide clearer evidence on the benefits of combined treatment. Participants will be randomly assigned to one of two groups: one receiving 160 mg of aspirin daily before bedtime, and the other receiving the same aspirin dose plus a daily weight-adjusted dose of tinzaparin (LMWH) injected in the morning. Treatments start before 16 weeks of pregnancy and continue until 36 weeks gestation. Risk assessment uses a recognized model combining ultrasound, blood tests, and medical history. Throughout the study, women will have blood samples taken at 20-24, 32-34, and 36 weeks to measure various biomarkers related to inflammation and placental health. Regular phone calls will track medication adherence and any side effects. The main outcome measured is the occurrence of preeclampsia up to delivery, with additional outcomes including early preeclampsia, gestational hypertension, preterm birth, and newborn health until hospital discharge. The total participation lasts from enrollment until delivery, with ongoing monitoring.
CONDITIONS
Brief Title
LDA and LMWH vs LDA Alone in High-risk Patients for Preeclampsia Prevention
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Singleton pregnancy
- High risk for preeclampsia (risk >1:150) based on FMF screening combining first-trimester ultrasound, biochemical markers, and medical history
- Gestational age less than 16 weeks at enrollment
- Maternal age 18 years or older
- Willing and able to provide written informed consent
- Adequate ability for follow-up with direct telephone communication and accessible residence
You will not qualify if you...
- Multiple pregnancy
- Current permanent aspirin use for other medical reasons
- Serious congenital fetal abnormality detected on ultrasound
- Contraindications to aspirin or low molecular weight heparin such as hypersensitivity, active peptic ulcer disease, bleeding disorders, severe thrombocytopenia, recent significant bleeding, or history of heparin-induced thrombocytopenia
- Severe pre-existing renal failure (creatinine clearance less than 30 mL/min)
- Unable to provide informed consent
- Low likelihood of adequate follow-up due to remote residence without telephone access or temporary accommodation structures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - From enrollment (less than 16 weeks gestation) until 36 weeks gestation
Participants receive daily aspirin alone or aspirin plus weight-adjusted low molecular weight heparin starting before 16 weeks gestation until 36 weeks gestation.
Blood samples collected at 20-24, 32-34, and 36 weeks gestation; regular telephone follow-up to monitor adherence and adverse events
Follow-up
Duration - From delivery until hospital discharge (up to 3 months)
Participants are monitored from delivery until up to 3 months after delivery for neonatal outcomes and complications.
Monitoring includes assessments at delivery and up to 28 days after delivery
Trial Site Locations
Total: 1 location
1
First Department of Obstetrics and Gynecology, Alexandra Hospital
Athens, Attica, Greece, 11528
Actively Recruiting
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Research Team
D
Dimitrios Baroutis, MD, MSc, PhD(c)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Low-molecular-weight heparin for prevention of preeclampsia and other placenta-mediated complications: a systematic review and meta-analysis.
Monica Cruz-Lemini, Juan Carlos Vázquez, Johana Ullmo...
https://pubmed.ncbi.nlm.nih.gov/34301348The competing risk approach for prediction of preeclampsia.
David Wright, Alan Wright, Kypros H Nicolaides
https://pubmed.ncbi.nlm.nih.gov/31733203The 2021 International Society for the Study of Hypertension in Pregnancy classification, diagnosis & management recommendations for international practice.
Laura A Magee, Mark A Brown, David R Hall...
https://pubmed.ncbi.nlm.nih.gov/35066406Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia.
Daniel L Rolnik, David Wright, Liona C Poon...
https://pubmed.ncbi.nlm.nih.gov/28657417Preeclampsia.
Laura A Magee, Kypros H Nicolaides, Peter von Dadelszen
https://pubmed.ncbi.nlm.nih.gov/35544388