Combined Administration of Low Molecular Weight Heparin and Aspirin Versus Aspirin Alone in Gravidas at High Risk for Preeclampsia: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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. Low molecular weight heparin (LMWH) has shown potential benefits in addition to aspirin for preventing preeclampsia through its anticoagulant, anti-inflammatory, and endothelial protective effects. However, current evidence is limited and conflicting regarding the added value of LMWH to aspirin. This randomized controlled trial aims to evaluate the efficacy of combined aspirin and LMWH, compared to aspirin alone, for reducing the incidence of preeclampsia in high-risk gravidas.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Greece
First Department of Obstetrics and Gynecology, Alexandra Hospital
RECRUITING
Athens
Contact Information
Primary
Dimitrios Baroutis, MD, MSc, PhD(c)
dbaroutis@gmail.com
+306978275745
Time Frame
Start Date: 2023-01-18
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 100
Treatments
Active_comparator: Aspirin Alone
Participants receive aspirin 160 mg orally once daily before bedtime from enrollment (\<16 weeks gestation) until 36 weeks gestation.
Experimental: Aspirin plus LMWH
Participants receive aspirin 160 mg orally once daily before bedtime PLUS weight-adjusted tinzaparin subcutaneously once daily in the morning (4,500 Anti-Xa IU for weight ≤60 kg, 6,000 Anti-Xa IU for weight 60-90 kg, 8,000 Anti-Xa IU for weight \>90 kg) from enrollment (\<16 weeks gestation) until 36 weeks gestation.
Related Therapeutic Areas
Sponsors
Leads: Alexandra Hospital, Athens, Greece

This content was sourced from clinicaltrials.gov