Status:
ENROLLING_BY_INVITATION
LMWH for Treatment of Early Fetal Growth Restriction (HepaGrowth)
Lead Sponsor:
Centro Hospitalar de Lisboa Central
Collaborating Sponsors:
NOVA Medical School
Conditions:
Fetal Growth Retardation
Prematurity
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Early fetal growth restriction (FGR) is associated with considerable fetal and neonatal morbimortality. Placental thrombosis, infarcts and hypercoagulability are frequently seen in these pregnancies, ...
Detailed Description
FGR is the second leading cause of perinatal mortality, being associated with approximately 30% of stillbirths. Early FGR is associated with substantial disturbances of placental implantation and feta...
Eligibility Criteria
Inclusion
- being 18 years old or older
- being able to provide consent
- having a viable singleton pregnancy with diagnosed early FGR confirmed in our unit according to the 2020 International Society of Ultrasound in Obstetrics \& Gynecology (ISUOG) criteria (one solitary parameter: estimated fetal weight/ abdominal circumference lower than the 3rd centile or absent end-diastolic flow in umbilical artery; or estimated fetal weight/abdominal circumference below the 10th centile combined with either umbilical artery pulsatility index \> 95th centile or uterine artery mean pulsatility index \> 95th centile)
Exclusion
- multiple gestation;
- diagnosed fetal chromosomal abnormalities;
- associated fetal morphological malformations;
- evidence of fetal infection (serological or after invasive testing);
- use of LMWH or NFH in the index pregnancy before randomization or start of any of these medications for another indication if the patient is in the control group
- present use of systemic salicylates in anti-inflammatory dosage (\> 150mg/day) or NSAIDs (including ketorolac)
- maternal history of allergy to LMWH or non-fractionated heparin (NFH);
- hypersensitivity to pork products;
- maternal history of heparin-induced thrombocytopenia;
- maternal thrombocytopenia (platelets \< 100 000);
- history of maternal hemophilia or Von Willebrand disease
- presence of placental hematoma;
- maternal diabetic retinopathy;
- bacterial endocarditis;
- active clinically significant bleeding and conditions with a high risk of hemorrhage, including recent hemorrhagic stroke, gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities;
- persistent blood pressure \> 160/100 mmHg, despite optimal anti-hypertensive regimen;
- history of severe renal disease (eGFR \<30mL/min);
- known or suspected hepatic impairment;
- current participation in another clinical trial;
- patients that are not part of the national health system (SNS);
- delivery already scheduled, or predicted in the next 7 days.
Key Trial Info
Start Date :
July 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04762992
Start Date
July 18 2022
End Date
December 30 2026
Last Update
August 13 2025
Active Locations (1)
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1
Centro de Diagnóstico Pré-Natal, Maternidade Dr. Alfredo da Costa, Centro Hospitalar Universitário de Lisboa Central
Lisbon, Portugal, 1050-170