By InvitationPhase 3

LMWH for Treatment of Early Fetal Growth Restriction (HepaGrowth)

Portugal12 participantsStarted 2022-07-18

Plain-language 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, suggesting a role for the activation of the coagulation cascade in the genesis of FGR. Patients will be randomized for low-molecular weight heparin or standard of care, and the outcomes of both arms (gestational age at delivery, gestational and fetal morbidity) will be compared.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. 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 criteria

✕. 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;

What they're measuring

Gestational age at delivery

Timeframe: day of delivery

Trial details

NCT IDNCT04762992

SponsorCentro Hospitalar de Lisboa Central

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-30

View on ClinicalTrials.gov More Fetal Growth Retardation trials