Early fetal growth restriction MedDRA version: 20.0 Level: LLT Classification code 10070532 Term: Fetal growth restriction System Organ Class: 100000004868
Conditions
Interventions
Trade Name: Enoxaparina Rovi 4.000 UI (40 mg)/0,4 mL Solution for injection in pre-filled syringe
Product Name: Enoxaparina Rovi
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN o
Sponsors
Centro Hospitalar Universitário de Lisboa Central, EPE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible women referred to our FGR unit who consent to participate in the study. Eligible women are considered those who fulfill all the following eligibility criteria: a) being over 18 years old; b) being able to provide consent; c) having a viable singleton pregnancy with diagnosed early FGR confirmed in our unit according to the 2016 consensus criteria Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: diagnosed fetal chromosomal abnormalities; c) associated fetal morphological malformations; d) evidence of fetal infection (serological or after invasive testing); e) use of aspirin, LMWH or NFH in the index pregnancy before randomization; f) maternal history of allergy to LMWH or non-fractionated heparin (NFH); g) hypersensitivity to pork products; h) maternal history of heparin-induced thrombocytopenia; i) maternal thrombocytopenia (platelets 160/100 mmHg, despite optimal anti-hypertensive regimen; p) active ulcerative or angiodysplastic diseases; q) history of severe renal disease (eGFR <30mL/min).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Our global aim is to assess if LMWH improves the outcomes of early-restricted fetuses (ERF).;Secondary Objective: 1) To determine if enoxaparin increases the mean neonatal birth weight and decreases neonatal intensive care admissions 2) To determine if enoxaparin improves maternal and fetal Doppler parameters in this group of patients 3) To determine if enoxaparin is associated with alterations in placental pathology 4) To determine if enoxaparin is associated with alterations in Sflt1-PLGF ratio 5) To determine if there is a change in number or composition of STD-EV between healthy and FGR pregnancies 6) To determine if enoxaparin is associated with alterations in STD-EV in FGR pregnancies;Primary end point(s): Primary: Gestational age at delivery;Timepoint(s) of evaluation of this end point: At delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary: Evolution of fetal doppler parameters (umbilical artery pulsatility index, middle cerebral artery pulsatility index, cerebral-placental ratio, ductus venosus pulsatility index); evolution of maternal doppler parameters (uterine artery pulsatility index); maternal weight gain during pregnancy; newborn weight, percentile, umbilical artery pH and Apgar score in the 5th minute; neonatal intensive care admission and duration of admission; a composite outcome of severe neonatal morbidity (evidence of one or more of: intraventricular hemorrhage grade 3 or 4; cystic periventricular leukomalacia; chronic lung disease; retinopathy of prematurity requiring treatment; necrotizing enterocolitis requiring surgery); gestational hypertension or preeclampsia; placental abruption; antepartum hemorrhage; maternal thrombocytopenia (platelets < 100 000 x 109/L); stillbirth; preterm birth; mode of delivery; indication for delivery; postpartum hemorrhage; placental pathology; sFLT1-PLGF ratio; STD-EV (number and composition) ;Timepoint(s) of evaluation of this end point: During all pregnancy and after delivery | — |
Countries
Portugal
Contacts
Public ContactCatarina Palma dos Reis
Centro Hospitalar Universitário Lisboa Central
Outcome results
None listed