Enoxaparin sodium for Fetal growth restriction

Inclusion criteria

• {"criterion_text":"- Age >= 18 years old\n- Able to provide consent\n- Having a viable singleton pregnancy with diagnosed early FGR confirmed in our unit according to the 2016 consensus criteria (Gordijn SJ, Beune IM, Thilaganathan B, Papageorghiou A, Baschat AA, Baker PN, et al. Consensus definition of fetal growth restriction: a Delphi procedure. Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology. 2016;48(3):333-9)"}

Exclusion criteria

• {"criterion_text":"- Multiple gestations\n- Maternal thrombocytopenia (platelets < 100 000)\n- History of maternal hemophilia or Von Willebrand disease\n- Presence of placental hematoma\n- Maternal diabetic retinopathy\n- Bacterial endocarditis\n- 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\n- Persistent blood pressure > 160/100 mmHg, despite optimal anti-hypertensive regimen\n- History of severe renal disease (eGFR <30mL/min)\n- Known or suspected hepatic impairment\n- Current participation in another clinical trial\n- Diagnosed fetal chromosomal abnormalities\n- Patients that are not part of the national health system (SNS)\n- Delivery already scheduled, or predicted in the next 7 days\n- Associated fetal morphological malformation\n- Evidence of fetal infection (serological or after invasive testing)\n- 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\n- Present use of systemic salicylates in anti-inflammatory dosage (> 150 mg/day) or NSAIDs (including ketorolac)\n- Maternal history of allergy to LMWH or non-fractionated heparin (NFH)\n- Hypersensitivity to pork products\n- Maternal history of heparin-induced thrombocytopenia"}

Primary endpoints

• {"endpoint_text":"- Gestational age at delivery","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Evolution of fetal Doppler parameters (umbilical artery pulsatility index, middle cerebral artery pulsatility index, cerebralplacental ratio, ductus venosus pulsatility index)\n- Evolution of maternal doppler parameters (uterine artery pulsatility index)\n- Maternal body mass index (BMI) at moment of randomization\n- Newborn weight, percentile, umbilical artery pH and Apgar score in the 5th minute\n- Neonatal intensive care admission and duration of admission\n- 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)\n- Gestational hypertension or preeclampsia\n- Placental abruption\n- Antepartum hemorrhage\n- Maternal thrombocytopenia (platelets < 100 000 x 109/L)\n- Stillbirth\n- Mode of delivery\n- Indication for delivery\n- Postpartum hemorrhage\n- Placental pathology\n- sFLT1-PLGF ratio\n- Syncytiotrophoblast derived vesicles (STD-EVS)","definition_or_measurement_approach":""}

Portugal

Earliest CTIS Part Ii Submission Date

03-09-2024

Latest Decision Or Authorization Date

16-09-2024

Processing Time Days

13

Number Of Sites

1

Number Of Participants

160

Primary sponsor

Full Name

Unidade Local De Saude De Sao Jose E.P.E.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Portugal

Third parties

• {"country":"United Kingdom","full_name":"University Of Oxford","duties_or_roles":"codes: 4","organisation_type":"Educational Institution"}
• {"country":"Portugal","full_name":"Nova Medical School","duties_or_roles":"codes: 1,12,5,8","organisation_type":"Educational Institution"}