Heparin in the treatment of fetal growth restrictio

Phase 1

• Conditions: Early fetal growth restriction; MedDRA version: 20.0Level: LLTClassification code 10070532Term: Fetal growth restrictionSystem Organ Class: 100000004868; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2020-000315-76-PT
• Lead Sponsor: Centro Hospitalar Universitário de Lisboa Central, EPE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-11
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 120

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

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 < 100 000); k) history of maternal anticoagulant hemostatic disorder; j) presence of placental hematoma; k) maternal diabetic retinopathy; l) bacterial endocarditis; m) high risk of bleeding (recent ophthalmological, spinal or brain surgery); n) previous hemorrhagic stroke; o) persistent blood pressure > 160/100 mmHg, despite optimal anti-hypertensive regimen; p) active ulcerative or angiodysplastic diseases; q) history of severe renal disease (eGFR <30mL/min).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified