TREATMENT OF INTRAUTERINE GROWTH RESTRICTION WITH LOW MOLECULAR WEIGHT HEPARIN: RANDOMIZED CLINICAL TRIAL (TRACIP STUDY) - TRACIP

Fundació Sant Joan de Déu0 sites50 target enrollmentJuly 31, 2017

Overview

No summary available.

Registry

who.int

Start Date

July 31, 2017

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•Women older than 18 years.
•Unique gestations
•Diagnosis of early placental intrauterine growth (according to Delphi classification): \<32 weeks at diagnosis \+ Doppler AU with absent / reverse flow or (estimated fetal weight \<10 percentile \+ pulsed Doppler ultrasonography) or (estimated fetal weight • Patient giving written informed consent to participate in the study.
•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 50
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•Chromosopathies, genetic alterations or fetal malformations.
•Diagnostic treatment with low molecular weight heparins, oral anticoagulants or acetylsalicylic acid prior to inclusion.
•History of heparin\-induced thrombocytopenia.
•Active hemorrhage or increased risk of bleeding due to changes in hemostasis.
•Severe hepatic or pancreatic function disorder.
•Organic lesions that may bleed (eg, active peptic ulcer, hemorrhagic stroke, aneurysms, or brain tumors).