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

Phase 1

Conditions: EARLY INTRAUTERINE GROWTH RESTRICTION
MedDRA version: 20.0Level: LLTClassification code 10048488Term: Growth intrauterine retardSystem Organ Class: 100000114573
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2017-001905-33-ES

Lead Sponsor: Fundació Sant Joan de Déu

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 50

Inclusion Criteria

• 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

Exclusion Criteria

• 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).