Status:
COMPLETED
Treatment of Intrauterine Growth Restriction With Low Molecular Heparin.
Lead Sponsor:
Fundació Sant Joan de Déu
Collaborating Sponsors:
Servicio de Asesoría a la Investigación y Logística SL
Conditions:
Intrauterine Growth Restriction
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
TREATMENT OF INTRAUTERINE GROWTH RESTRICTION WITH LOW MOLECULAR WEIGHT HEPARIN.
Detailed Description
TREATMENT OF INTRAUTERINE GROWTH RESTRICTION WITH LOW MOLECULAR WEIGHT HEPARIN: RANDOMIZED CLINICAL TRIAL (TRACIP STUDY).
Eligibility Criteria
Inclusion
- 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 \<percentile 10 + pulsed uterine artery Doppler).
- Patient giving written informed consent to participate in the study.
Exclusion
- 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).
Key Trial Info
Start Date :
January 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2023
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03324139
Start Date
January 25 2018
End Date
February 19 2023
Last Update
April 22 2024
Active Locations (1)
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1
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, Spain, 08950