Treatment of Intrauterine Growth Restriction With Low Molecular Heparin.
NCT ID: NCT03324139
Last Updated: 2024-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
48 participants
INTERVENTIONAL
2018-01-25
2023-02-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Study Group
Treatment with low molecular weight Heparin.
Low molecular weight heparin
Patients included in this study group will receive 3,500 IU / 0.2 ml / day of Bemiparina sc, from inclusion to delivery (estimated median of 5-6 weeks, with a maximum of 13 weeks).
Control Group
Treatment with Placebo.
Placebos
Patients included in this study group will placebo (same presentation as the active drug), from inclusion to delivery (estimated median of 5-6 weeks, with a maximum of 13 weeks).
Interventions
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Low molecular weight heparin
Patients included in this study group will receive 3,500 IU / 0.2 ml / day of Bemiparina sc, from inclusion to delivery (estimated median of 5-6 weeks, with a maximum of 13 weeks).
Placebos
Patients included in this study group will placebo (same presentation as the active drug), from inclusion to delivery (estimated median of 5-6 weeks, with a maximum of 13 weeks).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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).
18 Years
FEMALE
No
Sponsors
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Servicio de Asesoría a la Investigación y Logística SL
OTHER
Fundació Sant Joan de Déu
OTHER
Responsible Party
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Principal Investigators
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Edurne Mazarico
Role: PRINCIPAL_INVESTIGATOR
Hospital Sant Joan de Deu
Locations
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Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, Spain
Countries
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References
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Mazarico E, Peguero A, Camprubi M, Rovira C, Gomez Roig MD, Oros D, Ibanez-Burillo P, Schoorlemmer J, Masoller N, Tassies MD, Figueras F. Study protocol for a randomised controlled trial: treatment of early intrauterine growth restriction with low molecular weight heparin (TRACIP). BMJ Open. 2018 Oct 23;8(10):e020501. doi: 10.1136/bmjopen-2017-020501.
Other Identifiers
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2017-001905-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FSJD-TRACIP-2017
Identifier Type: -
Identifier Source: org_study_id
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