Treatment of Intrauterine Growth Restriction With Low Molecular Heparin. (TRACIP)

Fundació Sant Joan de Déu

Status and phase: Completed; Phase 3

Conditions: Intrauterine Growth Restriction

Treatments: Drug: Low molecular weight heparin; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT03324139

FSJD-TRACIP-2017

2017-001905-33 (EudraCT Number)

Details and patient eligibility

About

TREATMENT OF INTRAUTERINE GROWTH RESTRICTION WITH LOW MOLECULAR WEIGHT HEPARIN.

Full description

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

Enrollment: 48 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 <percentile 10 + pulsed uterine artery Doppler).
• Patient giving written informed consent to participate in the study.

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

Study Group

Experimental group

Description:

Treatment with low molecular weight Heparin.

Treatment:

Drug: Low molecular weight heparin

Control Group

Placebo Comparator group

Description:

Treatment with Placebo.

Treatment:

Drug: Placebos