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

F

Fundació Sant Joan de Déu

Status and phase

Unknown
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

50 estimated 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

50 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

Trial contacts and locations

0

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Central trial contact

Ainhoa Andueza

Data sourced from clinicaltrials.gov

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