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

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001905-33-ES

Enrollment

Registered

2017-07-31

Start date

2017-10-25

Completion date

Unknown

Last updated

2017-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EARLY INTRAUTERINE GROWTH RESTRICTION MedDRA version: 20.0 Level: LLT Classification code 10048488 Term: Growth intrauterine retard System Organ Class: 100000114573

Interventions

Trade Name: HIBOR 3.500 UI Product Name: LOW MOLECULAR WEIGHT HEPARIN Pharmaceutical Form: Injection INN or Proposed INN: heparin Other descriptive name: LOW MOLECULAR WEIGHT HEPARIN SODIUM Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Women older than 18 years. • Unique gestations • Diagnosis of early placental intrauterine growth (according to Delphi classification): =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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).

Design outcomes

Primary

Measure	Time frame
Main Objective: TO DEMONSTRATE THE EFFICACY OF LOW MOLECULAR WEIGHT HEPARIN IN THE PROLONGATION OF GESTATION TIME IN PATIENTS DIAGNOSED WITH EARLY INTRAUTERINE GROWTH RESTRICTION (IGR) .;Secondary Objective: • Demonstrate the efficacy of low molecular weight heparin in reducing neonatal morbidity in pregnancies diagnosed with early IGR. • Demonstrate that low molecular weight heparin improves the pro-angiogenic and anti-inflammatory profile both at the maternal and placental levels in gestations diagnosed with early IGR. • Demonstrate the efficacy of low molecular weight heparin in reducing thrombotic and ischemic placental lesions.;Primary end point(s): Gestational age (weeks) at birth (dated by ultrasonography <14 weeks by measurement of caudal skull length);Timepoint(s) of evaluation of this end point: 13 WEEKS	—

Measure

Time frame

Main Objective: TO DEMONSTRATE THE EFFICACY OF LOW MOLECULAR WEIGHT HEPARIN IN THE PROLONGATION OF GESTATION TIME IN PATIENTS DIAGNOSED WITH EARLY INTRAUTERINE GROWTH RESTRICTION (IGR) .;Secondary Objective: • Demonstrate the efficacy of low molecular weight heparin in reducing neonatal morbidity in pregnancies diagnosed with early IGR. • Demonstrate that low molecular weight heparin improves the pro-angiogenic and anti-inflammatory profile both at the maternal and placental levels in gestations diagnosed with early IGR. • Demonstrate the efficacy of low molecular weight heparin in reducing thrombotic and ischemic placental lesions.;Primary end point(s): Gestational age (weeks) at birth (dated by ultrasonography <14 weeks by measurement of caudal skull length);Timepoint(s) of evaluation of this end point: 13 WEEKS

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 13 WEEKS;Secondary end point(s): Intrauterine growth retardation: Neonatal weight below the 10th percentile of our population + umbilical artery pulsatility index during the third trimester (on two separate occasions> 48h) above the 95th percentile	—

Countries

Spain

Contacts

Public ContactSilvia Martínez

SAIL SL

silvia.martinez@sail-biometria.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026