Clinical trial NCT03324139: Treatment of Intrauterine Growth Restriction With Low Molecular Heparin.
Official title: Treatment of Intrauterine Growth Restriction With Low Molecular Heparin: Randomized Clinical Trial. Tratamiento Del Crecimiento Intrauterino Restringido Precoz Con Heparina de Bajo Peso Molecular: Ensayo clínico Aleatorizado.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intrauterine Growth Restriction
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Servicio de Asesoría a la Investigación y Logística SL
First posted: 2017-10-27
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, double-blind, two-parallel, placebo-controlled, phase III multicenter clinical trial.
Primary purpose: TREATMENT

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 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).

Primary outcomes:
measure: Efficacy of low molecular weight heparin in the prolongation of gestation.
timeFrame: 13 weeks maximum
Secondary outcomes:
measure: Efficacy of low molecular weight heparin in reducing neonatal morbidity
timeFrame: 13 weeks maximum
measure: Demonstrate that low molecular weight heparin improves the pro-angiogenic and anti-inflammatory profile.
timeFrame: 13 weeks maximum
measure: Efficacy of low molecular weight heparin in reducing thrombotic and ischemic placental lesions
timeFrame: 13 weeks maximum
Other outcomes:
Locations:
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Déu
state: Barcelona
Study officials:
affiliation: Hospital Sant Joan de Deu
name: Edurne Mazarico
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.