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Completed

NCT Number: NCT03324139

Treatment of Intrauterine Growth Restriction With Low Molecular Heparin.

TREATMENT OF INTRAUTERINE GROWTH RESTRICTION WITH LOW MOLECULAR WEIGHT HEPARIN.

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Key information

Conditions

Intrauterine Growth Restriction Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Retardation Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona, 08950, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Low molecular weight heparin

Drug

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).

Other names: heparin

Placebos

Drug

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 names: sodium chloride (0.9%)

Primary outcomes

  1. Efficacy of low molecular weight heparin in the prolongation of gestation.

    Time frame: 13 weeks maximum

    Measured as gestational age (weeks) at birth (dated by ultrasonography <14 weeks by measurement of caudal skull length).

Secondary outcomes

  1. Efficacy of low molecular weight heparin in reducing neonatal morbidity

    Time frame: 13 weeks maximum

    Measured as the presence of one or more of the following: Perinatal mortality (> 22 weeks of gestation - <28 days postpartum), Significant neonatal morbidity (convulsions, intraventricular haemorrhage> grade III, periventricular leukomalacia, hypoxic-ischemic encephalopathy, abnormal electroencephalogram, necrotizing enterocolitis, acute renal failure (serum creatinine> 1.5 mg / dL) or cardiac failure (requiring inotropic agents), Perinatal mortality (22 weeks to 28 postnatal days), Biomarkers.

  2. Demonstrate that low molecular weight heparin improves the pro-angiogenic and anti-inflammatory profile.

    Time frame: 13 weeks maximum

    Measured as the presence of one or more of the following: mother blood biomarkers (sFlt and PlGF), biomerkers, umbilical cord blood biomarkers (TNF alfa, IL6, IFN gamma, FGF basic, VEGF and PlGF), mRNA in trophoblast.( IL6, INFg, TNF alfa, VEGFA, VEGFB, FGF2 y RQVEGF).

  3. Efficacy of low molecular weight heparin in reducing thrombotic and ischemic placental lesions

    Time frame: 13 weeks maximum

    Measured as the presence of one or more of the following: 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), Preeclampsia, Gestational age (weeks) at birth, Premature delivery before 34 weeks of gestation, Urgent cesarean section due to loss of fetal well-being, Neonatal weight, Neonatal acidosis (arterial pH <7.10 + EB> 12mEq / L), Days stay in the Neonatal Intensive Care Unit, mRNA in trophoblast.

Sponsors and collaborators

Lead sponsor

Fundació Sant Joan de Déu

Other

Collaborators

  • Servicio de Asesoría a la Investigación y Logística SL

Registry information

Official study 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.

Acronym: TRACIP

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Oct 27, 2017
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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