Treatment of Intrauterine Growth Restriction With Low Molecular Heparin.

Phase 3

Completed

• Conditions: Intrauterine Growth Restriction
• Interventions: Drug: Placebos; Drug: Low molecular weight heparin

• Registration Number: NCT03324139
• Lead Sponsor: Fundació Sant Joan de Déu

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).

Study Timeline

• Study First Submitted: 2017-09-15
• Study First Submitted QC: 2017-10-23
• Study First Posted: 2017-10-27
• Study Start: 2018-01-25
• Primary Completion: 2022-04-30
• Study Completion: 2023-02-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Placebos	Treatment with Placebo.
Study Group	Low molecular weight heparin	Treatment with low molecular weight Heparin.

Primary Outcome Measures

Name	Time	Method
Efficacy of low molecular weight heparin in the prolongation of gestation.	13 weeks maximum	Measured as gestational age (weeks) at birth (dated by ultrasonography \<14 weeks by measurement of caudal skull length).

Secondary Outcome Measures

Name	Time	Method
Efficacy of low molecular weight heparin in reducing thrombotic and ischemic placental lesions	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.
Efficacy of low molecular weight heparin in reducing neonatal morbidity	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.
Demonstrate that low molecular weight heparin improves the pro-angiogenic and anti-inflammatory profile.	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).

Trial Locations

Locations (1)

Hospital Sant Joan de Déu; 🇪🇸 Esplugues de Llobregat, Barcelona, Spain