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

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.

TREATMENT OF INTRAUTERINE GROWTH RESTRICTION WITH LOW MOLECULAR WEIGHT HEPARIN.

Study Overview

• Status: Completed
• Conditions: Intrauterine Growth Restriction
• Intervention / Treatment: Drug: Low molecular weight heparin; Drug: Placebos

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Esplugues de Llobregat, Barcelona, Spain, 08950
      • Hospital Sant Joan de Déu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; Treatment with low molecular weight Heparin.	Drug: Low molecular weight heparin; 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
Placebo Comparator: Control Group; Treatment with Placebo.	Drug: Placebos; 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%)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of low molecular weight heparin in reducing neonatal morbidity	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.	13 weeks maximum
Demonstrate that low molecular weight heparin improves the pro-angiogenic and anti-inflammatory profile.	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).	13 weeks maximum
Efficacy of low molecular weight heparin in reducing thrombotic and ischemic placental lesions	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.	13 weeks maximum

Collaborators and Investigators

• Sponsor: Fundació Sant Joan de Déu
• Collaborators: Servicio de Asesoría a la Investigación y Logística SL
• Investigators: Principal Investigator: Edurne Mazarico, Hospital Sant Joan de Déu

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2018
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): February 19, 2023

Study Registration Dates

• First Submitted: September 15, 2017
• First Submitted That Met QC Criteria: October 23, 2017
• First Posted (Actual): October 27, 2017

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Pregnancy Complications; Growth Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Growth Retardation; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Calcium heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin
• Other Study ID Numbers: FSJD-TRACIP-2017; 2017-001905-33 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No