Treatment of Intrauterine Growth Restriction With Low Molecular Heparin.

Intrauterine Growth Restriction Clinical Trial

— TRACIP  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03324139
• Other study ID #: FSJD-TRACIP-2017
• Secondary ID: 2017-001905-33
• Status: Completed
• Phase: Phase 3
• Start date: January 25, 2018
• Est. completion date: February 19, 2023

Study information

• Verified date: April 2024
• Source: Fundació Sant Joan de Déu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

TREATMENT OF INTRAUTERINE GROWTH RESTRICTION WITH LOW MOLECULAR WEIGHT HEPARIN.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 19, 2023
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Intrauterine Growth Restriction

Intervention

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).
• 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).

Locations

Country	Name	City	State
Spain	Hospital Sant Joan de Déu	Esplugues de Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Sant Joan de Déu	Servicio de Asesoría a la Investigación y Logística SL

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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