Treatment of Intrauterine Growth Restriction With Low Molecular Heparin.

NCT03324139 | Completed Phase 3

• 2 other identifiers: FSJD-TRACIP-20172017-001905-33
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

TREATMENT OF INTRAUTERINE GROWTH RESTRICTION WITH LOW MOLECULAR WEIGHT HEPARIN.

Conditions

Intrauterine Growth Restriction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Efficacy of low molecular weight heparin in reducing neonatal morbidity

  13 weeks maximum

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

  13 weeks maximum

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

  13 weeks maximum

Study Arms (2)

Study Group

EXPERIMENTAL

Treatment with low molecular weight Heparin.

Drug: Low molecular weight heparin

Control Group

PLACEBO COMPARATOR

Treatment with Placebo.

Drug: Placebos

Interventions

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).

Also known as: heparin

Study Group

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).

Also known as: sodium chloride (0.9%)

Control Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Chromosopathies, genetic alterations or fetal malformations.
• 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).

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead
• Servicio de Asesoría a la Investigación y Logística SL: collaborator

Study Sites (1)

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Related Publications (1)

• 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.

  PMID: 30355790 DERIVED

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Heparin, Low-Molecular-Weight; Heparin; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Edurne Mazarico

  Hospital Sant Joan de Deu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, double-blind, two-parallel, placebo-controlled, phase III multicenter clinical trial.

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: October 27, 2017
• Study Start: January 25, 2018
• Primary Completion: April 30, 2022
• Study Completion: February 19, 2023
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)