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

Primary Purpose

Intrauterine Growth Restriction

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Low molecular weight heparin
Placebos
Sponsored by
Fundació Sant Joan de Déu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intrauterine Growth Restriction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Hospital Sant Joan de Déu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study Group

Control Group

Arm Description

Treatment with low molecular weight Heparin.

Treatment with Placebo.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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).
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.

Full Information

First Posted
September 15, 2017
Last Updated
October 23, 2017
Sponsor
Fundació Sant Joan de Déu
Collaborators
Servicio de Asesoría a la Investigación y Logística SL
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1. Study Identification

Unique Protocol Identification Number
NCT03324139
Brief Title
Treatment of Intrauterine Growth Restriction With Low Molecular Heparin.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2017 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Sant Joan de Déu
Collaborators
Servicio de Asesoría a la Investigación y Logística SL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrauterine Growth Restriction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A randomized, double-blind, two-parallel, placebo-controlled, phase III multicenter clinical trial.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
Treatment with low molecular weight Heparin.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Treatment with Placebo.
Intervention Type
Drug
Intervention Name(s)
Low molecular weight heparin
Other Intervention Name(s)
heparin
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
sodium chloride (0.9%)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Efficacy of low molecular weight heparin in the prolongation of gestation.
Description
Measured as gestational age (weeks) at birth (dated by ultrasonography <14 weeks by measurement of caudal skull length).
Time Frame
13 weeks maximum
Secondary Outcome Measure Information:
Title
Efficacy of low molecular weight heparin in reducing neonatal morbidity
Description
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.
Time Frame
13 weeks maximum
Title
Demonstrate that low molecular weight heparin improves the pro-angiogenic and anti-inflammatory profile.
Description
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).
Time Frame
13 weeks maximum
Title
Efficacy of low molecular weight heparin in reducing thrombotic and ischemic placental lesions
Description
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.
Time Frame
13 weeks maximum

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ainhoa Andueza
Phone
+34 93 600 97 33
Ext
70043
Email
aandueza@fsjd.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edurne Mazarico
Organizational Affiliation
Hospital Sant Joan de Deu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Sant Joan de Déu
City
Esplugues de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edurne Mazarico Gallego, MD Ph
Email
emazarico@sjdhospitalbarcelona.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30355790
Citation
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.
Results Reference
derived

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Treatment of Intrauterine Growth Restriction With Low Molecular Heparin.

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