Can Low Molecular Weight Heparin During Pregnancy With Intrauterine Growth Restriction Increase Birth Weight?

NCT01390051 | Completed Phase 4

• 1 other identifier: M-20110042
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of the study is to investigate if treatment with an anticoagulant drug increases birth weight in pregnancies complicated by fetal growth restriction.

Conditions

Fetal Growth Retardation

Keywords

birth weight; thrombosis; anticoagulant therapy

Outcome Measures

Primary Outcomes (1)

• birth weight

  We compare birth weight in children born of women from the 2 study arms

  Birth weight registered at birth

Secondary Outcomes (1)

• maternal morbidity

  Comorbidity registered up to one year after birth

Study Arms (2)

Innohep

ACTIVE COMPARATOR

Tinzaparin 4500 I.U. sub cutaneous once daily until gestational week 37

Drug: Innohep (Tinzaparin); Drug: tinzaparin

no treatment

NO INTERVENTION

Interventions

Innohep (Tinzaparin) DRUG

Dose: 4,500 IU daily in half of the study populationrandomised to treatment

Also known as: Innohep

Innohep

tinzaparin DRUG

Dose 4,500 IE daily

Also known as: Innohep

Innohep

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton pregnancy
• IUGR shown by ultrasonography:
• Can understand and read Danish

You may not qualify if:

• Age below 18 years
• Pregestational weight \< 90 kilograms
• Not able to give informed consent
• Chronic kidney disease with creatinine \>150 μmol/l
• Chronic hypertension with blood pressure \>140/90 mmHg
• Diabetes mellitus; type 1 or 2 or gestational diabetes
• Inflammatory bowel disease
• Severe heart disease (including mechanical heart valves)
• Drug or alcohol abuse
• Known coagulopathy (von Willebrand disease, thrombocytopenia, carrier of haemophilia)
• Treatment with vitamin K antagonists
• Known allergy to low LMWH
• Previous heparin-induced thrombocytopenia (HIT (type II))
• Clinically significant bleeding within the last month
• Women with indication for prophylactic treatment with LMWH during pregnancy e.g. previous thromboembolic disease or serious types of thrombophilia (deficiency of antithrombin, protein C or protein S)

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• LEO Pharma: collaborator

Study Sites (3)

Consultant phD professor Anne-Mette Hvas

Aarhus, Central Jutland, 8200, Denmark

Location

Department of Obstetrics

Herning, 7400, Denmark

Location

Department of Obstetrics

Randers, Denmark

Location

MeSH Terms

Conditions

Fetal Growth Retardation; Birth Weight; Thrombosis

Interventions

Tinzaparin

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; Body Weight; Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Anne-Mette Hvas, PhD, professor

  Department of Clinical Biochemistry, Aarhus University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: July 8, 2011
• Study Start: July 1, 2011
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 18, 2016

Record last verified: 2016-07

Locations

DK (3)