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

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

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

Study Overview

• Status: Completed
• Conditions: Fetal Growth Retardation
• Intervention / Treatment: Drug: Innohep (Tinzaparin); Drug: tinzaparin

Detailed Description

Clinical purpose:

1. To examine whether treatment with low molecular weight heparin in pregnant women with Intrauterine Growth Restriction (IUGR)increases the birth weight of the child. Our hypothesis is that an increased birth weight leads to reduced morbidity and mortality among these children.

Laboratory purposes:

1. To evaluate three new methods to monitor the effect of LMWH.
2. To investigate if 2 biochemical markers are positive predictors of IUGR IUGR is defined as a foetus that grows less than expected. IUGR is estimated to occur in up to 5% of all pregnancies, and IUGR is the second most common cause of perinatal morbidity and mortality. Thus, 75% of all stillbirths are caused by IUGR. IUGR is diagnosed by ultrasonography. In IUGR the uteroplacental blood flow is often compromised resulting in foetal growth restriction.

Design: The study is a prospective randomised study where pregnant women with suspected severe IUGR are randomised either to treatment with Innohep® or no treatment. Half of the women receive Innohep® and half of the women do not receive treatment.

Endpoints The primary endpoint is the difference in birth weight in children born of women receiving Innohep® during pregnancy and children born of women who have not received Innohep® during pregnancy

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Herning, Denmark, 7400
    • Department of Obstetrics
  • Randers, Denmark
    • Department of Obstetrics
  • Central Denmark Region
    • Aarhus, Central Denmark Region, Denmark, 8200
      • Consultant phD professor Anne-Mette Hvas

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Singleton pregnancy
2. IUGR shown by ultrasonography:
3. Can understand and read Danish

Exclusion Criteria:

1. Age below 18 years
2. Pregestational weight < 90 kilograms
3. Not able to give informed consent
4. Chronic kidney disease with creatinine >150 μmol/l
5. Chronic hypertension with blood pressure >140/90 mmHg
6. Diabetes mellitus; type 1 or 2 or gestational diabetes
7. Inflammatory bowel disease
8. Severe heart disease (including mechanical heart valves)
9. Drug or alcohol abuse
10. Known coagulopathy (von Willebrand disease, thrombocytopenia, carrier of haemophilia)
11. Treatment with vitamin K antagonists
12. Known allergy to low LMWH
13. Previous heparin-induced thrombocytopenia (HIT (type II))
14. Clinically significant bleeding within the last month
15. 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)
16. Chromosome anomaly in the child
17. Severe malformations in the child
18. Contraindication to Innohep®
19. Gestational week > 32 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: no treatment
Active Comparator: Innohep; Tinzaparin 4500 I.U. sub cutaneous once daily until gestational week 37	Drug: Innohep (Tinzaparin); Dose: 4,500 IU daily in half of the study populationrandomised to treatment; Other Names: Innohep; Drug: tinzaparin; Dose 4,500 IE daily; Other Names: Innohep

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
birth weight	We compare birth weight in children born of women from the 2 study arms	Birth weight registered at birth

Secondary Outcome Measures

Outcome Measure	Time Frame
maternal morbidity	Comorbidity registered up to one year after birth

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital; LEO Pharma
• Investigators: Principal Investigator: Anne-Mette Hvas, PhD, professor, Department of Clinical Biochemistry, Aarhus University Hospital, Denmark

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: July 6, 2011
• First Submitted That Met QC Criteria: July 7, 2011
• First Posted (Estimate): July 8, 2011

Study Record Updates

• Last Update Posted (Estimate): August 18, 2016
• Last Update Submitted That Met QC Criteria: August 17, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: thrombosis; birth weight; anticoagulant therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Body Weight; Fetal Diseases; Pregnancy Complications; Growth Disorders; Birth Weight; Fetal Growth Retardation; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin
• Other Study ID Numbers: M-20110042