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

NCT ID: NCT01390051

Last Updated: 2016-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2016-07-31

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.

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

Conditions

Fetal Growth Retardation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Innohep

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

Group Type: ACTIVE_COMPARATOR

Innohep (Tinzaparin)

Intervention Type: DRUG

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

tinzaparin

Intervention Type: DRUG

Dose 4,500 IE daily

no treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Innohep (Tinzaparin)

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

Intervention Type: DRUG

tinzaparin

Dose 4,500 IE daily

Intervention Type: DRUG

Other Intervention Names

Innohep; Innohep

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

LEO Pharma

INDUSTRY

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne-Mette Hvas, PhD, professor

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Biochemistry, Aarhus University Hospital, Denmark

Locations

Consultant phD professor Anne-Mette Hvas

Aarhus, Central Jutland, Denmark

Department of Obstetrics

Herning, , Denmark

Department of Obstetrics

Randers, , Denmark

Countries

Denmark

Other Identifiers

M-20110042

Identifier Type: -

Identifier Source: org_study_id