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

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital; LEO Pharma
• Treatments: Dalteparin; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin

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