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

Fetal Growth Retardation Clinical Trial

— IUGR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01390051
• Other study ID #: M-20110042
• Status: Completed
• Phase: Phase 4
• First received: July 6, 2011
• Last updated: August 17, 2016
• Start date: July 2011
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Birth Weight
• Fetal Growth Retardation

Intervention

Drug:
• Innohep (Tinzaparin)
Dose: 4,500 IU daily in half of the study populationrandomised to treatment
• tinzaparin
Dose 4,500 IE daily

Locations

Country	Name	City	State
Denmark	Consultant phD professor Anne-Mette Hvas	Aarhus	Central Denmark Region
Denmark	Department of Obstetrics	Herning
Denmark	Department of Obstetrics	Randers

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, LEO Pharma

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	birth weight	We compare birth weight in children born of women from the 2 study arms	Birth weight registered at birth	No
Secondary	maternal morbidity		Comorbidity registered up to one year after birth	No