Clinical trial NCT01390051: Can Low Molecular Weight Heparin During Pregnancy With Intrauterine Growth Restriction Increase Birth Weight?
Official title: Can Treatment With Low Molecular Weight Heparin During Pregnancy With Intrauterine Growth Restriction Increase Birth Weight?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fetal Growth Retardation
Keywords: birth weight
thrombosis
anticoagulant therapy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: LEO Pharma
First posted: 2011-07-08
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: birth weight
timeFrame: Birth weight registered at birth
Secondary outcomes:
measure: maternal morbidity
timeFrame: Comorbidity registered up to one year after birth
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Consultant phD professor Anne-Mette Hvas
state: Central Denmark Region
city: Herning
country: Denmark
facility: Department of Obstetrics
city: Randers
country: Denmark
facility: Department of Obstetrics
Study officials:
affiliation: Department of Clinical Biochemistry, Aarhus University Hospital, Denmark
name: Anne-Mette Hvas, PhD, professor
role: PRINCIPAL_INVESTIGATOR
References: