Fetal Growth Retardation
Conditions
Keywords
birth weight, thrombosis, anticoagulant therapy
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
Interventions
Dose: 4,500 IU daily in half of the study populationrandomised to treatment
DRUGtinzaparin
Dose 4,500 IE daily
Sponsors
Aarhus University Hospital
LEO Pharma
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| birth weight | Birth weight registered at birth | We compare birth weight in children born of women from the 2 study arms |
Secondary
| Measure | Time frame |
|---|---|
| maternal morbidity | Comorbidity registered up to one year after birth |
Countries
Denmark
Outcome results
None listed