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

Study Overview
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Brief Summary
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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
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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: To evaluate three new methods to monitor the effect of LMWH. 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

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

Conditions
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Fetal Growth Retardation

Intervention / Treatment
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* Drug: Innohep (Tinzaparin)
* Drug: tinzaparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Singleton pregnancy IUGR shown by ultrasonography: Can understand and read Danish Exclusion Criteria: Age below 18 years Pregestational weight < 90 kilograms Not able to give informed consent Chronic kidney disease with creatinine >150 μmol/l Chronic hypertension with blood pressure >140/90 mmHg Diabetes mellitus; type 1 or 2 or gestational diabetes Inflammatory bowel disease Severe heart disease (including mechanical heart valves) Drug or alcohol abuse Known coagulopathy (von Willebrand disease, thrombocytopenia, carrier of haemophilia) Treatment with vitamin K antagonists Known allergy to low LMWH Previous heparin-induced thrombocytopenia (HIT (type II)) Clinically significant bleeding within the last month 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) Chromosome anomaly in the child Severe malformations in the child Contraindication to Innohep® Gestational week > 32 weeks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Innohep<br>Tinzaparin 4500 I.U. sub cutaneous once daily until gestational week 37 | Drug: Innohep (Tinzaparin)<br>* Dose: 4,500 IU daily in half of the study populationrandomised to treatment<br>* Other names: Innohep;Drug: tinzaparin<br>* Dose 4,500 IE daily<br>* Other names: Innohep;|
| No Intervention: no treatment<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| birth weight | We compare birth weight in children born of women from the 2 study arms | Birth weight registered at birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal morbidity |  | Comorbidity registered up to one year after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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birth weight, thrombosis, anticoagulant therapy