Can Low Molecular Weight Heparin During Pregnancy With Intrauterine Growth Restriction Increase Birth Weight? (IUGR)
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|ClinicalTrials.gov Identifier: NCT01390051|
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : August 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Fetal Growth Retardation||Drug: Innohep (Tinzaparin) Drug: tinzaparin||Phase 4|
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.
- 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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Can Treatment With Low Molecular Weight Heparin During Pregnancy With Intrauterine Growth Restriction Increase Birth Weight?|
|Study Start Date :||July 2011|
|Primary Completion Date :||July 2016|
|Study Completion Date :||July 2016|
Active Comparator: Innohep
Tinzaparin 4500 I.U. sub cutaneous once daily until gestational week 37
Drug: Innohep (Tinzaparin)
Dose: 4,500 IU daily in half of the study populationrandomised to treatment
Other Name: InnohepDrug: tinzaparin
Dose 4,500 IE daily
Other Name: Innohep
|No Intervention: no treatment|
- birth weight [ Time Frame: Birth weight registered at birth ]We compare birth weight in children born of women from the 2 study arms
- maternal morbidity [ Time Frame: Comorbidity registered up to one year after birth ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01390051
|Consultant phD professor Anne-Mette Hvas|
|Aarhus, Central Denmark Region, Denmark, 8200|
|Department of Obstetrics|
|Herning, Denmark, 7400|
|Department of Obstetrics|
|Principal Investigator:||Anne-Mette Hvas, PhD, professor||Department of Clinical Biochemistry, Aarhus University Hospital, Denmark|