Can Low Molecular Weight Heparin During Pregnancy With Intrauterine Growth Restriction Increase Birth Weight? (IUGR)
Recruitment status was Recruiting
The purpose of the study is to investigate if treatment with an anticoagulant drug increases birth weight in pregnancies complicated by fetal growth restriction.
Fetal Growth Retardation
Drug: Innohep (Tinzaparin)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Can Treatment With Low Molecular Weight Heparin During Pregnancy With Intrauterine Growth Restriction Increase Birth Weight?|
- birth weight [ Time Frame: until november 2013 ] [ Designated as safety issue: No ]We compare birth weight in children born of women from the 2 study arms
- maternal morbidity [ Time Frame: until November 2013 ] [ Designated as safety issue: No ]
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||November 2013|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: Innohep||
Drug: Innohep (Tinzaparin)
Dose: 4,500 IU daily in half of the study population that are randomised to treatment
Other Name: InnohepDrug: tinzaparin
Dose 4,500 IE daily
Other Name: Innohep
|No Intervention: no treatment|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01390051
|Contact: Anne-Mette Hvas, MD||+45 8949 firstname.lastname@example.org|
|Contact: Anette T Hansen, MD||+45 8949 email@example.com|
|Consultant Anne-Mette Hvas||Recruiting|
|Aarhus, Central Denmark Region, Denmark, 8200|
|Contact: Anette Tarp Hansen, MD +45 8949 5392 firstname.lastname@example.org|
|Sub-Investigator: Anette T Hansen, MD|
|Principal Investigator: Anne-Mette Hvas, MD|
|Principal Investigator:||Anne-Mette Hvas, MD||Department of Clinical Biochemistry, Aarhus University Hospital, Denmark|