Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT01390051
Status:
COMPLETED
Last Update Posted:
2016-08-18
First Post:
2011-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Can Low Molecular Weight Heparin During Pregnancy With Intrauterine Growth Restriction Increase Birth Weight?
Sponsor:
University of Aarhus
Organization:
Study Overview
Official Title:
Can Treatment With Low Molecular Weight Heparin During Pregnancy With Intrauterine Growth Restriction Increase Birth Weight?
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IUGR
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: