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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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


Sponsor: University of Aarhus

Current Primary Outcome: birth weight [ Time Frame: Birth weight registered at birth ]

We compare birth weight in children born of women from the 2 study arms


Original Primary Outcome: birth weight [ Time Frame: until november 2013 ]

We compare birth weight in children born of women from the 2 study arms


Current Secondary Outcome: maternal morbidity [ Time Frame: Comorbidity registered up to one year after birth ]

Original Secondary Outcome: maternal morbidity [ Time Frame: until November 2013 ]

Information By: University of Aarhus

Dates:
Date Received: July 6, 2011
Date Started: July 2011
Date Completion:
Last Updated: August 17, 2016
Last Verified: July 2016