Clinical Trial: Effectiveness of Dalteparin Therapy as Intervention in Recurrent Pregnancy Loss

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

Official Title: Phase III Study Analyzing the Effectiveness of Dalteparin Therapy as Intervention in Recurrent Pregnancy Loss

Brief Summary: With this clinical trial the investigators will analyze whether the rate of pregnancy losses before the 24th week of gestation can be reduced by dalteparin treatment in habitual aborters.

Detailed Summary:

Recurrent pregnancy loss (RPL) is a common health problem with three or more loses affecting 1-2% and two or more losses affecting up to 5% of women at the reproductive age (Brenner 2003).

Several aetiologies have been identified or are under discussion to play a role in RPL, including chromosomal translocations and inversions, anatomic alterations of the uterus, endocrinological abnormalities, autoimmune disorders infection, smoking and alcohol consumption, exposure to environmental factors as well as coagulation and immunoregulatory defects (Pandey 2005, Lee 2000). About 30-40% of cases of RPL remain unexplained after standard gynaecological, hormonal and karyotype analysis (Rey 2000).

As stated by Pandey et al (Pandey 2005), a successful implantation during pregnancy requires a balanced equilibrium between coagulation, fibrinolysis and vascular remodeling by the process of angiogenesis in order to avoid excess fibrin accumulation in placental vessels and intervillous spaces (Buchholz 2003). However, thrombosis in decidual vessels is reported to be one of the major causes of RPL (Arias 1998) and could be explained by excessive thrombosis of the placental vessels, placental infarction, and secondary uteroplacental insufficiency.

Recurrent pregnancy loss is a well-described complication of the antiphospholipid antibody syndrome and is thought to be associated with thrombosis of placental vessels, often with evidence for placental infarction. More recently, inherited thrombophilic abnormalities have been linked to RPL and other obstetric complications. At least 16 case-control studies found a high prevalence of factor V Leiden (FVL) in women with unexplained RPL (up to 30%) compared to 1% to 10% of control subjects with odds ratios ranging from 2 to 5 (Press et al. 2002). Li
Sponsor: University of Jena

Current Primary Outcome: ongoing intact pregnancy at 24 weeks of gestation [ Time Frame: at 24 weeks of gestation ]

Original Primary Outcome: ongoing intact pregnancy at 24 weeks of gestation

Current Secondary Outcome:

  • late pregnancy complication, defined as at least one of the following: preterm delivery, placenta insufficiency, intrauterine growth retardation, preeclampsia and abruptio placentae [ Time Frame: 6-8 weeks after delivery ]
  • foetus with structural anomalies [ Time Frame: 6-8 weeks after delivery ]
  • side effects of dalteparin therapy (e.g. thrombocytopenia, osteoporosis, haemorrhage) [ Time Frame: 6-8 weeks after delivery ]
  • life birth [ Time Frame: 6-8 weeks after delivery ]
  • preterm delivery (< 37 weeks of gestation) [ Time Frame: 6-8 weeks after delivery ]


Original Secondary Outcome:

  • live birth
  • late pregnancy complication, defined as at least one of the following:
  • preterm delivery (before 37 weeks of gestation)
  • placenta insufficiency,
  • intrauterine growth restriction < 5. percentile,
  • preeclampsia
  • abruptio placentae
  • foetus with structural anomalies
  • symptomatic thromboembolic events
  • side effects of dalteparin therapy (e.g. thrombocytopenia, osteoporosis, haemorrhage)


Information By: University of Jena

Dates:
Date Received: November 15, 2006
Date Started: November 2006
Date Completion:
Last Updated: September 16, 2014
Last Verified: September 2014