LMWH to Prevent Preeclampsia and Fetal Growth Restriction - Tabular View

Tracking Information

First Received Date ^ICMJE

November 30, 2005

Last Updated Date

March 3, 2006

Start Date ^ICMJE

January 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

The composite primary outcome measure will be the occurrence of preeclampsia, fetal growth restriction FGR or both.

Change History

Complete list of historical versions of study NCT00260520 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Perinatal death, abruptio placentae, cesarean section, gestational age at delivery, placental weight, birth weight distribution by centile, the growth rate of fetal fat and lean body mass, and rate of maternal complications.

Descriptive Information

Brief Title ^ICMJE

LMWH to Prevent Preeclampsia and Fetal Growth Restriction

Official Title ^ICMJE

Low Molecular Weight Heparin Vs No Treatment in Pregnant Women With Previous Preeclampsia or Fetal Growth Restriction Who Were Heterozygote for Factor V Leiden or Prothrombin Gene G20210A Mutation

Brief Summary

Detailed Description

The objective of this trial will be to determine whether prophylactic low-molecular weight heparin therapy in pregnant women with the heterozygous Factor V Leiden and G20210A prothrombin gene mutations thrombophilia and a history of severe preeclampsia and/or severe fetal growth restriction reduces the risk of the composite outcome of preeclampsia, fetal growth restriction, or both. We also will assess the effect of treatment on other indicators of maternal and neonatal complications, and the growth of fetal body composition in terms of fat and lean body mass.

Study Phase

Phase IV

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Condition ^ICMJE

Preeclampsia

Intervention ^ICMJE

Drug: Dalteparin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

December 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Previous severe preeclampsia
Previous severe fetal growth restriction
Heterozygous Factor V Leiden
Heterozygous G20210A prothrombin gene mutations

Exclusion Criteria:

renal disease
chronic hypertension
preexisting diabetes mellitus
homozygosity for Factor V Leiden
homozygosity for prothrombin G20210A mutation
hyperhomocysteinemia
protein C deficency
protein S deficency
antithrombin deficiency
positive anticardiolipin antibodies
positive lupus anticoagulant

Gender

Female

Ages

20 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00260520

Responsible Party

Study ID Numbers ^ICMJE

06-03-1942

Study Sponsor ^ICMJE

University of Florence

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Giorgio Mello, MD

Department of Gynecology, Perinatology and Human Reproduction, University of Florence, Italy

Information Provided By

University of Florence

Verification Date

December 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP