Clinical trial NCT01828697: Comparison of Low and Intermediate Dose Low-molecular-weight Heparin to Prevent Recurrent Venous Thromboembolism in Pregnancy
Official title: Low-molecular-weight Heparin to Prevent Recurrent VTE in Pregnancy: a Randomized Controlled Trial of Two Doses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Deep Venous Thrombosis
Pulmonary Embolism
Keywords: Low-molecular-weight heparin
Pregnancy
Venous thrombosis
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Netherlands Organisation for Scientific Research
name: Aspen Pharma
name: CHU of Saint Etienne: French Ministry of Health Grant (sponsor of the French part of the study)
name: Rotunda Hospital: Definitive Interventions and Feasibility Awards (DIFA) 2017 (sponsor of the Irish part of the study))
First posted: 2013-04-11
Enrollment: 1110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized-controlled open-label trial comparing two different doses of low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the American College of Chest Physicians (ACCP), but it is not known which dose is more efficacious in preventing recurrent venous thromboembolism in pregnancy.

Patients enter the study and will be randomized as soon as a home test confirms pregnancy. LMWH will be administered until 6 weeks postpartum. Follow-up will continue until 3 months postpartum. Patients will be recruited by their treating physician, either an obstetrician or internist.


Eligibility criteria: Inclusion Criteria:

* Age: 18 years or older, and;
* Pregnancy confirmed by urinary pregnancy test, and;
* Gestational age \< 14 weeks, and;
* Previous objectively confirmed VTE, either unprovoked, in the presence of use of oral contraceptives or estrogen/progestagen use, or related to pregnancy or the postpartum period, or minor risk factors (e.g. long distance travel, minor trauma).

Exclusion Criteria:

* Previous VTE related to a major provoking risk factor (e.g. surgery, major trauma or plaster cast immobilisation in the 3 months prior to VTE) as the sole risk factor, or;
* Indication for treatment with therapeutic dose anticoagulant therapy (e.g. treatment of acute VTE; permanent use of therapeutic anticoagulants outside of pregnancy), or;
* Inability to provide informed consent, or;
* Any contraindication listed in the local labelling of LMWH.

Primary outcomes:
measure: Symptomatic confirmed deep venous thrombosis
timeFrame: From date of randomization up to 6 weeks postpartum
measure: Symptomatic confirmed pulmonary embolism
timeFrame: From date of randomization up to 6 weeks postpartum
Secondary outcomes:
measure: Symptomatic confirmed deep venous thrombosis
timeFrame: From date of randomization up to 3 months postpartum
measure: Symptomatic confirmed pulmonary embolism
timeFrame: From date of randomization up to 3 months postpartum
Other outcomes:
measure: Major bleeding
timeFrame: During pregnancy until 3 months postpartum
measure: Composite of major bleeding and clinically relevant non-major bleeding
timeFrame: During pregnancy until 3 months postpartum
measure: Early postpartum hemorrhage
timeFrame: Within 24 hours of delivery
measure: Blood transfusion < 6 weeks after delivery
timeFrame: Within 6 weeks of delivery
measure: Blood transfusion < 24 hours postpartum
timeFrame: Within 24 hours of delivery
measure: Late postpartum hemorrhage
timeFrame: From 24 hours postpartum to 6 weeks postpartum
measure: Mortality
timeFrame: During pregnancy until 3 months postpartum
measure: Minor bleeding
timeFrame: During pregnancy until 3 months postpartum
measure: Skin complications
timeFrame: During pregnancy until 3 months postpartum
measure: Easy bruising
timeFrame: During pregnancy until 3 months postpartum
measure: Necessity to switch to other LMWH
timeFrame: During pregnancy until 6 weeks postpartum
measure: Heparin-induced thrombocytopenia
timeFrame: During pregnancy until 3 months postpartum
measure: Congenital anomalies or birth defects
timeFrame: During pregnancy until 3 months postpartum
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine | NewYork-Presbyterian
state: New York
city: Leuven
country: Belgium
facility: KU Leuven
city: Ottawa
country: Canada
facility: The Ottawa Hospital
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Besançon
country: France
facility: CHU de Besancon
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Brest
country: France
facility: CHU de Brest
city: Caen
country: France
facility: CHU de Caen
city: Clermont-Ferrand
country: France
facility: CHU de Clermont - Ferrand
city: Colombes
country: France
facility: APHP Louis Mourier
city: Grenoble
country: France
facility: CHU de Grenoble
city: Limoges
country: France
facility: CHU de Limoges
city: Marseille
country: France
facility: Hopiteaux de Marseille
city: Marseille
country: France
facility: Marseille St Joseph
city: Nancy
country: France
facility: CHU de Nancy
city: Nice
country: France
facility: CHU de Nice
city: Nîmes
country: France
facility: CHU de Nîmes
city: Paris
country: France
facility: APHP Antoine Béclère
city: Paris
country: France
facility: APHP Port Royal
city: Paris
country: France
facility: CHU de Poitiers
city: Roanne
country: France
facility: Centra Hospitalier de Roanne
city: Saint Etienne
country: France
facility: Hopital Nord, CHU de Saint Etienne
city: Saint-Denis
country: France
facility: La Réunion - Saint-Denis
city: Saint-Pierre
country: France
facility: La Réunion deSt Pierre
city: Sète
country: France
facility: Polyclinique de Sète
city: Toulon
country: France
facility: CHIC de Toulon
city: Tours
country: France
facility: CHU de Tours
city: Cork
country: Ireland
facility: Corke University Hospital
city: Dublin
country: Ireland
facility: Coombe Women's Hospital
city: Dublin
country: Ireland
facility: Rotunda Hospital
city: Dublin
country: Ireland
facility: The National Maternity Hospital
city: Letterkenny
country: Ireland
facility: Letterkenny University Hospital
city: Limerick
country: Ireland
facility: University Hospital Limerick
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: Noord-Holland
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Almere
country: Netherlands
facility: Flevoziekenhuis
city: Amsterdam
country: Netherlands
facility: OLVG oost
city: Amsterdam
country: Netherlands
facility: SLAZ
city: Amsterdam
country: Netherlands
facility: VU medical center
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuizen
city: Arnhem
country: Netherlands
facility: Rijnstate hospital
city: Assen
country: Netherlands
facility: Wilhelmina Ziekenhuis
city: Beverwijk
country: Netherlands
facility: Rode Kruis Ziekenhuis
city: Breda
country: Netherlands
facility: Amphia ziekenhuis
city: Delft
country: Netherlands
facility: Reinier de Graaf Groep
city: Den Haag
country: Netherlands
facility: Bronovo ziekenhuis
city: Den Haag
country: Netherlands
facility: HAGA ziekenhuis
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Doetinchem
country: Netherlands
facility: Slingeland
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer
city: Ede
country: Netherlands
facility: Gelderse Vallei
city: Goes
country: Netherlands
facility: Admiraal de Ruijter Ziekenhuis
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
city: Groningen
country: Netherlands
facility: Martini Ziekenhuis
city: Groningen
country: Netherlands
facility: UMCG
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis
city: Harderwijk
country: Netherlands
facility: St Jansdal
city: Heerlen
country: Netherlands
facility: Atrium MC
city: Leeuwarden
country: Netherlands
facility: MC Leeuwarden
city: Leiden
country: Netherlands
facility: LUMC
city: Maastricht
country: Netherlands
facility: MUMC
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Ziekenhuis
city: Nijmegen
country: Netherlands
facility: St. Radboud UMC
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Tilburg
country: Netherlands
facility: TweeSteden
city: Utrecht
country: Netherlands
facility: Diakonessen Utrecht
city: Utrecht
country: Netherlands
facility: UMCU
city: Veldhoven
country: Netherlands
facility: Máxima MC
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Moscow
country: Russian Federation
facility: Federal State Institution "Research Center for Obstetrics, Gynecology and Perinatology"
city: Barcelona
country: Spain
facility: Vall d'Hebron Hospital
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Saskia Middeldorp, MD PhD
role: PRINCIPAL_INVESTIGATOR
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