Comparison of Low and Intermediate Dose Low-molecular-weight Heparin to Prevent Recurrent Venous Thromboembolism in Pregnancy

PHASE4CompletedINTERVENTIONAL
Enrollment

1,110

Participants

Timeline

Start Date

April 24, 2013

Primary Completion Date

October 31, 2021

Study Completion Date

October 31, 2021

Conditions
Deep Venous ThrombosisPulmonary Embolism
Interventions
DRUG

Low dose nadroparin

"Fixed low dose nadroparin:~* \< 100 kg: 2850 IU subcutaneously once-daily~* 100 kg and above: 3800 IU subcutaneously once-daily"

DRUG

Intermediate dose nadroparin

"Intermediate weight-adjusted dose nadroparin:~* \< 50 kg: 3800 IU subcutaneously once-daily;~* 50 to \< 70 kg: 5700 IU subcutaneously once-daily;~* 70 to \< 100 kg: 7600 IU subcutaneously once-daily;~* 100 kg or above: 9500 IU subcutaneously once-daily."

DRUG

Low dose enoxaparin

"Fixed low dose enoxaparin:~* \< 100 kg: 40 mg subcutaneously once-daily~* 100 kg and above: 60 mg subcutaneously once-daily"

DRUG

Intermediate dose enoxaparin

"Intermediate weight-adjusted dose enoxaparin:~* \< 50 kg: 60 mg subcutaneously once-daily, or;~* 50 kg to \< 70 kg: 80 mg subcutaneously once-daily, or;~* 70 kg to \< 100 kg: 100 mg subcutaneously once-daily, or;~* 100 kg or above: 120 mg subcutaneously once-daily."

DRUG

Low dose dalteparin

"Fixed low dose dalteparin:~* \< 100 kg: 5000 IU subcutaneously once-daily~* 100 kg and above: 7500 IU subcutaneously once-daily"

DRUG

Intermediate dose dalteparin

"Intermediate weight-adjusted dose dalteparin:~* \< 50 kg: 7500 IU subcutaneously once-daily, or;~* 50 kg to \< 70 kg: 10000 IU subcutaneously once-daily, or;~* 70 kg to \< 100 kg: 12500 IU subcutaneously once-daily, or;~* 100 kg or above: 15000 IU subcutaneously once-daily."

DRUG

Fixed low dose tinzaparin

"Fixed low dose tinzaparin:~* \< 100 kg: 3500 IU subcutaneously once-daily~* 100 kg and above: 4500 IU subcutaneously once-daily"

DRUG

Intermediate dose tinzaparin

"Intermediate weight-adjusted dose tinzaparin:~* \< 50 kg: 4500 IU subcutaneously once-daily, or;~* 50 kg to \< 70 kg: 7000 IU subcutaneously once-daily, or;~* 70 kg to \< 100 kg: 10000 IU subcutaneously once-daily, or;~* 100 kg or above: 12000 IU subcutaneously once-daily."

Trial Locations (72)

New York

"Weill Cornell Medicine , NewYork-Presbyterian"

Unknown

KU Leuven, Leuven

The Ottawa Hospital, Ottawa

Aalborg University Hospital, Aalborg

Aarhus University Hospital, Aarhus

CHU de Besancon, Besançon

CHU de Bordeaux, Bordeaux

CHU de Brest, Brest

CHU de Caen, Caen

CHU de Clermont - Ferrand, Clermont-Ferrand

APHP Louis Mourier, Colombes

CHU de Grenoble, Grenoble

CHU de Limoges, Limoges

Hopiteaux de Marseille, Marseille

Marseille St Joseph, Marseille

CHU de Nancy, Nancy

CHU de Nice, Nice

CHU de Nîmes, Nîmes

APHP Antoine Béclère, Paris

APHP Port Royal, Paris

CHU de Poitiers, Paris

Centra Hospitalier de Roanne, Roanne

La Réunion - Saint-Denis, Saint-Denis

Hopital Nord, CHU de Saint Etienne, Saint-Etienne

La Réunion deSt Pierre, Saint-Pierre

Polyclinique de Sète, Sète

CHIC de Toulon, Toulon

CHU de Tours, Tours

Corke University Hospital, Cork

Coombe Women's Hospital, Dublin

Rotunda Hospital, Dublin

The National Maternity Hospital, Dublin

Letterkenny University Hospital, Letterkenny

University Hospital Limerick, Limerick

Jeroen Bosch Ziekenhuis, 's-Hertogenbosch

Flevoziekenhuis, Almere Stad

OLVG oost, Amsterdam

SLAZ, Amsterdam

VU medical center, Amsterdam

Gelre Ziekenhuizen, Apeldoorn

Rijnstate hospital, Arnhem

Wilhelmina Ziekenhuis, Assen

Rode Kruis Ziekenhuis, Beverwijk

Amphia ziekenhuis, Breda

Reinier de Graaf Groep, Delft

Deventer Ziekenhuis, Deventer

Slingeland, Doetinchem

Albert Schweitzer, Dordrecht

Gelderse Vallei, Ede

Admiraal de Ruijter Ziekenhuis, Goes

Groene Hart Ziekenhuis, Gouda

Martini Ziekenhuis, Groningen

UMCG, Groningen

Spaarne Gasthuis, Haarlem

St Jansdal, Harderwijk

Atrium MC, Heerlen

MC Leeuwarden, Leeuwarden

LUMC, Leiden

MUMC, Maastricht

Canisius-Wilhelmina Ziekenhuis, Nijmegen

St. Radboud UMC, Nijmegen

Erasmus MC, Rotterdam

Bronovo ziekenhuis, The Hague

HAGA ziekenhuis, The Hague

TweeSteden, Tilburg

Diakonessen Utrecht, Utrecht

UMCU, Utrecht

Máxima MC, Veldhoven

Oslo University Hospital, Oslo

"Federal State Institution Research Center for Obstetrics, Gynecology and Perinatology", Moscow

Vall d'Hebron Hospital, Barcelona

1105 AZ

Academic Medical Center, Amsterdam

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Netherlands Organisation for Scientific Research

OTHER_GOV

collaborator

Aspen Pharma

UNKNOWN

collaborator

CHU of Saint Etienne: French Ministry of Health Grant (sponsor of the French part of the study)

UNKNOWN

collaborator

Rotunda Hospital: Definitive Interventions and Feasibility Awards (DIFA) 2017 (sponsor of the Irish part of the study))

UNKNOWN

lead

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER