Low molecular weight heparin (FRagmin®) in pregnant women with a history of Uteroplacental Insufficiency and Thrombophilia: a randomised trial

ISRCTN	ISRCTN87325378
DOI	https://doi.org/10.1186/ISRCTN87325378
Secondary identifying numbers	N/A

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 30/11/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Study website

Contact information

Prof J.I.P. de Vries
Scientific

VU Medical Center
Department of Obstetrics and Gynaecology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Email	JIP.deVries@VUMC.nl

Study information

Study design	Multicentre, randomised, active controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	FRUIT-study
Study hypothesis	Low molecular weight heparin plus aspirin reduces the recurrence of preeclampsia and/or small for gestational age infants before 34 weeks gestational age in women with documented thrombophilia with a history of preeclampsia and/or small for gestational age infants with birth before 34 weeks.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Condition	Pre-eclampsia, Small for Gestational Age (SGA)
Intervention	Two armed study: A: daily dalteparin (starting between 6 - 12 weeks pregnancy) throughout gestation plus aspirin (starting before 12 weeks gestation to 36 weeks) B: aspirin only (starting before 12 weeks to 36 weeks) Both arms receive regular controls for women with a history of preeclampsia. In arm A: examination of Anti Factor Xa activity at 20 and 30 weeks.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Dalteparin, aspirin
Primary outcome measure	Reduction of preeclampsia before 34 weeks gestational age.
Secondary outcome measures	1. Reduction in spontaneous abortion, maternal admission to hospital and neonatal intensive care admission 2. Increase in gestational age and weight at birth
Overall study start date	20/01/2000
Overall study end date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	154
Participant inclusion criteria	1. Patients with a history of preeclampsia and/or small for gestational age infants before 34 weeks gestation and documented thrombophilia restricted to protein C and protein S deficiency, Activated Protein C (APC) resistance, Factor V Leiden mutation, Factor II mutation, anticardiolipin antibodies, lupus anticoagulant 2. Aged greater than 18 years 3. Informed consent
Participant exclusion criteria	1. Antithrombin deficiency 2. Diabetes mellitus 3. Known malignancy 4. Gastro-duodenic ulcer 5. Severe renal or hepatic insufficiency 6. Thrombo-embolism in history 7. Hemorrhagic diathesis 8. Idiopathic thrombocytopenia
Recruitment start date	20/01/2000
Recruitment end date	31/12/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

VU Medical Center

Amsterdam
1007 MB
Netherlands

Sponsor information

VU University Medical Center (The Netherlands)
University/education

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Website	http://www.vumc.nl/zorg/
"ROR"	https://ror.org/00q6h8f30

Funders

Funder type

Industry

Pharmacia & Upjohn Company (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2012		Yes	No