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
Protocol serial number	N/A
Sponsor	VU University Medical Center (The Netherlands)
Funder	Pharmacia & Upjohn Company (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Multicentre, randomised, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	FRUIT-study
Study objectives	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
Health condition(s) or problem(s) studied	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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Dalteparin, aspirin
Primary outcome measure(s)	Reduction of preeclampsia before 34 weeks gestational age.
Key secondary outcome measure(s)	1. Reduction in spontaneous abortion, maternal admission to hospital and neonatal intensive care admission 2. Increase in gestational age and weight at birth
Completion date	31/12/2009

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	154
Key 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
Key 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
Date of first enrolment	20/01/2000
Date of final enrolment	31/12/2009

VU Medical Center

Amsterdam
1007 MB
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2012		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes