Condition category
Pregnancy and Childbirth
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
30/11/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.nvog.nl

Contact information

Type

Scientific

Primary contact

Prof J.I.P. de Vries

ORCID ID

Contact details

VU Medical Center
Department of Obstetrics and Gynaecology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
JIP.deVries@VUMC.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Phase

Not Specified

Drug names

Dalteparin, aspirin

Primary outcome measures

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 trial start date

20/01/2000

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

154

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

Trial participating centre

VU Medical Center
Amsterdam
1007 MB
Netherlands

Sponsor information

Organisation

VU University Medical Center (The Netherlands)

Sponsor details

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Sponsor type

University/education

Website

http://www.vumc.nl/zorg/

Funders

Funder type

Industry

Funder name

Pharmacia & Upjohn Company (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22118560

Publication citations

  1. Results

    de Vries JI, van Pampus MG, Hague WM, Bezemer PD, Joosten JH, , Low-molecular-weight heparin added to aspirin in the prevention of recurrent early-onset pre-eclampsia in women with inheritable thrombophilia: the FRUIT-RCT., J. Thromb. Haemost., 2012, 10, 1, 64-72, doi: 10.1111/j.1538-7836.2011.04553.x.

Additional files

Editorial Notes