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Follow-up of the FRUIT-RCT, aspirin resistance and cardiovascular risk factors in women after recurrent hypertensive disorders of pregnancy.


- candidate number21824
- NTR NumberNTR5106
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-mrt-2015
- Secondary IDsNL51093.029.14 
- Public TitleFollow-up of the FRUIT-RCT, aspirin resistance and cardiovascular risk factors in women after recurrent hypertensive disorders of pregnancy.
- Scientific TitleFollow-up of the FRUIT-RCT, aspirin resistance and cardiovascular risk factors in women after recurrent hypertensive disorders of pregnancy.
- ACRONYMFollow-up FRUIT-RCT
- hypothesis1: aspirin resistance is related to the occurrence of hypertensive disorders of pregnancy.
2: women with a history of recurrent hypertensive disorder of pregnancy develop cardiovascular risk factors more frequently than women with a history of single hypertensive disorder of pregnancy.
- Healt Condition(s) or Problem(s) studiedHypertensive disorders of pregnancy, Pre-eclampsia, Trombophilia, Aspirin resistance, Cardiovascular risk factors
- Inclusion criteriaInclusion in the previous FRUIT-RCT and living in the Netherlands.
For the parallel study: indication of aspirin use during pregnancy.
- Exclusion criteriaDiabetes Mellitus;
Drugs that are known to alter platelet function (e.g. NSAIDís, tirofiban, eptifibatide, abciximab, clopidogrel, prasugel, ticagrelor, beta-lactam antibiotics, dextran, SSRIís, clomipramine & amitriptyline, dipyridamole, verapamil, diltiazem , ginkgo biloba, ginseng, St Johnís wort) within 2 weeks before testing.
Major surgical procedure within one week before enrollment;
Recent cardiovascular event < 3 months
Alcohol use one day before testing aspirin resistance
Abnormal cell count.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-apr-2015
- planned closingdate1-apr-2017
- Target number of participants128
- InterventionsParticipants of the previous FRUIT-RCT receive 10 days aspirin.
For the parallel study women need to have an indication for aspirin usage in pregnancy.
- Primary outcomeAspirin resistance and cardiovascular risk factors.
- Secondary outcomeMetabolic syndrome
- TimepointsStart as soon as possible.
- Trial web siteNone
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD Carolien Abheiden
- CONTACT for SCIENTIFIC QUERIESMD Carolien Abheiden
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- Publications
- Brief summaryThe multicenter FRUIT-RCT demonstrated that adding low-molecular-weight heparin (LMWH) to the standard care aspirin, is beneficial in preventing early-onset hypertensive disorders of pregnancy (HD) in women with inheritable thrombophilia. Bujold et al suggested in a letter to the editor, responding to the FRUIT-RCT1 that the effect of LMWH could have been mainly beneficial in the subgroup of women who are resistant to aspirin. To evaluate this potential relationship we perform a two stage experiment: firstly evaluation of aspirin resistance in the non-pregnant FRUIT-RCT, and secondly the evaluation of aspirin resistance during pregnancy and post-puerperium. Furthermore, we want to assess the prevalence of cardiovascular risk factors in women with inheritable thrombophilia and a history of recurrent HD. We want to examine if women with a history of recurrent hypertensive disorder of pregnancy develop cardiovascular risk factors more frequently than women with a history of single HD.
- Main changes (audit trail)
- RECORD19-mrt-2015 - 31-mei-2015


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