|- candidate number||21824|
|- NTR Number||NTR5106|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-mrt-2015|
|- Secondary IDs||NL51093.029.14 |
|- Public Title||Follow-up of the FRUIT-RCT, aspirin resistance and cardiovascular risk factors in women after recurrent hypertensive disorders of pregnancy. |
|- Scientific Title||Follow-up of the FRUIT-RCT, aspirin resistance and cardiovascular risk factors in women after recurrent hypertensive disorders of pregnancy. |
|- ACRONYM||Follow-up FRUIT-RCT|
|- hypothesis||1: 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) studied||Hypertensive disorders of pregnancy, Pre-eclampsia, Trombophilia, Aspirin resistance, Cardiovascular risk factors|
|- Inclusion criteria||Inclusion in the previous FRUIT-RCT and living in the Netherlands. |
For the parallel study: indication of aspirin use during pregnancy.
|- Exclusion criteria||Diabetes 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 received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-apr-2015|
|- planned closingdate||1-apr-2017|
|- Target number of participants||128|
|- Interventions||Participants 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 outcome||Aspirin resistance and cardiovascular risk factors. |
|- Secondary outcome||Metabolic syndrome|
|- Timepoints||Start as soon as possible.|
|- Trial web site||None|
|- CONTACT FOR PUBLIC QUERIES||MD Carolien Abheiden|
|- CONTACT for SCIENTIFIC QUERIES||MD Carolien Abheiden|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|VU University Medical Center|
|- Brief summary||The 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)|
|- RECORD||19-mrt-2015 - 31-mei-2015|