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| [ Print-friendly version ] |
| Impact of dalteparin in pregnancy |
| ISRCTN | ISRCTN78732833 |
| ClinicalTrials.gov identifier | |
| Public title | Impact of dalteparin in pregnancy |
| Scientific title | Dalteparin in prevention of recurrence of severe obstetrical complications in women without thrombophilia |
| Acronym | N/A |
| Serial number at source | CER Sainte-Justine 1006 |
| Study hypothesis | A prophylactic dose of dalteparin may prevent the recurrence of placental mediated complications in women without thrombophilia. |
| Ethics approval | Ethics approval received from the Comité d’éthique de recherche (CER) du CHU Sainte-Justine on the 16th March 2000 (ref: 1006). |
| Study design | Randomised open trial |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Severe obstetrical complications |
| Participants - inclusion criteria |
1. Normal thrombotic screen
2. Female patients aged more than 17 years 3. Pregnancy less than 17 weeks 4. Signature of the consent form 5. One of the following in previous pregnancy: 5.1. Severe preeclampsia with delivery less than 34 weeks 5.2. Severe intrauterine growth restriction (IUGR) 5.3. Abruptio placentae with delivery less than 34 weeks or foetal death 5.4. One idiopathic foetal death after 20 weeks 5.5. Two or more of idiopathic foetal death between 12 - 19 weeks |
| Participants - exclusion criteria |
1. Multiple pregnancy
2. Alcohol or illicit drug use 3. Severe medical condition other than chronic hypertension 4. Foetal malformation or chromosomal anomaly 5. Uterine malformation or infection 6. Abdominal trauma 7. Any known cause of foetal death |
| Anticipated start date | 16/03/2000 |
| Anticipated end date | 20/06/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 276 |
| Interventions | Randomisation (1:1) to dalteparin (5000 IU daily) versus no treatment from randomisation until 36 - 37 weeks of pregnancy. Total duration of follow-up for all treatment arms will be from randomisation until departure from the hospital after delivery. |
| Primary outcome measure(s) |
Composite outcome of one of:
1. Severe preeclampsia 2. Severe IUGR 3. Major abruptio placentae Primary outcomes will be measured at delivery. |
| Secondary outcome measure(s) |
1. Non-severe preeclampsia, measured at delivery
2. Non-severe IUGR, measured at delivery 3. Gestational age at delivery, measured at delivery 4. Pregnancy complications, measured at delivery 5. Hospitalisation length, measured at delivery and departure from the hospital after delivery 6. Admission to intensive care unit, measured at departure from the hospital after delivery |
| Sources of funding |
1. Canadian Foundation for Women's Health (Canada)
2. Pharmacia and Upjohn Inc. (USA) |
| Trial website | |
| Publications | |
| Contact name | Dr Evelyne Rey |
| Address | 3175 Côte sainte-Catherine |
| City/town | Montreal (QC) |
| Zip/Postcode | H3T 1C5 |
| Country | Canada |
| Tel | +1 514 345 4706 |
| Fax | +1 514 345 4648 |
| evelyne_rey@ssss.gouv.qc.ca | |
| Sponsor | Canadian Foundation for Women's Health (Canada) |
| Address | 780 Echo Drive |
| City/town | Ottawa (ON) |
| Zip/Postcode | K1S 5R7 |
| Country | Canada |
| Tel | +1 800 561 2416 |
| helpdesk@sogc.com | |
| Sponsor website: | http://www.cfwh.org |
| Date applied | 18/04/2008 |
| Last edited | 29/04/2008 |
| Date ISRCTN assigned | 29/04/2008 |
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