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11 February 2012
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| [ Print-friendly version ] |
| International Trial of Antioxidant for the Prevention of Preeclampsia |
| ISRCTN | ISRCTN85024310 |
| ClinicalTrials.gov identifier | |
| Public title | International Trial of Antioxidant for the Prevention of Preeclampsia |
| Scientific title | Antioxidants for the prevention of preeclampsia: a randomised controlled trial |
| Acronym | INTAPP |
| Serial number at source | MCT-62005 |
| Study hypothesis | To determine whether daily supplementation of vitamin C and vitamin E reduce the incidence of gestational hypertension (with or without proteinuria) and its adverse conditions. |
| Lay summary | |
| Ethics approval | Centre De Recherche De L'Hopital Sainte-Justine, Comité d'éthique de la recherche gave approval on the 1st December 2003. |
| Study design | Randomised controlled trial |
| Countries of recruitment | Argentina, Belgium, Canada, China, Mexico |
| Disease/condition/study domain | Gestational hypertension with or without proteinuria (preeclampsia) |
| Participants - inclusion criteria |
1. The woman is pregnant between 12^0/7 and 18^6/7 completed weeks
2. At least 18 years of age 3. Speaks a language known by the medical staff 4. Plans to deliver in a participating hospital |
| Participants - exclusion criteria |
1. Daily Vitamin C intake equal or more than 200 mg
2. Daily Vitamin E intake equal or more than 50 IU 3. Uses warfarin (coumadin) 4. Known major foetal abnormalities, including chromosomal anomalies in the current pregnancy 5. Has one of the following conditions: 5.1. Untreated hypo/hyperthyroidism 5.2. Renal disease with altered renal function (creatinine more than two times the upper limit of the normal range value) 5.3. Any collagen vascular disease (including lupus erythromatosus, scleroderma) 5.4. Active or chronic hepatitis 5.5. Epilepsy 5.6. Cancer 5.7. Threatened abortion (the woman had two or more miscarriages) 5.8. Illicit drug use or alcohol abuse (more than or equal to two drinks a day during current pregnancy) |
| Anticipated start date | 15/01/2004 |
| Anticipated end date | 30/06/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 10000 low risk; 2500 high risk |
| Interventions |
Group One (Experimental): Daily supplementation with 1 g Vitamin C, 400 IU Vitamin E
Group Two (Control): Matching placebo The duration of the follow-up varies for each participant. The woman is randomised between 12^0/7 to 18^6/7 weeks of pregnancy and she takes the medication daily until the date of delivery. Trial details received: 12 Sept 2005 |
| Primary outcome measure(s) | Gestational hypertension, with or without proteinuria and adverse conditions. The data is recorded from the medical chart after post-partum hospital discharge. The period covered is: pregnancy, from randomisation to post-partum hospital discharge. |
| Secondary outcome measure(s) |
Outcome indicators are assessed from randomisation until post-partum hospital discharge. The following sources are used: prenatal record from treating MD, data recorded in CRF by study nurse at the three follow-up visits, postpartum and newborn hospital chart of mother and baby.
The period covered is: pregnancy, from randomisation to postpartum hospital discharge. 1. Preeclampsia 2. Maternal death 3. Severe preeclampsia 4. Preterm delivery less than 32 and less than 37 weeks’ gestation (gestational age corrected by early ultrasound scan) 5. Intrauterine growth restriction (less than third centile) 6. Perinatal mortality 7. Spontaneous abortion 8. Premature rupture of membranes 9. Antenatal inpatient days 10. Neonatal mortality indicators |
| Sources of funding | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-62005) |
| Trial website | http://www.gereq.net/intapp |
| Publications | 2005 interim results in http://www.ncbi.nlm.nih.gov/pubmed/15924519 |
| Contact name | Dr William D. Fraser |
| Address |
Hôpital Sainte-Justine
Département d'Obstétrique-Gynécologie 3175, Chemin de la Côte-Ste-Catherine 4e Étage, Bloc 9 Local 4986-B |
| City/town | Montréal |
| Zip/Postcode | H3T 1C5 |
| Country | Canada |
| Tel | +1 514 345 4931 ext. 4155 |
| Fax | +1 514 345 2195 |
| william.fraser@umontreal.ca | |
| Sponsor | Hospital Sainte-Justine (Montréal) (Canada) |
| Address | 3175 Chemin Côte Ste-Catherine |
| City/town | Montréal |
| Zip/Postcode | H3T 1C5 |
| Country | Canada |
| Sponsor website: | http://www.chu-sainte-justine.org/Accueil/default.aspx |
| Date applied | 26/09/2005 |
| Last edited | 17/11/2009 |
| Date ISRCTN assigned | 26/09/2005 |
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