International Trial of Antioxidant for the Prevention of Preeclampsia
| ISRCTN | ISRCTN85024310 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85024310 |
| Secondary identifying numbers | MCT-62005 |
- Submission date
- 26/09/2005
- Registration date
- 26/09/2005
- Last edited
- 15/09/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr William D. Fraser
Scientific
Scientific
Hôpital Sainte-Justine
Département d'Obstétrique-Gynécologie
3175, Chemin de la Côte-Ste-Catherine
4e Étage, Bloc 9
Local 4986-B
Montréal
H3T 1C5
Canada
| Phone | +1 514 345 4931 ext. 4155 |
|---|---|
| william.fraser@umontreal.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Antioxidants for the prevention of preeclampsia: a randomised controlled trial |
| Study acronym | INTAPP |
| Study objectives | 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. |
| Ethics approval(s) | Centre De Recherche De L'Hopital Sainte-Justine, Comité d'éthique de la recherche gave approval on the 1st December 2003. |
| Health condition(s) or problem(s) studied | Gestational hypertension with or without proteinuria (preeclampsia) |
| Intervention | 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 |
| Intervention type | Supplement |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 15/01/2004 |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 10000 low risk; 2500 high risk |
| Key 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 |
| Key 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) |
| Date of first enrolment | 15/01/2004 |
| Date of final enrolment | 30/06/2008 |
Locations
Countries of recruitment
- Argentina
- Belgium
- Canada
- China
- Mexico
Study participating centre
Hôpital Sainte-Justine
Montréal
H3T 1C5
Canada
H3T 1C5
Canada
Sponsor information
Hospital Sainte-Justine (Montréal) (Canada)
Hospital/treatment centre
Hospital/treatment centre
3175 Chemin Côte Ste-Catherine
Montréal
H3T 1C5
Canada
| Website | http://www.chu-sainte-justine.org/Accueil/default.aspx |
|---|---|
"ROR" |
https://ror.org/01gv74p78 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-62005)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | interim results | 01/06/2005 | Yes | No | |
| Other publications | Circulating very long-chain saturated fatty acids in early pregnancy: association with blood pressure and weight gain | 10/09/2025 | 15/09/2025 | Yes | No |
| Results article | 01/03/2010 | 15/09/2025 | Yes | No |
Editorial Notes
15/09/2025: Publication references added.
