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: 17/11/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr William D. Fraser
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
Email	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

Sponsor information

Hospital Sainte-Justine (Montréal) (Canada)
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