Condition category
Pregnancy and Childbirth
Date applied
26/09/2005
Date assigned
26/09/2005
Last edited
17/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.gereq.net/intapp

Contact information

Type

Scientific

Primary contact

Dr William D. Fraser

ORCID ID

Contact details

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
+1 514 345 4931 ext. 4155
william.fraser@umontreal.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-62005

Study information

Scientific title

Antioxidants for the prevention of preeclampsia: a randomised controlled trial

Acronym

INTAPP

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Vitamin C, vitamin E

Primary outcome measures

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 trial start date

15/01/2004

Overall trial end date

30/06/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

10000 low risk; 2500 high risk

Participant 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)

Recruitment start date

15/01/2004

Recruitment end date

30/06/2008

Locations

Countries of recruitment

Argentina, Belgium, Canada, China, Mexico

Trial participating centre

Hôpital Sainte-Justine
Montréal
H3T 1C5
Canada

Sponsor information

Organisation

Hospital Sainte-Justine (Montréal) (Canada)

Sponsor details

3175 Chemin Côte Ste-Catherine
Montréal
H3T 1C5
Canada

Sponsor type

Hospital/treatment centre

Website

http://www.chu-sainte-justine.org/Accueil/default.aspx

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-62005)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2005 interim results in http://www.ncbi.nlm.nih.gov/pubmed/15924519

Publication citations

  1. Interim results

    Fraser WD, Audibert F, Bujold E, Leduc L, Xu H, Boulvain M, Julien P, The vitamin E debate: implications for ongoing trials of pre-eclampsia prevention., BJOG, 2005, 112, 6, 684-688, doi: 10.1111/j.1471-0528.2005.00675.x.

Additional files

Editorial Notes