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ISRCTN
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ISRCTN00416244
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ClinicalTrials.gov identifier
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Public title
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Australasian Collaborative Trial of Vitamin C and Vitamin E supplementation for the prevention of pre-eclampsia
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Scientific title
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Acronym
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ACTS
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Serial number at source
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N/A
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Study hypothesis
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Primary hypotheses:
The primary hypotheses of the study are that vitamin C and E supplementation from 14 weeks gestation in nulliparous women:
1. Reduces the incidence of small for gestational age infants
2. Reduces the incidence of clinical pre-eclampsia
3. Reduces the risk of death or serious adverse outcome for the infant
Secondary hypothesis:
The secondary hypothesis is that vitamin C and E supplementation from 14 weeks gestation in nulliparous women reduces the risks of adverse outcomes for the woman up to six weeks postpartum.
Please note that the target number of participants was added as of 10/09/2007.
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Lay summary
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Ethics approval
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Not provided at time of registration.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Australia
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Disease/condition/study domain
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Pre-eclampsia
Intrauterine growth restriction
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Participants - inclusion criteria
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All nulliparous women presenting to the antenatal clinic at the collaborating centre with a singleton pregnancy, between 14-22 weeks gestation, a normal blood pressure, and expected to give birth at the collaborating centre. Informed, written consent is necessary and there must be no contraindication to vitamin C or E therapy.
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Participants - exclusion criteria
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Women with any of the following: multiple pregnancy, life threatening fetal anomaly on ultrasound, known thrombophilia, chronic renal failure, hemochromatosis, women on heparin, warfarin or antihypertensive therapy.
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Anticipated start date
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01/12/2001
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Anticipated end date
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31/01/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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1877
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Interventions
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Vitamin C (1000 mg) and Vitamin E (400 IU) daily compared with placebo
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Primary outcome measure(s)
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1. Incidence of small for gestational age infants
2. Clinical pre-eclampsia
3. Death or serious adverse pregnancy outcome for the infant
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Secondary outcome measure(s)
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Severe adverse outcomes for the woman up to six weeks postpartum.
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Sources of funding
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National Health and Medical Research Council 207744
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Trial website
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Publications
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1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16641396
2. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18664297
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20849609
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Contact name
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Prof
Caroline
Crowther
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Address
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University of Adelaide
Women's & Children's Hospital
72 King William Road
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City/town
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North Adelaide
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Zip/Postcode
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5006
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Country
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Australia
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Tel
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+61 (0)8 8161 7647
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Fax
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+61 (0)8 8161 7652
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Email
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caroline.crowther@adelaide.edu.au
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Sponsor
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The University of Adelaide (Australia)
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Address
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-
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City/town
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Adelaide
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Zip/Postcode
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SA 5006
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Country
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Australia
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Tel
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+61 (0)8 8161 7647
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Fax
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+61 (0)8 8161 7652
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Email
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caroline.crowther@adelaide.edu.au
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Date applied
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18/03/2005
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Last edited
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27/01/2011
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Date ISRCTN assigned
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17/06/2005
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