Australasian Collaborative Trial of Vitamin C and Vitamin E supplementation for the prevention of pre-eclampsia

ISRCTN	ISRCTN00416244
DOI	https://doi.org/10.1186/ISRCTN00416244
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Caroline Crowther
Scientific

University of Adelaide
Women's & Children's Hospital
72 King William Road
North Adelaide
5006
Australia

Phone	+61 (0)8 8161 7647
Email	caroline.crowther@adelaide.edu.au

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Scientific title
Study acronym	ACTS
Study objectives	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.
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Pre-eclampsia Intrauterine growth restriction
Intervention	Vitamin C (1000 mg) and Vitamin E (400 IU) daily compared with placebo
Intervention type	Supplement
Primary outcome measure	1. Incidence of small for gestational age infants 2. Clinical pre-eclampsia 3. Death or serious adverse pregnancy outcome for the infant
Secondary outcome measures	Severe adverse outcomes for the woman up to six weeks postpartum.
Overall study start date	01/12/2001
Completion date	31/01/2005

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	1877
Key inclusion criteria	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.
Key exclusion criteria	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.
Date of first enrolment	01/12/2001
Date of final enrolment	31/01/2005

University of Adelaide

North Adelaide
5006
Australia

The University of Adelaide (Australia)
University/education

-
Adelaide
SA 5006
Australia

Phone	+61 (0)8 8161 7647
Email	caroline.crowther@adelaide.edu.au
"ROR"	https://ror.org/00892tw58

Research council

National Health and Medical Research Council 207744

No information available

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

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	27/04/2006	Yes	No
Results article	results	30/07/2008	Yes	No
Results article	results	17/09/2010	Yes	No