Condition category
Pregnancy and Childbirth
Date applied
18/03/2005
Date assigned
17/06/2005
Last edited
27/01/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Caroline Crowther

ORCID ID

Contact details

University of Adelaide
Women's & Children's Hospital
72 King William Road
North Adelaide
5006
Australia
+61 (0)8 8161 7647
caroline.crowther@adelaide.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

ACTS

Study hypothesis

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

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Pre-eclampsia
Intrauterine growth restriction

Intervention

Vitamin C (1000 mg) and Vitamin E (400 IU) daily compared with placebo

Intervention type

Supplement

Phase

Not Specified

Drug names

Vitamin C and Vitamin E

Primary outcome measures

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 trial start date

01/12/2001

Overall trial end date

31/01/2005

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1877

Participant 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.

Recruitment start date

01/12/2001

Recruitment end date

31/01/2005

Locations

Countries of recruitment

Australia

Trial participating centre

University of Adelaide
North Adelaide
5006
Australia

Sponsor information

Organisation

The University of Adelaide (Australia)

Sponsor details

-
Adelaide
SA 5006
Australia
+61 (0)8 8161 7647
caroline.crowther@adelaide.edu.au

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

National Health and Medical Research Council 207744

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

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

Publication citations

  1. Results

    Athukorala C, Rumbold AR, Willson KJ, Crowther CA, The risk of adverse pregnancy outcomes in women who are overweight or obese., BMC Pregnancy Childbirth, 2010, 10, 56, doi: 10.1186/1471-2393-10-56.

  2. Rumbold AR, Crowther CA, Haslam RR, Dekker GA, Robinson JS, , Vitamins C and E and the risks of preeclampsia and perinatal complications., N. Engl. J. Med., 2006, 354, 17, 1796-1806, doi: 10.1056/NEJMoa054186.

  3. Ju H, Rumbold AR, Willson KJ, Crowther CA, Borderline gestational diabetes mellitus and pregnancy outcomes., BMC Pregnancy Childbirth, 2008, 8, 31, doi: 10.1186/1471-2393-8-31.

Additional files

Editorial Notes