Condition category
Neonatal Diseases
Date applied
18/03/2005
Date assigned
17/06/2005
Last edited
26/09/2007
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
Womens and Childrens 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

ACTORDS

Study hypothesis

Primary hypotheses:
Prenatal administration of repeat doses of corticosteroids at weekly intervals to women who remain at risk of preterm birth at less than 32 weeks gestation:
1. Reduces the risk of neonatal lung disease
2. Adversely affects fetal and neonatal measures of growth

Secondary hypothesis:
Prenatal administration of repeat doses of corticosteroids at weekly intervals to women who remain at risk of preterm birth at less than 32 weeks gestation increases the risk of maternal infection

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

Neonate respiratory distress syndrome

Intervention

11.4 mg Celestone Chronodose or saline placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Celestone Chronodose

Primary outcome measures

Neonatal respiratory outcomes:
1. Birthweight
2. Length and head circumference at birth
3. Primary discharge from hospital

Secondary outcome measures

On the mother:
1. Clinical chorioamnionitis requiring intrapartum antibiotics, maternal postpartum pyrexia greater than 38.0°C
2. Other measures of morbidity

On the infant:
Other measures of foetal and neonatal morbidity.

Overall trial start date

01/01/1998

Overall trial end date

31/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women with a singleton, twin or triplet pregnancy
2. Gestational age less than 32 weeks who have received initial treatment of corticosteroid seven or more days ago
3. Responsible clinician considers her to be at continued risk of preterm birth
4. Informed, written signed consent
5. No contraindication to further corticosteroid therapy

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration.

Participant exclusion criteria

1. Women with chorioamnionitis requiring urgent delivery
2. Women in whom the L/S ratio or equivalent test, if determined, is judged to be mature
3. Women who are in the second stage of labour
4. Women in whom corticosteroid therapy is considered essential
5. No contraindication to further corticosteroid therapy

Recruitment start date

01/01/1998

Recruitment end date

31/12/2004

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 Project (Australia) (ref: 980185)

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

Results in:
1. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16765760
2. http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&cmd=Retrieve&list_uids=17881750

Publication citations

  1. Crowther CA, Haslam RR, Hiller JE, Doyle LW, Robinson JS, , Neonatal respiratory distress syndrome after repeat exposure to antenatal corticosteroids: a randomised controlled trial., Lancet, 2006, 367, 9526, 1913-1919, doi: 10.1016/S0140-6736(06)68846-6.

  2. Crowther CA, Doyle LW, Haslam RR, Hiller JE, Harding JE, Robinson JS, , Outcomes at 2 years of age after repeat doses of antenatal corticosteroids., N. Engl. J. Med., 2007, 357, 12, 1179-1189, doi: 10.1056/NEJMoa071152.

Additional files

Editorial Notes