Condition category
Neonatal Diseases
Date applied
01/08/2005
Date assigned
19/09/2005
Last edited
10/08/2007
Prospective/Retrospective
Prospectively 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
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

Study hypothesis

The primary hypothesis of this study is that the administration of progesterone to women considered at risk of preterm birth will reduce the risk of neonatal respiratory distress syndrome.

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

Not specified

Trial type

Prevention

Patient information sheet

Condition

Neonatal respiratory distress syndrome

Intervention

Eligible women will be randomised to either 100 mg vaginal progesterone or placebo treatment groups.

Intervention type

Drug

Phase

Not Specified

Drug names

Progesterone

Primary outcome measures

Neonatal lung disease

Secondary outcome measures

1. Adverse outcomes for the woman
2. Maternal emotional wellbeing
3. Adverse outcomes for the infant
4. Costs of health care

Overall trial start date

01/10/2005

Overall trial end date

01/01/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Pregnant women with a history of prior spontaneous preterm birth at less than 34 weeks gestation.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

984

Participant exclusion criteria

Women with preterm prelabour ruptured membranes, active labour (defined as the presence of uterine activity and cervical dilatation greater than 3 cm), known fetal anomaly, or any contraindication to progesterone therapy or to continuation of the pregnancy (e.g. chorioamnionitis requiring delivery).

Recruitment start date

01/10/2005

Recruitment end date

01/01/2009

Locations

Countries of recruitment

Australia

Trial participating centre

University of Adelaide
Adelaide
5006
Australia

Sponsor information

Organisation

The University of Adelaide (Australia)

Sponsor details

North Terrace
Adelaide
5005
Australia
+61 (0)8 8161 7647
caroline.crowther@adelaide.edu.au

Sponsor type

University/education

Website

http://www.adelaide.edu.au/

Funders

Funder type

Not defined

Funder name

None to date. Application to National Health and Medical Research Council

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

Publication citations

Additional files

Editorial Notes