Australasian Collaborative Trial of Vaginal Progesterone Therapy

ISRCTN	ISRCTN20269066
DOI	https://doi.org/10.1186/ISRCTN20269066
Protocol serial number	N/A
Sponsor	The University of Adelaide (Australia)
Funder	None to date. Application to National Health and Medical Research Council

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
Adelaide
5006
Australia

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Australasian Collaborative Trial of Vaginal Progesterone Therapy
Study objectives	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(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Progesterone
Primary outcome measure(s)	Neonatal lung disease
Key secondary outcome measure(s)	1. Adverse outcomes for the woman 2. Maternal emotional wellbeing 3. Adverse outcomes for the infant 4. Costs of health care
Completion date	01/01/2009

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	984
Key inclusion criteria	Pregnant women with a history of prior spontaneous preterm birth at less than 34 weeks gestation.
Key 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).
Date of first enrolment	01/10/2005
Date of final enrolment	01/01/2009

University of Adelaide

Adelaide
5006
Australia

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	26/09/2017		Yes	No
Protocol article	protocol	24/02/2009		Yes	No

18/12/2017: publication references added.