Australasian Collaborative Trial of Vaginal Progesterone Therapy
| ISRCTN | ISRCTN20269066 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20269066 |
| Secondary identifying numbers | N/A |
- Submission date
- 01/08/2005
- Registration date
- 19/09/2005
- Last edited
- 18/12/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Caroline Crowther
Scientific
Scientific
University of Adelaide
Women's & Children's Hospital
72 King William Road
Adelaide
5006
Australia
| Phone | +61 (0)8 8161 7647 |
|---|---|
| caroline.crowther@adelaide.edu.au |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | Australasian Collaborative Trial of Vaginal Progesterone Therapy |
| 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(s) | Not provided at time of registration. |
| Condition | Neonatal respiratory distress syndrome |
| Intervention | Eligible women will be randomised to either 100 mg vaginal progesterone or placebo treatment groups. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Progesterone |
| Primary outcome measure | 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 study start date | 01/10/2005 |
| Overall study end date | 01/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 984 |
| Participant inclusion criteria | Pregnant women with a history of prior spontaneous preterm birth at less than 34 weeks gestation. |
| 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
Study participating centre
University of Adelaide
Adelaide
5006
Australia
5006
Australia
Sponsor information
The University of Adelaide (Australia)
University/education
University/education
North Terrace
Adelaide
5005
Australia
| Phone | +61 (0)8 8161 7647 |
|---|---|
| caroline.crowther@adelaide.edu.au | |
| Website | http://www.adelaide.edu.au/ |
"ROR" |
https://ror.org/00892tw58 |
Funders
Funder type
Not defined
None to date. Application to National Health and Medical Research Council
No information available
Results and Publications
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 24/02/2009 | Yes | No | |
| Results article | results | 26/09/2017 | Yes | No |
Editorial Notes
18/12/2017: publication references added.
