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Australasian Collaborative Trial of Vaginal Progesterone Therapy

Australasian Collaborative Trial of Vaginal Progesterone Therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN20269066
Enrollment
984
Registered
2005-09-19
Start date
2005-10-01
Completion date
Unknown
Last updated
2018-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal respiratory distress syndrome Neonatal Diseases Respiratory distress syndrome

Interventions

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

Sponsors

The University of Adelaide (Australia)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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).

Design outcomes

Primary

MeasureTime frame
Neonatal lung disease

Secondary

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

Countries

Australia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026