Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT06906757
Description:
Data sharing will align with PLATIPUS (NCT06461429) policy. Version 1, Apr-2024
Once data unblinding no longer compromises the integrity of the trial, a de-identified data set collected for the analysis of domains within PLATIPUS will be made available.
Conditions
1. All domains in which the participant is co-enrolled are closed to recruitment\* (\*Where one or more domains in which a participant is co-enrolled are not yet closed to recruitment, the participant's data may be provided, without the treatment code, to prevent unblinding in unfinished domains).
2. Primary domain conclusions/analyses have been published, AND
3. The 2-year follow-up of participants within the domain/s of interest is/are complete.
Supporting materials (Core Protocol, Domain-Specific Appendices, Data Dictionaries and Domain-Specific Statistical Analysis Plans) will be available.
Contact: University of Melbourne - info@platipustrial.org.
Study:
NCT06906757
Study Brief:
Preterm Rupture of Membranes Optimising Antibiotics Trial