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 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT06011057
Description:
The sample size is small, so there is a risk of breaching participant privacy and identifiability even with de-identified data sets. We want to prioritize protecting patient confidentiality.
Participants were not consented for broad data sharing, only for use of their data specifically for this study. Additional consent processes would be needed to enable sharing.
There are logistical barriers around data de-identification, establishing a repository, and creating data use agreements which are beyond the scope of this study.
The research questions can be adequately answered through analysis of aggregated data and publication of results. Sharing individual-level data is not necessary to achieve the specific aims.
The sensitive nature of pregnancy loss data further underscores the need for confidentiality safeguards. Participants may not feel comfortable with their pregnancy information being shared widely.
Study:
NCT06011057
Study Brief:
Evaluation of Serum Levels of C Reactive Protein (CRP) and Its Correlation With Fetal Ultrasound Parameters in the Prediction of Threatened Miscarriage in the First Trimester