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 @ 12:57 PM
Ignite Modification Date:
2025-12-24 @ 12:57 PM
NCT ID:
NCT06277661
Description:
In accordance with the NIH Policy for Data Management and Sharing, we've carefully considered the data expected to be generated and the best approach to maximize the appropriate sharing of scientific data while also protecting the privacy of human subjects participating in research. We expect remnant biospecimens to be minimal after study execution and will therefore not submit biospecimens. Also of note, obstetric complications, postnatal complications, severe maternal morbidity (SMM), and pregnancy-related mortality (PRM) are rare occurrences. Details surrounding this information are publicly available in birth and death certificates and could be aligned with other information to identify a research participant. Thus, to protect participant privacy, we do not plan to share raw data but will produce collapsed variables for data sharing.
Study:
NCT06277661
Study Brief:
The Mom and Infant Outcomes (MOMI) Study