UCLA Perinatal Biospecimen Repository (NCT05035160)
๐ฉบ Plain-English Summary (8th-Grade Level)
The purpose of this investigator-initiated prospective observational cohort study is to establish the new UCLA Perinatal Biospecimen Repository (Perinatal Repository) for collection, storage, and distribution of the human data and biospecimens of the participants with perinatal pathology. The secure and shared high-quality resource of clinical data and biological specimens (Repository Materials), across pregnancy pathology related to research protocols at the Afshar's Lab will be created. Core variables of interest include clinical characteristics and relevant biological samples. Intention to collect perinatal data is aiding the efficiency and effectiveness of de-identified biorepository for pregnancy-at-risk outcome research. The primary aims of the project are: * To design the Case Report Forms (CRFs) for the clinical and biospecimen data. * To create and update the project-specific policies, agreements, and Standard Operating Procedures (SOPs). * To develop the data management system to assure personal health information de-identification, data integrity, participants welfare, and protocol compliance. * To develop and implement a quality management system for the Repository. * To collect and record in the Repository protocol-related clinical information. * To organize a consistent system to bank high-quality biospecimens while protecting participant-donor safety and privacy. * To establish the policies and procedures for Repository Materials dissemination and research collaboration. * To analyze the scientific results of the Repository creation. The secondary aim of the study is to provide a mechanism to store and share for research purposes the de-identified biospecimen and information about participants at risk for adverse pregnancy outcomes.
Who can join: Review the eligibility criteria below.
Location: Afshar Lab, Department of Obstetrics & Gynecology, UCLA โ Los Angeles, California
Age range: 1 Minute
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- Afshar Lab, Department of Obstetrics & Gynecology, UCLA โ Los Angeles, California
๐ Contact the Study Coordinator
Phone: (805) 338-5593
Email: yafshar@mednet.ucla.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.