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UCLA Perinatal Biospecimen Repository

About

Brief Summary

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.

Study Type
observational_patient_registry
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
Yes
Minimum Age
N/A
Maximum Age
N/A

Inclusion Criteria:

  • Pregnant and postpartum birthing persons aged 18 and over with perinatal pathology;
  • Healthy pregnant and postpartum birthing persons;
  • Healthy non-pregnant birthing persons (healthy volunteers).

Exclusion Criteria:

  • Pregnant and postpartum birthing person unwilling to give written informed consent to participate in the study.

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Study Stats
Protocol No.
21-001018
Category
Obstetrics & Gynecology
Contact
Irina Gontschar
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT05035160
For detailed technical eligibility, visit ClinicalTrials.gov.