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UCLA Perinatal Biospecimen Repository

NCT05035160 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-12-29

No results posted yet for this study

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.

Conditions

  • Pregnancy
  • High-Risk Pregnancy

Sponsors & Collaborators

Principal Investigators

  • Yalda Afshar, MD, PhD, MD. PHD · University of California, Los Angeles

Eligibility

Min Age
1 Minute
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-30
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05035160 on ClinicalTrials.gov