UCLA Perinatal Biospecimen Repository
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
🗓️ Study Start (Actual) 30 July 2021
🗓️ Primary Completion (Estimated) 30 July 2026
✅ Study Completion (Estimated) 30 July 2026
👥 Enrollment (Estimated) 500
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Los Angeles, California, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 1 Minute to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 August 2021
  • First Submitted that Met QC Criteria 31 August 2021
  • First Posted 5 September 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 24 September 2023
  • Last Update Posted 26 September 2023
  • Last Verified September 2023