UCLA Perinatal Biospecimen Repository

NCT05035160 | Recruiting

• 1 other identifier: IRB#21-001018
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; High-Risk Pregnancy

Keywords

Fetus; Obstetrics; Perinatal Care; Pregnancy; Specimen Collection

Outcome Measures

Primary Outcomes (1)

• Number of participants of the Perinatal Repository

  To establish the Perinatal Repository for collection, storage, and distribution of the human data and biospecimens of the participants with perinatal pathology

  From July 30, 2021, to December 31, 2028

Study Arms (3)

Group 1

Pregnant and postpartum birthing persons with perinatal pathology.

Group 2

Healthy pregnant and postpartum birthing persons.

Group 3

Healthy non-pregnant persons (healthy volunteers).

Eligibility Criteria

• Age: 1 Minute+
• Gender Eligibility Details: The study has no inclusion criteria based on gender, race, ethnicity, and language spoken. The protocol contains inclusion criteria for enrollment in the study associated with term "pregnancy/childbearing potential". The nature of and scientific rationale for the inclusions: This observational study will establish the new UCLA Perinatal Biospecimen Repository, to collect, storage and distribute the clinical data and biospecimens of the participants with perinatal pathology. Therefore, pregnant and postpartum birthing persons are the target population for this clinical protocol.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ages Eligible for Study: Child, Adult Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Study Population: Any UCLA Health patient that is at risk for perinatal pathology. Estimated Enrollment: 1000 participants.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Yalda Afshar, MD, PhD: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

Afshar Lab, Department of Obstetrics & Gynecology, UCLA

Los Angeles, California, 90095, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* Blood: whole blood, plasma, serum; * Placenta samples: RNAlater, snap freeze, 70% Alcohol, FFPE; * Umbilical cord: snap freeze, FFPE; * POC: 70% Alcohol and FFPE; * Cell Lines: HUVEC, trophoblastic, and other; * Protein, RNA, DNA; * Breastmilk; * Urine; * Other biospecimens.

Study Officials

• Yalda Afshar, MD, PhD, MD. PHD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yalda Afshar, MD. PhD

CONTACT

(805) 338-5593; yafshar@mednet.ucla.edu

Jenny Lester, BS

CONTACT

323-428-2338; jlester@mednet.ucla.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, Lab Director, Assistant Professor, UCLA, Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 5, 2021
• Study Start: July 30, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From July 30, 2021, to July 30, 2026.
• Access Criteria: Distribution rules and criteria used to determine the adequacy of investigators' requests to acquire the Material from the Repository are set forth in the "UCLA Perinatal Biospecimen Repository Advisory Committee" Policy and "Request Form for the UCLA Perinatal Biospecimen Repository Advisory Committee".

Locations

US (1)