UCLA Perinatal Biospecimen Repository

Part of paid clinical trials in Los Angeles, California.

Sponsor
Yalda Afshar, MD, PhD
Study ID
NCT05035160
Status
Recruiting
Apply to this trial

Conditions

  • High-Risk Pregnancy
  • Pregnancy

Eligibility Criteria

Sex
ALL
Age
1 Minute - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Jul 30, 2021
Status verified
Dec 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Group 1
    Pregnant and postpartum birthing persons with perinatal pathology.
  • Arm: Group 2
    Healthy pregnant and postpartum birthing persons.
  • Arm: Group 3
    Healthy non-pregnant persons (healthy volunteers).

Primary Outcome Measure

Number of participants of the Perinatal Repository [ Time Frame: From July 30, 2021, to December 31, 2028 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Afshar Lab, Department of Obstetrics & Gynecology, UCLALos AngelesCalifornia90095
Yalda Afshar, MD, PhD
[email protected]
(805) 338-5593
Jenny Lester, MPH
[email protected]
323-428-2338

Find similar trials in Los Angeles, CA

By research site
Afshar Lab, Department of Obstetrics & Gynecology, UCLA· Los Angeles, CA

Related Studies