| NCT ID | NCT05035160 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yalda Afshar, MD, PhD |
| Condition | Pregnancy |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2021-07-30 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2021-07-30 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Yalda Afshar, MD, PhD, MD. PHD
PRINCIPAL INVESTIGATOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT05035160 clinical trial?
This trial is open to participants of all sexes, aged 1 Minute or older, studying Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05035160 currently recruiting?
Yes, NCT05035160 is actively recruiting participants. Contact the research team at yafshar@mednet.ucla.edu for enrollment information.
Where is the NCT05035160 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT05035160 clinical trial?
NCT05035160 is sponsored by Yalda Afshar, MD, PhD. The principal investigator is Yalda Afshar, MD, PhD, MD. PHD at University of California, Los Angeles. The trial plans to enroll 1,000 participants.