Clinical trial NCT05035160: UCLA Perinatal Biospecimen Repository
Official title: UCLA Perinatal Biospecimen Repository
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy
High-Risk Pregnancy
Keywords: Fetus
Obstetrics
Perinatal Care
Pregnancy
Specimen Collection
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2021-09-05
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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: 500 participants.

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.

Detailed description: Duration of the project - 5 years. The approximate number of participants - 500. The number of visits - from one to 6. Duration of the subject's participation in the study - from 1 day to 12 months. Follow-up period: from enrollment to postpartum visit. Core variables of interest comprise the birthing person's/ fetus'/ neonate's clinical characteristics and relevant biological samples: maternal blood, cord blood, plasma, serum, urine, breastmilk, placenta, umbilical cord, amniotic fluid, the product of conception (POC), and cell lines. Collection and retaining of the biospecimens will be performed by the study team across perinatal pathology cases at the UCLA Health Medical Centers for up to 15 years.

Biospecimens will be collected prospectively to the Perinatal Repository. Clinical data will be linked to the biospecimens.

Participation in the Repository Protocol can be offered by the PI/ designee for the outpatients and inpatients. Eligibility criteria will be checked during the baseline visit. The informed consent form should be signed at enrolment, following which baseline medical history will be collected. Procedures and assessments will be performed according to the routine standard at UCLA Health, and are documented as available (with the exception of Informed Consent).

Enrolment/ Baseline Visit: After consenting, the birthing person will be asked to donate blood (maternal blood) or/ and urine specimen to the Repository. Trained research team personnel will collect the biospecimens per standard operating procedures. The study protocol provides for the collection of blood samples as a procedure combined with routine blood sampling for clinical laboratory testing.

For research purposes, it is intended to collect a small additional amount of the venous maternal blood - less than 10 mL per procedure. The blood will not be drawn for research more often than twice in a single week. Blood draws will be performed as follow: Red Top Tube (Serology tube) - at least 4 mL and Lavender Top Tube (EDTA tube) - at least 4 mL. Blood samples will be collected for whole blood, plasma, and serum banking.

Collection of the cord blood after delivery will be performed once in the same order. The research Protocol does not involve collecting any specimens of the vital neonates, such as venous blood or urine.

Follow-up Visits: For pregnant birthing persons, biospecimens donation during follow-up visits is optional, based on the PI decision. Repository Material will be collected by the research team during follow-up research visits (each once per pregnancy trimester):

1. st Trimester Visit (from conception to 12 weeks): medical history, pregnancy and fetus status, AE, biobank specimens: blood and urine.
2. nd Trimester Visit (from week 13 to week 27): medical history, pregnancy and fetus status, AE, biobank specimens: blood and urine.
3. rd Trimester Visit: (from week 28 until birth): medical history, pregnancy and fetus status, biobank specimens: blood and urine.

Delivery/ End of Pregnancy Visit: Medical history, pregnancy status, pregnancy outcome, neonatal/ fetus status, neonatal/ fetus outcome, AE, biobank specimens: maternal blood, cord blood (UC blood), maternal urine, placenta, umbilical cord, amniotic fluid.

The umbilical cord and placenta are temporary fetus organs. For the Repository collection, placenta, umbilical cord, and therefore, cord blood, will be obtained for the Repository purposes after childbirth.

In case of a miscarriage, abortion, or stillbirth, the participant will be asked to donate POC tissue to the Repository.

Postpartum Visit: Medical history, pregnancy outcome, neonatal status, neonatal outcome, AE, biobank specimens: maternal blood, maternal urine, breastmilk.

For non-pregnant healthy volunteers, participation in the project is limited to the one-time biospecimens donation and granting access to their medical records.

After collecting the necessary clinical information, all personal identifiable information of the participant will be encoded. The PI will retain access to the codes.

In case of an MTA arrangement and providing access to the Repository to the third party, only de-identified participants' information and de-identified biospecimens can be shared.

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.

Primary outcomes:
measure: Number of participants of the Perinatal Repository
timeFrame: From July 30, 2021, to July 30, 2026.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Afshar Lab, Department of Obstetrics & Gynecology, UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Yalda Afshar, MD, PhD, MD. PHD
role: PRINCIPAL_INVESTIGATOR
References: