Pregnancy Repository (PR)

Repository for Biospecimens From Pregnant Patients

An essential part of clinical research is the availability and accessibility of human biospecimens for the identification of biomarkers, new treatments and measurement of response to therapy. Proteins, RNA and DNA can be extracted and studied as well. This is a critical first step in performing many fundamental molecular biology experiments. A variety of biospecimens are utilized for research including but not limited to normal and malignant tissues, blood, and other body fluids.

In order to obtain high-quality biospecimens, they must be acquired serially, stored according to current standards, and matched with clinical information for maximum value. As such, the investigators would like to create a repository of biospecimens collected from pregnant patients who are seen at Mount Sinai Hospital and other research hospitals in Toronto. Mount Sinai provides personnel and infrastructure to serve the largest (7500 births/year) and highest complex Maternity program in Ontario. Of the 7500 patients a year, at least 2500 are considered high risk pregnancies, where there's a possibility of preeclampsia, placenta accreta and a host of other complications. For this study, biological specimens - blood, cervical and placental samples - will be collected from these high-risk groups in order to better understand the causes of the underlying conditions.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy Related; Fetal Growth Retardation; Preeclampsia; Cervix; Pregnancy; Placental Insufficiency
• Intervention / Treatment: Other: Biospecimen collection

Detailed Description

The study will be non-interventional and designed for prospective sample collection and concurrent analysis.

Primary Objective #1: The primary objective is to provide a mechanism for system-wide patient engagement for banking and sourcing high-quality biologic specimens including tissues and bodily fluids. The study will be initiated at 3 sites - Sunnybrook Health Sciences Centre, North York General Hospital and Mt.Sinai Hospital - in the hopes of creating a translational research environment where patient data and biospecimens can inform future clinical practice.

The aim is to do this by:

1. Establishing a comprehensive, secure and de-identified registry/database that includes current and future cases at high risk for abnormal placentation and healthy controls for comparison with patient consent.
2. Comparing cases of suspected abnormal placentation with a control group of women with no evidence of abnormal placentation.

Primary Objective #2: Feasibility study that aims to provide preliminary insights into the biological markers and processes associated with abnormal placentation. By comparing a larger control group to those experiencing abnormal placentation, the investigators seek to understand potential biomarker differences. This phase is explorative in nature and is designed to determine the viability of our research approach and generate preliminary data.

Secondary Objective: The secondary objective is to facilitate research studies with utilization of these biologic specimens, including full-scale trials, should our initial findings warrant them.

The blood samples will be useful in identifying the molecular biomarkers that are indicative of disease, while the placental and cervical samples are important to better understand the underlying physiology of perinatal disease. The aim is therefore to establish both a clinical database and a blood/tissue bio-bank. By more comprehensively understanding the pathophysiology of invasive placentation, the goal is to develop high specificity testing modalities, perhaps through novel maternal serum biomarkers, to aid in diagnosis, management and improved outcomes for both mothers and their babies.

Patients will be consented during their visit to the hospital, and blood/cervical samples will be collected serially at each visit. Patient data will be collected from the Electronic Medical Record systems and paper charts, and this will be entered into REDCap. The biological samples will be sent to Sunnybrook Research Institute for storage.

Both blood and tissue specimens will be collected during regular patient visits. Biospecimens will be labeled with an anonymous study identifier that will be linked to corresponding clinical data and specimen annotation. Specimens will be stored in appropriate temperature and storage conditions before they are transported to Sunnybrook - where the specimens will be stored long-term. Specimens that are inadequate for study because of poor cell viability or insufficient tissue will be destroyed.

Cervical and blood samples will be taken serially from patients during their regular clinic visits. Up to 20 mL of blood and plasma may be collected for research use via venipuncture. Efforts will be made to only collect the minimum volume necessary for research use. At the patient's request, the research blood volume may be further reduced. Secondly, 10 mL of cord blood will be collected after the delivery of the baby from the umbilical vein attached to the placenta. Lastly, 1-5g samples of placental villous tissue will be collected after delivery from all subjects who have consented to this. Removal of these very small amounts of tissue will not interfere with routine histopathological examination conducted in the usual clinical care of subjects. All these samples will be labelled with the appropriate study number and kept at Sunnybrook for storage. Consent for biospecimen collection will also include permission for future use of their de-identified samples in collaborative projects with other institutions. All such collaborative projects would be subject to Ethics Board consent and relevant material transfer agreements.

• Study Type: Observational
• Enrollment (Estimated): 7000

Contacts and Locations

• Study Contact: Name: Sascha Drewlo, PhD; Phone Number: 683853 1-416-480-6100; Email: sascha.drewlo@sri.utoronto.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Women age 18-45 who are pregnant

Description

Inclusion Criteria:

• Consenting pregnant adults (age 18-45 years) with known or suspected risk for abnormal placentation (Abnormal Placentation Group)
• Consenting pregnant adults (age 18-45 years) with low-risk pregnancies (Control Group)
• Singleton or multiple pregnancy
• Ongoing clinical care at the participating sites, with delivery at the same institution.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Abnormal Placentation; Women with a singleton or multiple pregnancy that are known or suspected of having abnormal placentation	Other: Biospecimen collection; Biospecimens, including maternal blood and cervical mucus will be collected serially during pregnancy. After delivery tissue samples from the placenta and umbilical cord blood will be collected.; Other Names: Registry/data collection from subject's medical records
Control; Women with a singleton or multiple pregnancy with a low-risk pregnancy.	Other: Biospecimen collection; Biospecimens, including maternal blood and cervical mucus will be collected serially during pregnancy. After delivery tissue samples from the placenta and umbilical cord blood will be collected.; Other Names: Registry/data collection from subject's medical records

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarker levels	Biomarkers for disease will be quantified in biospecimens.	18 months
Pathology	From the database, the presence or absence of perinatal pathologies recorded in the patient's medical records will be determined. These data will be compared with biomarker levels to determine if they are correlated.	9 months

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Sascha Drewlo, PhD, Sunnybrook Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2031

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fetal Diseases; Pregnancy Complications; Placenta Diseases; Hypertension, Pregnancy-Induced; Growth Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pre-Eclampsia; Fetal Growth Retardation; Placental Insufficiency
• Other Study ID Numbers: 4316

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is currently no plan to share IPD outside of the study team as per institutional REB guidelines. Any researchers wishing to access study IPD can contact the PI.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No