Pregnancy Repository

NCT06339606 | Not Yet Recruiting

• 1 other identifier: 4316
• Study Type: observational
• Target: 7,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pregnancy Related; Fetal Growth Retardation; Placental Insufficiency; Preeclampsia; Cervix; Pregnancy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Abnormal Placentation

Women with a singleton or multiple pregnancy that are known or suspected of having abnormal placentation

Other: Biospecimen collection

Control

Women with a singleton or multiple pregnancy with a low-risk pregnancy.

Other: Biospecimen collection

Interventions

Biospecimen collection OTHER

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.

Also known as: Registry/data collection from subject's medical records

Abnormal Placentation; Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female, must be pregnant
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women age 18-45 who are pregnant

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples (up to 20 mL) will be collected serially during pregnancy. Cervical swabs will be collected serially during the first 30 weeks of pregnancy. Tissue specimens from the placenta (1-5 g) will be collected after delivery. Umbilical cord blood (10 mL) will be collected after delivery.

MeSH Terms

Conditions

Fetal Growth Retardation; Placental Insufficiency; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Placenta Diseases; Hypertension, Pregnancy-Induced

Study Officials

• Sascha Drewlo, PhD

  Sunnybrook Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sascha Drewlo, PhD

CONTACT

1-416-480-6100; sascha.drewlo@sri.utoronto.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: April 1, 2024
• Study Start: May 1, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): April 30, 2031
• Last Updated: April 24, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share