Pregnancy Repository

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorSunnybrook Health Sciences Centre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

Women age 18-45 who are pregnant

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Biospecimen collection

    Other intervention

    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.

Treatment groups

7,000 Participants
are divided into 2 treatment groups
Group A: Abnormal Placentation1 intervention
Group B: Control1 intervention

Trial outcomes

Primary outcomes

1

Biomarker levels

Biomarkers for disease will be quantified in biospecimens.

Time frame
18 months
2

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.

Time frame
9 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: