Recruiting

Precision Medicine

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT04412681

Conditions

Pre-Eclampsia

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Enhanced PE Screening

Study Details

Brief summary:

This study aims to evaluate the feasibility of implementing a clinical model for precision screening of early pre-eclampsia into the current prenatal screening service at Sunnybrook Health Sciences Center (SHSC).

Conditions

Pre-Eclampsia

Study ID

NCT04412681

Start date

Mar 1, 2021

Status verified date

Mar, 2021

Completion date

Jun 1, 2022

Anticipated

Primary completion date

Jun 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Women with a singleton pregnancy > 18 years old
2. Not on low dose aspirin
3. Carrying a live fetus with crown rump length (CRL) between 41 and 84mm
4. Able to provide informed consent
5. Having a nuchal translucency ultrasound

Exclusion Criteria:

1. Women with a singleton pregnancy < 18 years old
2. Women currently taking low dose aspirin
3. Women declining a nuchal translucency ultrasound
4. Women unable to provide informed consent
5. Women with a multiple pregnancy
6. Women with a demised fetus or a CRL <41mm and >84mm

Study Design

Enrollment

1000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: PE Enhanced Screening

The PE screening program entails the following for all participants:

  • provision of additional demographic and risk factors
  • provision of mean arterial pressure
  • standard nuchal translucency scan as part of their first trimester screening (FTS) with the addition of the measurement of the uterine artery Doppler by a certified sonographer
  • standard blood sample (as part of the FTS)
  • results of the PE screening (in the format of a screening report) will be provided to the study team and participant's healthcare provider

Interventions

Enhanced PE Screening

To better identify women at risk for pre-eclampsia during pregnancy.

Primary outcome measure

  • Feasibility of Screening Tool [ Time Frame: 11.3-13.6 weeks gestation ]

Central Contacts and Locations

Central contacts

Ronzoni

4164804920stefania.ronzoni@sunnybrook.ca

Locations

Sunnybrook Health Sciences center

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Stefania Ronzoni

stefania.ronzoni@sunnybrook.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Mar 22, 2021

Last verified

Mar, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2021-03-22.