NCT02305745

Brief Summary

Evaluating the long term cardiovascular risks of those mothers who have been diagnosed with preeclampsia in pregnancy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

3.3 years

First QC Date

November 28, 2014

Last Update Submit

September 3, 2019

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

  • Persistence of high blood pressure (hypertension) and cardiovascular biomarkers in the blood at 6 months after a pregnancy with preeclampsia

    Six months after delivery

Study Arms (2)

Preeclampsia- observational

45 women with preeclampsia

Other: Observational

No preeclampsia- observational

10 women without preeclampsia

Other: Observational

Interventions

ObservationalOTHER
No preeclampsia- observationalPreeclampsia- observational

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We plan to enroll 40 participants in the study: 30 women who have been diagnosed with preeclampsia and 10 women who have had a normal pregnancy.

You may qualify if:

  • Women with a pregnancy complicated by pre-eclampsia and women who are healthy and have had a normal singleton pregnancy(controls)

You may not qualify if:

  • Women with any of the following conditions will be excluded in both the control \& preeclampsia groups:
  • known kidney disease prior to pregnancy or laboratory evidence of proteinuria prior to pregnancy
  • diabetes (Type I, Type II or Gestational Diabetes)
  • known Cardiovascular Disease (myocardial infarction, angina, stroke, or transient ischemic attack
  • multiple pregnancies (twins or more)
  • who do not understand English or French will be excluded In addition to those listed above, for the control group, women must have no other major maternal pregnancy complications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital, General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Dr Laura Gaudet

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2014

First Posted

December 3, 2014

Study Start

August 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

September 6, 2019

Record last verified: 2019-09

Locations

CA(1)