CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 46 enrolled
Drug / intervention
inactivated seasonal flu vaccinebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02451332
NCT02451332N/ACompleted

Prenatal Inflammation and Perinatal Outcomes

University of Calgary·interventional·Posted May 21, 2015·Updated Nov 13, 2020

In Brief

A clinical study evaluating inactivated seasonal flu vaccine for Pregnancy. Completed, enrolled 46 participants across 1 site.

Detailed Summary

Preventing poor perinatal outcomes is the goal of all prenatal care, yet just who will go on to develop preeclampsia or have a growth-restricted baby is notoriously difficult to predict. A growing body of evidence suggests inflammatory markers can help predict poor outcomes, even prior to, and beyond, the current pregnancy. Our project will measure the response of one robust inflammatory marker, C-reactive protein (CRP), to a safe immune provocation recommended for all pregnant women (the seasonal influenza vaccine), and to find out whether CRP response is associated with increased risk for gestational hypertension, preeclampsia, preterm delivery, or birth weight. This work will help inform whether inflammatory markers should become part of routine prenatal care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPregnancy
CountriesCanada

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 21, 2015
Enrollment StartOct 1, 2015
Primary CompletionDec 1, 2019
Study CompletionAug 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 11.1 years ago

Interventions

inactivated seasonal flu vaccinebiological

Women will receive the flu vaccine, and have capillary blood spots collected on day 0 and day 3.