Prenatal Inflammation and Perinatal Outcomes

NCT02451332 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2020-11-13

No results posted yet for this study

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.

Conditions

  • Pregnancy

Interventions

BIOLOGICAL

inactivated seasonal flu vaccine

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

Sponsors & Collaborators

Principal Investigators

  • Monica G Kidd, MD · (403) 956-2313

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2019-12-31
Completion
2020-08-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02451332 on ClinicalTrials.gov