NCT02451332

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

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

May 19, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

4.2 years

First QC Date

May 19, 2015

Last Update Submit

November 11, 2020

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • C-reactive protein (CRP) increase

    three days post-vaccine compared to pre-vaccine

Study Arms (1)

vaccinated

EXPERIMENTAL

These women will have received the seasonal influenza vaccine.

Biological: inactivated seasonal flu vaccine

Interventions

inactivated seasonal flu vaccineBIOLOGICAL

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

vaccinated

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women carrying singleton pregnancies at low risk of obstetrical complication.

You may not qualify if:

  • Pre-pregnancy BMI \> 40,
  • pre-existing diabetes,
  • essential hypertension,
  • epilepsy,
  • more than one prior preterm deliveries,
  • previous stillbirth,
  • previous Cesarean section,
  • gestational hypertension prior to 34 weeks,
  • placenta previa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Calgary Primary Care Network Low-Risk Maternity Clinic

Calgary, Alberta, T2J7A4, Canada

Location

Related Publications (32)

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Study Officials

  • Monica G Kidd, MD

    (403) 956-2313

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

May 19, 2015

First Posted

May 21, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2019

Study Completion

August 1, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations

CA(1)