Prenatal Inflammation and Perinatal Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02451332
Recruitment Status : Recruiting
First Posted : May 21, 2015
Last Update Posted : October 16, 2018
Northwestern University
Information provided by (Responsible Party):
Monica Kidd, University of Calgary

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.

Condition or disease Intervention/treatment Phase
Pregnancy Biological: inactivated seasonal flu vaccine Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Prenatal Inflammation and Perinatal Outcomes
Study Start Date : October 2015
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Shot

Arm Intervention/treatment
Experimental: vaccinated
These women will have received the seasonal influenza vaccine.
Biological: inactivated seasonal flu vaccine
Women will receive the flu vaccine, and have capillary blood spots collected on day 0 and day 3.

Primary Outcome Measures :
  1. C-reactive protein (CRP) increase [ Time Frame: three days post-vaccine compared to pre-vaccine ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02451332

Contact: Monica G Kidd, MD (403) 956-2313

Canada, Alberta
South Calgary Primary Care Network Low-Risk Maternity Clinic Recruiting
Calgary, Alberta, Canada, T2J7A4
Contact: Theresa Cooke    (403) 452-7167   
Sponsors and Collaborators
University of Calgary
Northwestern University
Principal Investigator: Monica G Kidd, MD (403) 956-2313

Publications of Results:
Other Publications:
Ghosh TK, Ghosh S, Bhattacharjee D. 2011. C-reactive protein levels in women with pregnancy induced hypertension. Bangladesh Journal of Medical Science 10:159-162.

Responsible Party: Monica Kidd, Clinical Associate Professor, University of Calgary Identifier: NCT02451332     History of Changes
Other Study ID Numbers: REB15/1418
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Pathologic Processes
Immunologic Factors
Physiological Effects of Drugs