Research with human participants

Overview of medical research in the Netherlands

Pregnancy outcome in pregnancies complicated by upper respiratory infections

Published:
Last updated:

The aim of the research is to gain more knowledge on the influence upper respiratory infections on the course of pregnancies.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Viral infectious disorders
Study type
Observational invasive

ID

NL-OMON34899

Source

ToetsingOnline

Brief title

Pregnancy and upper respiratory infections

Condition

  • Viral infectious disorders

Synonym

common cold, flu, upper respiratory infections

Research involving

Human

Sponsors and support

Primary sponsor :
Universitair Medisch Centrum Utrecht
Source(s) of monetary or material Support :
Ministerie van OC&W

Intervention

Keyword :
Pregnancy, respiratory infection

Outcome measures

Primary outcome

Pregnancy outcome (duration of pregnancy, birth weight, Apgar score, pH / base

excess of umbilical cord blood, admission of neonate to neonatal ward)

Secondary outcome

Correlation between maternal and fetal antibodies against viruses causing upper

respiratory tract infections.

Background summary

Last flu season has shown that pregnant women are at increased risk of
(complications of) influenza infection. However nearly nothing is known about
other upper respiratory infections during pregnancy, neither whether pregnant
women are more or less at risk of acquiring them nor if they are at increased
risk of complications. Therefor it is usefull to research this so in the future
pregnant women can be informed and / or treated.

Study objective

The aim of the research is to gain more knowledge on the influence upper
respiratory infections on the course of pregnancies.

Study design

This is a prospective observational cohort study. Pregnancy outcome of women
with and without new influenza A H1N1 infection will be compared.

Study burden and risks

The risks and burden associated with participation are nil. The amount of blood
sampled is limited. Blood samples are normally taken at times women indergo
venipunture anyway (with exception of those who deliver very fast).

Public
Universitair Medisch Centrum Utrecht

Lundlaan 6
3584 EA Utrecht
NL
Scientific
Universitair Medisch Centrum Utrecht

Lundlaan 6
3584 EA Utrecht
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

Pregnant women, adults, able to sign informed consent

Exclusion criteria

Incapacitated subjects, women referred during labour

Design

Study type :
Observational invasive
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Diagnostic

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
700
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Universitair Medisch Centrum Utrecht (Utrecht)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Universitair Medisch Centrum Utrecht (Utrecht)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Universitair Medisch Centrum Utrecht (Utrecht)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL30382.041.09