What is the prevalence of ASB and incidence of UTIs during pregnancy in women with DM or GDM compared to pregnant women without diabetes? In addition, risk factors for ASB and UTIs, as well as consequences of ASB and UTIs will be investigated. These…
ID
Source
Brief title
PRABUTI studie
Condition
- Diabetic complications
- Maternal complications of pregnancy
- Urinary tract signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Prevalence of ASB, incidence of UTIs during pregnancy, diagnosed by dipstick
and urine culture.
Secondary outcome
Hospitalization rate
Pregnancy duration
Birth weight
Prevalence causative uropathogens
Prevalence virulencefactors of E.Coli.
Background summary
Women with diabetes mellitus (DM) have a high incidence and complication rate
of urinary tract infections (UTIs). UTIs are common during pregnancy, as well
as asymptomatic bacteriuria (ASB). ASB may lead to UTI, pyelonephritis and
sepsis in the mother and contribute to low birthweight babies and preterm birth
(before 37 weeks). Pregnant women with DM or gestational diabetes (GDM) have
two additive risk factors for developing a UTI with the possible consequences
during and after pregnancy. Furthermore, in contrast to curent Dutch
guidelines, international guidelines include routine screening and treating ASB
in pregnancy to prevent UTI and pyelonephritis. However the routine care abroad
is not really comparable to obstetrical care in the Netherlands. Therefore,
more research in the Netherlands is indicated.
Study objective
What is the prevalence of ASB and incidence of UTIs during pregnancy in women
with DM or GDM compared to pregnant women without diabetes? In addition, risk
factors for ASB and UTIs, as well as consequences of ASB and UTIs will be
investigated. These investigations include genotyping of different virulence
factors of the causative bacteria.
Study design
Prospective cohort study
Study burden and risks
The burden of this research consists of data collection from the medical chart
from the mother and the child, a short questionnaire on factors related to
bacteriuria filled out by the pregnant woman at the routine screening and urine
samples at the 12 (±2 weeks) and 32 (± 2 weeks) weeks prenatal visit. Urine
will be screened anonymous after these visits in the laboratory by a
combination of a nitrite and leukocytes test. If one of these tests is positive
a urine culture will be performed. The results of the tests stay anonymous and
are not notified to the patient or to the treating doctor.
Hanzeplein 1, entry 24
9713 GZ Groningen
Nederland
Hanzeplein 1, entry 24
9713 GZ Groningen
Nederland
Listed location countries
Age
Inclusion criteria
o Women
o Pregnant
o Older then 18 years old
o Informed consent
Exclusion criteria
o No understanding of Dutch or English language (we estimate that less than 5% of the patients have no understanding of Dutch language)
o Patients with pre-existing medical conditions with known association with UTI except for pregnancy and diabetes and without functional and anatomical abnormalities of the urinary tract
Design
Recruitment
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 | NL25199.042.08 |