To determine the vaginal microbiota composition during preeclampsia
ID
Source
Brief title
Condition
- Autoimmune disorders
- Maternal complications of pregnancy
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome of the study is to determine the composition and subsequently
the difference of the vaginal microbiome between the patients with preeclampsia
and the uncomplicated pregnancies.
Secondary outcome
not applicable
Background summary
Human microbiota composition has a critical role in health and host response
modulation, therefore microbiota composition is most likely crucially important
for mother and fetus during pregnancy. It was reported that the vaginal
microbiota composition is less diverse during pregnancy, majorly dominated by
two species of Lactobacillus, in order to maintain the acidic pH and to inhibit
growth of opportunistic pathogens in the vagina. However little is known about
the composition of vaginal microbiota during pregnancy disorders such as
preeclampsia. The pathogenesis of preeclampsia involves aberrant inflammation
and inadequate innate and cellular immune activation suggesting a possible
implication of the microbiome as well. Dysbiosis of the vaginal microbiome can
be associated with pregnancy complications and can influence the conventional
neonatal gut microbiota.
Study objective
To determine the vaginal microbiota composition during preeclampsia
Study design
Observational explorative tudy
Study burden and risks
Vaginal swabs will be taken during regular pregnancy routine check-up, which
will not affect the regular number of visits to the hospital/midwife clinic,
nor will pose an extra risk for the individuals. This study investigates
preeclampsia associated vaginal microbiota changes which might be different
from the regular pregnancies and therefore may lead to possible therapeutic
treatments. None of the subjects will have a direct benefit of this study.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
-signed informed consent
-age: 18- 40 years
-healthy
- first pregnancy
- between 25-35 weeks pregnant
- preeclampsia (defined as blood pressure >=140/90 on more than two occasions 4 hours apart, plus proteinuria on a random urine sample)
Exclusion criteria
-vaginal bleeding
-vaginal infection
-urinary tract infection
-use of antibiotics
-body mass index <18 and >30
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 | NL58341.042.16 |