The aim of this pilot study is validate the multiplex PCR for bacterial vaginosis and candidiasis on the basis of Nugent score, Amsel criteria, clinical diagnosis of candidiasis and culture before and after treatment. Besides that we will measure…
ID
Source
Brief title
Condition
- Vulvovaginal disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A. Outcome of culture on Gardnerella vaginalis, C. albicans, yeasts,
trichomoniasis and beta-hemolytic streptococcal infections
- Positive
- Negative
- can't be measured
B. Outcome gram-stain for bacterial vaginosis
- Positive
- Negative
- can't be measured
C. Outcome Multiplex PCR analysis on bacterial vaginosis, atopobium vaginae,
lactobacillus spp.
Negative
1. Normocenosis: normal vaginal flora
Positive
Anaerobic disbiosis: bacterial vaginosis with explanation disbalanced vaginal
flora, significantly more anaerobe bacteria
Doubtful positive
3. Mezocenosis: changed vaginal flora with increased anaerobe bacteria.
4. Unexplained disbiosis: decreased lactobacillus, no increase of anaerobe
bacteria.
Can't be measured
5. Result of test is unreliable: not specified but will be given to a specific
grade of Cq of total bacteria.
D. Outcome Multiplex PCR analysis on Candida species: AmpliSens C. albicans,
C. glabrata, C. krusei-MULTIPRIME-FRT PCR.
- Positive
- Negative
- can't be measured
E. Outcome PCR analysis on Trichomoniasis
- Positive
- Negative
- can't be measured
F. Outcome PCR analysis on C. trachomatis
- Positive
- Negative
- can't be measured
G. Outcome PCR analysis on N. gonorrhoeae
- Positive
- Negative
- can't be measured
Secondary outcome
Clinical diagnoses based on complaints and vaginal inspection on which we give
a treatment.
- Bacterial vaginois
- Candidiasis
- Trichomoniasis
- Infection with ß -hemolytic streptococcal group A
- C. trachomatis
- N. gonorrhoeae
Presentation of symptoms
- Duration of symptoms
- Amount of discharge
- Color discharge
- Fishy odor of discharge
- Fishy odor of discharge after intercourse
- Itching
- Burning
- Vaginal redness of irritation
- Pain
- Symptoms related to menstruation cycle
- Dyspareunia
- Seriousness of complaints
- Bleeding after intercourse
- Symptoms gone after treatment
- Dysuria
- Abdominal pain
Physical examination
- Vaginal redness or irritation
- Amount of discharge
- Color of discharge
- Friable white discharge
- Frothy white discharge
- Purulent discharge
- Bleeding cervix at speculum examination
- Erythematous cervix
- Fishy odor of discharge
- Fishy odor after KOH
- Acidity of discharge
- Clue cells on wet mount
- Motile trichomonads on wet mount
- Budding yeast, pseudohyphae, and hyphae on a wet mount of the discharge;
adding 10 percent potassium hydroxide
Time needed to do the following test in minutes
- Acidity measurement
- whiff-amine test
- Microscopial evalution with wet mount or potassium hydroxide
Outcome microbioma analysis with bacterial 16S rDNA analysis by nex-gen
sequencing (Illumina MiSeq)
- Positieve
- Negative
- Can't be measured
Background summary
Fluor vaginalis is the most common gynecological problem in the general
practitioners practice with an incidence of 40 á 50 per 1000 female patients a
year. Candidiasis and bacterial vaginosis are the most common causes of
discharge problems. Bacterial vaginosis can cause preterm delivery, post
postpartum fever, endometritis after curettage and endometritis after a
cesarean. The diagnosis candidiasis and bacterial vaginosis both can be made on
clinical view in combination with bedside diagnostics (Amsel criteria), and/or
culture, and/or cytology. The NHG standard (general practioners standard)
advises to do bedside diagnostics (Amsel criteria) but these are
labor-intensive with limited sensitivity and specificity. Recently there is a
multiplex PCR analysis available for diagnosing bacterial vaginosis and
candidiasis. The aim of this pilot study is to evaluate the
multiplex PCR for diagnosing bacterial vaginosis and candidiasis in fluor
vaginalis patients.
Study objective
The aim of this pilot study is validate the multiplex PCR for bacterial
vaginosis and candidiasis on the basis of Nugent score, Amsel criteria,
clinical diagnosis of candidiasis and culture before and after treatment.
Besides that we will measure the time needed to do whiff-amine testing and
analysing wet mount slides for a possible cost-benefit analysis.
Study design
This study contains pregnant and non-pregnant women who visit the gynecological
outpatient clinic in the Bronovo hospital and Roosevelt clinic with discharge
complaints. The control group contains women without specific discharge
complaints. There will we take medical history, physical evaluation and 3 forms
of diagnostic tests (culture, PCR and gram-staining).
The control group is needed for validation of the Multiplex PCR. When the
multiplex PCR is proper functioning it is expected that is gives the same
negative result as the gold standard for bacterial vaginosis and candidiasis in
women without complaints.
Because this is a pilot study and a power analysis can not yet be made there
will be included 60 women with discharge complaints and 20 women without
discharge complaints. The time of inclusion will take 2 till 3 months.
Patients will be treated on clinical diagnosis or if unclear on PCR analysis
outcome. There will be a follow up after 4 weeks where response on therapy will
be determined and where vaginal swabs will be taken for the second time. The
control group will also have a follow up in 4 weeks at the gynaecologie
outpatient clinic or at the Roosevelt clinic. For validating the multuplex PCR
we want to have insight into the reproducebility and variation of the vaginal
flora of the patient without complaints.
Study burden and risks
The burden for patients will consist of 2 measuring moments, first at
presentation of symptoms, taking history, examination of the vagina and taking
3 vaginal swabs. Second at follow up in 4 weeks, evaluation of therapy (if
given), vaginal swabs and wet mount will be taken again. There are no risks
associated with participation in this study. Benefits for the patient while
participating is a comprehensive analysis of discharge complaints and an
accurate follow-up.
Bronovolaan 5
Den Haag 2597 AX
NL
Bronovolaan 5
Den Haag 2597 AX
NL
Listed location countries
Age
Inclusion criteria
Major criteria:
Increase of discharge
Odor of discharge;Minor criteria:
Color change of discharge
Itching, irritation or redness
Exclusion criteria
Postmenopausal women
Immune compromised women
Women who had a vaginal ultrasound with gel on the day of inclusion
Women with complaints of vulva in stead of vagina
Women who have been treated with antibiotics or clotrimazole for vaginal infections the last 3 months
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL51257.098.14 |