ASB-studyASB-study

Screening and treating Screening and treating asasymptomatic ymptomatic bbacteriuria in pregnancyacteriuria in pregnancy

Brenda Kazemier (AMC)Suzanne Geerlings (AMC)Prof. Christianne de Groot (VU)Prof. Ben Willem Mol (AMC)

Symposium 3 handen op 1 buik 13/12/11Symposium 3 handen op 1 buik 13/12/11

BacteriaBacteria UrineUrine

http://4.bp.blogspot.com/_bAIZPjDtT_Q/TNsTfObFrXI/AAAAAAAAGes/yzeidwY2CC8/s1600/pee.jpgwww.bacteriapictures.nethttp://4.bp.blogspot.com/-IHm3oSut4-U/TbfJk77WWgI/AAAAAAAAA2o/fyQP8qo3OKs/s1600/ultrasounds.jpg

PregnancyPregnancy

Urinary tract and Urinary tract and pregnancypregnancy

http://health.nytimes.com/health/guides/disease/urinary-tract-infection/background.htmlhttp://www.nvscc.com/images/normal_female_anatomy.jpg

What is ASB?What is ASB?Urine is normally sterile (contains no

bacteria)

2-10% have bacteria in urine without complaints

ASB = ASymptomatic Bacteriuria

What is ASB?What is ASB?

Outside pregnancy no problems with ASB

In pregnancy untreated ASB can lead to pyelonephritis (up to 30%)

Also increased risk of preterm delivery and delivering a low birthweight baby

Screening and treating Screening and treating ASBASBOther countries routinely screen and treat

ASB

Dutch obstetric guideline: not enough evidence for routine screen and treat program

Usefulness of screening depends on incidence in population

In Netherlands different antenatal care system

Evidence Evidence Author

Year

ASB diagnosis

Intervention N Endpoint

Kass 1960 <32 wks GA Sulfamethopyridazine vs placebo 214 pyelonephritis

Kincaid 1965 <26 wks GA Sulphamethodiazine vs placebo 145 pyelonephritis

Gold 1966 Any GA Sulfadiazide vs placebo 65 pyelonephritis

Little 1966 First visit Different types of antibiotics vs placeo 265 pyelonephritis

Elder 1966 Not stated Sulfasymazine 0.5g until delivery vs placebo 106 Bacterial clearance

Pathak 1969 <24 wk GA Nitrofurantoin vs placebo 178 Bacterial clearance

Elder 1971 First visit Tetracycline 6wks vs placebo 281 pyelonephritis

Brumfitt 1975 First visit Single dose sulphonamide vs placebo 425 Low bw, pyelonephritis

EvidenceEvidence Author Year ASB

diagnosisIntervention Endpoint

Robertson 1968 Not stated Cycloserine 250mg vs sulphadimine 500mg

Symptomatic infection

Bint 1979 Not stated Pivmecillinam 400mg vs ampicillin 500mg Bacterial eradication

Campbell-Brown

1987 First visit Cephalexin vs pivmecillinam/pivampicillin Symptomatic infection

Bayrak 2007 2nd trimester

Single dose fosfomycin trometamol vs 5 day cefuroxim

Bacterial eradication

Estebanez 2009 First visit (18 wks GA)

Single dose vs 7-day course amoxicillin-clavulanate

Bacterial eradication

Lumbiganon 2009 12-32 wks AD

1 day vs 7 day nitrofurantoin Bacterial eradication

Research questionsResearch questionsWhat is the incidence of ASB in the

Dutch population?Is a screening strategy with a dipslide

useful and costeffective?Does treatment with nitrofurantoin

decrease the incidence of pyelonephritis and preterm delivery?

What are the riskfactors for developing ASB ?

Study designStudy designAlongside the Triple P

◦ Screeningpart (4400 women)◦ Treatpart (230 women)

Population: singletons

Use logistic network of

ASB screeningASB screeningGold standard is urinary culture

Dutch primary antenatal care no direct access to microbiology lab urinary culture not feasible

Alternative: dipslide◦ Sensitivity: 98 *◦ Specificity: 99.6 *

* Mignini 2009 obstetrics and gynaecology

ASB screeningASB screeningScreening between 16-22 weeks

Easy to implement in Triple P screening◦ Need of emptying bladder for cervical

length measurement

Exclusion criteria:◦ Previous spontaneous preterm delivery

<34wks◦ Diabetes Mellitus◦ Allergy to nitrofurantoin

ASB treatASB treat

Randomized controlled trial

230 women

Intervention: 2x100mg nitrofurantoin for 5 days or placebo

One week after finishing studymedication again urine dipslide

EndpointsEndpointsPrimary endpoint:

◦ Pyelonephritis and/or preterm delivery <34 weken

Secondary endpoints:◦ Neonatal and maternal morbidity/mortality◦ Costeffectiveness

Screening for ASB Screening for cervical-length Screening for both

Current situationCurrent situation105 women participated in ASB

screening

51 also had a cervical length measurement

12 positive dipslide

2 randomisations◦ 2 thinking about participation◦ 4 excluded◦ 3 refusers◦ 1 got symptomatic before randomisation

Why research in primary Why research in primary care?care?Effect of screening study needs to be

investigated in whole population

Improve risk selection and care in primary setting◦ Treat patients accordingly within their own

setting

4 hands on one belly

4 hands on one pregnant 4 hands on one pregnant belly:belly:

http://static.zoom.nl/78783E7FA227DD69B691F42FB910B2EC-4-handen-op-1-buik.jpg

Primary carePrimary care

Secondary care

Secondary care

Pregnant womanPregnant woman

Tertiary care

Tertiary care

Participating centres:Participating centres:Primary care:

◦ Espérance, Arnhem◦ MaMa, Velserbroek◦ EVA, Varsseveld◦ FARA, Ede

Secondary care:◦ Flevoziekenhuis, Almere◦ Diakonessenhuis, Utrecht◦ Atrium Medisch Centrum, Heerlen

Tertiary care:◦ AMC, Amsterdam◦ Vu, Amsterdam◦ MMC, Veldhoven

Distribution care Distribution care NetherlandsNetherlands

◦20 weeks ultrasound screening referral

from midwivery practice to:

My dreams for 2012My dreams for 2012Follow in Triple P’s great footstepsFinish ASB study in 12 monthsPublish in high impact journal

Increase the participating centres Increase the participating centres of the ASB study to at least 20 of the ASB study to at least 20 ultrasoundcentresultrasoundcentres

Thank you for your Thank you for your attention!attention!

Want to participate?Email or call Brenda:

◦B.m.kazemier@amc.uva.nl◦Tel: 0630471389 ◦Website: www.studies-obsgyn.nl/asb◦Approach me after symposium