Obstetrics

 
 APOSTEL VIII
 
 Dutch TRUFFLE
 
 2Close
 
 APRIL
 Highlow
 
 PC
 Quadruple P
 
 SIMPLE III
 
 Stop or Go?
 
 STRIDER
 
 SUGAR-DIP
 
 KEUZEHULP IMPLEMENTATIE
 
 INDEX
 MOTHER
 NethOSS
 Ppromexil-III
 ALLO
 AMPHIA
 APOSTEL-I
 APOSTEL-II
 APOSTEL-III
 APOSTEL-IV
 
 Apostel VI
 ASB
 CHIPS
 DIGITAT
 ECV Implementation
 > EuFis
 Fluxim
 GlucoMOMS
 HTA Longterm conseq.
 HTA Preference study
 HYPITAT
 HYPITAT-II
 HyRAS (Hypitat followup)
 Implementatie Tour
 IUPC
 PIMPP
 PPROMCerclage
 PPROMEXIL
 PreCare
 PROBAAT
 PROBAAT-II
 PROBAAT-S
 ProTWIN
 SimpleII
 STAN
 TeMpOH-1
 TeMpOH-3
 TOSTI
 TOTEM
 Triple P
 TRUFFLE
 WOMB study

 ABCD-study
 BIG CHANGE
 CAMPUR
 Cancer in pregnancy
 Doula study
 ECV tocolysis
 ECV Uterine relaxation
 EuroHeartSurvey
 FRUIT
 HP4ALL-PC
 HP4ALL-RS
 IMPACT
 INCAS
 IRIS
 Keizerlijk litteken
 MAKE
 OOPUS
 PRELHUDE
 PROMISES
 RAVEL
 SIMPLE
 STAN followup
 VET study
 VIS-project
 Wat bevalt beter
 ZAHARA II
 ZAHARA 3
 ZOBASII
 

 

EuFiS

European Fibronectin Study

 

Go to the EuFiS website.

 

Objective
Fetal fibronectin is an accurate predictor for the occurrence of preterm birth among women with threatened preterm labour. At present, the risk assessment for imminent preterm delivery consists either of observation of the frequency of  contractions, vaginal examinations, cervical length measurements, and/or qualitative fibronectin testing. Women who are thought to be at high risk are treated with tocolytics and corticosteroids. The use of a quantitative fibronectin test might be a cost-effective strategy to reduce unnecessary treatment.

This study will assess the capacity of quantitative fetal fibronectin testing as compared to or in addition of cervical length measurements and vaginal digital exams to predict preterm delivery in women with symptoms of preterm labour.

 

Study design
European multicenter cohort study.

 

Study population
A cohort of 500 pregnant women between 24 and 34 weeks of gestational age with preterm contractions and intact membranes.

 

Test under study
Quantitative fibronectin test.

 

Outcome measures
The primary outcome measure will be delivery within 7 days.
Secondary outcome measures will be gestational age at delivery, birth weight, neonatal morbidity, neonatal mortality and costs.

 

Power/data analysis
This study is powered to determine sensitivities of the quantitative fibronectin test.
We calculated by using the Wilson test that a sample size of 100 produces a two-sided 90% confidence interval with a width equal to 0,10 when the sample proportion is 0,90.
Given the anticipated 20% urgent cases of preterm delivery, at least 500 patients are needed in this study. Sample size heuristics for multivariable modelling indicate that including 500 patients allows the inclusion of at least 10 variables.

 

Time schedule
2012 – 2014

 

Projectleader
Prof. dr. B.W. Mol, gynaecoloog, epidemioloog.
Academic Medical Center, Amsterdam.

 

Subsidy
Hologic

 

Contact
Drs. Esmé Kamphuis, arts-onderzoeker.
Academic Medical Center, Amsterdam
eufis@studies-obsgyn.nl
       
Drs. Gert-Jan van Baaren, arts-onderzoeker.
Academic Medical Center, Amsterdam
eufis@studies-obsgyn.nl