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Prediction of Preterm delivery by the Electrohysterogram.


- candidate number10620
- NTR NumberNTR3173
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-dec-2011
- Secondary IDs 
- Public TitlePrediction of Preterm delivery by the Electrohysterogram.
- Scientific TitlePrediction of Preterm delivery by the Electrohysterogram.
- ACRONYMPoPE
- hypothesisThe electrohysterogram is better predictor of preterm delivery than current diagnostics.
- Healt Condition(s) or Problem(s) studiedPreterm birth
- Inclusion criteria1. Patients admitted for threatened preterm labor;
2. Gestational age between 23+5 and 34+0 weeks;
3. Clinically evaluated symptoms of preterm labor: at least 6 contractions in 60 minutes based on the (cardio)tocogram and/or maternal perception.
- Exclusion criteriaPatients in active labor: Cervical dilatation ≥3cm.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-feb-2012
- planned closingdate1-feb-2013
- Target number of participants100
- Interventions1. Electrohysterogram: Power spectral density peak frequency, conduction velocity;
2. Current diagnostics: Digital examination, cervical length, fetal fibronectin.
- Primary outcomeSensitivity, specificity, positive and negative predicting value for predicting preterm delivery within 7 days from measurement.
- Secondary outcomeArea Under the Curcve of the ROC curve for predicting preterm delivery within 7 days from measurement.
- TimepointsAll diagnostics will be performed at admission. Electrohysterogram information will be blinded to the attending physician.

Test characteristics will be determined for delivery within 7 days from measurement.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Hinke Lau, de
- CONTACT for SCIENTIFIC QUERIES Hinke Lau, de
- Sponsor/Initiator Maxima Medisch Centrum Veldhoven
- Funding
(Source(s) of Monetary or Material Support)
Maxima Medical Center
- PublicationsN/A
- Brief summaryAn multicenter observational cohort study with the objective to evaluate the electrohysterogram as clinical tool for the diagnosis of imminent preterm delivery compared to standard diagnostic tests (fetal fibronectin, digital examination, cervical length). Study population: 100 pregnant women admitted for threatening preterm labor, gestational age between 23+5 and 34 weeks. All patients will receive standard diagnostic tests and an electrohysterogram recording. Main study parameters: sensitivity, specificity and area under the curve (AUC) for delivery within 1,2,4,7 and 14 days from the measurement.
- Main changes (audit trail)
- RECORD5-dec-2011 - 6-feb-2012


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