The electrohysterogram is better predictor of preterm delivery than current diagnostics.
ID
Bron
Verkorte titel
Aandoening
Preterm delivery, threatening preterm labor
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Sensitivity, specificity, positive and negative predicting value for predicting preterm delivery within 7 days from measurement.
Achtergrond van het onderzoek
An 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.
Doel van het onderzoek
The electrohysterogram is better predictor of preterm delivery than current diagnostics.
Onderzoeksopzet
All 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.
Onderzoeksproduct en/of interventie
1. Electrohysterogram: Power spectral density peak frequency, conduction velocity;
2. Current diagnostics: Digital examination, cervical length, fetal fibronectin.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patients in active labor: Cervical dilatation ≥3cm.
Opzet
Deelname
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| Register | ID |
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