Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring and Nonlaboring Patients by Practicing Clinicians
Aperçu de l'étude
Statut
Les conditions
Description détaillée
The SureCALL® Labor Monitor® (SureCALL®) is a transabdominal electromyography monitor intended to measure uterine activity. It is intended for use on pregnant women, with singleton pregnancies, using surface electrodes on the maternal abdomen. The device is intended for use by healthcare professionals in a clinical setting.
This multi-reader multi-case study was designed to evaluate the performance of SureCALL® to the predicate Tocodynamometer device (TOCO).
This study involved 25 women at a Gestational Age of 36 weeks or less and 5 women at a Gestation Age of greater than 36 and not in labor at five clinical sites. Each study subject was instrumented with two technologies for measuring uterine activity:
- Standard tocodynamometer attached to the maternal abdomen,
- SureCALL® with a set of abdominal surface electrodes for uterine electromyography attached to the maternal abdomen
An assessment was obtained and quantified from masked, qualified clinical obstetrician readers for the evaluation of the equivalence of both labor monitor devices by identifying in isolation the individual uterine contraction signals and the peak of each contraction signal as recorded by each labor monitor device.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Arizona
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Phoenix, Arizona, États-Unis, 85013
- St. Joseph's Hospital and Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19101
- Drexel University College of Medicine
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Texas
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Beaumont, Texas, États-Unis, 77702
- Southeast Texas OB/GYN Associates
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Galveston, Texas, États-Unis, 77555
- University of Texas Medical Branch
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Houston, Texas, États-Unis, 77054
- Woman's Hospital of Texas
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Singleton Pregnancy
- Informed Consent Required
Exclusion Criteria:
- Multifetal Pregnancy
- Informed Consent Not Given
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cas uniquement
- Perspectives temporelles: Transversale
Cohortes et interventions
Groupe / Cohorte |
|---|
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Pregnant, Preterm, In Labor
Gestation Age at or less than 36 weeks, clinically determined to be in labor
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Pregnant, Preterm, Nonlaboring
Gestation Age at or less than 36 weeks, clinically determined to not be in labor
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Pregnant, Term, Nonlaboring
Gestation Age more than 36 weeks, clinically determined to not be in labor
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Comparison of SureCALL® and Tocodynamometer Detection of Contraction Events, as Identified by Readers
Délai: 9 - 41 Minutes
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Agreement will be assessed by coefficient of individual agreement (CIA) derived from a dataset of all Reader-marked contractions.
In addition, sensitivity and false positive rate per hours will be estimated for each patient by each reader.
If CIA ≥ 0.445 (Barnhart, 2007, section 3) or CIA>0.8,
Pan 2010), the SureCALL® is not significantly different than the TOCO.
|
9 - 41 Minutes
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Timothy B Waterhouse, MD, Reproductive Research Technologies, LP
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- RRT-12-01
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