- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07720531
Smart Normal Labor: Healthcare Providers' Experience With an AI-Based Mobile App (Smart labor)
Smart Normal Labor From Healthcare Providers' Perspective: Evaluating Clinical Decision-Making Speed, Diagnostic Accuracy, Satisfaction, and Experience Using an AI-Based Mobile Application
Pregnancy and childbirth are uniquely important events in women's lives because they are accompanied by major physical, emotional, and psychological changes. Maternal satisfaction, emotional well-being, and perceptions of childbirth are strongly influenced by the quality of labor management. A woman's childbirth experience is shaped by multiple factors, including communication, autonomy, and active participation in the decision-making process. These factors are widely recognized as important indicators of the quality of maternity care. [1]
Recent demographic changes and global population growth have placed increasing demands on healthcare systems, particularly maternal health services. High birth rates in some regions, combined with shortages of trained healthcare professionals, have created a need for scalable, adaptable, and innovative models of care. In response to these challenges, digital health technologies have emerged as promising tools to enhance the quality of maternity care and support both healthcare providers and pregnant women. [2]
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
General Objective
To evaluate the impact of an artificial intelligence (AI)-based smart normal labor application on healthcare providers' clinical decision-making speed, diagnostic accuracy, satisfaction, and overall clinical experience during the management of normal labor.
Specific Objectives
To assess the effect of the AI-based smart normal labor application on the speed of clinical decision-making among obstetricians and nurses during the management of normal labor.
To evaluate the effect of the AI-based smart normal labor application on diagnostic accuracy during the management of normal labor.
To evaluate healthcare providers' satisfaction with the AI-based smart normal labor application.
To assess healthcare providers' overall clinical experience while using the AI-based smart normal labor application during normal labor management.
To identify barriers and facilitators associated with the adoption and usability of the AI-based smart normal labor application in clinical practice.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Basma W Basma
- Numéro de téléphone: 01552602703
- E-mail: Basma.wageh@deltauniv.edu.eg
Lieux d'étude
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Dakahlia Governorate
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Al Mansurah, Dakahlia Governorate, Egypte, 35712
- Recrutement
- Basma wageah Basma
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Contact:
- Basma W Basma, phd
- Numéro de téléphone: 01552602703
- E-mail: Basma.wageh@deltauniv.edu.eg
-
Contact:
- Basma W Elrefay, phd
- Numéro de téléphone: 01090412521
- E-mail: Basma.wageh@deltauniv.edu.eg
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria
Participants must meet the following conditions to be included in the study:
- Healthcare providers (obstetricians and nurses) currently working in the Labor Kiosk, Obstetrics and Gynecology Department, or Outpatient Gynecology Clinics at Mansoura University Hospital.
- Direct involvement in the care and supervision of women in active labor.
- For the intervention group: previous exposure to and use of the AI-based smart normal labor application for a minimum defined period (e.g., 1 month).
- For the control group: no prior use of the AI-based application, following standard care practices.
- Willingness to participate and provide informed consent. Exclusion Criteria
Participants will be excluded if they:
- Are healthcare providers not directly involved in labor management (e.g., administrative staff or laboratory personnel).
- Have less than the minimum required clinical experience in labor management (e.g., <6 months).
- Are on leave or unavailable during the study period.
- Decline to participate or do not provide informed consent.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: AI-Based Smart Normal Labor Application
Healthcare providers use the AI-based Smart Normal Labor Application during the management of normal labor to support clinical decision-making, labor monitoring, and timely identification of labor-related conditions.
|
participants who actively use the AI application during labor management,
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Aucune intervention: Routine Care Group
Healthcare providers provide routine normal labor management according to standard institutional protocols without using the AI-based Smart Normal Labor Application.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Primary Outcome
Délai: During labor management (from the onset of active labor until delivery, assessed up to 6-8 hours).
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The time required for healthcare providers to make appropriate clinical decisions during the management of normal labor, measured using a structured clinical decision-making assessment tool.
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During labor management (from the onset of active labor until delivery, assessed up to 6-8 hours).
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Secondary Outcome
Délai: During labor management (from the onset of active labor until delivery, assessed up to 6-8 hours).
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Clinical decision-making accuracy will be assessed using a validated Clinical Decision-Making Checklist for Normal Labor.
Total scores range from [minimum] to [maximum], with higher scores indicating greater clinical decision-making accuracy.
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During labor management (from the onset of active labor until delivery, assessed up to 6-8 hours).
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
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
- Smart Normal Labor
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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