- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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]
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Basma W Basma
- Numero di telefono: 01552602703
- Email: Basma.wageh@deltauniv.edu.eg
Luoghi di studio
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Dakahlia Governorate
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Al Mansurah, Dakahlia Governorate, Egitto, 35712
- Reclutamento
- Basma wageah Basma
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Contatto:
- Basma W Basma, phd
- Numero di telefono: 01552602703
- Email: Basma.wageh@deltauniv.edu.eg
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Contatto:
- Basma W Elrefay, phd
- Numero di telefono: 01090412521
- Email: Basma.wageh@deltauniv.edu.eg
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
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participants who actively use the AI application during labor management,
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Nessun intervento: Routine Care Group
Healthcare providers provide routine normal labor management according to standard institutional protocols without using the AI-based Smart Normal Labor Application.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Primary Outcome
Lasso di tempo: 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).
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Secondary Outcome
Lasso di tempo: 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).
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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- Smart Normal Labor
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Lavoro normale
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Aydin Adnan Menderes UniversityCompletatoDurata del lavoro | Labor Bain | e Soddisfazione per la Nascita Durante il Parto Vaginale FisiologicoTurchia (Türkiye)
Prove cliniche su The intervention group
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Children's Hospital Los AngelesAmerican Psychological FoundationReclutamento
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Medical University of South CarolinaKaiser PermanenteReclutamentoViolenza, fisica | Ferita da arma da fuocoStati Uniti
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National Taiwan UniversityNon ancora reclutamento
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University of ZurichETH Zurich (Switzerland)Reclutamento
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Cairo UniversityCompletatoSclerosi multipla recidivante-remittenteEgitto
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Superior UniversityAttivo, non reclutanteArtrosi al ginocchioPakistan
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Oregon Health and Science UniversityNational Institute of Mental Health (NIMH); University of Connecticut; University... e altri collaboratoriNon ancora reclutamento
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KK Women's and Children's HospitalCompletatoCambio di pesoSingapore
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Gazi UniversityCompletatoEsposizione ambientale | Sviluppo infantile | PrecoceTacchino
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Memorial Sloan Kettering Cancer CenterTerminatoLe famiglie o i parenti prossimi dei pazienti trattati presso MSKCC per carcinomi a cellule squamose non cutanei del | Tratto aerodigestivo superioreStati Uniti