- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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]
Study Overview
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Basma W Basma
- Phone Number: 01552602703
- Email: Basma.wageh@deltauniv.edu.eg
Study Locations
-
-
Dakahlia Governorate
-
Al Mansurah, Dakahlia Governorate, Egypt, 35712
- Recruiting
- Basma wageah Basma
-
Contact:
- Basma W Basma, phd
- Phone Number: 01552602703
- Email: Basma.wageh@deltauniv.edu.eg
-
Contact:
- Basma W Elrefay, phd
- Phone Number: 01090412521
- Email: Basma.wageh@deltauniv.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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,
|
|
No 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary Outcome
Time Frame: During labor management (from the onset of active labor until delivery, assessed up to 6-8 hours).
|
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.
|
During labor management (from the onset of active labor until delivery, assessed up to 6-8 hours).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Secondary Outcome
Time Frame: During labor management (from the onset of active labor until delivery, assessed up to 6-8 hours).
|
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.
|
During labor management (from the onset of active labor until delivery, assessed up to 6-8 hours).
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Smart Normal Labor
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Normal Labor
-
Assiut UniversityCompleted
-
Delta University for Science and TechnologyCompletedSmart Normal LaborEgypt
-
Sohag UniversityNot yet recruitingUmbilical Cord of Normal LaborEgypt
-
Jehan George SadekRecruitingVaginal Delivery | Normal LaborEgypt
-
Assiut UniversityNot yet recruitingNormal Pregnancy | Labor Active Dilated Cm
-
University of Medicine and Pharmacy CraiovaUniversity of AthensSuspendedObstetric Labor Complications | Normal LaborGreece, Romania
-
Antalya Bilim UniversityCompletedChildbirth | Normal Labor | Labor Pain and to Reduce PainTurkey (Türkiye)
-
Assiut UniversityCompleted
-
Ben marzouk SofieneCompletedPlacenta Accreta | Placenta Previa | Normal PregnancyTunisia
-
Umeå UniversityCompletedIdiopathic Normal Pressure Hydrocephalus
Clinical Trials on The intervention group
-
M.D. Anderson Cancer CenterCompletedPain | Pain Syndrome | Symptom ManagementUnited States
-
Esbjerg Hospital - University Hospital of Southern...University of Southern Denmark; Region of Southern DenmarkNot yet recruiting
-
Izmir University of EconomicsSaglik Bilimleri Universitesi; Health Institutes of TurkeyCompletedEducation | NursingTurkey
-
Universidad de la SabanaCompletedDementia | Weakness in the Exercise of the Family Caregiver Role of Older Adults With DementiaColombia
-
Emory UniversityUniversity of California, San Francisco; National Institute of Environmental... and other collaboratorsCompleted
-
ALI BAHADIRLIBursa Yüksek İhtisas Education and Research HospitalCompletedGestational Diabetes Mellitus in PregnancyTurkey
-
TC Erciyes UniversityCompletedCardiac Surgery | Breathing Exercises | Incentive SpirometryTurkey
-
Xiaoqi LinCompletedGrowth | Cognition | Nutrition | Infant Health | Family CaregivingChina
-
The Hong Kong Polytechnic UniversityWuhan Union Hospital, ChinaCompletedStomach Neoplasms | Cancer SurvivorsChina
-
Mackay Medical CollegeCompleted