Smart Normal Labor: Healthcare Providers' Experience With an AI-Based Mobile App (Smart labor)

July 21, 2026 updated by: Basma Wageah Mohamed Mohamed Elrefay, Delta University for Science and Technology

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

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
427

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria

Participants must meet the following conditions to be included in the study:

  1. Healthcare providers (obstetricians and nurses) currently working in the Labor Kiosk, Obstetrics and Gynecology Department, or Outpatient Gynecology Clinics at Mansoura University Hospital.
  2. Direct involvement in the care and supervision of women in active labor.
  3. 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).
  4. For the control group: no prior use of the AI-based application, following standard care practices.
  5. Willingness to participate and provide informed consent. Exclusion Criteria

Participants will be excluded if they:

  1. Are healthcare providers not directly involved in labor management (e.g., administrative staff or laboratory personnel).
  2. Have less than the minimum required clinical experience in labor management (e.g., <6 months).
  3. Are on leave or unavailable during the study period.
  4. Decline to participate or do not provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: The intervention group
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Delta University for Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 21, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Smart Normal Labor

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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