NCT07720531

Brief Summary

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. \[2\]

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
427

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 6, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Completed
Last Updated

July 22, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

April 4, 2026

Last Update Submit

July 21, 2026

Conditions

Keywords

Normal LaborClinical Decision-Making in LaborArtificial Intelligence

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome

    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 Outcomes (1)

  • Secondary Outcome

    During labor management (from the onset of active labor until delivery, assessed up to 6-8 hours).

Study Arms (2)

AI-Based Smart Normal Labor Application

EXPERIMENTAL

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

Routine Care Group

NO INTERVENTION

Healthcare providers provide routine normal labor management according to standard institutional protocols without using the AI-based Smart Normal Labor Application.

Interventions

participants who actively use the AI application during labor management,

AI-Based Smart Normal Labor Application

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basma wageah Basma

Al Mansurah, Dakahlia Governorate, 35712, Egypt

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: quasi-experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

April 4, 2026

First Posted

July 22, 2026

Study Start

May 6, 2026

Primary Completion

July 21, 2026

Study Completion

July 30, 2026

Last Updated

July 22, 2026

Record last verified: 2026-01

Locations