NCT07438314

Brief Summary

The study aimed to evaluate the effectiveness of an artificial intelligence-based educational guide to prevent surgical site infection among women delivering via cesarean section. Research hypotheses: H0: An artificial intelligence-based educational guide will not have any effect on reducing the rate of surgical site infection among women delivering via caesarean section. H1: An artificial intelligence-based educational guide will have a significant positive effect on reducing the rate of surgical site infection among women delivering via cesarean section. A purposive sample of 300 CS delivered women was divided randomly by using computer-generated randomization. into a control and intervention group, 150 women each. The control group received standard care. The intervention group received standard care plus the Artificial Intelligence guide

  • After discharge, the researcher contacts study subjects every day by WhatsApp and phone call for any questions and to remind them of the upcoming follow-up visit.
  • Women were asked to photograph the incision site and send it via WhatsApp using an end-to-end encrypted messaging platform to evaluate the wound condition. All photos were deleted immediately after completing the study for women's privacy.
  • At the 10th postoperative day (±3 days), a follow-up was performed in the Outpatient Clinic because the majority of SSIs developed between POD5 and POD10, and due to the importance of timely identification and referral of SSIs.
  • According to the study protocol, all women were followed until 30 days after CS. Follow-up was performed in the outpatient clinic, and post-CS SSI screening questions were asked, a physical examination of the patient and determined whether the patient had an SSI as per the Centers for Disease Control and Prevention definition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 17, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

8 months

First QC Date

February 13, 2026

Last Update Submit

February 22, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • A structured interview Questionnaire

    This questionnaire consists of two parts: Part one is to obtain information about cesarean section women's demographic and obstetric characteristics (Age, Residence, Obstetric characteristics, Parity, Gestational age, Labor before operation, Status of membrane) and phone number Part two: to obtain information about medical history (pre-existing conditions, diabetes mellitus, anemia, obesity, hypertension). Part three: to obtain information about cesarean section women's Operational characteristics (Type of the CS, Duration of CS, pre and postoperative antibiotic prophylaxis, Type of Abdominal incision, Post-operative hospital stay, Type of Anesthesia, intraoperative complications, Bleeding (\> 1000 ml), blood transfusion, duration of operation, days in hospital postoperatively, patients' medication list and from the discharge list

    30 days after CS

Secondary Outcomes (1)

  • Criteria for defining surgical site infection (SSI). From US Centers for Disease Control and Prevention (CDC definition)(CDC, 2007).

    30 days after CS

Study Arms (2)

AI intervention

EXPERIMENTAL

* After discharge, the researcher contacts study subjects every day by WhatsApp and phone call for any questions and to remind them of the upcoming follow-up visit. * Women were asked to photograph the incision site and send it via WhatsApp using an end-to-end encrypted messaging platform to evaluate the wound condition. All photos were deleted immediately after completing the study for women's privacy. * At the postoperative day (±3 days), follow-up was performed in the Outpatient Clinic because the majority of SSIs developed between POD5 and POD10, and due to the importance of timely identification and referral of SSIs (Sway et al., 2019). * According to the study protocol all women were followed until 30 days after CS. Follow-up was performed in the Outpatient Clinic and post-CS SSI screening questions were asked. a physical examination of the patient was determined whether the patient had an SSI as per the Centers for Disease Control and Prevention definition Gave all instruction

Other: Artificial Intelligence-Based educational guide

ordinary intervention

ACTIVE COMPARATOR

women receive the usual nursing care

Other: Artificial Intelligence-Based educational guide

Interventions

The artifactual intelligence-based educational guide regarding cesarean section wound care provided for women after delivery and followed through with Daily educational messages, interactive dialogue, Reminders and alerts, Automated symptom checklists, and Photo-based wound monitoring

AI interventionordinary intervention

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsadult fertile women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 20-60 years who delivered via cesarean section (CS).
  • Own a smartphone with internet access.
  • Have basic digital literacy, defined as the ability to use mobile applications, read text messages, and communicate via WhatsApp or similar platforms.
  • Agree to participate voluntarily and provide informed consent.

You may not qualify if:

  • Women with severe comorbid medical or psychiatric conditions that may affect their participation or comprehension.
  • Women without smartphone access or with limited digital skills that prevent them from interacting with the AI-based educational guide.
  • Women with communication difficulties (e.g., hearing or speech impairment) that hinder engagement with the intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing

Mansoura / Egypt, Mansoura, 35516, Egypt

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Madiha HN Mohamed, professor

    faculty of nursing Mansoura university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

February 13, 2026

First Posted

February 27, 2026

Study Start

February 17, 2025

Primary Completion

October 10, 2025

Study Completion

December 16, 2025

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations