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Completed

NCT Number: NCT07438314

Artificial Intelligence-Based Educational Guide

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.

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Key information

Conditions

Surgical Site Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Nursing

Mansoura / Egypt, Mansoura, 35516, Egypt

About this study

Surgical site infections (SSIs) remain a significant concern in obstetric care, particularly following cesarean sections (CS), which are among the most frequently performed surgical procedures worldwide. SSIs not only prolong hospital stays but also increase healthcare costs and contribute to maternal morbidity. Emerging technologies, particularly artificial intelligence (AI), offer promising avenues for enhancing patient education and infection prevention strategies. Recent research demonstrated the potential of AI in healthcare education and infection control. A recent study found that AI-based educational programs significantly improved patients' knowledge and adherence to infection prevention protocols, leading to a 50% reduction in SSI rates post-cesarean section.

Many women, particularly those in rural or underserved communities, have limited access to healthcare professionals and postoperative follow-up care. AI-based educational tools, which can be delivered via mobile applications, SMS alerts, or digital platforms, have the potential to overcome geographical and economic barriers. This study supports the scalability and accessibility of AI-driven health education, particularly for vulnerable populations who may otherwise lack essential postoperative guidance

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Artificial Intelligence-Based educational guide

Other

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

Primary outcomes

  1. A structured interview Questionnaire

    Time frame: 30 days after CS

    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

Secondary outcomes

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

    Time frame: 30 days after CS

    This tool included criteria for defining surgical site infection (SSI) by CDC including:

    Superficial incisional SSI, Infection occurred within 30 days after the operation and the infec involves only skin or subcutaneous tissue of the incision and at least one of the following:

    • Purulent drainage
    • Organisms isolated from an aseptically obtained culture
    • At least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat, and the superficial incision is deliberately opened by surgeon, unless incision is culture-negative
    • Diagnosis of superficial incisional surgical site infection (SSI) by the surgeon or attending physician.

    Deep incisional SSI: Infection occurred 30 days after the operation, and the infection involved deep soft tissue of the incision and at least one of the following:

    • Purulent drainage from the deep incision
    • A deep incision spontaneously dehisces or is deliberately opened.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Effectiveness of Artificial Intelligence-Based Educational Guide to Prevent Surgical Site Infection Among Women Delivering Via Caesarean Section

Acronym: AI/SSI

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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