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Artificial Intelligence-Based Educational Guide

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07438314
Acronym
AI/SSI
Enrollment
300
Registered
2026-02-27
Start date
2025-02-17
Completion date
2025-12-16
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Site Infection

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.

Detailed description

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

Interventions

OTHERArtificial Intelligence-Based educational guide

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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
A structured interview Questionnaire30 days after CSThis 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

MeasureTime frameDescription
Criteria for defining surgical site infection (SSI). From US Centers for Disease Control and Prevention (CDC definition)(CDC, 2007).30 days after CSThis 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: 1. Purulent drainage 2. Organisms isolated from an aseptically obtained culture 3. 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 4. 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: 1. Purulent drainage from the deep incision 2. A deep incision spontaneously dehisces or is deliberately opened.

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORMadiha HN Mohamed, professor

faculty of nursing Mansoura university

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026