- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07438314
Artificial Intelligence-Based Educational Guide (AI/SSI)
Effectiveness of Artificial Intelligence-Based Educational Guide to Prevent Surgical Site Infection Among Women Delivering Via Caesarean Section
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Mansoura
-
Mansoura / Egypt, Mansoura, Egypt, 35516
- Faculty of Nursing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AI intervention
|
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
|
|
Active Comparator: ordinary intervention
women receive the usual nursing care
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 |
30 days after CS
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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:
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:
|
30 days after CS
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Madiha HN Mohamed, professor, faculty of nursing Mansoura university
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0657
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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