Post Cesarian Section Wound Infections At Emergency Room

NCT06491381 | Completed

• 1 other identifier: obstet1724
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to compare the incidence of post-cesarean section wound infections between emergency and elective cesarean deliveries at El-hussien Hospital. The main questions it aims to answer are: Is there a difference in surgical site infection rates between emergency and elective cesarean sections? What are the other outcome measures associated with emergency versus elective cesarean deliveries? Participants will be 220 patients undergoing cesarean section, divided into two groups: 110 patients undergoing emergency cesarean delivery in the Emergency Unit 110 patients undergoing elective cesarean delivery Researchers will compare the emergency cesarean group to the elective cesarean group to see if there are differences in surgical site infection rates and other relevant outcome measures.

Conditions

Surgical Wound Infection

Keywords

Surgical site infections; Elective Cesarean delivery; Emergency Room

Outcome Measures

Primary Outcomes (1)

• Post Caesarian Section Wound Infections

  * The wounds will be inspected. The presence of minor or major wound infection will be recorded on an audit form. * Wound infection will be defined as: Purulent discharge present within or exuding from the wound. Painful spreading erythema indicative of cellulitis. • An infection will be defined as minor if deep tissue destruction or lymphangitis is absent, and major if these elements, wound dehiscence or systemic symptoms, is present.

  6 weeks after surgery.

Secondary Outcomes (6)

• Wound Healing Complications

  6 weeks after surgery.

• Length of Hospital Stay

  6 weeks after surgery.

• Surgical Site Pain

  6 weeks after surgery.

• Antibiotic Usage

  6 weeks after surgery.

• Patient Satisfaction

  6 weeks after surgery.

Study Arms (2)

Elective Cesarean Delivery

This group will consist of 110 patients who are scheduled for planned cesarean deliveries at El-hussien Hospital. These patients will have non-emergency indications for cesarean section, such as previous cesarean delivery, breech presentation, maternal request, or other medical indications that allow for scheduled surgery. Participants in this group will undergo standard pre-operative preparation and receive routine post-operative care as per hospital protocols. Their surgical site will be monitored for signs of infection during their hospital stay and follow-up period.

Procedure: Cesarean delivery

Emergency Cesarean Delivery

This group will consist of 110 patients who undergo unplanned, emergency cesarean deliveries at the Emergency Unit of El-hussien Hospital. Indications for emergency cesarean section may include, but are not limited to, fetal distress, placental abruption, cord prolapse, failed induction of labor, or arrest of labor progression. Patients with premature rupture of membranes will be excluded from this group due to their increased risk of infection. Participants in this group will receive urgent pre-operative preparation and post-operative care as per hospital emergency protocols. Their surgical sites will be monitored for signs of infection during their hospital stay and follow-up period, similar to the elective group.

Procedure: Cesarean delivery

Interventions

Cesarean delivery PROCEDURE

The cesarean section will begin with a Pfannenstiel incision above the pubic bone, followed by blunt dissection to separate tissue layers and retracting the rectus muscles for peritoneal cavity access. A transverse or vertical peritoneal incision will expose the uterus, and a transverse incision on the lower uterine segment will be made for delivery. The baby will be delivered, the umbilical cord clamped and cut, and the baby handed to the pediatric team. The placenta will be detached and delivered, and the uterus will be closed with multiple layers of sutures. The abdominal layers will be closed with absorbable Polyglactin (Vicryl) sutures for the rectus sheath and subcutaneous tissue, and non-absorbable Polypropylene sutures for the skin. A sterile dressing will be applied to protect the wound and promote a clean healing environment, ensuring proper surgical technique, tissue handling, and minimizing post-operative complications.

Elective Cesarean Delivery; Emergency Cesarean Delivery

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: This study is open to female participants only. The inclusion of only female participants is due to the nature of the study, which focuses on cesarean section deliveries. Cesarean sections are surgical procedures performed exclusively on pregnant women to deliver their babies. As pregnancy and childbirth are biological processes unique to individuals with female reproductive organs, male participants are not eligible for this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

This study will include 220 patients undergoing cesarean section at El-hussien Hospital, equally divided into two groups of 110 each. One group will consist of emergency cesarean deliveries performed in the Emergency Unit, excluding cases with premature rupture of membranes. The other group will include elective, scheduled cesarean deliveries. This diverse population will allow for a comprehensive comparison of surgical site infection rates and other outcomes between emergency and elective cesarean sections.

You may qualify if:

• Age \> 18
• Managed with elective CS or Emergency CS
• BMI \< 25 Kg/m2

You may not qualify if:

• Immunodeficiency or diabetes.
• Premature rupture of membrane
• Bleeding disorder.
• Previous uterine surgery except previous CS.
• Malignancy.
• Refusal to participate.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Hussein University Hospital

Cairo, Cairo Governorate, 11633, Egypt

Location

MeSH Terms

Conditions

Surgical Wound Infection; Emergencies

Interventions

Cesarean Section

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: May 1, 2023
• Primary Completion: July 30, 2024
• Study Completion: August 1, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available beginning 9 months after the main study results are published. Researchers who provide a methodologically sound proposal will be allowed access to the data. Proposals should be directed to the corresponding author. The corresponding author will also be responsible for making the data available to approved researchers. To gain access, data requestors will need to sign a data access agreement. The data will be available for 5 years for researchers whose proposed use of the data has been approved.
• Access Criteria: Researchers must submit a written proposal to the corresponding author outlining the research questions, methodology, team qualifications, and potential impact. Proposals will be reviewed based on scientific merit, compatibility with original study objectives, feasibility, and potential to advance medical knowledge or patient care. Requestors must agree to use the data only for the approved purpose, maintain confidentiality and security, not identify or contact participants, and acknowledge the original study in publications. Researchers must sign a data use agreement covering data access terms, security, publication guidelines, and result sharing with the original team. Priority may be given to early career researchers, those from low- and middle-income countries, and collaborative projects. The corresponding author reserves the right to deny access if criteria are not met or if there are concerns about responsible data use.

Locations

EG (1)