Post Cesarian Section Wound Infections At Emergency Room

NCT ID: NCT06491381

Last Updated: 2025-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Surgical Wound Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Cesarean delivery

Intervention Type 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.

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.

Cesarean delivery

Intervention Type 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.

Interventions

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Cesarean delivery

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al-Hussein University Hospital

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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obstet1724

Identifier Type: -

Identifier Source: org_study_id

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