Changing sterile gloves during wound closure to reduce infections after cesarean sections
Impact of Changing Sterile Glove at the Time of Wound Closure to Reduce Surgical Site Infection in Women Undergoing Elective Cesarean Section; a Prospective Randomized Controlled Clinical Trial
This study is testing if changing sterile gloves during wound closure can help reduce infections in women having elective cesarean sections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 220 (estimated) |
| Ages | 20 Years to 35 Years |
| Sex | Female |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Assiut) |
| Trial ID | NCT06257940 on ClinicalTrials.gov |
What this trial studies
This study assesses whether changing sterile gloves at the time of wound closure can reduce the incidence of surgical site infections (SSI) in women undergoing elective cesarean sections (CS). Given the high rates of CS in Egypt, where the procedure is often performed without standardized practices, this observational study aims to evaluate a simple intervention that could improve patient outcomes. The study will include women aged 20-35 with term singleton pregnancies and will exclude those with certain medical conditions or complications. By focusing on a common surgical procedure, the study seeks to address a significant public health issue.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 20-35 with a singleton viable fetus and a body mass index under 30.
Not a fit: Patients who are obese, have anemia, or present with other medical complications or emergency situations will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the rate of surgical site infections in women undergoing cesarean sections.
How similar studies have performed: While the specific intervention of changing gloves at wound closure is novel, similar studies have shown that infection control measures can significantly impact surgical outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 20-35 years. * Non obese with body mass index (BMI) \< 30 kg/m2. * Term pregnancy ≥ 37 weeks +0 days. * Singleton. * Viable fetus. Exclusion Criteria: * Obese women with body mass index (BMI) ≥ 30 kg/m2. * Anemic women with hemoglobin level \< 10.5 g/dl. * Immuno-compromised women with medical disorders with pregnancy as diabetes mellitus, hypertension, cardiac, hepatic or renal disorders. * Women with anticipated pelvic adhesions as cases with history of endometriosis, pelvic inflammatory diseases or more than previous 3 CSs. * Multifetal pregnancy. * Emergency CS. * Women with antepartum hemorrhage (placenta previa or placenta accrete spectrum disorder). * Obstetric cases with increased risk of infection as premature rapture of membranes (PROMs). * Women refusing to participate in the study.
Where this trial is running
Assiut
- assiut University — Assiut, Egypt (Recruiting)
Study contacts
- Study coordinator: : Naglaa Hamada Mohamed Ahmed, master
- Email: drnaglaahamada@gmail.com
- Phone: +201151786690
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.