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Evaluation of the Effect of Different Methods of Vaginal Preparation Before Cesarean Section on Postoperative Infections

Comparison of the Effect of Vaginal Preparation with Povidone-Iodine Solution and Metronidazole Gel on Infectious Outcomes after Cesarean Section: A randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251227068466N1
Enrollment
150
Registered
2025-12-29
Start date
2026-01-09
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Condition 1: Infection of obstetric surgical wound following cesarean section. Condition 2: Other infection of genital tract following delivery. Condition 3: . Condition 4: Other infection of genital tract following delivery. Condition 5: Pyrexia of unknown origin following delivery. Infection of obstetric surgical wound Endometritis following delivery Endometritis following delivery Pyrexia of unknown origin following delivery

Interventions

Intervention 1: Vaginal preparation with 10% Povidone–Iodine solution: After achieving anesthesia and before surgical incision, a sterile 4×4 gauze soaked in the solution is applied using a sterile fo

Sponsors

Hamedan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Pregnant women aged 18 to 45 years Women with term pregnancy between 37 and 42 weeks Women scheduled for elective cesarean section No active labor at the time of admission

Exclusion criteria

Exclusion criteria: Premature rupture of membranes before surgery Chorioamnionitis Body temperature equal to or greater than 38 degrees Celsius at admission Presence of active infection at the time of admission Vaginal fungal infections Vaginal viral infections Use of antibiotics affecting vaginal flora within the past 30 days Immunodeficiency Insulin dependent diabetes mellitus Refusal to participate in the study Known hypersensitivity to iodine Known hypersensitivity to metronidazole

Design outcomes

Primary

MeasureTime frame
Postoperative fever. Timepoint: Up to the tenth day after surgery and at each temperature measurement. Method of measurement: Body temperature is measured orally using a digital thermometer; fever is considered positive if =38°C is recorded in two consecutive measurements.;Endometritis. Timepoint: On the third, tenth, and forty-second days after surgery. Method of measurement: Clinical signs such as fever, uterine tenderness, and purulent discharge are assessed using the standard REPR Checklist; CBC and CRP tests are performed if necessary.;Surgical site infection. Timepoint: On the third, tenth, and forty-second days after surgery. Method of measurement: Surgical site infection is assessed using the SSI 2025 CDC/NHSN checklist, based on clinical signs including purulent discharge, wound dehiscence, pain, swelling, and redness.

Secondary

MeasureTime frame
Overall pain intensity of the patient after cesarean section. Timepoint: Days 3, 10, and 42 after cesarean section. Method of measurement: Using the ten-centimeter Visual Analogue Scale, where the patient marks the line to indicate pain intensity, and the distance from zero to the mark is measured in centimeters.;Postoperative hospital stay duration. Timepoint: Until hospital discharge. Method of measurement: Recording the number of days hospitalized from patient records.;Additional antibiotic use or unplanned visits for infection treatment. Timepoint: Up to day 42 after cesarean section and at each unplanned visit. Method of measurement: Recording additional antibiotic doses and the date and reason for each unplanned visit from patient records and patient interviews.;Local adverse effects related to the intervention. Timepoint: During 42 days after surgery. Method of measurement: Recording any change, discomfort, or abnormal reaction in the vaginal area as self-reported by the patient.;Unplanned revisit to healthcare center or physician. Timepoint: During six weeks after delivery. Method of measurement: Recording the date and reason for each unplanned visit from patient records and patient interviews.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamideh Parsapour

Hamedan University of Medical Sciences

fatemeh.dv2000@gmail+98 81 3827 6055

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026