Preoperative Vaginal Cleansing With Povidone Iodine and the Risk of Post Cesarean Endometritis

Infection; Cesarean Section Clinical Trial

Official title:

Preoperative Vaginal Cleansing With Povidone Iodine and the Risk of Post Cesarean Endometritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02693483
• Other study ID #: povidone iodine
• Status: Recruiting
• Phase: Phase 4
• First received: February 15, 2016
• Last updated: February 25, 2016
• Start date: April 2015
• Est. completion date: October 2016

Study information

• Verified date: February 2016
• Source: Ain Shams Maternity Hospital
• Contact: Amr A Riad, MD
• Phone: 01005347179
• Email: amr.riad[@]med.asu.edu.eg
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial Summary

Preoperative vaginal cleansing with povidone iodine and the risk of post cesarean endometritis.

Description:

Study Population:

Women undergoing cesarean sections will be enrolled in this study after obtaining verbal consent as there are no extra interventional measures that will be undertaken in the study apart from routine investigations and procedures done during cesarean sections, being already approved in signed consent to undergo treatment.

The nature and aim of the work will be fully discussed to all women who will agree to participate in the study. Verbal consent will be obtained from all patients enrolled in the study which is approved by the local ethical committee.

Preoperative evaluation of patients included:

1. Medical history taking including:

• Personal (name, age)

• Complaint (in patient word)

• Present history

• Medical history (Diabetes mellitus, Hypertension)

• Past history (any surgeries)

• Family history

2. Physical examination including vital data (blood pressure,pulse, temperature)

3. Routine hematologic laboratory tests including complete blood picture & random blood sugar.

4. The surgical site will be assessed at least once before cesarean section if the participant presented to emergency department with findings concerning for surgical-site infection.

5. Indication for cesarean section.

6. Duration of ruptured membranes if found.

7. Risk of infection including Diabetes mellitus, immuno-compromised, rupture of membranes and corticosteroid therapy.

Steps:

Patients In the study group (povidone iodine group) patients will be prepared with vaginal cleansing with povidone-iodine along with the usual abdominal scrub. Vaginal cleansing will be done with 3 gauze pieces soaked with 10% povidone iodine in a sterilized bowl and the scrub will be done from the vaginal apex to introitus with attention to the anterior, posterior and lateral vaginal wall. After vaginal cleansing the gloves will be changed to perform the abdominal scrub.

Patients in the control group (no vaginal cleansing group) will not have any vaginal wash (even tap water will not be used).

In both groups, patients will receive preoperative per protocol prophylactic I.V. antibiotics (third generation cephalosporin ) before skin incision.

Operative technique:

During this study all cases will be subjected to exclusion and inclusion criteria. Any risk of infection will be assessed including rupture of membranes, Diabetes mellitus, immune-compromised and corticosteroid therapy….etc. Cesarean section will be performed with estimation of operative duration in time and mean operative blood loss.

Post operative care:

Follow up for temperature of 38°C and greater during first 24 hours of surgery and endometritis will be diagnosed by fever 38.4°C and greater with any of the following (uterine tenderness ,foul smelling lochia or positive C-reactive protein).

Mean hospital stay in days will be determined. N.B: Culture of the upper genital tract are virtually impossible to obtain without contaminating the specimen by the microorganisms in the vagina. Therefore, they rarely add significant information that enhances clinical decision-making.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 306
• Est. completion date: October 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Patients 18-40 years of age who will undergo cesarean deliveries.

2. Able to communicate well with the investigator & to comply with the requirements of the entire study.

3. Verbal consent obtained from subject and husband / witness before undergoing the study entry (with the understanding that consent may be withdrawn by the patient at any time without prejudice).

Exclusion Criteria:

1. Patients with allergy to iodine containing solutions.

2. Patients with ante-partum hemorrhage.

3. Patients with ruptured membranes.

4. Patients with any known disease that increases the risk of infection e.g. immunocompromized, those receiving steroids ...etc.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Endometritis
• Infection; Cesarean Section

Intervention

Drug:
• 10% povidone iodine
Vaginal cleansing will be done with 3 gauze pieces soaked with 10% povidone iodine in a sterilized bowl and the scrub will be done from the vaginal apex to introitus with attention to the anterior, posterior and lateral vaginal wall

Locations

Country	Name	City	State
Egypt	Ain Shams maternity hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects with post cesarean endometritis	Number of Subjects with post cesarean endometritis as diagnosed by fever 38.4°C and greater in first 48 hours after cesarean section with any of the following (uterine tenderness, foul smelling lochia or positive C-reactive protein)	48 hours	Yes
Secondary	Number of Subjects with allergic reaction to povidone iodine	Number of Subjects with allergic reaction to povidone iodine	48 hours	Yes