Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 3 for:    "Endometritis" | "Plasma Substitutes"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02693483
Recruitment Status : Unknown
Verified February 2016 by Amr Ahmed Mahmoud Riad, Ain Shams Maternity Hospital.
Recruitment status was:  Recruiting
First Posted : February 26, 2016
Last Update Posted : February 26, 2016
Sponsor:
Information provided by (Responsible Party):
Amr Ahmed Mahmoud Riad, Ain Shams Maternity Hospital

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

Condition or disease Intervention/treatment Phase
Infection; Cesarean Section Drug: 10% povidone iodine Phase 4

  Hide Detailed Description

Detailed 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preoperative Vaginal Cleansing With Povidone Iodine and the Risk of Post Cesarean Endometritis
Study Start Date : April 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: povidone iodine
153 cases undergoing cesarean sections will have preoperative vaginal cleansing with 10% povidone iodine
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
Other Name: betadine

No Intervention: no vaginal cleansing
153 cases undergoing cesarean sections



Primary Outcome Measures :
  1. Number of Subjects with post cesarean endometritis [ Time Frame: 48 hours ]
    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)


Secondary Outcome Measures :
  1. Number of Subjects with allergic reaction to povidone iodine [ Time Frame: 48 hours ]
    Number of Subjects with allergic reaction to povidone iodine



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02693483


Contacts
Layout table for location contacts
Contact: Amr A Riad, MD 01005347179 ext +2 amr.riad@med.asu.edu.eg

Locations
Layout table for location information
Egypt
Ain Shams maternity hospital Recruiting
Cairo, Egypt
Sponsors and Collaborators
Ain Shams Maternity Hospital

Layout table for additonal information
Responsible Party: Amr Ahmed Mahmoud Riad, Lecturer of obstetrics and gynecology, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT02693483     History of Changes
Other Study ID Numbers: povidone iodine
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: February 26, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Endometritis
Plasma Substitutes
Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases
Iodine
Cadexomer iodine
Povidone-Iodine
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Blood Substitutes