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Trial record 2 of 3 for:    "Endometritis" | "Plasma Substitutes"

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

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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

Tracking Information
First Submitted Date  ICMJE February 15, 2016
First Posted Date  ICMJE February 26, 2016
Last Update Posted Date February 26, 2016
Study Start Date  ICMJE April 2015
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2016)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2016)
Number of Subjects with allergic reaction to povidone iodine [ Time Frame: 48 hours ]
Number of Subjects with allergic reaction to povidone iodine
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preoperative Vaginal Cleansing With Povidone Iodine and the Risk of Post Cesarean Endometritis
Official Title  ICMJE Preoperative Vaginal Cleansing With Povidone Iodine and the Risk of Post Cesarean Endometritis
Brief Summary Preoperative vaginal cleansing with povidone iodine and the risk of post cesarean endometritis.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Infection; Cesarean Section
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: povidone iodine
    153 cases undergoing cesarean sections will have preoperative vaginal cleansing with 10% povidone iodine
    Intervention: Drug: 10% povidone iodine
  • No Intervention: no vaginal cleansing
    153 cases undergoing cesarean sections
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 25, 2016)
306
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2016
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02693483
Other Study ID Numbers  ICMJE povidone iodine
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Amr Ahmed Mahmoud Riad, Ain Shams Maternity Hospital
Study Sponsor  ICMJE Ain Shams Maternity Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ain Shams Maternity Hospital
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP