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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

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

  Show Detailed Description

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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



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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
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Contact: Amr A Riad, MD 01005347179 ext +2 amr.riad@med.asu.edu.eg

Locations
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Egypt
Ain Shams maternity hospital Recruiting
Cairo, Egypt
Sponsors and Collaborators
Ain Shams Maternity Hospital

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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:
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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