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Vaginal Antimicrobacterial Preparation Before Cesarean Secation for Endometritis Prevention

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: NCT03093194
Recruitment Status : Unknown
Verified April 2017 by HILA BEN-ASHER MD, Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
First Posted : March 28, 2017
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
HILA BEN-ASHER MD, Rambam Health Care Campus

Brief Summary:

The investigators designed a randomized controlled trial to evaluate whether perioperative Vaginal preparation is superior to no Vaginal preparation in decreasing post CS endometritis. Since CS is performed in about 30% of all births and infection complicates 6-11% of all CS reducing the rate of this post CS complication can have a major impact not only on the hospital occupancy and costs but also on the new mother experience and ability to face the challenge that awaits for her with her newborn.

In this study patients will be randomly assigned into two groups. The experiment group will not undergo any vaginal preparation. The control will undergo perioperative vaginal preparation with antiseptic soap followed by chlorohexidine-alcohol Both groups will be checked for cervical dilation with sterile gloves before surgery.

Primary outcome - signs of endometritis (e.g. erythema around surgical scar, discharge or pain). Patients will be followed daily until discharge. A blood count will be drewn before discharge to rule out signs of infection. Patients will be contacted 6 weeks after surgery by telephone to inquire about any signs of infection, Emergency Room visits or ambulatory visits to the doctor due to endometritis. The participants will be asked if they had positive skin culture or other wound complications such as cellulitis, seroma or scar separation.

The investigators estimated that 1040 patients will have to enroll into the study, 520 in each group in order to have 80% power to detect 50% difference in the endometritis rates between the two groups with a two tailed α level of 0.05.

The data analysis was conducted according to the per-protocol principle.


Condition or disease Intervention/treatment Phase
A Known Allergy to Antiseptic Soap Women Who Had Any Infection in the Perioperative Period A Known Allergy to Chlorohexidine Alcohol or Shellfis Other: vaginal preparation before CS with Septal soap and septol. Other: No vaginal preparation before CS with Septal soap and septol. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1040 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patients will be randomaly assigned into two groups. The experiment group will not undergo vaginal preparation. The control will undergo perioperative vaginal preparation with antiseptic soap and chlorohexidine-alcohol.

All patients participating in this trail will sign a written informed consent. All patients will receive preventative antibiotics peri-operatively according to the our hospital protocol.

Exclusion criteria are a known allergy to antiseptic soap, chlorohexidine-alcohol or shellfish, or patients who had any infection in the perioperative period.

Inclusion criteria: an elective or emergent CS in a woman who did not report having a fever or skin infection signs in the 5 days prior to surgery.

Once a patient is admitted to the delivery room, approximately 7 days to several hours before CS each patient will be assigned randomly to a group using a computerized randomization software.

Masking: Double (Care Provider, Outcomes Assessor)
Masking Description: The study is not double blind, therefore is subjected to the care provider bias. Outcomes assessment might also be over or under evaluated by the physician following the patients outside the hospital.
Primary Purpose: Prevention
Official Title: Vaginal Antimicrobacterial Preparation Before Cesarean Secation for Endometritis Prevention
Estimated Study Start Date : April 10, 2017
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2020

Arm Intervention/treatment
Active Comparator: Women going CS without vaginal preparation before surgery
Women going CS without vaginal preparation before surgery. No vaginal preparation before CS with Septal soap and septol.
Other: No vaginal preparation before CS with Septal soap and septol.
No vaginal preparation before CS with Septal soap and septol.

Placebo Comparator: Women going CS with vaginal preparation before surgery
Women going CS with vaginal preparation before surgery. vaginal preparation before CS with Septal soap and septol.
Other: vaginal preparation before CS with Septal soap and septol.
vaginal preparation before CS with Septal soap and septol.




Primary Outcome Measures :
  1. rates of endometritis [ Time Frame: 2.5 years ]
    rates of endometritis


Secondary Outcome Measures :
  1. rates of Urinary Tract Infections [ Time Frame: 2.5 years ]
    rates of Urinary Tract Infections



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

an elective or emergent CS in a woman who did not report having a fever or skin infection signs in the 5 days prior to surgery.

Exclusion Criteria:

  1. a known allergy to antiseptic soap, chlorohexidine-alcohol or shellfish
  2. women who had any infection in the perioperative period.

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): NCT03093194


Contacts
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Contact: Hila Ben-Asher, MD +972-54-7440442 alonhila28@gmail.com
Contact: Yuval Ginsberg +972-52-3571199 y_ginsberg@rambam.health.gov.il

Sponsors and Collaborators
Rambam Health Care Campus
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: HILA BEN-ASHER MD, Principal Investigator, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03093194    
Other Study ID Numbers: RAMBAMMV
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometritis
Hypersensitivity
Immune System Diseases
Pelvic Inflammatory Disease
Adnexal Diseases
Uterine Diseases