Vaginal Antimicrobacterial Preparation Before Cesarean Secation for Endometritis Prevention

• ClinicalTrials.gov Identifier: NCT03093194
• Recruitment Status: Unknown
• First Posted: March 28, 2017
• Last Update Posted: April 5, 2017
• Sponsor: Rambam Health Care Campus
• Information provided by (Responsible Party): HILA BEN-ASHER MD, Rambam Health Care Campus

Study Description

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

Detailed Description:

BACKGROUND In the last decades, caesarean sections rate have escalated steadily worldwide. In 2013, more than 32.7% births in the United States were by cesarean section 1. These high rates of cesarean deliveries are of substantial concern due to the potential associated complications such as endometritis (6-11%) 2, wound complications (1-2%) 2, hemorrhage, injury to pelvic organs (0.2-0.5%)2, and thromboembolic disorders (100-240 per100,000) 3 .

One of the common complications following CS is endometritis. Post cs endometritis prolongs the patient hospitalization therefore not only elevating the hospital's costs but also intervening with the mother's ability to take care and bond with the new baby. It also poses a risk on future fertility by increasing the risk of long term complications including Asherman's syndrome and in rare cases may necessitate a hysterectomy. Therefore, decreasing post cs endometritis is a substantial goal for the OBGYN practitioner.

In the current literature a debate surrounds the contribution of perioperative vaginal preparation to the prevention of post CS endometritis. In a meta-analysis of seven randomized trials vaginal preparation before CS using povidone-iodine in addition to abdominal preparation showed a significantly reduced frequency of postoperative endometritis 4. However, this benefit was restricted to women with ruptured membranes and the benefit for all women undergoing CS is still undetermined. Currently there is no recommendation for routine perioperative vaginal preparation before CS.The benefit of perioperative vaginal preparation is the motivation for this study. The design of this study is a randomized controlled trial meant to evaluate whether perioperative Vaginal preparation is superior to no Vaginal preparation in decreasing post CS endometritis Furthermore, in past settings povidone-iodine had been tested. Povidone-iodine compromised the thyroid function of the physicians and was replaced by chlorohexdine solution. Since that transition no trails have revised the prevention of endometritis after vaginal preparation with chlorhexidine.

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.

METHODS Women will be randomly assign the patients 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.

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 patient who had any infection in the perioperative period.

Inclusion criteria: an elective or emergent CS in a patient 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 the decision to perform a CS will be made and all inclusion criteria met, each patient will be assigned randomly to a group using a computerized randomization software.

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.

STATISTICAL ANALYSIS The sample size was calculated for this trail assuming a rate of endometritis of 6% on the basis of the rates known in literature 2 . A 4% lower rate of endometritis is expected in the vaginal preparation group compared with the no vaginal preparation group. A total of 1040 patients will have to enroll in our 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. Data will be stratified according to other factors such as maternal age, BMI, medical background and specifically diabetes or autoimmune conditions, gestational age, and ethnicity. Relative risk of primary outcome will be calculated with 95% confidence interval.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Haas DM, Morgan S, Contreras K, Kimball S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2020 Apr 26;4:CD007892. doi: 10.1002/14651858.CD007892.pub7.

• 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
• Last Update Posted: April 5, 2017
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Endometritis; Hypersensitivity; Immune System Diseases; Pelvic Inflammatory Disease; Adnexal Diseases; Uterine Diseases