Vaginal Antimicrobacterial Preparation Before Cesarean Secation for Endometritis Prevention

NCT03093194 | Unknown

• 1 other identifier: RAMBAMMV
• Study Type: interventional
• Target: 1,040
• Locations: 0 countries
• Sites: N/A

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.

Conditions

A Known Allergy to Antiseptic Soap; Women Who Had Any Infection in the Perioperative Period; A Known Allergy to Chlorohexidine Alcohol or Shellfis

Outcome Measures

Primary Outcomes (1)

• rates of endometritis

  rates of endometritis

  2.5 years

Secondary Outcomes (1)

• rates of Urinary Tract Infections

  2.5 years

Study Arms (2)

Women going CS without vaginal preparation before surgery

ACTIVE COMPARATOR

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.

Women going CS with vaginal preparation before surgery

PLACEBO COMPARATOR

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.

Interventions

vaginal preparation before CS with Septal soap and septol. OTHER

vaginal preparation before CS with Septal soap and septol.

Women going CS with 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.

Women going CS without vaginal preparation before surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Related Publications (1)

• 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(4):CD007892. doi: 10.1002/14651858.CD007892.pub7.

  PMID: 32335895 DERIVED

Central Study Contacts

Hila Ben-Asher, MD

CONTACT

+972-54-7440442; alonhila28@gmail.com

Yuval Ginsberg

CONTACT

+972-52-3571199; y_ginsberg@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 12, 2017
• First Posted: March 28, 2017
• Study Start: April 10, 2017
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2020
• Last Updated: April 5, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share