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Vaginal Antimicrobacterial Preparation Before Cesarean Secation for Endometritis Prevention

NCT03093194 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1040

Last updated 2017-04-05

No results posted yet for this study

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

Interventions

OTHER

vaginal preparation before CS with Septal soap and septol.

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.

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-10
Primary Completion
2019-04-30
Completion
2020-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03093194 on ClinicalTrials.gov