Back to resultsProphylactic Antibiotic After Perineal Tear (PATPET)
Primary Purpose
Puerperal Infection
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Cefazolin (Cefamezin)
Sponsored by
About this trial
This is an interventional prevention trial for Puerperal Infection
Eligibility Criteria
Inclusion Criteria:
- age 18-45
- perineal tear 2nd and 1st degree( episiotomy)
Exclusion Criteria:
- 3rd and 4 th degree perineal tear
- antibiotic indication during delivery
- cesarian section delivery
Sites / Locations
- Meir Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Prophylactic antibiotic treatment
No intervention
Arm Description
Will be given Cefamezin antibiotic within 6 hours of delivery
Will not get antibiotic prophylactics
Outcomes
Primary Outcome Measures
Number of participants with a fever after delivery
Maternal fever above 38 C (Celsius)
Secondary Outcome Measures
Way of delivery
Type of delivery- vacuum-assisted delivery vs. vaginally
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04763486
Brief Title
Prophylactic Antibiotic After Perineal Tear
Acronym
PATPET
Official Title
Prophylactic Antibiotic Treatment for Perineal Tear After Delivery: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Current World Health Organization guidelines recommend routine antibiotic prophylaxis for women with perineal tear 3rd and 4th degree but not for 2nd degree because of insufficient evidence of effectiveness. The investigators aimed to investigate whether antibiotic prophylaxis prevented maternal infection after the first and second perineal tear after vaginal birth.
Detailed Description
The PATPET trial is a randomized, controlled trial done at tertiary hospital obstetric units in Israel. Women who had first and second-degree tear (or after episiotomy) after delivery at 37 weeks or greater gestation, with no indication for ongoing prescription of antibiotics in the post-partum period and no contraindications to prophylactic Cefamezin (cefazolin), were randomly assigned (1:1) to receive a single intravenous dose of prophylactic antibiotic or not.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Puerperal Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parturition
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prophylactic antibiotic treatment
Arm Type
Experimental
Arm Description
Will be given Cefamezin antibiotic within 6 hours of delivery
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Will not get antibiotic prophylactics
Intervention Type
Drug
Intervention Name(s)
Cefazolin (Cefamezin)
Intervention Description
Cefamezin 2 gr within 6 hour of delivery
Primary Outcome Measure Information:
Title
Number of participants with a fever after delivery
Description
Maternal fever above 38 C (Celsius)
Time Frame
6 weeks of delivery
Secondary Outcome Measure Information:
Title
Way of delivery
Description
Type of delivery- vacuum-assisted delivery vs. vaginally
Time Frame
6 weeks of delivery
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Delivery
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 18-45
perineal tear 2nd and 1st degree( episiotomy)
Exclusion Criteria:
3rd and 4 th degree perineal tear
antibiotic indication during delivery
cesarian section delivery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yair Daykan, Dr
Phone
+972542198231
Email
yair.dykan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gil Shechter, Dr
Organizational Affiliation
Meir Medical Center , Tel Aviv University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba,
ZIP/Postal Code
11125
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Yes
Learn more about this trial
Prophylactic Antibiotic After Perineal Tear
We'll reach out to this number within 24 hrs