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Prophylactic 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
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Puerperal Infection

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

First Posted
July 29, 2019
Last Updated
February 20, 2021
Sponsor
Meir Medical Center
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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

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