Prophylactic Antibiotic After Perineal Tear | NCT04763486

Studies
Prophylactic Antibiotic After Perineal Tear

NCT04763486

Sponsor

Meir Medical Center

Status

Unknown status

Last Update Posted

Feb 23, 2021Actual

Enrollment

2,500Estimated

Phase

Not Applicable

Conditions

Puerperal Infection

Interventions

Cefazolin (Cefamezin)

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Estimated

Primary Completion Date

Mar 1, 2022Estimated

Completion Date

Mar 1, 2023Estimated

First Submitted Date

Jul 29, 2019

First Submission Date that Met QC Criteria

Feb 18, 2021

First Posted Date

Feb 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2021

Last Update Posted Date

Feb 23, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prophylactic antibiotic treatment	Experimental	Will be given Cefamezin antibiotic within 6 hours of delivery	Drug: Cefazolin (Cefamezin)
No intervention	No Intervention	Will not get antibiotic prophylactics

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cefazolin (Cefamezin)	Drug	Cefamezin 2 gr within 6 hour of delivery	Prophylactic antibiotic treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with a fever after delivery	Maternal fever above 38 C (Celsius)	6 weeks of delivery

Secondary Outcomes

Measure	Description	Time Frame
Way of delivery	Type of delivery- vacuum-assisted delivery vs. vaginally	6 weeks of delivery

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Delivery

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yair Daykan, Dr	Contact	+972542198231		yair.dykan@gmail.com

Overall Officials

Name	Affiliation	Role
Gil Shechter, Dr	Meir Medical Center , Tel Aviv University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Meir Medical Center		Kfar Saba		11125	Israel

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Yes

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011645	Puerperal Infection

Ancestor Terms

ID	Term
D011251	Pregnancy Complications, Infectious
D007239	Infections
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002437	Cefazolin

Ancestor Terms

ID	Term
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930

Browse Leaves

Not provided

Browse Branches

Not provided