Prophylactic Antibiotic After Perineal Tear

NCT ID: NCT04763486

Last Updated: 2021-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-03-01

Brief Summary

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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

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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.

Conditions

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Puerperal Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parturition
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Prophylactic antibiotic treatment

Will be given Cefamezin antibiotic within 6 hours of delivery

Group Type EXPERIMENTAL

Cefazolin (Cefamezin)

Intervention Type DRUG

Cefamezin 2 gr within 6 hour of delivery

No intervention

Will not get antibiotic prophylactics

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cefazolin (Cefamezin)

Cefamezin 2 gr within 6 hour of delivery

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yair Daykan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gil Shechter, Dr

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center , Tel Aviv University

Locations

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Meir Medical Center

Kfar Saba, , Israel

Site Status

Countries

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Israel

Central Contacts

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Yair Daykan, Dr

Role: CONTACT

+972542198231

Other Identifiers

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0189-19-MMC

Identifier Type: -

Identifier Source: org_study_id

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