Prophylactic Antibiotic After Perineal Tear

Not Applicable

• Conditions: Puerperal Infection
• Interventions: Drug: Cefazolin (Cefamezin)

• Registration Number: NCT04763486
• Lead Sponsor: Meir Medical Center

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.

Study Timeline

• Study First Submitted: 2019-07-29
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-18
• Last Update Submitted: 2021-02-20
• Study First Posted: 2021-02-21
• Last Update Posted: 2021-02-23
• Study Start: 2021-03-01
• Primary Completion: 2022-03-01
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2500

Inclusion Criteria

• age 18-45
• perineal tear 2nd and 1st degree( episiotomy)

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Exclusion Criteria

• 3rd and 4 th degree perineal tear
• antibiotic indication during delivery
• cesarian section delivery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prophylactic antibiotic treatment	Cefazolin (Cefamezin)	Will be given Cefamezin antibiotic within 6 hours of delivery

Primary Outcome Measures

Name	Time	Method
Number of participants with a fever after delivery	6 weeks of delivery	Maternal fever above 38 C (Celsius)

Secondary Outcome Measures

Name	Time	Method
Way of delivery	6 weeks of delivery	Type of delivery- vacuum-assisted delivery vs. vaginally

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba,, Israel