---
title: Prophylactic Antibiotic After Perineal Tear
nct_id: NCT04763486
overall_status: UNKNOWN
phase: NA
sponsor: Meir Medical Center
study_type: INTERVENTIONAL
primary_condition: Puerperal Infection
countries: Israel
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04763486.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04763486"
ct_last_update_post_date: 2021-02-23
last_seen_at: "2026-05-12T07:04:30.614Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Prophylactic Antibiotic After Perineal Tear

**Official Title:** Prophylactic Antibiotic Treatment for Perineal Tear After Delivery: a Randomized Controlled Trial

**NCT ID:** [NCT04763486](https://clinicaltrials.gov/study/NCT04763486)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 2500
- **Lead Sponsor:** Meir Medical Center
- **Conditions:** Puerperal Infection
- **Start Date:** 2021-03-01
- **Completion Date:** 2023-03-01
- **CT.gov Last Update:** 2021-02-23

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 45 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** Yes

```
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
```

## Arms

- **Prophylactic antibiotic treatment** (EXPERIMENTAL) — Will be given Cefamezin antibiotic within 6 hours of delivery
- **No intervention** (NO_INTERVENTION) — Will not get antibiotic prophylactics

## Interventions

- **Cefazolin (Cefamezin)** (DRUG) — Cefamezin 2 gr within 6 hour of delivery

## Primary Outcomes

- **Number of participants with a fever after delivery** _(time frame: 6 weeks of delivery)_ — Maternal fever above 38 C (Celsius)

## Secondary Outcomes

- **Way of delivery** _(time frame: 6 weeks of delivery)_

## Locations (1)

- Meir Medical Center, Kfar Saba, Israel

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.meir medical center|kfar saba||israel` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04763486.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04763486*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*