NCT04763486

Prophylactic Antibiotic After Perineal Tear

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,500 (estimated)
• Sponsor: Meir Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Puerperal Infection

Interventions

Type	Name	Description
DRUG	Cefazolin (Cefamezin)	Cefamezin 2 gr within 6 hour of delivery

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-03-01
• Completion: 2023-03-01
• First posted: 2021-02-21
• Last updated: 2021-02-23

Locations

1 site across 1 country: Israel