Prophylactic Antibiotic After Perineal Tear (PATPET)

Clalit Health Services

Status: Unknown

Conditions: Puerperal Infection

Treatments: Drug: Cefazolin (Cefamezin)

Study type: Interventional

Funder types: Other

Identifiers

NCT04763486

0189-19-MMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,500 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,500 participants in 2 patient groups

Prophylactic antibiotic treatment

Experimental group

Description:

Will be given Cefamezin antibiotic within 6 hours of delivery

Treatment:

Drug: Cefazolin (Cefamezin)

No intervention

No Intervention group

Description:

Will not get antibiotic prophylactics