Prophylactic Antibiotic After Perineal Tear

Puerperal Infection Clinical Trial

— PATPET  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04763486
• Other study ID #: 0189-19-MMC
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: February 2021
• Source: Meir Medical Center
• Contact: Yair Daykan, Dr
• Phone: +972542198231
• Email: yair.dykan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2500
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Puerperal Infection

Intervention

Drug:
• Cefazolin (Cefamezin)
Cefamezin 2 gr within 6 hour of delivery

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba,

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with a fever after delivery	Maternal fever above 38 C (Celsius)	6 weeks of delivery
Secondary	Way of delivery	Type of delivery- vacuum-assisted delivery vs. vaginally	6 weeks of delivery