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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04763486
Other study ID # 0189-19-MMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
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Recruiting NCT01039051 - Diet and Lifestyle Intervention Study in Postpartum Women in China Phase 2/Phase 3
Recruiting NCT03397615 - Effect of Vaginal Douching With Betadine Before CS for Prevention of Post Operative Infections N/A
Recruiting NCT00136370 - Prevention of Perinatal Sepsis (PoPS): Evaluation of Chlorhexidine Wipes of Birth Canal and Newborn Phase 3