Puerperal Infection
Conditions
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.
Interventions
DRUGCefazolin (Cefamezin)
Cefamezin 2 gr within 6 hour of delivery
Sponsors
Meir Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
parturition
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with a fever after delivery | 6 weeks of delivery | Maternal fever above 38 C (Celsius) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Way of delivery | 6 weeks of delivery | Type of delivery- vacuum-assisted delivery vs. vaginally |
Countries
Israel
Contacts
Primary ContactYair Daykan, Dr
Outcome results
None listed