Puerperal Infection Clinical Trial
— PATPETOfficial title:
Prophylactic Antibiotic Treatment for Perineal Tear After Delivery: a Randomized Controlled Trial
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.
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 |
Country | Name | City | State |
---|---|---|---|
Israel | Meir Medical Center | Kfar Saba, |
Lead Sponsor | Collaborator |
---|---|
Meir Medical Center |
Israel,
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 |
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