Role of Prophylactic Antibiotics in Preventing Pelvic Infection After Surgical Evacuation
- Conditions
- Antibiotics Causing Adverse Effects in Therapeutic Use
- Registration Number
- NCT05040334
- Lead Sponsor
- Cairo University
- Brief Summary
To determine the role of antibiotic prophylaxis in the surgical management of miscarriage.
- Detailed Description
Patients will be randomized to receive either prophylactic antibiotic \[a single dose of oral doxycycline (200 mg) and metronidazole (500 mg)\] or placebo using identical sealed envelopes.Included cases are those with early miscarriage (within the first trimester 12 6/7 weeks of gestation) , missed or incomplete miscarriage, undergoing surgical management will be included in the study.
Technique:
The investigators will prepare 138 identical envelops, half of them filled with a label group(1) who are the group to receive the antibiotic prophylaxis with all instruction details, while the other half filled with a label identifying ( group 2) who are the placebo group. All envelops will be prepared by the investigator and sealed before starting enrollment. After enrollment, each participant will be allowed to choose one envelop to determine to which group the patient will be assigned to.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 138
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change of pelvic infection after surg ical evacuation of miscarriage with use of antibiotic prophylaxis. 2 weeks from surgery White cell count \>12 \*10\^9 cells / L by CBC
- Secondary Outcome Measures
Name Time Method Change in the risk of severe puerperal sepsis following the surgical procedure 2 weeks from surgery Signs of puerperal sepsis in form of puerperal pyrexia \>38 C and/or purulent vaginal discharge
Trial Locations
- Locations (1)
Department of Obstetrics and Gynecology, Kasr Al-Ainy University Hospital, Cairo University.
🇪🇬Cairo, Egypt