NCT05040334

Role of Prophylactic Antibiotics in Preventing Pelvic Infection After Surgical Evacuation

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Antibiotics Causing Adverse Effects in Therapeutic Use

Interventions

Type	Name	Description
DRUG	Group 1: Antibiotic receiving group	Group 1; receiving antibiotic prophylaxis; single dose of oral doxycycline (200 mg) tablet and metronidazole (500 mg) tablet 2 hours before the surgical evacuation Group B ;receiving placebo 2 hours before the surgical evacuation

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-04-01
• Completion: 2022-05-01
• First posted: 2021-09-10
• Last updated: 2022-03-28

Locations

1 site across 1 country: Egypt