Role of Prophylactic Antibiotics in Preventing Pelvic Infection After Surgical Evacuation

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Antibiotics Causing Adverse Effects in Therapeutic Use

Treatments: Drug: Group 1: Antibiotic receiving group

Study type: Interventional

Funder types: Other

Identifiers

NCT05040334

Cairo University Obygyn

Details and patient eligibility

About

To determine the role of antibiotic prophylaxis in the surgical management of miscarriage.

Full 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.

Enrollment: 138 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Maternal age :18-35 years
• Gestational age: up to 12 6/7 weeks of gestation (confirmed by a reliable date for the last menstrual period or /and 1st trimester ultrasound scan).
• Singleton miscarriage
• Type of miscarriage: Incomplete or Missed miscarriage
• Surgical evacuation will be done within 2 weeks of diagnosis of miscarriage .

Exclusion criteria

• Maternal age: younger than 18 years
• Induced miscarriage of pregnancy
• Septic miscarriage
• Evidence of infection
• Morbid obesity (BMI≥40kg/m2)
• Allergy to prophylactic antibiotics (i.e., doxycycline or metronidazole)
• Antibiotics use within 7 days before randomization

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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138 participants in 2 patient groups, including a placebo group

group(1)

Active Comparator group

Description:

69 patients receiving a single dose of oral doxycycline (200 mg) and metronidazole (500 mg)tablets

Treatment:

Drug: Group 1: Antibiotic receiving group

Group (2)

Placebo Comparator group

Description:

69 patients receiving placebo

Treatment:

Drug: Group 1: Antibiotic receiving group