Role of Prophylactic Antibiotics in Preventing Pelvic Infection After Surgical Evacuation

Study Overview
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Brief Summary
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To determine the role of antibiotic prophylaxis in the surgical management of miscarriage.

Detailed Description
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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.

Official Title
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Role of Prophylactic Antibiotics in Preventing Pelvic Infection After Surgical Evacuation

Conditions
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Antibiotics Causing Adverse Effects in Therapeutic Use

Intervention / Treatment
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* Drug: Group 1: Antibiotic receiving group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1;receiving antibiotic prophylaxis Group 2; Not receiving antibiotics
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group(1)<br>69 patients receiving a single dose of oral doxycycline (200 mg) and metronidazole (500 mg)tablets | Drug: Group 1: Antibiotic receiving group<br>* 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<br>* Other names: Group 2 :placebo receiving group;|
| Placebo Comparator: Group (2)<br>69 patients receiving placebo | Drug: Group 1: Antibiotic receiving group<br>* 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<br>* Other names: Group 2 :placebo receiving group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of pelvic infection after surg ical evacuation of miscarriage with use of antibiotic prophylaxis. | White cell count >12 *10^9 cells / L by CBC | 2 weeks from surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the risk of severe puerperal sepsis following the surgical procedure | Signs of puerperal sepsis in form of puerperal pyrexia >38 C and/or purulent vaginal discharge | 2 weeks from surgery |