Antibiotics Causing Adverse Effects in Therapeutic Use
Conditions
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.
Interventions
DRUGGroup 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
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
138 identical envelops, half of them filled with a label(Group 1) who are the Prophylactic antibiotic group with all instruction details, while the other half are labelled (group 2) who are the Placebo group with all instruction details. 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 she will be assigned.
Intervention model description
Group 1;receiving antibiotic prophylaxis Group 2; Not receiving antibiotics
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Contacts
Primary ContactMarwa Mo Eid, Ass.professor
Backup ContactNihal Mo El-Demiry, Lecturer
Outcome results
None listed