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To determine the role of antibiotic prophylaxis in the surgical management of miscarriage.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group(1) | Active Comparator | 69 patients receiving a single dose of oral doxycycline (200 mg) and metronidazole (500 mg)tablets |
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| Group (2) | Placebo Comparator | 69 patients receiving placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 1: Antibiotic receiving group | Drug | 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 |
| 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 |
| 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marwa Mo Eid, Ass.professor | Contact | 01001225079 | marwameid2014@gmail.com | |
| Nihal Mo El-Demiry, Lecturer | Contact | 01006049052 | n.eldemiry@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Marwa Mo Eid, Ass.prof. | Cairo University | Study Director |
| Nihal Mo El-Demiry, lecturer | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology, Kasr Al-Ainy University Hospital, Cairo University. | Recruiting | Cairo | Egypt |
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Group 1;receiving antibiotic prophylaxis Group 2; Not receiving antibiotics
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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.
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