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| Tracking Information | |||||||||
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| First Received Date ICMJE | September 14, 2006 | ||||||||
| Last Updated Date | March 10, 2008 | ||||||||
| Start Date ICMJE | May 2006 | ||||||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Hospital re-admission [ Time Frame: 7 days after hospital discharge ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00376493 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Prolonged Treatment for Infected Abortion After Hospital Discharge. | ||||||||
| Official Title ICMJE | Prolonged Treatment for Infected Abortion After Hospital Discharge. | ||||||||
| Brief Summary | Patients with infected abortion will be treated with dilatation and curettage, intravenous antibiotics. The purpose of this study is to verify if it is necessary to keep the use of oral antibiotics after hospital discharge. |
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| Detailed Description | The use of 7-10 days of treatment for infected/septic abortion is not based on clinical trials. A recent evidence showed that endometritis post cesarean section needs no treatment after hospital discharge. The objective of this study is to verify if this finding also applies to infected abortions. After in hospital treatment, the patients will be randomized to the traditional treatment (metronidazole and doxycycline) or to placebo until 10 days of treatment is completed. Active follow-up will be done every 2 days, and the patient will be reevaluated at the end of treatment. Cure will be defined as the absence of fever, pain and bleeding. Failure of treatment will be considered as the need for hospitalization or additional antibiotics. |
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| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Septic Abortion | ||||||||
| Intervention ICMJE | Drug: metronidazole and doxycycline | ||||||||
| Study Arms / Comparison Groups |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Terminated | ||||||||
| Enrollment ICMJE | 56 | ||||||||
| Completion Date | December 2007 | ||||||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 14 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Brazil | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00376493 | ||||||||
| Responsible Party | Ricardo Francalacci Savaris, Hospital de Clínicas de Porto Alegre | ||||||||
| Study ID Numbers ICMJE | APA 05-452 | ||||||||
| Study Sponsor ICMJE | Hospital de Clinicas de Porto Alegre | ||||||||
| Collaborators ICMJE | Fundo de Incentivo a Pesquisa (FIPE-HCPA) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Hospital de Clinicas de Porto Alegre | ||||||||
| Verification Date | December 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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