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Sponsors and Collaborators: |
Hospital de Clinicas de Porto Alegre Fundo de Incentivo a Pesquisa (FIPE-HCPA) |
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Information provided by: | Hospital de Clinicas de Porto Alegre |
ClinicalTrials.gov Identifier: | NCT00376493 |
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.
Condition | Intervention | Phase |
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Septic Abortion |
Drug: metronidazole and doxycycline |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Prolonged Treatment for Infected Abortion After Hospital Discharge. |
Enrollment: | 56 |
Study Start Date: | May 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Use of antibiotics after hospital discharge
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Drug: metronidazole and doxycycline
use of metronidazole 500mg/day and doxycycline 200mg/day up to 10 days
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2: Placebo Comparator
Use of placebo
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Drug: metronidazole and doxycycline
use of metronidazole 500mg/day and doxycycline 200mg/day up to 10 days
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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.
Ages Eligible for Study: | 14 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Brazil, Rio Grande do Sul | |
Hospital de Clínicas de Porto Alegre | |
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003 | |
Brazil, RS | |
Hospital de Clínicas de Porto Alegre | |
Porto Alegre, RS, Brazil, 90035-003 |
Principal Investigator: | Ricardo F Savaris, MD, PhD | Hospital de Clínicas de Porto Alegre |
Principal Investigator: | Adriani O Galão, MD, PhD | Hospital de Clínicas de Porto Alegre |
Responsible Party: | Hospital de Clínicas de Porto Alegre ( Ricardo Francalacci Savaris ) |
Study ID Numbers: | APA 05-452 |
Study First Received: | September 14, 2006 |
Last Updated: | March 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00376493 |
Health Authority: | Brazil: Ministry of Health |
Abortion Infection Antibiotics Treatment Pregnancy complications |
Metronidazole Abortion, Septic Pregnancy Complications |
Pregnancy Complications, Infectious Abortion, Spontaneous Doxycycline |
Antimalarials Anti-Infective Agents Anti-Bacterial Agents Antiparasitic Agents Antiprotozoal Agents |
Radiation-Sensitizing Agents Therapeutic Uses Physiological Effects of Drugs Infection Pharmacologic Actions |