Trials / Terminated
TerminatedNCT00376493
Prolonged Treatment for Infected Abortion After Hospital Discharge.
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Hospital de Clinicas de Porto Alegre · Academic / Other
- Sex
- Female
- Age
- 14 Years – 50 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | metronidazole and doxycycline | use of metronidazole 500mg/day and doxycycline 200mg/day up to 10 days |
Timeline
- Start date
- 2006-05-01
- Primary completion
- 2007-12-01
- Completion
- 2007-12-01
- First posted
- 2006-09-15
- Last updated
- 2008-03-13
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT00376493. Inclusion in this directory is not an endorsement.