Prolonged Treatment for Infected Abortion After Hospital Discharge. (APA)
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ClinicalTrials.gov Identifier: NCT00376493 |
Recruitment Status :
Terminated
(The rate of cure in both arms was higher than expected)
First Posted : September 15, 2006
Last Update Posted : March 13, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Septic Abortion | Drug: metronidazole and doxycycline | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 56 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Prolonged Treatment for Infected Abortion After Hospital Discharge. |
Study Start Date : | May 2006 |
Actual Primary Completion Date : | December 2007 |
Actual Study Completion Date : | December 2007 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
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 |
Placebo Comparator: 2
Use of placebo
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Drug: metronidazole and doxycycline
use of metronidazole 500mg/day and doxycycline 200mg/day up to 10 days |
- Hospital re-admission [ Time Frame: 7 days after hospital discharge ]
- minimal or absent vaginal bleeding [ Time Frame: 7 days after hospital discharge ]
- walking normally [ Time Frame: 7 days after hospital discharge ]
- important decrease of pain [ Time Frame: 7 days after hospital discharge ]
- no fever [ Time Frame: 7 days after hospital discharge ]

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Ages Eligible for Study: | 14 Years to 50 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- History of intrauterine manipulation with contaminated objects.
- Vaginal secretion with fetid odor
- Presence of pus flowing through the cervical uterine
- Presence of peritonitis
- Leucocytosis (> 14,000 leucocytes/mL)
- Vasodilatation, bounding pulse and paradoxically warm periphery with tachycardia (Heart rate> 110 bpm)
- Cyanosis and/or paleness
- tachypnea(> 30mpm)
- Arterial hypotension (SAP< 90mmHg)
- Oliguria
- Fever (> or = than 37,8°C)
Exclusion Criteria:
- Refusal to participate in the project
- Prior use of antibiotics within one week
- Known allergy to Doxycycline or Metronidazole
- Presence of tubo-ovarian abscess

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376493
Brazil | |
Hospital de Clínicas de Porto Alegre | |
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003 | |
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: | Ricardo Francalacci Savaris, Hospital de Clínicas de Porto Alegre |
ClinicalTrials.gov Identifier: | NCT00376493 |
Other Study ID Numbers: |
APA 05-452 |
First Posted: | September 15, 2006 Key Record Dates |
Last Update Posted: | March 13, 2008 |
Last Verified: | December 2007 |
Abortion Infection Antibiotics Treatment Pregnancy complications |
Abortion, Septic Pregnancy Complications, Infectious Infection Abortion, Spontaneous Pregnancy Complications Metronidazole |
Doxycycline Anti-Infective Agents Anti-Bacterial Agents Antiprotozoal Agents Antiparasitic Agents Antimalarials |