Prolonged Treatment for Infected Abortion After Hospital Discharge.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Septic Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Use of antibiotics after hospital discharge

Group Type ACTIVE_COMPARATOR

metronidazole and doxycycline

Intervention Type DRUG

use of metronidazole 500mg/day and doxycycline 200mg/day up to 10 days

2

Use of placebo

Group Type PLACEBO_COMPARATOR

metronidazole and doxycycline

Intervention Type DRUG

use of metronidazole 500mg/day and doxycycline 200mg/day up to 10 days

Interventions

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metronidazole and doxycycline

use of metronidazole 500mg/day and doxycycline 200mg/day up to 10 days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

14 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No