Prolonged Treatment for Infected Abortion After Hospital Discharge.

Study Overview
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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.

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.

Official Title
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Prolonged Treatment for Infected Abortion After Hospital Discharge.

Conditions
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Septic Abortion

Intervention / Treatment
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* Drug: metronidazole and doxycycline


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Use of antibiotics after hospital discharge | Drug: metronidazole and doxycycline<br>* use of metronidazole 500mg/day and doxycycline 200mg/day up to 10 days<br>|
| Placebo Comparator: 2<br>Use of placebo | Drug: metronidazole and doxycycline<br>* use of metronidazole 500mg/day and doxycycline 200mg/day up to 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital re-admission |  | 7 days after hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| minimal or absent vaginal bleeding |  | 7 days after hospital discharge | 
| walking normally |  | 7 days after hospital discharge | 
| important decrease of pain |  | 7 days after hospital discharge | 
| no fever |  | 7 days after hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abortion, Infection, Antibiotics, Treatment, Pregnancy complications