A Randomized Clinical Trial on the Use or Not of Antibiotics After Hospital Discharge in Septic Abortion.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Clinical cure defined as no fever, no abdominal pain or bleeding.
研究概览
简要总结
The use of antibiotics in post-partum infection has been abbreviated. After 48 hours of clinical improvement, the patient is discharged from the hospital without antibiotics. No trials has been found in cases of septic abortion.
The purpose of the present study is to verify the need of antibiotics after clinical improvement in cases of septic abortion.
详细描述
Septic abortion is still a major cause of maternal mortality in developing countries. According to the WHO, 1 woman dies for every 270 illegal abortion (Ahman E, 2004). Infected abortion has an important role in maternal morbidity and mortality (Stubblefield PG, 1994). the diagnosis of infected abortion must be considered when a patient presents a history of delayed menses, vaginal bleeding, abdominal pain and fever (Brasil, 2000)
Prompt diagnosis and treatment are paramount steps to prevent complications. At Hospital de Clínicas de Porto Alegre, the use of gentamycin plus clindamicin before curettage is preconized (Savaris R, 2006). Nevertheless, the time of treatment it is not well established, varying from 7-14 days (Brasil, 2000).
A recent study with post-partum endometritis has shown that it is not necessary to extend the treatment to 14 days, after clinical improvement (Turnquest MA, 1998; French LM, 2004)
A randomized clinical trial comparing placebo with the standard protocol of treatment would define weather both treatments are equivalent or not.
Comparison: The prolonged use of antibiotics, after intravenous use of antibiotics and clinical improvement, will be compared to the use of placebo in cases of septic abortion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients admitted at the hospital with a diagnosis of infected abortion and about to be discharged from the hospital.
- •Use of intravenous antibiotics (gentamicin and clindamycin)
- •Improvement of the clinical conditions for at least 48 hours (no fever, eating and walking normally, reduced vaginal bleeding)
排除标准
- •Unwilling to participate in the study.
- •Use of antibiotics previously within one week.
- •Presence of tubo-ovarian abscess.
- •Known allergy to doxycycline or metronidazole.
研究组 & 干预措施
1
Patients that receive up to 10 days of doxycycline 200mg/day and metronidazole 500mg/day
干预措施: doxycycline plus metronidazole (Drug)
2
Patients that do not receive antibiotics, only placebo
干预措施: placebo (Drug)
结局指标
主要结局
Clinical cure defined as no fever, no abdominal pain or bleeding.
时间窗: 10 days after hospital discharge
次要结局
未报告次要终点