Prolonged Treatment for Infected Abortion After Hospital Discharge.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Hospital re-admission
研究概览
简要总结
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.
详细描述
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.
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
- 14 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
- •Fever (> or = than 37,8°C)
排除标准
- •Refusal to participate in the project
- •Prior use of antibiotics within one week
- •Known allergy to Doxycycline or Metronidazole
- •Presence of tubo-ovarian abscess
研究组 & 干预措施
1
Use of antibiotics after hospital discharge
干预措施: metronidazole and doxycycline (Drug)
2
Use of placebo
干预措施: metronidazole and doxycycline (Drug)
结局指标
主要结局
Hospital re-admission
时间窗: 7 days after hospital discharge
次要结局
- 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)