A Randomized Clinical Trial Between Clindamycin Once and Thrice a Day in Septic Abortion.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Cure (Clinical Improvement Defined as Reduce of Pain, Bleeding and no Fever for 48h)
研究概览
简要总结
Septic abortion is a serious condition. Women with septic abortion are treated with clindamycin plus gentamicin using divided doses, i.e., thrice a day.
The objective of this study is to compare the rates of cure between once or thrice a day use of clindamycin with gentamicin in cases of septic abortion.
详细描述
Obstetric infections are very common, especially in developing countries, as a consequence of the practice of unsafe abortion. In these countries, an estimated five million women each year are hospitalized due to complications from induced abortions, which equates to a rate of 5-7 per thousand women.
Abortion remains a leading cause of maternal death in developing countries. According to the World Health Organization, it is estimated that 1 in 8 maternal deaths occur from complications of illegal abortion. Septic abortions play an important role in the maternal morbidity and mortality. The diagnosis of septic abortion should be considered when a woman of reproductive age presents with menstrual delay, vaginal bleeding accompanied by abdominal pain and fever.
In 1989, Plaisance et al. demonstrated that Clindamycin, an antibiotic used for septic abortion, could be prescribed at a dose of 12/12 hours, and bacterial inhibitory serum levels were similar to those in divided doses 6/6 hours. In 2003, Livingston et al. published the results of gentamicin and clindamycin combined in a single daily dose for cases of post-cesarean endometritis. Administration of clindamycin differed by being in a dose of 2700mg daily dose of different fractional 6/6 hours, or 8/8 hours, and the cure rates were 82% (45 of 56 cases successes) in a single daily dose (13). The etiology of postpartum endometritis is similar to that in infected abortion (14, 15), but little information exists regarding the use of single daily dose in this disease.
A retrospective study recently conducted by our group showed that patients with infected abortion treated with Clindamycin single dose achieved cure rates of 98% (95% CI - 95 to 99%), suggesting an equivalence between a single daily dose and treatment conventional three daily doses.
OBJECTIVES The objective of this study is to verify the equivalence of using Clindamycin once a day versus 3 times daily in the rates of cure 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
- •Women with clinical diagnosis of septic abortion: Briefly, a suspicion of infected/septic abortion was confirmed by the presence of at least one of the following clinical signs: a history of intrauterine manipulation with contaminated objects; foul-smelling vaginal discharge; purulent discharge from the cervix; signs of peritoneal irritation; leukocytosis (leukocyte count > 14,000/mL); fever (temperature ≥ 37.8°C); or signs of a systemic inflammatory response, including tachycardia (heart rate > 110 bpm), tachypnoea (respiratory rate > 30 breaths/min), arterial hypotension (systolic blood pressure < 90 mmHg), oliguria, cyanosis, or pallor.
排除标准
- •Refuse to participate in the study
- •Use of antibiotics with 1 week prior randomization
- •Known allergy to clindamycin or gentamycin
研究组 & 干预措施
clindamycin once a day
Clindamycin 2700mg+gentamycin 240mg+ 250ml sterile saline solution i.v. once a day until clinical improvement
干预措施: Clindamycin (Drug)
clindamycin thrice a day
Clindamycin 900mg i.v. 8/8 h diluted in 250ml of sterile saline solution. In one of the solutions, 240 mg of gentamicin was diluted once a day.
干预措施: Clindamycin (Drug)
结局指标
主要结局
Cure (Clinical Improvement Defined as Reduce of Pain, Bleeding and no Fever for 48h)
时间窗: cure at 72 hours
Clinical improvement was defined by meeting all of the following criteria for a minimum of 48 consecutive hours: Reduction in pain, Reduction in vaginal bleeding, Absence of fever (afebrile)" Treatment failure was defined as the occurrence of any of the following events during hospital admission: Persistence of fever (temperature ≥37.8ºC), Worsening of abdominal pain, Persistent vaginal bleeding, Necessity to change the primary antibiotic (clindamycin), Addition of any other intravenous or oral antibiotics. For the purposes of analysis, patients who were lost to follow-up were classified as treatment failures.
次要结局
- Hospital Readmission Within 7 Days(7 days)