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临床试验/NCT01585129
NCT01585129终止4 期

Treatment Utility of Postpartum Antibiotics in Chorioamnionitis

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2010年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
80
试验地点
2
主要终点
Number of Paricipants With Endometritis

研究概览

简要总结

To determine if prophylactic postpartum antibiotics are required post-cesarean delivery for pregnancies with treated chorioamnionitis.

详细描述

Bacterial infection of the amniotic cavity, termed "chorioamnionitis", is a major cause of perinatal mortality and maternal morbidity. Early administration of broad-spectrum antibiotic therapy in the laboring patient with chorioamnionitis has both neonatal and maternal benefits. Less known is the ideal postpartum antibiotic regimen - or if postpartum antibiotics are even required at all - needed to decrease febrile morbidity. Current practice has seen a wide range of practice styles ranging from no treatment to antibiotic prophylaxis for up to 48 hours after delivery.

If antibiotics are prescribed, there is good evidence to support one additional dose of antibiotics as compared to 24 hour dosing to decrease the rate of endometritis. Less clear is whether antibiotics are required at all for the properly treated patient with chorioamnionitis who requires a cesarean delivery. One study comparing continued antibiotics versus no-treatment failed to show a difference in the rate of postpartum endometritis. The conclusion from this study was that continuation of preoperative clindamycin and gentamicin in the postoperative period did not reduce the risk of endometritis compared to a single preoperative dose however this study was terminated early due to failure to recruit their stated sample size.

Puerperal endometritis rates vary by mode of delivery but it is known that the rate is lower in vaginal deliveries as compared to cesarean delivery. The patient with chorioamnionitis that requires a cesarean delivery makes an excellent study target. Given the lack of studied protocols, there currently are many acceptable methods for treating the patient with chorioamnionitis. Our proposed study plans to evaluate the two most common methods of treatment to determine the most effective regimen. If post-delivery antibiotics do not show a benefit to these highest risk subjects, it is likely inferred that patients that undergo a vaginal delivery will not require antibiotics as well.

Specific Aims There is conflicting data regarding the necessity of post-delivery antibiotics for patients with chorioamnionitis who undergo cesarean delivery. The primary objective of this study is to determine if postpartum antibiotics are necessary for antepartum treated cases of chorioamnionitis in patients undergoing a cesarean section.

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
Single (Participant)

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

入选标准

  • Clinical diagnosis of chorioamnionitis
  • Undergoing cesarean section for delivery

排除标准

  • Multiple gestations,
  • Allergy to beta-lactam antibiotics
  • Patients with estimated creatinine clearance (ClCr) less than 70 mL/min
  • Maternal fever explained by etiology other than chorioamnionitis
  • Inability to comply with the study protocol.

研究组 & 干预措施

Postpartum Antibiotics

Experimental

Patients will receive one additional dose of postpartum antibiotics (Clinda, Gentamicin)

干预措施: Postpartum Antibiotics (Drug)

No postpartum antibiotics

Placebo Comparator

No further postpartum antibiotics

干预措施: No postpartum antibiotics (Drug)

结局指标

主要结局

Number of Paricipants With Endometritis

时间窗: 7 days post-partum

Endometritis is defined as uterine infection and is diagnosed by maternal temp \> 38.0C on two occasions over a 4 hour period or any temp \> 39.0C after delivery \> 12 hours after delivery. Endometritis will be managed per currently accepted endometritis protocol - (Amp 2 gQ6, Gentamicin 5 mg/kg q24, Clindamycin 900 mg q8).

次要结局

  • Number of Participants With Infection-related Complications(7 days post-partum)
  • Duration of Hospital Stay After Cesarean Delivery(Up to 7 Days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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