Randomized double blinded controlled trial to compare the efficacy of Extended spectrum antibiotics with narrow spectrum antibiotic as prophylaxis in Cesarean delivery for the prevention of post Cesarean endometritis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,996
- 试验地点
- 1
- 主要终点
- surgical site infection until 42days postoperative
研究概览
简要总结
Cesarean delivery (CD) are the most commonly performed surgical procedure worldwide . According to Cochrane Database Systematic Review in 2002 endometritis is the most frequent post Cesarean complication classically reported in upto 50% of patients . Cesarean delivery is associated with a significantly higher post-operative infections such as surgical site infection, urinary tract infection (SSI,UTI) and uterine infection rate when compared to following vaginal birth and instrumental deliveries .In the present era due to increasing number of Cesarean deliveries infections are likely to become a significant health and economic burden .
Post–Cesarean delivery endometritis is generally believed to have a polymicrobial etiology resulting from ascension of bacteria from the lower to the upper genital tract. There is overwhelming evidence that antibiotic prophylaxis for cesearean delivery is effective in preventive maternal infectious morbidity.
Cefazolin was used as prophylaxis after cord clamping based on evidence of National institute for Health and Care Excellence (NICE) guidelines 2011 .Based on a study done in CMCH and The Society of Obstetricians and Gynaecologists of Canada( SOGC) 2010, this was changed to using Cefazolin 15-30 minutes prior to skin incision in order to decrease the surgical site infection.
The association between ureaplasm urealyticum colonization of the chorioamnion at Cesarean delivery (CD) and an increased risk of post – Cesarean delivery endometritis occurred despite the routine use of intraoperative prophylactic antibiotics . When these organisms are detected , there is a 3-8 fold increased risk of endometritis or wound infection post Cesarean delivery.
Broad-spectrum antibiotics when used, were associated with a statistically significant reduction in endometritis and wound infection compared to narrow-spectrum antibiotics . Length of hospital stay was significantly shorter when broad-spectrum antibiotics were used. The leading option as a second-line broad-spectrum antibiotic for Cesarean delivery appears to be Azithromycin, which has a longer half-life (68 hours) , higher tissue concentrations and lower transplacental passage than several other antibiotics commonly used for this indication. In addition, azithromycin is active against both aerobes and anaerobes, as well as Ureaplasmas, resulting in significantly less endometritis and wound infection than in studies in which other antibiotics were used.
In the present study we aim to compare the following outcome measures in the mother such as surgical site infection , endometritis , UTI & serious infections . The duration of hospital stay in mothers will be looked at.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •pregnant women with completed 37 weeks undergoing cesarean section.
排除标准
- •Patients with known allergy to Cephalosporin and Azithromycin Patient who have received antibiotics within a week prior to the delivery or intrapartum propylaxis for chorioamnionitis.
结局指标
主要结局
surgical site infection until 42days postoperative
时间窗: endometritis until 42days post operative | surgical site infection until 42days postoperative | urinary tract infection until 42days postoperative | length of hospital stay attributed to mothers illness .At the end of 42 days postoperative ,patient will reassed
endometritis until 42days post operative
时间窗: endometritis until 42days post operative | surgical site infection until 42days postoperative | urinary tract infection until 42days postoperative | length of hospital stay attributed to mothers illness .At the end of 42 days postoperative ,patient will reassed
urinary tract infection until 42days postoperative
时间窗: endometritis until 42days post operative | surgical site infection until 42days postoperative | urinary tract infection until 42days postoperative | length of hospital stay attributed to mothers illness .At the end of 42 days postoperative ,patient will reassed
length of hospital stay attributed to mothers illness .At the end of 42 days postoperative ,patient will reassed
时间窗: endometritis until 42days post operative | surgical site infection until 42days postoperative | urinary tract infection until 42days postoperative | length of hospital stay attributed to mothers illness .At the end of 42 days postoperative ,patient will reassed
次要结局
- anaphylactic reactions(number of readmisions until 6 weeks postoperative)