Antibiotic Prophylaxis in Ragged Placental Membranes: A Prospective, Multicenter, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 716
- 主要终点
- Incidence of postpartum endometritis
研究概览
简要总结
In some centres, women are routinely given a course of antibiotics postnatally if ragged placental membranes were present at delivery. The investigators examined the necessity such an intervention.
详细描述
Postpartum endometritis resulting in sepsis remain one of the leading cause of maternal mortality in developing countries. Ragged placental membrane is a risk factor for endometritis and is not infrequently encountered. Several hospitals in Malaysia, largely those geographically-removed currently practice administering prophylactic antibiotics for women with ragged placental membranes. The aim is to reduce the risk of postpartum endometritis in a subgroup of women who may present in dire straits. The investigators sought to examine the necessity of such protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All women who delivered vaginally beyond 24+0 weeks of gestation and were found to have ragged or retained placental membranes immediately after the third stage of labour were invited to participate in the study.
排除标准
- •Fever, within 5 days preceding delivery (Axillary temperature > 37.5oC on 2 or more occasions at least 1 hour apart or temperature > 38oC on one occasion). This also includes intrapartum fever.
- •Required oral or intravenous antibiotics for any other obstetric-related (ex. third or fourth degree tears, preterm prelabour rupture of membranes) or non- obstetric related (ex. pneumonia, acute pyelonephritis) reasons
- •Prolonged rupture of membrane (>18 hours)
- •Retroviral disease, on long term oral or parenteral steroid or receiving other forms of immunosuppressants, including chemotherapy within the last one year.
- •Vaginal delivery for an intrauterine death
- •Penicillin allergy
研究组 & 干预措施
Prophylaxis
Current protocol of administering antibiotics maintained
干预措施: Prophylactic antibiotics (Drug)
No prophylaxis
Antibiotics withheld, with appropriate observation and follow up
干预措施: No prophylaxis (Amox-clav withheld) (Other)
结局指标
主要结局
Incidence of postpartum endometritis
时间窗: 6 weeks postpartum
Postpartum endometritis is defined as follows, when presenting anytime within 6 weeks postpartum 1. Fever (Axillary temperature \> 37.5 degrees Celcius on 2 or more occasions at least 1 hour apart or temperature \> 38 degrees Celcius on one occasion), occurring in the absence of apparent source of infection or alternative foci of infection. 2. Increasing lochia loss or offensive lochia. 3. Lower abdominal pain or suprapubic tenderness on palpation. The diagnosis is further supported by the following: 1. Elevated total white cell count \> 11.0 x 109 cells/L 2. Positive genital swab culture. Incidence is calculated as follows: Number of patients diagnosed with endometritis in each arm/total number of patients allocated to each arm
次要结局
- Rate of surgical evacuation of retained products of conception(6 weeks postpartum)
- Rate of Blood transfusion(6 weeks postpartum)
- ICU admission rate(6 weeks postpartum)
研究者
Voon Hian Yan
Principal Investigator
Sarawak General Hospital