Randomized Controlled Trial on the Effects of Different Antibiotic Regimens in Preterm Premature Rupture of Membranes After 34 Weeks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- mode of birth checklist
研究概览
简要总结
To investigate the effects of different antibiotic regimens used in preterm premature rupture of membranes (PPROM) on maternal and fetal outcomes after 34 weeks of gestation.
详细描述
Background: To investigate the effects of different antibiotic regimens used in preterm premature rupture of membranes (PPROM) on maternal and fetal outcomes after 34 weeks of gestation.
Methods: A total of 40 pregnant women diagnosed with PPROM after the 34th week of gestation were included in the study and randomly divided into two equal groups. Group-1: Sulbactam + ampicillin, azithromycin, and amoxicillin. Group-2: Ceftriaxone, clarithromycin, and amoxicillin. For all cases, obstetric history, time of delivery, latency period, infection markers, neonatal birth weight, APGAR scores, NICU requirement and length of stay, type of delivery and maternal complications were recorded.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancies,
- •PPROM after 34 weeks of gestation
排除标准
- •Patients with fetal anomalies
- •Preeclampsia, gestational or pregestational diabetes mellitus,
- •Multiple pregnancies,
- •Chorioamnionitis, placental abruption, cord prolapse, fetal distress, or other complicated pregnancies.
- •Maternal immunodeficiency
- •The presence of other infections requiring antibiotic therapy, antenatal corticosteroid use, chronic diseases,
- •Unwillingness to participate and sign the detailed informed consent form
结局指标
主要结局
mode of birth checklist
时间窗: From enrollment to the end of treatment at 4 weeks"
Effect of different antibiotic regimens on fetal and maternal outcomes: mode of birth checklist
neonatal birth weight
时间窗: From enrollment to the end of treatment at 4 weeks"
neonatal birth weight
1st and 5th minute APGAR scores
时间窗: From enrollment to the end of treatment at 4 weeks"
1st and 5th minute APGAR scores
need for NICU (neonatal intensive care unit) admission
时间窗: From enrollment to the end of treatment at 4 weeks"
need for NICU (neonatal intensive care unit) admission
duration of NICU stay
时间窗: From enrollment to the end of treatment at 4 weeks"
duration of NICU stay.
White blood cell (WBC) count
时间窗: From enrollment to the end of treatment at 4 weeks"
White blood cell (WBC) count was measured every 48 hours
C-reactive protein (CRP) levels
时间窗: From enrollment to the end of treatment at 4 weeks"
C-reactive protein (CRP) level was measured every 48 hours
Maternal complications
时间窗: From enrollment to the end of treatment at 4 weeks"
Maternal complications; chorioamnionitis, placental abruption
次要结局
未报告次要终点
研究者
Onur Karaaslan
YuzuncuYıl
Yuzuncu Yıl University