NCT06917157撤回4 期
Latency Antibiotics for Previable Rupture Of Membranes: LAPROM Trial
The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of participants that delivered their babies after membrane rupture
研究概览
简要总结
The purpose of this study is to see if the use of prophylactic antibiotics in the expectant management of PPROM less than 22 weeks significantly reduce the rate of delivery within 7 days and to see if the use of prophylactic antibiotics in the expectant management of PPROM between 20 and 22 weeks decrease composite neonatal morbidity.
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
- 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
- 否
入选标准
- •Preterm premature rupture of membranes at less than 22 weeks.
- •Membrane rupture had occurred within 36 hours of randomization.
- •Cervical dilatation is 3 cm or less (on visual or clinical examination).
- •4 or fewer contractions in the 60-minute monitoring period before randomization.
- •Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age
- •Gestational age at randomization less than 22 weeks (≤21 weeks and 6 days) based on clinical information.
排除标准
- •Nonreasoning fetal testing
- •Vaginal bleeding
- •Maternal or fetal indication for immediate delivery
- •Cervical cerclage in place
- •Receipt of latency antibiotics prior to randomization (azithromycin, ampicillin, or amoxicillin)
- •Allergy to Penicillins or Azithromycin
- •Febrile illness requiring antibiotics
- •Placenta previa
- •Multifetal gestation
研究组 & 干预措施
Administration of antibiotics prophylactically at the time of membrane rupture
Experimental
Membrane rupture per inclusion criteria will be less than 22 weeks
干预措施: Administration of antibiotics prophylactically at the time of membrane rupture (Drug)
Administration of antibiotics non-prophylactically at 22 weeks
Active Comparator
干预措施: Administration of antibiotics non-prophylactically at 22 weeks (Drug)
结局指标
主要结局
Number of participants that delivered their babies after membrane rupture
时间窗: from baseline to day 7
次要结局
- Latency, defined as the duration between rupture of membranes and delivery(from rupture of membranes to delivery(about 1-126 days after baseline))
- Number of participants that have Chorioamnionitis(Baseline upto delivery (about 1-126 days after baseline))
- Number of participants that develop sepsis(From baseline upto discharge (about 1-4 days post delivery))
- Number of maternal deaths(From baseline upto discharge (about 1-4 days post delivery))
- Number of admissions to intensive care unit (ICU)(From baseline upto discharge (about 1-4 days post delivery))
- Number of participants that develop postpartum hemorrhage(From baseline upto discharge (about 1-4 days post delivery))
- Number of participants that develop maternal postpartum infection(within 6 weeks of delivery)
- Number of participants that develop maternal venous thromboembolism(within 6 weeks of delivery)
研究者
Khalil Chahine
Principal Investigator
The University of Texas Health Science Center, Houston
研究点 (1)
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