Outpatient Antibiotics Following Previable Rupture of Membranes (pPPROM) Between 18 0/7 and 22 6/7 Weeks Gestational Age
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 6
- 主要终点
- Delivery within 28 days
研究概览
简要总结
A randomized, controlled, non-placebo trial to primarily assess the effect of oral, outpatient antibiotics (i.e., azithromycin and amoxicillin) on latency (i.e., proportion of patients that deliver within 28 days from membrane rupture) following previable, prelabor rupture of membranes between 18 0/7 and 22 6/7 weeks gestational age.
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
- 是
入选标准
- •English-speaking
- •Live, singleton gestation
- •Patient able to provide informed consent
- •Gestational age between 18 weeks and 0 days and 22 weeks and 6 days at the time of -membrane rupture
- •Diagnosis of preterm, prelabor rupture of membranes by clinical exam findings of either 1) visualization of amniotic fluid passing from the cervical canal and/or pooling in the vagina via sterile speculum examination, 2) a basic pH (i.e., positive nitrazine) test of vaginal fluid, 3) arborization (i.e., ferning) of dried vaginal fluid identified via microscopic examination, and/or 4) an amniotic fluid index (AFI) of less than 4cm
排除标准
- •Gestational dating performed or confirmed by ultrasound at ≥ 18 weeks and 0 days gestational age
- •Patient desires pregnancy interruption or induction of labor
- •Known major fetal anomaly or aneuploidy
- •Amniocentesis ≤ 7 days of diagnosis of rupture of membranes
- •Cervical cerclage placement ≤ 7 days of diagnosis of rupture of membranes
- •Known drug allergy or significant adverse reactions to macrolide or penicillin antibiotics
- •Current antibiotic use at the time of membrane rupture diagnosis
- •Vaginal bleeding at the time of membrane rupture diagnosis or within first 24 hours from diagnosis
- •Febrile at the time of membrane rupture diagnosis (i.e., temperature ≥ 38 degrees Celsius) and/or within first 24 hours of diagnosis
- •Active preterm labor at the time of membrane rupture diagnosis (i.e., consistent contraction pattern associated with cervical change) and/or within first 24 hours of diagnosis
- •Cervical dilation of ≥ 4 cm
- •Prolapse of fetal parts beyond the level of the internal cervical os
- •Declination to complete full, 7-day outpatient monitoring prior to hospital re-admission should rupture occur during the 22nd week of gestation
研究组 & 干预措施
Antibiotics
Patients randomized into the treatment (i.e., antibiotics) arm of the study will be treated with a seven-day course of oral azithromycin and amoxicillin. Azithromycin will be dosed as single 500 mg dose (2-250mg oral tablets) administered immediately following randomization, yet prior to discharge to home, followed with 1-250mg oral tablet daily for 4 additional days (for a total of 5 days). Amoxicillin will be dosed as a single-500mg oral tablet three times daily for 7 days with first dose also being given prior to discharge home.
干预措施: Azithromycin Pill (Drug)
Antibiotics
Patients randomized into the treatment (i.e., antibiotics) arm of the study will be treated with a seven-day course of oral azithromycin and amoxicillin. Azithromycin will be dosed as single 500 mg dose (2-250mg oral tablets) administered immediately following randomization, yet prior to discharge to home, followed with 1-250mg oral tablet daily for 4 additional days (for a total of 5 days). Amoxicillin will be dosed as a single-500mg oral tablet three times daily for 7 days with first dose also being given prior to discharge home.
干预措施: Amoxicillin Pill (Drug)
结局指标
主要结局
Delivery within 28 days
时间窗: 28 days from date of rupture
The proportion of patients that undergo a spontaneous or medically-indicated delivery within 28 days from diagnosis of previable prelabor rupture of membranes (pPPROM)
次要结局
- Severe neonatal morbidity composite(From date of delivery to date of hospital discharge (up to 6 months))
- Severe maternal morbidity composite(From diagnosis of membrane rupture to 6 weeks following delivery)
研究者
David Hackney MD, MS
Division Director, Maternal-Fetal Medicine
University Hospitals Cleveland Medical Center