Vaginal Cleansing With Chlorhexidine Gluconate in Women With Preterm Pre-labor Rupture of Membranes in Order to Prolong Pregnancy Latency and Reduce Intraamniotic Inflammation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pregnancy latency
研究概览
简要总结
Randomized controlled trial studying the use of vaginal cleansing with chlorhexidine gluconate for pregnant women with PPROM (preterm pre labor rupture of membranes). The primary outcome will be pregnancy latency. Secondary outcomes will include various maternal and neonatal outcomes, and inflammatory markers from maternal blood, amniotic fluid, fetal cord blood and placental analysis.
详细描述
A randomized controlled trial, including pregnant women > 18 years old with early onset PPROM occurring between the time of peri-viability through the early third trimester (20 weeks 0 days - 33 weeks 0 days) at Albany Medical Center.
Women will be consented by a physician member of the research team on labor and delivery after clinical diagnosis of PPROM. Participation will be completely voluntary and not impact routine prenatal care for PPROM, which may include but not be limited to hospital admission, standard latency antibiotics, NICU consultation, fetal growth ultrasounds, fetal monitoring, and delivery will be based on physician assessment and not impacted by this study. Participation in the study will involve prospective data collection on maternal, fetal, and neonatal characteristics, randomization into a control and treatment group, collection of maternal serum, fetal cord blood and vaginal fluid. Subjects will be randomized into control and treatment groups via block randomization. Exclusions will include any contraindications to expectant management for PPROM noted at the time on admission, such as preterm labor, chorioamnionitis, maternal sepsis and fetal distress.
The time commitment for each subject will include the time from diagnosis of PPROM until their delivery. Although outcome measures will be collected from each neonate, no further participation from subjects will be required after time of their delivery.
Treatment Group: Women diagnosed with PPROM (20 - 33 weeks) randomized to the treatment group will undergo vaginal cleansing with chlorhexidine gluconate within 24 hours of their diagnosis. This specific procedure will only be done once.
The vaginal cleansing procedure will be performed by a single investigator, Dr. Cagino, to ensure consistency. The patient will be examined in dorsal lithotomy position with a standard speculum. A sterile 2x2 gauze placed on ringed forceps will be soaked in sterile 2% chlorhexidine gluconate in
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant patients at our institution with PPROM diagnosed between 20 - 33 weeks
排除标准
- •active preterm labor or imminent delivery expected at the time of PPROM diagnosis
- •maternal sepsis or chorioamnionitis
- •any contraindications to expectant management (fetal distress, placental abruption with maternal hemodynamic instability or fetal distress cord prolapse)
- •preeclampsia
- •intrauterine growth restriction (IUGR)
- •no antibiotics or steroids given within 7 days prior to the time of enrollment
- •multiple gestation
- •placenta previa
- •fetal part visualized at initial exam
- •visual cervical dilation at initial exam
结局指标
主要结局
Pregnancy latency
时间窗: Delivery
The time measured in days from the diagnosis of pre labor premature rupture of membranes (PPROM) to delivery.
次要结局
- rate of composite neonatal morbidity(through study completion, up to 1 year)
- Number of participants with clinical chorioamnionitis(Through study completion, an average of 1 year)
- rate of neonatal death(through study completion, up to 1 year)
- Amniotic fluid inflammatory markers(Within 24 hours of admission, 7 days after admission, day of delivery)
- White blood cell count, cells per liter(Within 24 hours of admission, 7 days after admission, day of delivery)
- fetal demise(through study completion, up to 1 year)
- Serum inflammatory markers(Within 24 hours of admission, 7 days after admission, day of delivery)
- Rate of placental abnormalities on pathology evaluation(studied postpartum, up to 1 week)
- Rate of histologic chorioamnionitis(studied postpartum, up to 1 week)
- Rate of maternal sepsis(through study completion, up to 1 year)