NCT04230967已完成不适用
Ambulation for Latency During Expectant Management of PPROM: A Randomized Controlled Trial (AMBLE)
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年3月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Latency (measured in days) from from randomization to delivery
研究概览
简要总结
Ambulation in pregnancy has been proposed to decrease stress and anxiety, increasing preterm birth. Whether ambulation is causally related to latency is unknown. The FitBit will be used for tracking the number of steps taken daily by each participant, and for encouraging the intervention group to walk. The FitBit is the most widely used physical activity tracker in medical research, and its use has been validated for research use in pregnant women. The purpose of the study is to evaluate whether ambulation in patients with preterm premature rupture of the membranes (PPROM) prolongs latency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women aged 12-55
- •Gestational age 23 0/7 to 35 0/7 weeks
- •PPROM confirmed by clinical diagnosis which includes sterile speculum examination with pooling, ferning, and nitrazine tests, or the Amnisure ROM Test
- •Planned inpatient expectant management with delivery goal >=7 days from enrollment
- •Ability to provide informed consent in English or Spanish
排除标准
- •Imminent delivery
- •Transverse or footling breech presentation (if multiple gestation, presenting fetus)
- •Unstable lie (if multiple gestation, presenting fetus)
- •Funic presentation (if multiple gestation, presenting fetus)
- •Active vaginal bleeding
- •Regular, painful contractions (>=3 in 10 minutes for 30 minutes or more) consistent with labor
- •Clinical contraindication to ambulation as determined by the managing physician
- •Physician declines to have the patient approached for participation
- •Lethal fetal anomalies
结局指标
主要结局
Latency (measured in days) from from randomization to delivery
时间窗: 12 weeks
次要结局
- Maternal Infectious morbidity(at delivery)
- # of subjects with Cesarean delivery (and emergent cesarean delivery)(at delivery)
- Time to delivery (time-to-event outcome)(12 weeks)
- Fetal or neonatal death(at discharge)
- Composite adverse fetal/neonatal outcome(at discharge)
- Measurement of Anxiety outcomes utilizing State Trait Anxiety Inventory (STAI)(7 days)
- Umbilical arterial pH < 7.00(at delivery)
- # of neonates with Small for gestational age(at delivery)
- Gestational age at delivery < 34 weeks(at delivery)
- Neonatal length of hospital stay, based on admission to NICU or intermediate care unit(at discharge)
- # of subjects with Placental abruption(at delivery)
- # of subjects with Maternal venous thromboembolism(at delivery)
- Measurement of Depression outcomes utilizing Edinburgh Depression Scale (EDS)(7 days)
- # of neonates with Neonatal necrotizing enterocolitis (NEC)(at discharge)
- # of neonates with Bronchopulmonary dysplasia (BPD)(at discharge)
- Composite adverse maternal outcome (CMAO)(at discharge)
- Maternal Readmission(within 6 weeks of delivery- 6 weeks)
- Delivered at >7 days post randomization(at delivery)
- Maternal antepartum hospitalization length of stay(from admission to delivery)
- Measurement of Stress outcomes utilizing Perceived Stress Scale (PSS)(7 days)
- Measurement of Patient Satisfaction by validated satisfaction survey between 2 groups(at delivery)
- # of neonates with Neonatal intraventricular hemorrhage (IVH) grades III or IV(at discharge)
- # of neonates with Neonatal periventricular leukomalacia (PVL)(at discharge)
- # of neonates with Neonatal retinopathy of prematurity (ROP).(at discharge)
- # of subjects with Umbilical cord prolapse(at delivery)
- Apgar score < 5 at 5 minutes of life(at delivery)
- Gestational age at delivery < 28 weeks(at delivery)
研究者
Beth Leong Pineles
Fellow
The University of Texas Health Science Center, Houston
研究点 (2)
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