Steps to Extend Latency in Preterm Prelabor Rupture of Membranes (STEP)
The goal of this quasi-experimental study is to determine if there are improved outcomes for patients with preterm prelabor rupture of membranes (PPROM) who walk daily. The main question it aims to answer is:
- Are patients with PPROM who walk at least 3500 steps per day more likely to stay pregnant longer than those who walk less?
Participants will be encouraged to walk ≥3500 steps per day from the time of diagnosis until delivery and their daily step counts will be recorded. Researchers will compare those who actually walk ≥3500 steps per day to those who walk less.
研究概览
详细说明
The primary objective of this study is to determine if there is increased latency to delivery for patients with PPROM who ambulate ≥3500 steps per day compared to those who ambulate less. The investigators have chosen a goal of 3500 steps as this equates to approximately 30 minutes of moderate-intensity walking, and ACOG endorses the US Department of Health and Human Services Physical Activity Guidelines which recommend at least 150 minutes of moderate intensity aerobic activity per week during pregnancy.
The secondary objective of this study is to determine whether there is a lower risk of adverse maternal and neonatal outcomes for patients with PPROM who ambulate ≥3500 steps per day compared to those who ambulate less. Maternal adverse outcomes that will be assessed include rate of intra-amniotic infection, placental abruption, umbilical cord prolapse, cesarean delivery for non-reassuring fetal heart tracing, and thromboembolic events. Neonatal adverse outcomes that will be assessed include gestational age at delivery, birth weight, APGAR score at 5 minutes, requirement for NICU admission, length of stay, and neonatal death. The investigators will also assess the average steps per day for each participant and type of smartphone (i.e. Android vs iPhone).
Inclusion criteria include patients admitted to Cedars-Sinai with PPROM between the gestational ages of 24w0d and 33w6d who have planned inpatient management of at least 7 days, a phone capable of monitoring and sharing step count, and a singleton or dichorionic twin gestation. Exclusion criteria include patients with malpresentation (specifically, transverse, footling breech, or funic presentation), active preterm labor, or active vaginal bleeding.
This is a quasi-experimental study. All patients will be encouraged to ambulate ≥3500 steps per day. Patients will then be categorized into two cohorts: those who ambulated ≥3500 steps per day and those who ambulated <3500 steps per day. Outcomes will be compared between the two cohorts.
The duration of the study for each patient is the length of time from admission to delivery.
The study will be conducted at one site only, Cedars-Sinai.
At the time of study recruitment, patients will be given information about exercise in pregnancy and encouraged to ambulate at least 3500 steps per day. They will also be asked to share their daily step count via their smartphone health app with a member of the research team. All other antepartum, intrapartum, and postpartum care will be standard and/or per the primary obstetrician's discretion. After hospital discharge, a member of the research team will record the patient's daily step count and extract demographic information as well as obstetric and neonatal outcomes from the EMR.
Our primary outcome is the mean number of days of latency to delivery, and the investigators will use a Welch's t-test to assess the difference between our two study groups. The investigators will then use a multivariable linear regression analysis to account for potentially confounding variables.
For our secondary outcomes, the investigators will assess time from diagnosis to delivery using a log-rank test followed by a cox regression analysis. Additionally, maternal demographic and obstetric outcomes as well as neonatal outcomes will be compared using chi square and t-test for categorical and continuous variables, respectively.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Glenda Marshall, MD
- 电话号码:4243244193
- 邮箱:glenda.marshall@cshs.org
研究联系人备份
- 姓名:Gabriela Dellapiana, MD
- 电话号码:3104237417
学习地点
-
-
California
-
Los Angeles、California、美国、90048
- Cedars-Sinai Medical Center
-
接触:
- Glenda Marshall, MD
- 电话号码:4243244193
- 邮箱:glenda.marshall@cshs.org
-
接触:
- Gabriela Dellapiana, MD
- 电话号码:3104237417
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Planned inpatient expectant management of ≥7 days
- Phone capable of monitoring and sharing step count
- Singleton or dichorionic twin gestation
Exclusion Criteria:
- Any records flagged "break the glass" or "research opt out"
- Transverse, footling breech, or funic presentations
- Active preterm labor
- Active vaginal bleeding
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Encouraged to Ambulate
All patients will be encouraged to ambulate ≥3500 steps per day |
Ambulate ≥3500 steps per day |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Days of latency until delivery
大体时间:From hospital admission to delivery
|
From hospital admission to delivery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of participants who experience a thromboembolic event
大体时间:From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
|
|
Number of participants who experience a postpartum hemorrhage
大体时间:From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
Postpartum hemorrhage is defined as EBL/QBL >= 1000mL |
From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
|
Number of participants who experience maternal sepsis
大体时间:From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
|
|
Number of participants who are admitted to the Intensive Care Unit (ICU)
大体时间:From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
|
|
Days of postpartum length of stay
大体时间:From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
|
|
Mode of delivery
大体时间:Day of delivery
|
Vaginal delivery versus cesarean section |
Day of delivery
|
|
Estimated or quantitative delivery blood loss
大体时间:From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
|
|
Number of participants who experience an intraamniotic infection
大体时间:From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
From admission until maternal hospital discharge, an average of 1-4 days after delivery
|
|
|
Number of patients who experience a placental abruption
大体时间:From admission until delivery
|
From admission until delivery
|
|
|
Number of patients who experience an umbilical cord prolapse
大体时间:From admission until delivery
|
From admission until delivery
|
|
|
Spontaneous versus induced labor
大体时间:From admission until delivery
|
From admission until delivery
|
|
|
Indication for cesarean delivery
大体时间:Day of delivery
|
Only for patients who deliver via cesarean delivery |
Day of delivery
|
|
Gestational age at delivery
大体时间:Day of delivery
|
Day of delivery
|
|
|
Neonatal birth weight
大体时间:Day of delivery
|
Day of delivery
|
|
|
APGAR score at 5 minutes of life
大体时间:5 minutes of life on day of delivery
|
APGAR score (Appearance, Pulse, Grimace, Activity, and Respiration) is on a scale from 0-10. Lower scores indicate that infants are more likely to require resuscitation. |
5 minutes of life on day of delivery
|
|
Umbilical cord blood gas values
大体时间:Day of delivery
|
Arterial pH, CO2, and base excess |
Day of delivery
|
|
Number of neonates who require Neonatal Intensive Care Unit (NICU) admission
大体时间:From delivery until day of neonatal hospital discharge, varies based on gestational age at delivery
|
From delivery until day of neonatal hospital discharge, varies based on gestational age at delivery
|
|
|
Neonatal length of hospital stay
大体时间:From delivery until day of neonatal hospital discharge, varies based on gestational age at delivery
|
From delivery until day of neonatal hospital discharge, varies based on gestational age at delivery
|
|
|
Number of participants who receive at least one course of antenatal corticosteroids
大体时间:From admission until delivery
|
From admission until delivery
|
|
|
Number of participants who receive antenatal magnesium sulfate
大体时间:From admission until delivery
|
From admission until delivery
|
|
|
Number of neonatal deaths
大体时间:From admission until day of neonatal hospital discharge (or death when applicable), varies based on gestational age at delivery
|
From admission until day of neonatal hospital discharge (or death when applicable), varies based on gestational age at delivery
|
合作者和调查者
调查人员
- 首席研究员:Gabriela Dellapiana, MD、Cedars-Sinai Medical Center
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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