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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Glenda Marshall, MD
- 電話番号:4243244193
- メール:glenda.marshall@cshs.org
研究連絡先のバックアップ
- 名前:Gabriela Dellapiana, MD
- 電話番号:3104237417
研究場所
-
-
California
-
Los Angeles、California、アメリカ、90048
- Cedars-Sinai Medical Center
-
コンタクト:
- Glenda Marshall, MD
- 電話番号:4243244193
- メール:glenda.marshall@cshs.org
-
コンタクト:
- Gabriela Dellapiana, MD
- 電話番号:3104237417
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:他の
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Encouraged to Ambulate
All patients will be encouraged to ambulate ≥3500 steps per day |
Ambulate ≥3500 steps per day |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Days of latency until delivery
時間枠:From hospital admission to delivery
|
From hospital admission to delivery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of participants who experience a thromboembolic event
時間枠: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
時間枠: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
時間枠: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)
時間枠: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
時間枠: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
時間枠:Day of delivery
|
Vaginal delivery versus cesarean section |
Day of delivery
|
|
Estimated or quantitative delivery blood loss
時間枠: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
時間枠: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
時間枠:From admission until delivery
|
From admission until delivery
|
|
|
Number of patients who experience an umbilical cord prolapse
時間枠:From admission until delivery
|
From admission until delivery
|
|
|
Spontaneous versus induced labor
時間枠:From admission until delivery
|
From admission until delivery
|
|
|
Indication for cesarean delivery
時間枠:Day of delivery
|
Only for patients who deliver via cesarean delivery |
Day of delivery
|
|
Gestational age at delivery
時間枠:Day of delivery
|
Day of delivery
|
|
|
Neonatal birth weight
時間枠:Day of delivery
|
Day of delivery
|
|
|
APGAR score at 5 minutes of life
時間枠: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
時間枠:Day of delivery
|
Arterial pH, CO2, and base excess |
Day of delivery
|
|
Number of neonates who require Neonatal Intensive Care Unit (NICU) admission
時間枠: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
時間枠: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
時間枠:From admission until delivery
|
From admission until delivery
|
|
|
Number of participants who receive antenatal magnesium sulfate
時間枠:From admission until delivery
|
From admission until delivery
|
|
|
Number of neonatal deaths
時間枠: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
|
協力者と研究者
捜査官
- 主任研究者:Gabriela Dellapiana, MD、Cedars-Sinai Medical Center
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- STUDY00004892
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
To protect patient confidentiality
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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