- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07935161
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Glenda Marshall, MD
- Telefonnummer: 4243244193
- E-post: glenda.marshall@cshs.org
Studera Kontakt Backup
- Namn: Gabriela Dellapiana, MD
- Telefonnummer: 3104237417
Studieorter
-
-
California
-
Los Angeles, California, Förenta staterna, 90048
- Cedars-Sinai Medical Center
-
Kontakt:
- Glenda Marshall, MD
- Telefonnummer: 4243244193
- E-post: glenda.marshall@cshs.org
-
Kontakt:
- Gabriela Dellapiana, MD
- Telefonnummer: 3104237417
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Encouraged to Ambulate
All patients will be encouraged to ambulate ≥3500 steps per day |
Ambulate ≥3500 steps per day |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Days of latency until delivery
Tidsram: From hospital admission to delivery
|
From hospital admission to delivery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of participants who experience a thromboembolic event
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: Day of delivery
|
Vaginal delivery versus cesarean section |
Day of delivery
|
|
Estimated or quantitative delivery blood loss
Tidsram: 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
Tidsram: 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
Tidsram: From admission until delivery
|
From admission until delivery
|
|
|
Number of patients who experience an umbilical cord prolapse
Tidsram: From admission until delivery
|
From admission until delivery
|
|
|
Spontaneous versus induced labor
Tidsram: From admission until delivery
|
From admission until delivery
|
|
|
Indication for cesarean delivery
Tidsram: Day of delivery
|
Only for patients who deliver via cesarean delivery |
Day of delivery
|
|
Gestational age at delivery
Tidsram: Day of delivery
|
Day of delivery
|
|
|
Neonatal birth weight
Tidsram: Day of delivery
|
Day of delivery
|
|
|
APGAR score at 5 minutes of life
Tidsram: 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
Tidsram: Day of delivery
|
Arterial pH, CO2, and base excess |
Day of delivery
|
|
Number of neonates who require Neonatal Intensive Care Unit (NICU) admission
Tidsram: 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
Tidsram: 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
Tidsram: From admission until delivery
|
From admission until delivery
|
|
|
Number of participants who receive antenatal magnesium sulfate
Tidsram: From admission until delivery
|
From admission until delivery
|
|
|
Number of neonatal deaths
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Gabriela Dellapiana, MD, Cedars-Sinai Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STUDY00004892
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
To protect patient confidentiality
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