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.
Aperçu de l'étude
Statut
Statut
Les conditions
Les conditions
Intervention / Traitement
Intervention / Traitement
Description détaillée
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.
Type d'étude
Type d'étude
Inscription (Estimé)
Inscription
Phase
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
Coordonnées de l'étude
- Nom: Glenda Marshall, MD
- Numéro de téléphone: 4243244193
- E-mail: glenda.marshall@cshs.org
Sauvegarde des contacts de l'étude
- Nom: Gabriela Dellapiana, MD
- Numéro de téléphone: 3104237417
Lieux d'étude
-
-
California
-
Los Angeles, California, États-Unis, 90048
- Cedars-Sinai Medical Center
-
Contact:
- Glenda Marshall, MD
- Numéro de téléphone: 4243244193
- E-mail: glenda.marshall@cshs.org
-
Contact:
- Gabriela Dellapiana, MD
- Numéro de téléphone: 3104237417
-
-
Critères de participation
Critère d'éligibilité
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Nombre de bras
Armes et Interventions
Groupe de participants / BrasGroupe de participants / Bras |
Intervention / TraitementIntervention / Traitement |
|---|---|
|
Expérimental: Encouraged to Ambulate
All patients will be encouraged to ambulate ≥3500 steps per day |
Ambulate ≥3500 steps per day |
Que mesure l'étude ?
Principaux critères de jugement
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Days of latency until delivery
Délai: From hospital admission to delivery
|
From hospital admission to delivery
|
Mesures de résultats secondaires
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of participants who experience a thromboembolic event
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: Day of delivery
|
Vaginal delivery versus cesarean section |
Day of delivery
|
|
Estimated or quantitative delivery blood loss
Délai: 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
Délai: 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
Délai: From admission until delivery
|
From admission until delivery
|
|
|
Number of patients who experience an umbilical cord prolapse
Délai: From admission until delivery
|
From admission until delivery
|
|
|
Spontaneous versus induced labor
Délai: From admission until delivery
|
From admission until delivery
|
|
|
Indication for cesarean delivery
Délai: Day of delivery
|
Only for patients who deliver via cesarean delivery |
Day of delivery
|
|
Gestational age at delivery
Délai: Day of delivery
|
Day of delivery
|
|
|
Neonatal birth weight
Délai: Day of delivery
|
Day of delivery
|
|
|
APGAR score at 5 minutes of life
Délai: 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
Délai: Day of delivery
|
Arterial pH, CO2, and base excess |
Day of delivery
|
|
Number of neonates who require Neonatal Intensive Care Unit (NICU) admission
Délai: 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
Délai: 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
Délai: From admission until delivery
|
From admission until delivery
|
|
|
Number of participants who receive antenatal magnesium sulfate
Délai: From admission until delivery
|
From admission until delivery
|
|
|
Number of neonatal deaths
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Parrainer
Les enquêteurs
Les enquêteurs
- Chercheur principal: Gabriela Dellapiana, MD, Cedars-Sinai Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Début de l'étude
Achèvement primaire (Estimé)
Achèvement primaire
Achèvement de l'étude (Estimé)
Achèvement de l'étude
Dates d'inscription aux études
Première soumission
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Première publication
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour publiée
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
Autres numéros d'identification d'étude
- STUDY00004892
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
To protect patient confidentiality
Informations sur les médicaments et les dispositifs, documents d'étude
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