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Steps to Extend Latency in Preterm Prelabor Rupture of Membranes (STEP)

6 novembre 2026 aggiornato da: Gabriela Dellapiana, Cedars-Sinai Medical Center

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Gabriela Dellapiana, MD
  • Numero di telefono: 3104237417

Luoghi di studio

    • California
      • Los Angeles, California, Stati Uniti, 90048
        • Cedars-Sinai Medical Center
        • Contatto:
        • Contatto:
          • Gabriela Dellapiana, MD
          • Numero di telefono: 3104237417

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Encouraged to Ambulate

All patients will be encouraged to ambulate ≥3500 steps per day

Ambulate ≥3500 steps per day

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Days of latency until delivery
Lasso di tempo: From hospital admission to delivery
From hospital admission to delivery

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of participants who experience a thromboembolic event
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Day of delivery

Vaginal delivery versus cesarean section

Day of delivery
Estimated or quantitative delivery blood loss
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: From admission until delivery
From admission until delivery
Number of patients who experience an umbilical cord prolapse
Lasso di tempo: From admission until delivery
From admission until delivery
Spontaneous versus induced labor
Lasso di tempo: From admission until delivery
From admission until delivery
Indication for cesarean delivery
Lasso di tempo: Day of delivery

Only for patients who deliver via cesarean delivery

Day of delivery
Gestational age at delivery
Lasso di tempo: Day of delivery
Day of delivery
Neonatal birth weight
Lasso di tempo: Day of delivery
Day of delivery
APGAR score at 5 minutes of life
Lasso di tempo: 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
Lasso di tempo: Day of delivery

Arterial pH, CO2, and base excess

Day of delivery
Number of neonates who require Neonatal Intensive Care Unit (NICU) admission
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: From admission until delivery
From admission until delivery
Number of participants who receive antenatal magnesium sulfate
Lasso di tempo: From admission until delivery
From admission until delivery
Number of neonatal deaths
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Investigatore principale: Gabriela Dellapiana, MD, Cedars-Sinai Medical Center

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 novembre 2026

Completamento primario (Stimato)

1 dicembre 2027

Completamento dello studio (Stimato)

1 dicembre 2027

Date di iscrizione allo studio

Primo inviato

19 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

6 novembre 2026

Primo Inserito (Effettivo)

13 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • STUDY00004892

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

To protect patient confidentiality

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .