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

6. November 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

  • Name: Gabriela Dellapiana, MD
  • Telefonnummer: 3104237417

Studienorte

    • California
      • Los Angeles, California, Vereinigte Staaten, 90048
        • Cedars-Sinai Medical Center
        • Kontakt:
        • Kontakt:
          • Gabriela Dellapiana, MD
          • Telefonnummer: 3104237417

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Encouraged to Ambulate

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

Ambulate ≥3500 steps per day

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Days of latency until delivery
Zeitfenster: From hospital admission to delivery
From hospital admission to delivery

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of participants who experience a thromboembolic event
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Day of delivery

Vaginal delivery versus cesarean section

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

Only for patients who deliver via cesarean delivery

Day of delivery
Gestational age at delivery
Zeitfenster: Day of delivery
Day of delivery
Neonatal birth weight
Zeitfenster: Day of delivery
Day of delivery
APGAR score at 5 minutes of life
Zeitfenster: 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
Zeitfenster: Day of delivery

Arterial pH, CO2, and base excess

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Gabriela Dellapiana, MD, Cedars-Sinai Medical Center

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. November 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2027

Studienabschluss (Geschätzt)

1. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

19. Oktober 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. November 2026

Zuerst gepostet (Tatsächlich)

13. November 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

To protect patient confidentiality

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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