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Not yet recruitingNCT07935161STEPUpdated Nov 13, 2026

Steps to Extend Latency in Preterm Prelabor Rupture of Membranes

An interventional study of Ambulate in Preterm Prelabor Rupture of Membranes (PPROM), sponsored by Cedars-Sinai Medical Center. Not yet recruiting at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Other

Updated Nov 13, 2026Newly registeredGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 27 studies in Preterm Premature Rupture of the Membranes with a site in United States — 8 open to participants now, 10 under way, 1 of them phase 3. Preterm Premature Rupture of the Membranes · United States.

Planned enrollment
8th of 21
60 · median 56
Started
2026
with 1 other
No phase
9 of 27
3 open now
Registered
27th of 27
by date
Lead sponsor
1 of 27
Cedars-Sinai Medical Center

Among the 27 studies in Preterm Premature Rupture of the Membranes with a site in United States, this one is the 8th largest by planned enrollment of the 21 interventional ones that give a count, is one of 2 that started in 2026, is one of 9 with no phase, and was the 27th registered.

Preterm Premature Rupture of the Membranes

76 studies on the registry are indexed under Preterm Premature Rupture of the Membranes; 18 are open to participants now.

Browse Preterm Premature Rupture of the Membranes studies →

Open to participants now

8 of the 27 studies in Preterm Premature Rupture of the Membranes with a site in United States are open now. Recruiting first, the newest first:

2 more — sign in →

All 8 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 11 Preterm Premature Rupture of the Membranes studies recruiting now, 7 (64%) set no upper age limit and 4 (36%) stop at 75 or younger; 4 take children under 18; 3 take healthy volunteers.

This study: female · no healthy volunteers.

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02

Study summary

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.

Read the detailed description

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.

03

Conditions studied

  • Preterm Prelabor Rupture of Membranes (PPROM)

Keywords

  • PPROM
  • Exercise
  • Walking
  • Physical Activity
  • Pregnancy
  • Preterm Birth
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Planned inpatient expectant management of ≥7 days
  • Phone capable of monitoring and sharing step count
  • Singleton or dichorionic twin gestation

Exclusion criteria

Exclusion Criteria:

  • Any records flagged "break the glass" or "research opt out"
  • Transverse, footling breech, or funic presentations
  • Active preterm labor
  • Active vaginal bleeding
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Encouraged to Ambulate

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

    Behavioral: Ambulate

Interventions

  • BehavioralAmbulate

    Ambulate ≥3500 steps per day

06

What researchers measure

Primary outcomes

  1. Days of latency until delivery

    Time frame: From hospital admission to delivery

Secondary outcomes

  1. Number of participants who experience a thromboembolic event

    Time frame: From admission until maternal hospital discharge, an average of 1-4 days after delivery

  2. Number of participants who experience a postpartum hemorrhage

    Postpartum hemorrhage is defined as EBL/QBL \>= 1000mL

    Time frame: From admission until maternal hospital discharge, an average of 1-4 days after delivery

  3. Number of participants who experience maternal sepsis

    Time frame: From admission until maternal hospital discharge, an average of 1-4 days after delivery

  4. Number of participants who are admitted to the Intensive Care Unit (ICU)

    Time frame: From admission until maternal hospital discharge, an average of 1-4 days after delivery

  5. Days of postpartum length of stay

    Time frame: From admission until maternal hospital discharge, an average of 1-4 days after delivery

  6. Mode of delivery

    Vaginal delivery versus cesarean section

    Time frame: Day of delivery

  7. Estimated or quantitative delivery blood loss

    Time frame: From admission until maternal hospital discharge, an average of 1-4 days after delivery

  8. Number of participants who experience an intraamniotic infection

    Time frame: From admission until maternal hospital discharge, an average of 1-4 days after delivery

  9. Number of patients who experience a placental abruption

    Time frame: From admission until delivery

  10. Number of patients who experience an umbilical cord prolapse

    Time frame: From admission until delivery

  11. Spontaneous versus induced labor

    Time frame: From admission until delivery

  12. Indication for cesarean delivery

    Only for patients who deliver via cesarean delivery

    Time frame: Day of delivery

  13. Gestational age at delivery

    Time frame: Day of delivery

  14. Neonatal birth weight

    Time frame: Day of delivery

  15. APGAR score at 5 minutes of life

    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.

    Time frame: 5 minutes of life on day of delivery

  16. Umbilical cord blood gas values

    Arterial pH, CO2, and base excess

    Time frame: Day of delivery

  17. Number of neonates who require Neonatal Intensive Care Unit (NICU) admission

    Time frame: From delivery until day of neonatal hospital discharge, varies based on gestational age at delivery

  18. Neonatal length of hospital stay

    Time frame: From delivery until day of neonatal hospital discharge, varies based on gestational age at delivery

  19. Number of participants who receive at least one course of antenatal corticosteroids

    Time frame: From admission until delivery

  20. Number of participants who receive antenatal magnesium sulfate

    Time frame: From admission until delivery

  21. Number of neonatal deaths

    Time frame: From admission until day of neonatal hospital discharge (or death when applicable), varies based on gestational age at delivery

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — To protect patient confidentiality

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2026
First posted
Nov 13, 2026
StartEst.
Nov 2026
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2027
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07935161
Responsible party
Gabriela Dellapiana (Principal Investigator, Cedars-Sinai Medical Center) — Principal investigator
First posted
Nov 13, 2026
Start date
Nov 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Nov 13, 2026

Study contacts

Glenda Marshall, MD
Contact
glenda.marshall@cshs.org
4243244193
Gabriela Dellapiana, MD
Contact
3104237417
Gabriela Dellapiana, MD
principal investigator · Cedars-Sinai Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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