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

November 6, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Gabriela Dellapiana, MD
  • Phone Number: 3104237417

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
        • Contact:
        • Contact:
          • Gabriela Dellapiana, MD
          • Phone Number: 3104237417

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Encouraged to Ambulate

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

Ambulate ≥3500 steps per day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Days of latency until delivery
Time Frame: From hospital admission to delivery
From hospital admission to delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants who experience a thromboembolic event
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: Day of delivery

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

Only for patients who deliver via cesarean delivery
Day of delivery
Gestational age at delivery
Time Frame: Day of delivery
Day of delivery
Neonatal birth weight
Time Frame: Day of delivery
Day of delivery
APGAR score at 5 minutes of life
Time Frame: 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
Time Frame: Day of delivery

Arterial pH, CO2, and base excess
Day of delivery
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
From delivery until day of neonatal hospital discharge, varies based on gestational age at delivery
Neonatal length of hospital stay
Time Frame: 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
Time Frame: From admission until delivery
From admission until delivery
Number of participants who receive antenatal magnesium sulfate
Time Frame: From admission until delivery
From admission until delivery
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
From admission until day of neonatal hospital discharge (or death when applicable), varies based on gestational age at delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cedars-Sinai Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gabriela Dellapiana, MD, Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00004892

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To protect patient confidentiality

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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