Ambulation for Latency During Expectant Management of PPROM (AMBLE)

August 24, 2023 updated by: Beth Leong Pineles, The University of Texas Health Science Center, Houston

Ambulation for Latency During Expectant Management of PPROM: A Randomized Controlled Trial (AMBLE)

Ambulation in pregnancy has been proposed to decrease stress and anxiety, increasing preterm birth. Whether ambulation is causally related to latency is unknown. The FitBit will be used for tracking the number of steps taken daily by each participant, and for encouraging the intervention group to walk. The FitBit is the most widely used physical activity tracker in medical research, and its use has been validated for research use in pregnant women. The purpose of the study is to evaluate whether ambulation in patients with preterm premature rupture of the membranes (PPROM) prolongs latency.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

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 (Actual)

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.
100

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 Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Universtiy of Texas Health Science Center

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

12 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Pregnant women aged 12-55
  • Gestational age 23 0/7 to 35 0/7 weeks
  • PPROM confirmed by clinical diagnosis which includes sterile speculum examination with pooling, ferning, and nitrazine tests, or the Amnisure ROM Test
  • Planned inpatient expectant management with delivery goal >=7 days from enrollment
  • Ability to provide informed consent in English or Spanish

Exclusion Criteria

  • Imminent delivery
  • Transverse or footling breech presentation (if multiple gestation, presenting fetus)
  • Unstable lie (if multiple gestation, presenting fetus)
  • Funic presentation (if multiple gestation, presenting fetus)
  • Active vaginal bleeding
  • Regular, painful contractions (>=3 in 10 minutes for 30 minutes or more) consistent with labor
  • Clinical contraindication to ambulation as determined by the managing physician
  • Physician declines to have the patient approached for participation
  • Lethal fetal anomalies

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: Randomized
  • Interventional Model: Parallel 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: Ambulation Group
Participants in the ambulation arm will be allowed ad lib activity and instructed that they should walk at least once per day out of their room with a goal of 2,000 steps per day. The Fitbit InspireTM devices will be set to this goal and notifications will be given on the device for the participants meeting their goals. Upon enrollment, they will be given a pamphlet with instructions to ambulate out of the room at least once per day with a goal of 2,000 steps daily and their Fitbits will be pre-programmed with this goal. Study staff will also remind participants to ambulate via email, text or in-person if they are not meeting their goal of 2,000 steps per day.
Behavioral: Ambulation Group
Participants in the ambulation arm will be allowed ad lib activity and instructed that they should walk at least once per day out of their room with a goal of 2,000 steps per day. The Fitbit Inspire devices will be set to this goal and notifications will be given on the device for the participants meeting their goals
Active Comparator: Routine Care
Participants in the routine care arm will be allowed ad lib activity but no encouragement to walk will be given. They will not have any goals set on their Fitbits. Upon enrollment, they will be given pamphlets with no instruction on whether or not to ambulate and their Fitbits will be pre-programmed to have no goal.
Behavioral: Routine Care
No encouragement to ambulate will be provided to subjects. Their movement will be recorded

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
Latency (measured in days) from from randomization to delivery
Time Frame: 12 weeks
12 weeks

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
Maternal Infectious morbidity
Time Frame: at delivery
Chorioamnionitis, endometritis
at delivery
# of subjects with Placental abruption
Time Frame: at delivery
at delivery
# of subjects with Cesarean delivery (and emergent cesarean delivery)
Time Frame: at delivery
at delivery
# of subjects with Umbilical cord prolapse
Time Frame: at delivery
at delivery
# of subjects with Maternal venous thromboembolism
Time Frame: at delivery
at delivery
Maternal Readmission
Time Frame: within 6 weeks of delivery- 6 weeks
within 6 weeks of delivery- 6 weeks
Time to delivery (time-to-event outcome)
Time Frame: 12 weeks
12 weeks
Delivered at >7 days post randomization
Time Frame: at delivery
at delivery
Maternal antepartum hospitalization length of stay
Time Frame: from admission to delivery
from admission to delivery
Measurement of Stress outcomes utilizing Perceived Stress Scale (PSS)
Time Frame: 7 days
comparison between 2 groups- as measured by validated Stress survey. Scaled 0-4 corresponding response of Never to very often respectively. Change from baseline to day 7
7 days
Measurement of Anxiety outcomes utilizing State Trait Anxiety Inventory (STAI)
Time Frame: 7 days
comparison between 2 groups-as measured by validated anxiety survey. Scaled 1-4 corresponding response of Not at all to very much so. Change from baseline to day 7
7 days
Measurement of Depression outcomes utilizing Edinburgh Depression Scale (EDS)
Time Frame: 7 days
comparison between 2 groups-as measured by validated depression scale. Maximum score: 30 Possible Depression: 10 or greater Always look at item 10 (suicidal thoughts) Change from baseline to day 7
7 days
Measurement of Patient Satisfaction by validated satisfaction survey between 2 groups
Time Frame: at delivery
comparison between 2 groups-as measured by validated survey from the last questionnaire answered prior to delivery
at delivery
Fetal or neonatal death
Time Frame: at discharge
at discharge
Apgar score < 5 at 5 minutes of life
Time Frame: at delivery
at delivery
Umbilical arterial pH < 7.00
Time Frame: at delivery
at delivery
# of neonates with Small for gestational age
Time Frame: at delivery
defined as < 5th percentile weight for gestational age, assessed specifically by sex and race of the infant based on United States birth certificate data
at delivery
# of neonates with Neonatal intraventricular hemorrhage (IVH) grades III or IV
Time Frame: at discharge
as determined by cranial ultrasounds performed as part of routine clinical care and classified based on the Papule classification system
at discharge
# of neonates with Neonatal periventricular leukomalacia (PVL)
Time Frame: at discharge
at discharge
# of neonates with Neonatal necrotizing enterocolitis (NEC)
Time Frame: at discharge
at discharge
# of neonates with Neonatal retinopathy of prematurity (ROP).
Time Frame: at discharge
This diagnosis will be reached when an ophthalmologic examination of the retina has been performed and ROP is diagnosed at Stage I (demarcation line in the retina) or greater.
at discharge
# of neonates with Bronchopulmonary dysplasia (BPD)
Time Frame: at discharge
defined as oxygen requirement at 28 days of life or at 36 weeks postmenstrual age for infants born before 32 weeks.
at discharge
Gestational age at delivery < 28 weeks
Time Frame: at delivery
at delivery
Gestational age at delivery < 34 weeks
Time Frame: at delivery
at delivery
Neonatal length of hospital stay, based on admission to NICU or intermediate care unit
Time Frame: at discharge
at discharge
Composite adverse maternal outcome (CMAO)
Time Frame: at discharge
at discharge
Composite adverse fetal/neonatal outcome
Time Frame: at discharge
at discharge

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.
The University of Texas Health Science Center, Houston

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Thrasher Research Fund
Fitbit Health Solutions

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 (Actual)

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.
March 10, 2020

Primary Completion (Actual)

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.
July 22, 2022

Study Completion (Actual)

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.
March 30, 2023

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).
January 13, 2020

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.
January 13, 2020

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.
January 18, 2020

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.
August 28, 2023

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.
August 24, 2023

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.
August 1, 2023

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.
  • HSC-MS-19-0982

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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