Ambulation for Latency During Expectant Management of PPROM
NCT ID: NCT04230967
Last Updated: 2023-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2020-03-10
2023-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
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
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.
Routine Care
No encouragement to ambulate will be provided to subjects. Their movement will be recorded
Interventions
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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
Routine Care
No encouragement to ambulate will be provided to subjects. Their movement will be recorded
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
55 Years
FEMALE
No
Sponsors
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Fitbit Health Solutions
UNKNOWN
Thrasher Research Fund
OTHER
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Beth Leong Pineles
Fellow
Locations
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Universtiy of Texas Health Science Center
Houston, Texas, United States
Countries
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Other Identifiers
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HSC-MS-19-0982
Identifier Type: -
Identifier Source: org_study_id
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