Back to resultsAmbulation for Latency During Expectant Management of PPROM (AMBLE)
Primary Purpose
Preterm Premature Rupture of the Membranes, Pregnancy Complications, Pregnancy, High Risk
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ambulation Group
Routine Care
Sponsored by
About this trial
This is an interventional other trial for Preterm Premature Rupture of the Membranes focused on measuring pregnancy, PPROM
Eligibility Criteria
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
Sites / Locations
- Universtiy of Texas Health Science Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ambulation Group
Routine Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Latency (measured in days) from from randomization to delivery
Secondary Outcome Measures
Maternal Infectious morbidity
Chorioamnionitis, endometritis
# of subjects with Placental abruption
# of subjects with Cesarean delivery (and emergent cesarean delivery)
# of subjects with Umbilical cord prolapse
# of subjects with Maternal venous thromboembolism
Maternal Readmission
Time to delivery (time-to-event outcome)
Delivered at >7 days post randomization
Maternal antepartum hospitalization length of stay
Measurement of Stress outcomes utilizing Perceived Stress Scale (PSS)
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
Measurement of Anxiety outcomes utilizing State Trait Anxiety Inventory (STAI)
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
Measurement of Depression outcomes utilizing Edinburgh Depression Scale (EDS)
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
Measurement of Patient Satisfaction by validated satisfaction survey between 2 groups
comparison between 2 groups-as measured by validated survey from the last questionnaire answered prior to delivery
Fetal or neonatal death
Apgar score < 5 at 5 minutes of life
Umbilical arterial pH < 7.00
# of neonates with Small for gestational age
defined as < 5th percentile weight for gestational age, assessed specifically by sex and race of the infant based on United States birth certificate data
# of neonates with Neonatal intraventricular hemorrhage (IVH) grades III or IV
as determined by cranial ultrasounds performed as part of routine clinical care and classified based on the Papule classification system
# of neonates with Neonatal periventricular leukomalacia (PVL)
# of neonates with Neonatal necrotizing enterocolitis (NEC)
# of neonates with Neonatal retinopathy of prematurity (ROP).
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.
# of neonates with Bronchopulmonary dysplasia (BPD)
defined as oxygen requirement at 28 days of life or at 36 weeks postmenstrual age for infants born before 32 weeks.
Gestational age at delivery < 28 weeks
Gestational age at delivery < 34 weeks
Neonatal length of hospital stay, based on admission to NICU or intermediate care unit
Composite adverse maternal outcome (CMAO)
Composite adverse fetal/neonatal outcome
Full Information
NCT ID
NCT04230967
First Posted
January 13, 2020
Last Updated
August 24, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Fitbit Health Solutions, Thrasher Research Fund
1. Study Identification
Unique Protocol Identification Number
NCT04230967
Brief Title
Ambulation for Latency During Expectant Management of PPROM
Acronym
AMBLE
Official Title
Ambulation for Latency During Expectant Management of PPROM: A Randomized Controlled Trial (AMBLE)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
July 22, 2022 (Actual)
Study Completion Date
March 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Fitbit Health Solutions, Thrasher Research Fund
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Premature Rupture of the Membranes, Pregnancy Complications, Pregnancy, High Risk
Keywords
pregnancy, PPROM
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ambulation Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Ambulation Group
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Routine Care
Intervention Description
No encouragement to ambulate will be provided to subjects. Their movement will be recorded
Primary Outcome Measure Information:
Title
Latency (measured in days) from from randomization to delivery
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Maternal Infectious morbidity
Description
Chorioamnionitis, endometritis
Time Frame
at delivery
Title
# of subjects with Placental abruption
Time Frame
at delivery
Title
# of subjects with Cesarean delivery (and emergent cesarean delivery)
Time Frame
at delivery
Title
# of subjects with Umbilical cord prolapse
Time Frame
at delivery
Title
# of subjects with Maternal venous thromboembolism
Time Frame
at delivery
Title
Maternal Readmission
Time Frame
within 6 weeks of delivery- 6 weeks
Title
Time to delivery (time-to-event outcome)
Time Frame
12 weeks
Title
Delivered at >7 days post randomization
Time Frame
at delivery
Title
Maternal antepartum hospitalization length of stay
Time Frame
from admission to delivery
Title
Measurement of Stress outcomes utilizing Perceived Stress Scale (PSS)
Description
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
Time Frame
7 days
Title
Measurement of Anxiety outcomes utilizing State Trait Anxiety Inventory (STAI)
Description
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
Time Frame
7 days
Title
Measurement of Depression outcomes utilizing Edinburgh Depression Scale (EDS)
Description
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
Time Frame
7 days
Title
Measurement of Patient Satisfaction by validated satisfaction survey between 2 groups
Description
comparison between 2 groups-as measured by validated survey from the last questionnaire answered prior to delivery
Time Frame
at delivery
Title
Fetal or neonatal death
Time Frame
at discharge
Title
Apgar score < 5 at 5 minutes of life
Time Frame
at delivery
Title
Umbilical arterial pH < 7.00
Time Frame
at delivery
Title
# of neonates with Small for gestational age
Description
defined as < 5th percentile weight for gestational age, assessed specifically by sex and race of the infant based on United States birth certificate data
Time Frame
at delivery
Title
# of neonates with Neonatal intraventricular hemorrhage (IVH) grades III or IV
Description
as determined by cranial ultrasounds performed as part of routine clinical care and classified based on the Papule classification system
Time Frame
at discharge
Title
# of neonates with Neonatal periventricular leukomalacia (PVL)
Time Frame
at discharge
Title
# of neonates with Neonatal necrotizing enterocolitis (NEC)
Time Frame
at discharge
Title
# of neonates with Neonatal retinopathy of prematurity (ROP).
Description
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.
Time Frame
at discharge
Title
# of neonates with Bronchopulmonary dysplasia (BPD)
Description
defined as oxygen requirement at 28 days of life or at 36 weeks postmenstrual age for infants born before 32 weeks.
Time Frame
at discharge
Title
Gestational age at delivery < 28 weeks
Time Frame
at delivery
Title
Gestational age at delivery < 34 weeks
Time Frame
at delivery
Title
Neonatal length of hospital stay, based on admission to NICU or intermediate care unit
Time Frame
at discharge
Title
Composite adverse maternal outcome (CMAO)
Time Frame
at discharge
Title
Composite adverse fetal/neonatal outcome
Time Frame
at discharge
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Universtiy of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Ambulation for Latency During Expectant Management of PPROM
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