Preterm Premature Rupture of the MembranesAMBLENCT04230967
Ambulation for Latency During Expectant Management of PPROM
A study testing Ambulation Group and Routine Care in people with Preterm Premature Rupture of the Membranes and Pregnancy Complications, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 55 years, women only
- Conditions the study is for
- Preterm Premature Rupture of the Membranes, Pregnancy Complications, Pregnancy, High Risk
- What is being tested?
- Ambulation Group and Routine Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2020to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Clinical contraindication to ambulation as determined by the managing physician
- Physician declines to have the patient approached for participation
- Lethal fetal anomalies
Trial locations and contacts
1 site in 1 country.
United States1 site
Universtiy of Texas Health Science Center
Houston, Texas, 77030
About this study
Official title: 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.
- Being tested
- Ambulation Group, Routine Care
- Keywords
- pregnancy, PPROM
- Medical subject headings
- Preterm Premature Rupture of the Membranes, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulation GroupBehavioural
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 CareBehavioural
No encouragement to ambulate will be provided to subjects. Their movement will be recorded
| Study group | Role | What they receive |
|---|---|---|
| Ambulation Group | Experimental | 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. Receives: Behavioral: Ambulation Group |
| Routine Care | Active comparator | 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. Receives: Behavioral: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency (measured in days) from from randomization to delivery
Measured: 12 weeks
Secondary outcomes (27)
Maternal Infectious morbidity
Chorioamnionitis, endometritis
Measured: at delivery
# of subjects with Placental abruption
Measured: at delivery
# of subjects with Cesarean delivery (and emergent cesarean delivery)
Measured: at delivery
# of subjects with Umbilical cord prolapse
Measured: at delivery
# of subjects with Maternal venous thromboembolism
Measured: at delivery
Maternal Readmission
Measured: within 6 weeks of delivery- 6 weeks
Time to delivery (time-to-event outcome)
Measured: 12 weeks
Delivered at >7 days post randomization
Measured: at delivery
Maternal antepartum hospitalization length of stay
Measured: from admission to delivery
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
Measured: 7 days
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
Measured: 7 days
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
Measured: 7 days
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
Measured: at delivery
Fetal or neonatal death
Measured: at discharge
Apgar score < 5 at 5 minutes of life
Measured: at delivery
Umbilical arterial pH < 7.00
Measured: at delivery
# 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
Measured: at delivery
# 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
Measured: at discharge
# of neonates with Neonatal periventricular leukomalacia (PVL)
Measured: at discharge
# of neonates with Neonatal necrotizing enterocolitis (NEC)
Measured: at discharge
# 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.
Measured: at discharge
# 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.
Measured: at discharge
Gestational age at delivery < 28 weeks
Measured: at delivery
Gestational age at delivery < 34 weeks
Measured: at delivery
Neonatal length of hospital stay, based on admission to NICU or intermediate care unit
Measured: at discharge
Composite adverse maternal outcome (CMAO)
Measured: at discharge
Composite adverse fetal/neonatal outcome
Measured: at discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start10 Mar 2020
- Primary completion22 Jul 2022
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Premature Rupture of the MembranesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fitbit Health Solutions, Thrasher Research Fund
- Responsible party
- Principal investigator, Beth Leong Pineles, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230967
- Sponsor's protocol ID
- HSC-MS-19-0982
- Acronym
- AMBLE
- Status last verified
- Aug 2023
- First submitted
- 13 Jan 2020
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulation for Latency During Expectant Management of PPROM: A Randomized Controlled Trial (AMBLE)
- ClinicalTrials.gov ID
- NCT04230967
- Acronym / sponsor ID
- AMBLE / HSC-MS-19-0982
- Keywords
- pregnancy, PPROM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Fitbit Health Solutions, Thrasher Research Fund
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambulation Group | Experimental | Behavioral: Ambulation GroupParticipants 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. |
| Routine Care | Active comparator | Behavioral: Routine CareParticipants 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. |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambulation GroupParticipants 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 | Behavioural | Ambulation Group |
| Routine CareNo encouragement to ambulate will be provided to subjects. Their movement will be recorded | Behavioural | Routine Care |
Primary outcome
Latency (measured in days) from from randomization to delivery
Time frame: 12 weeks
27 secondary outcomes
Maternal Infectious morbidity
Time frame: at delivery
# of subjects with Placental abruption
Time frame: at delivery
# of subjects with Cesarean delivery (and emergent cesarean delivery)
Time frame: at delivery
# of subjects with Umbilical cord prolapse
Time frame: at delivery
# of subjects with Maternal venous thromboembolism
Time frame: at delivery
Maternal Readmission
Time frame: within 6 weeks of delivery- 6 weeks
Time to delivery (time-to-event outcome)
Time frame: 12 weeks
Delivered at >7 days post randomization
Time frame: at delivery
Maternal antepartum hospitalization length of stay
Time frame: from admission to delivery
Measurement of Stress outcomes utilizing Perceived Stress Scale (PSS)
Time frame: 7 days
Measurement of Anxiety outcomes utilizing State Trait Anxiety Inventory (STAI)
Time frame: 7 days
Measurement of Depression outcomes utilizing Edinburgh Depression Scale (EDS)
Time frame: 7 days
Measurement of Patient Satisfaction by validated satisfaction survey between 2 groups
Time frame: at delivery
Fetal or neonatal death
Time frame: at discharge
Apgar score < 5 at 5 minutes of life
Time frame: at delivery
Umbilical arterial pH < 7.00
Time frame: at delivery
# of neonates with Small for gestational age
Time frame: at delivery
# of neonates with Neonatal intraventricular hemorrhage (IVH) grades III or IV
Time frame: at discharge
# of neonates with Neonatal periventricular leukomalacia (PVL)
Time frame: at discharge
# of neonates with Neonatal necrotizing enterocolitis (NEC)
Time frame: at discharge
# of neonates with Neonatal retinopathy of prematurity (ROP).
Time frame: at discharge
# of neonates with Bronchopulmonary dysplasia (BPD)
Time frame: at discharge
Gestational age at delivery < 28 weeks
Time frame: at delivery
Gestational age at delivery < 34 weeks
Time frame: at delivery
Neonatal length of hospital stay, based on admission to NICU or intermediate care unit
Time frame: at discharge
Composite adverse maternal outcome (CMAO)
Time frame: at discharge
Composite adverse fetal/neonatal outcome
Time frame: at discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulation Group and Routine Care in people with Preterm Premature Rupture of the Membranes and Pregnancy Complications, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Latency (measured in days) from from randomization to delivery (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.