Universtiy of Texas Health Science Center
Houston, Texas, 77030, United States
Completed
NCT Number: NCT04230967
Ambulation for Latency During Expectant Management of PPROM
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.
Completed
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Notify MeKey information
Conditions
Age range
12 year–55 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Ambulation Group
BehavioralParticipants 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
BehavioralNo encouragement to ambulate will be provided to subjects. Their movement will be recorded
Primary outcomes
-
Latency (measured in days) from from randomization to delivery
Time frame: 12 weeks
Secondary outcomes
-
Maternal Infectious morbidity
Time frame: at delivery
Chorioamnionitis, endometritis
-
# 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
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)
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
-
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
-
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
-
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
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
Time frame: at discharge
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)
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
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)
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.
-
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
Sponsors and collaborators
Lead sponsor
The University of Texas Health Science Center, Houston
Other
Collaborators
- Fitbit Health Solutions
- Thrasher Research Fund
Registry information
Official study title
Ambulation for Latency During Expectant Management of PPROM: A Randomized Controlled Trial (AMBLE)
Acronym: AMBLE
Important dates
- Study start
- 2020
- Primary completion
- 2022
- Study completion
- 2023
- First posted
- Jan 18, 2020
- Registry last updated
- Aug 28, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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