An interventional study of Ambulation Group and Routine Care in Preterm Premature Rupture of the Membranes, Pregnancy Complications and Pregnancy, High Risk, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to female participants aged 12 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-08-28.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Other
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.
437 studies on the registry are indexed under Pregnancy Complications; 119 are open to participants now.
This study's enrollment of 100 is below the median of 147 across 220 interventional studies indexed under Pregnancy Complications.
Browse Pregnancy Complications studies →The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
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 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
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
No encouragement to ambulate will be provided to subjects. Their movement will be recorded
Latency (measured in days) from from randomization to delivery
Time frame: 12 weeks
Maternal Infectious morbidity
Chorioamnionitis, endometritis
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)
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
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
Time frame: 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
Time frame: 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
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
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
# 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
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).
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
# 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.
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The University of Texas Health Science Center, Houston