Ambulation for Latency During Expectant Management of PPROM
- Conditions
- Preterm Premature Rupture of the MembranesPregnancy ComplicationsPregnancy, High Risk
- Registration Number
- NCT04230967
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Latency (measured in days) from from randomization to delivery 12 weeks
- Secondary Outcome Measures
Name Time Method # of subjects with Cesarean delivery (and emergent cesarean delivery) at delivery Time to delivery (time-to-event outcome) 12 weeks Fetal or neonatal death at discharge Composite adverse fetal/neonatal outcome at discharge Measurement of Anxiety outcomes utilizing State Trait Anxiety Inventory (STAI) 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
# of neonates with Small for gestational age 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
Gestational age at delivery < 34 weeks at delivery Neonatal length of hospital stay, based on admission to NICU or intermediate care unit at discharge # of subjects with Placental abruption at delivery # of subjects with Maternal venous thromboembolism at delivery Measurement of Depression outcomes utilizing Edinburgh Depression Scale (EDS) 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
# of neonates with Bronchopulmonary dysplasia (BPD) at discharge defined as oxygen requirement at 28 days of life or at 36 weeks postmenstrual age for infants born before 32 weeks.
Composite adverse maternal outcome (CMAO) at discharge Maternal Readmission within 6 weeks of delivery- 6 weeks Delivered at >7 days post randomization at delivery Maternal antepartum hospitalization length of stay from admission to delivery Measurement of Stress outcomes utilizing Perceived Stress Scale (PSS) 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 Patient Satisfaction by validated satisfaction survey between 2 groups at delivery comparison between 2 groups-as measured by validated survey from the last questionnaire answered prior to delivery
# of neonates with Neonatal intraventricular hemorrhage (IVH) grades III or IV 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) at discharge # of neonates with Neonatal retinopathy of prematurity (ROP). 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 subjects with Umbilical cord prolapse at delivery Gestational age at delivery < 28 weeks at delivery Maternal Infectious morbidity at delivery Chorioamnionitis, endometritis
Umbilical arterial pH < 7.00 at delivery # of neonates with Neonatal necrotizing enterocolitis (NEC) at discharge Apgar score < 5 at 5 minutes of life at delivery
Trial Locations
- Locations (1)
Universtiy of Texas Health Science Center
🇺🇸Houston, Texas, United States
Universtiy of Texas Health Science Center🇺🇸Houston, Texas, United States