Pregnancy Complications, Pregnancy, High Risk, Preterm Premature Rupture of the Membranes
Conditions
Keywords
pregnancy, PPROM
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.
Interventions
BEHAVIORALAmbulation Group
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
BEHAVIORALRoutine Care
No encouragement to ambulate will be provided to subjects. Their movement will be recorded
Sponsors
Fitbit Health Solutions
Thrasher Research Fund
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
12 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Latency (measured in days) from from randomization to delivery | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| # of subjects with Placental abruption | at delivery | — |
| # of subjects with Cesarean delivery (and emergent cesarean delivery) | at delivery | — |
| # of subjects with Umbilical cord prolapse | at delivery | — |
| # of subjects with Maternal venous thromboembolism | at delivery | — |
| Maternal Readmission | within 6 weeks of delivery- 6 weeks | — |
| Time to delivery (time-to-event outcome) | 12 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 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 |
| 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 |
| 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 |
| Fetal or neonatal death | at discharge | — |
| Maternal Infectious morbidity | at delivery | Chorioamnionitis, endometritis |
| Umbilical arterial pH < 7.00 | at delivery | — |
| # 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 |
| # 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 necrotizing enterocolitis (NEC) | 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 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. |
| Gestational age at delivery < 28 weeks | at delivery | — |
| Gestational age at delivery < 34 weeks | at delivery | — |
| Neonatal length of hospital stay, based on admission to NICU or intermediate care unit | at discharge | — |
| Composite adverse maternal outcome (CMAO) | at discharge | — |
| Composite adverse fetal/neonatal outcome | at discharge | — |
| Apgar score < 5 at 5 minutes of life | at delivery | — |
Countries
United States
Outcome results
None listed