Ambulation for Latency During Expectant Management of PPROM

The University of Texas Health Science Center, Houston100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

100

Conditions

Preterm Premature Rupture of the Membranes Pregnancy Complications Pregnancy, High Risk

Interventions

Ambulation GroupBEHAVIORAL

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 CareBEHAVIORAL

No encouragement to ambulate will be provided to subjects. Their movement will be recorded

Eligibility

Sex: FEMALEMin age: 12 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Universtiy of Texas Health Science Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Latency (measured in days) from from randomization to delivery

Time frame: 12 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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