Clinical trial NCT04230967: Ambulation for Latency During Expectant Management of PPROM
Official title: Ambulation for Latency During Expectant Management of PPROM: A Randomized Controlled Trial (AMBLE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Premature Rupture of the Membranes
Pregnancy Complications
Pregnancy, High Risk
Keywords: pregnancy
PPROM
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Fitbit Health Solutions
name: Thrasher Research Fund
First posted: 2020-01-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Latency (measured in days) from from randomization to delivery
timeFrame: 12 weeks
Secondary outcomes:
measure: Maternal Infectious morbidity
timeFrame: at delivery
measure: # of subjects with Placental abruption
timeFrame: at delivery
measure: # of subjects with Cesarean delivery (and emergent cesarean delivery)
timeFrame: at delivery
measure: # of subjects with Umbilical cord prolapse
timeFrame: at delivery
measure: # of subjects with Maternal venous thromboembolism
timeFrame: at delivery
measure: Maternal Readmission
timeFrame: within 6 weeks of delivery- 6 weeks
measure: Time to delivery (time-to-event outcome)
timeFrame: 12 weeks
measure: Delivered at >7 days post randomization
timeFrame: at delivery
measure: Maternal antepartum hospitalization length of stay
timeFrame: from admission to delivery
measure: Measurement of Stress outcomes utilizing Perceived Stress Scale (PSS)
timeFrame: 7 days
measure: Measurement of Anxiety outcomes utilizing State Trait Anxiety Inventory (STAI)
timeFrame: 7 days
measure: Measurement of Depression outcomes utilizing Edinburgh Depression Scale (EDS)
timeFrame: 7 days
measure: Measurement of Patient Satisfaction by validated satisfaction survey between 2 groups
timeFrame: at delivery
measure: Fetal or neonatal death
timeFrame: at discharge
measure: Apgar score < 5 at 5 minutes of life
timeFrame: at delivery
measure: Umbilical arterial pH < 7.00
timeFrame: at delivery
measure: # of neonates with Small for gestational age
timeFrame: at delivery
measure: # of neonates with Neonatal intraventricular hemorrhage (IVH) grades III or IV
timeFrame: at discharge
measure: # of neonates with Neonatal periventricular leukomalacia (PVL)
timeFrame: at discharge
measure: # of neonates with Neonatal necrotizing enterocolitis (NEC)
timeFrame: at discharge
measure: # of neonates with Neonatal retinopathy of prematurity (ROP).
timeFrame: at discharge
measure: # of neonates with Bronchopulmonary dysplasia (BPD)
timeFrame: at discharge
measure: Gestational age at delivery < 28 weeks
timeFrame: at delivery
measure: Gestational age at delivery < 34 weeks
timeFrame: at delivery
measure: Neonatal length of hospital stay, based on admission to NICU or intermediate care unit
timeFrame: at discharge
measure: Composite adverse maternal outcome (CMAO)
timeFrame: at discharge
measure: Composite adverse fetal/neonatal outcome
timeFrame: at discharge
Other outcomes:
Locations:
city: Houston
country: United States
facility: Universtiy of Texas Health Science Center
state: Texas
Study officials:
References: