Ambulation for Latency During Expectant Management of PPROM

Study Overview
=================
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.

Official Title
-----------------
Ambulation for Latency During Expectant Management of PPROM: A Randomized Controlled Trial (AMBLE)

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

Intervention / Treatment
-----------------
* Behavioral: Ambulation Group
* Behavioral: Routine Care


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ambulation Group<br>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<br>* 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<br>|
| Active Comparator: Routine Care<br>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<br>* No encouragement to ambulate will be provided to subjects. Their movement will be recorded<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Latency (measured in days) from from randomization to delivery |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Infectious morbidity | Chorioamnionitis, endometritis | at delivery | 
| # 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) | 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 | 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 | 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 | 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 | at delivery | 
| Fetal or neonatal death |  | at discharge | 
| Apgar score < 5 at 5 minutes of life |  | at delivery | 
| Umbilical arterial pH < 7.00 |  | 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 | 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 | at discharge | 
| # 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). | 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. | 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. | at discharge | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnancy, PPROM