Ambulation for Latency During Expectant Management of PPROM (AMBLE)

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

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 Overview

• Status: Completed
• Conditions: Pregnancy Complications; Pregnancy, High Risk; Preterm Premature Rupture of the Membranes
• Intervention / Treatment: Behavioral: Ambulation Group; Behavioral: Routine Care

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Universtiy of Texas Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ambulation 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 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; 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
Active Comparator: Routine Care; 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; No encouragement to ambulate will be provided to subjects. Their movement will be recorded

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Thrasher Research Fund; Fitbit Health Solutions

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2020
• Primary Completion (Actual): July 22, 2022
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: pregnancy; PPROM
• Additional Relevant MeSH Terms: Wounds and Injuries; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Rupture; Pregnancy Complications
• Other Study ID Numbers: HSC-MS-19-0982

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No