Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 12 Years and 55 Years
Eligible Genders
Female
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Universtiy of Texas Health Science Center
Houston, Texas 77030
Contact:
Beth Pineles, MD, PhD
713-500-6421
beth.l.pineles@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Beth Pineles, MD, PhD
713-500-6421
beth.l.pineles@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.