Trials / Completed
CompletedNCT04230967
Ambulation for Latency During Expectant Management of PPROM
Ambulation for Latency During Expectant Management of PPROM: A Randomized Controlled Trial (AMBLE)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- The University of Texas Health Science Center, Houston · Academic / Other
- Sex
- Female
- Age
- 12 Years – 55 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
| BEHAVIORAL | Routine Care | No encouragement to ambulate will be provided to subjects. Their movement will be recorded |
Timeline
- Start date
- 2020-03-10
- Primary completion
- 2022-07-22
- Completion
- 2023-03-30
- First posted
- 2020-01-18
- Last updated
- 2023-08-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04230967. Inclusion in this directory is not an endorsement.