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Ambulation Group for Premature Rupture of Membranes (AMBLE Trial)

N/A
Waitlist Available
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at discharge
Awards & highlights

AMBLE Trial Summary

This trial will use FitBits to track how much pregnant women walk. They hope to find out if walking can help prevent preterm birth.

Eligible Conditions
  • Premature Rupture of Membranes
  • Pregnancy Complications
  • Pregnancies

AMBLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and at delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Latency (measured in days) from from randomization to delivery
Secondary outcome measures
# of neonates with Bronchopulmonary dysplasia (BPD)
# of neonates with Neonatal intraventricular hemorrhage (IVH) grades III or IV
# of neonates with Neonatal necrotizing enterocolitis (NEC)
+24 more

AMBLE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ambulation GroupExperimental Treatment1 Intervention
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.
Group II: Routine CareActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ambulation Group
2020
N/A
~100

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,860 Total Patients Enrolled
Thrasher Research FundOTHER
132 Previous Clinical Trials
94,274 Total Patients Enrolled
Fitbit Health SolutionsUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Ambulation for Latency During Expectant Management of PPROM
Beth Leong Pineles 2020. "Ambulation for Latency During Expectant Management of PPROM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04230967.
~20 spots leftby Apr 2025
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