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Ambulation for Latency During Expectant Management of PPROM

NCT04230967 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-08-28

No results posted yet for this study

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

  • Preterm Premature Rupture of the Membranes
  • Pregnancy Complications
  • Pregnancy, High Risk

Interventions

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

Sponsors & Collaborators

  • Fitbit Health Solutions

    collaborator UNKNOWN

  • Thrasher Research Fund

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-10
Primary Completion
2022-07-22
Completion
2023-03-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04230967 on ClinicalTrials.gov