Ambulation for Latency During Expectant Management of PPROM

NCT04230967 | Completed DMC

• 1 other identifier: HSC-MS-19-0982
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pregnancy; PPROM

Outcome Measures

Primary Outcomes (1)

• Latency (measured in days) from from randomization to delivery

  12 weeks

Secondary Outcomes (27)

• Maternal Infectious morbidity

  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

Study Arms (2)

Ambulation Group

EXPERIMENTAL

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

Routine Care

ACTIVE COMPARATOR

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

Interventions

Ambulation Group BEHAVIORAL

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

Ambulation Group

Routine Care BEHAVIORAL

No encouragement to ambulate will be provided to subjects. Their movement will be recorded

Routine Care

Eligibility Criteria

• Age: 12 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Fitbit Health Solutions: collaborator
• Thrasher Research Fund: collaborator

Study Sites (1)

Universtiy of Texas Health Science Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes; Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 18, 2020
• Study Start: March 10, 2020
• Primary Completion: July 22, 2022
• Study Completion: March 30, 2023
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)