Ambulation for Latency During Expectant Management of PPROM (AMBLE)

The University of Texas System (UT)

Status: Completed

Conditions: Pregnancy Complications; Preterm Premature Rupture of the Membranes; Pregnancy, High Risk

Treatments: Behavioral: Routine Care; Behavioral: Ambulation Group

Study type: Interventional

Funder types: Other

Identifiers

NCT04230967

HSC-MS-19-0982

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Ages: 12 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Ambulation Group

Experimental group

Description:

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.

Treatment:

Behavioral: Ambulation Group

Routine Care

Active Comparator group

Description:

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:

Behavioral: Routine Care