Ambulation for Latency during Expectant Management of PPROM: A Randomized Controlled Trial (AMBLE)
Beth Pineles, MD, PhD
BACKGROUND: Preterm prelabor rupture of the membranes (PPROM) causes preterm delivery, a major cause of neonatal and childhood morbidity and mortality. PPROM occurs in 3% of pregnancies.
GAP: Women are traditionally treated with hospitalization and bedrest or limited activity from the time of PPROM until delivery. However, evidence does not suggest that bedrest has any benefits, and a small, observational study suggests that ambulation prolongs pregnancy in women with PPROM.
HYPOTHESIS: Encouraging patients to walk at least 2,000 steps per day increases the time from PPROM to delivery (latency) compared with routine care.
METHODS: The study is an unmasked, two-armed randomized controlled trial to assess the impact of ambulation on latency from admission to delivery in women hospitalized with PPROM from 23 to 33 weeks of gestation. All participants will be given a complimentary Fitbit. Women will be instructed to wear the Fitbit 24 hours a day. Participants in the ambulation arm will be instructed that they should walk out of their room with a goal of 2,000 steps per day. The Fitbit devices will be set to this goal and notifications will be given on the device for the participants meeting their goals. Participants in the routine care arm will have no encouragement to walk. They will not have any goals set on their Fitbits.
IMPACT: This research is a first step toward optimizing care for women with PPROM and improving neonatal outcomes by increasing latency to delivery.