A RANDOMIZED MULTICENTER TRIAL ASSESSING A HOME UTERINE ACTIVITY MONITORING DEVICE USED IN THE ABSENCE OF DAILY NURSING CONTACT

OBJECTIVE: To evaluate the effectiveness of home uterine activity moni toring in the early detection of preterm labor among women with a hist ory of preterm delivery. STUDY DESIGN: Two hundred eighteen women from four centers were prospectively randomized to routine high-risk prena tal care alone (not monitored) or to the same prenatal care with twice -daily home uterine activity monitoring without daily nursing support (monitored). All women had a history of preterm delivery. The primary study end point was cervical status as measured by cervical dilatation at the time of diagnosis of preterm labor. RESULTS: The two study gro up populations at entry into the study were similar in medical and dem ographic characteristics. Of 187 women completing the trial, 21 (24.4% ) of the women in the monitored group (n = 86) and 22 (21.8%) of the w omen in the unmonitored (control) group (n = 101) experienced preterm labor (not significant). Mean cervical dilatation at the time of diagn osis of preterm labor was 1.7 cm in the monitored group and 2.8 cm in the unmonitored group (p = 0.004). A total of 52.4% of the women in th e monitored group had a cervical dilatation of <2 cm when preterm labo r was detected, compared with 18.2% of the women in the unmonitored gr oup (p = 0.019). The median duration of gestation after diagnosis of p reterm labor was 21.0 days for the monitored group and 3.0 days for th e unmonitored group (p = 0.016). CONCLUSION: The diagnosis of preterm labor for women using home uterine activity monitoring without daily n ursing contact was detected with less cervical dilatation than found i n those women not monitored. This earlier detection of preterm labor d emonstrates the utility and effectiveness of home uterine activity mon itoring devices and may lead to improved neonatal outcomes.