A randomized multicenter trial assessing a home uterine activity monitoring device used in the absence of daily nursing contact

Abstract

Objective: To evaluate the effectiveness of home uterine activity monitoring in the early detection of preterm labor among women with a history of preterm delivery.

Study design: Two hundred eighteen women from four centers were prospectively randomized to routine high-risk prenatal 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 group populations at entry into the study were similar in medical and demographic 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 women in the unmonitored (control) group (n = 101) experienced preterm labor (not significant). Mean cervical dilatation at the time of diagnosis 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 the monitored group had a cervical dilatation of < 2 cm when preterm labor was detected, compared with 18.2% of the women in the unmonitored group (p = 0.019). The median duration of gestation after diagnosis of preterm labor was 21.0 days for the monitored group and 3.0 days for the unmonitored group (p = 0.016).

Conclusion: The diagnosis of preterm labor for women using home uterine activity monitoring without daily nursing contact was detected with less cervical dilatation than found in those women not monitored. This earlier detection of preterm labor demonstrates the utility and effectiveness of home uterine activity monitoring devices and may lead to improved neonatal outcomes.