A MULTICENTER RANDOMIZED CONTROLLED TRIAL OF HOME UTERINE MONITORING - ACTIVE VERSUS SHAM DEVICE

OBJECTIVE: Our purpose was to determine the efficacy of a home uterine activity monitoring system for early detection of preterm labor and r eduction of preterm birth. STUDY DESIGN: A randomized, controlled, dou ble-blinded trial was performed in which pregnant women between 24 and 36 weeks' gestation and at high risk for preterm labor or birth were assigned to receive twice daily nursing contact and home uterine activ ity monitoring with either active (data revealed) or sham (data concea led) devices. Study end points included mean cervical dilatation and i ts mean change from a previous visit at preterm labor diagnosis, prete rm birth rate, and infant outcomes. Analysis of variance or logistic m odels including terms for site and group-by-site interaction effects w ere constructed for all variables. RESULTS: Of 1355 patients enrolled, 1292 were randomized, 1165 used home uterine activity monitoring devi ces, and 842 (72.3%) completed the study. Both device groups had simil ar demographics, enrollment and delivery gestational ages, discontinua tion rates, risk factors, birth weights, cervical dilatation at enroll ment and at preterm labor diagnosis, change in cervical dilatation at preterm labor diagnosis, rates of preterm labor and birth, and neonata l intensive care requirements. Power to detect a difference in cervica l dilatation greater than or equal to 1 cm at diagnosis of preterm lab or was 0.99 for all risk factors. CONCLUSIONS: Uterine activity data o btained from home uterine activity monitoring, when added to daily nur sing contact, were not linked to earlier diagnosis of preterm labor or lower rates of preterm birth or neonatal morbidity in pregnancies at high risk for preterm labor and birth.