Multicenter randomized clinical trial of home uterine activity monitoring: pregnancy outcomes for all women randomized. Randomized comparison of home uterine activity monitoring and routine care in patients discharged after treatment for preterm labor. Prevention of preterm birth by ambulatory assessment of uterine activity: a randomized study. Home uterine activity monitoring is associated with a reduction in preterm birth. A randomized comparison of home uterine activity monitoring in the outpatient management of women treated for preterm labor. Home uterine activity monitoring in France: a randomized, controlled trial. A multicenter randomized controlled trial of home uterine monitoring: active versus sham device. The Collaborative Home Uterine Monitoring Study (CHUMS) Group. Prevention of preterm birth in high-risk patients: the role of education and provider contact versus home uterine monitoring. Ambulatory uterine activity monitoring in the post-hospital care of patients with preterm labor. A prospective random trial of home uterine activity monitoring in pregnancies at increased risk of preterm labor. A randomized multicenter trial assessing a home uterine activity monitoring device used in the absence of daily nursing contact.
Our purpose was to evaluate the impact of home uterine activity monitoring on pregnancy outcomes among women at high risk for preterm labor and delivery.
                Women at high risk for preterm labor at three centers were randomly assigned to receive high-risk prenatal care alone (not monitored) or to receive the same care with twice-daily home uterine activity monitoring without increased nursing support (monitored). There were 339 women with singleton gestations randomized with caregivers blinded to group assignment. The two groups were medically and demographically similar at entry into the study.
                Women in the monitored group had prolonged pregnancy survival (p = 0.02) and were less likely to experience a preterm delivery (relative risk 0.59; p = 0.04). Infants born to monitored women with singleton gestations were less likely to be of low birth weight (< 2500 gm; relative risk 0.47, p = 0.003), and were less likely to be admitted to a neonatal intensive care unit (relative risk 0.5, p = 0.01).
                These data show, among women with singleton gestations at high risk for preterm delivery, that the use of home uterine activity monitoring alone, without additional intensive nursing care, results in improved pregnancy outcomes, including prolonged gestation, decreased risk for preterm delivery, larger-birth-weight infants, and a decreased need for neonatal intensive care. To determine whether home uterine activity monitoring reduces the likelihood of preterm birth in women successfully treated for preterm labor in their current pregnancies.
                Women between 20-34 weeks' gestation who had been treated successfully for preterm labor were solicited to participate in a randomized clinical trial of home uterine activity monitoring versus routine high-risk care. The sample size of 56 was based on power calculations using the results of earlier investigators. Twenty-eight women were randomized to home uterine activity monitoring and 29 were assigned to the type of care appropriate for women discharged after hospitalization for parenteral treatment of preterm labor. One of the routine-care subjects was lost to follow-up. The two groups were comparable in distribution for race, insurance status, multiple gestation, marital status, gestational age at beginning of the study, and incidence of prior preterm birth.
                The 28 women receiving routine care had a 54% incidence of preterm birth, whereas the incidence was 57% in monitored women (relative risk 1.08, 95% confidence interval 0.6-1.9; P = .79). The incidences of delivery before 32 weeks and 34 weeks also were unaffected by the intervention.
                Home uterine activity monitoring is not effective in reducing the likelihood of preterm delivery in patients successfully treated for preterm labor in their current pregnancies. Tocodynamometry, used on an ambulatory basis, has been shown to detect uterine activity. The objective of this study was to assess the effectiveness of ambulatory tocodynamometry in the early identification of preterm labor. In this investigation 67 women at risk for preterm labor were randomly divided into two groups: 34 received a uterine activity monitor while 33 patients used palpation. Approximately two thirds of the study sample developed preterm labor. Upon diagnosis of preterm labor, parturients in the control group had cervical dilatation of less than 3 cm (p less than 0.001) and effacement of greater than 50% more often than the monitored group (p less than 0.01). As a result there was a significant decrease in the number of patients who responded to tocolytic therapy in the unmonitored group. Among those with preterm labor the time gained in utero was greater in the monitored group (8.2 +/- 2.7 weeks) compared to the control group (4.2 +/- 2.9 weeks) (p less than 0.05). Subsequently 29 of 34 monitored patients attained term (36 completed gestational weeks) versus only 18 of the 33 patients in the unmonitored group (p less than 0.01). Although the sample size is relatively small, uterine activity monitoring in these very high risk patients resulted in an increased number of suitable candidates for tocolysis and allowed a significantly greater percentage of women to reach term. The value of home uterine activity monitoring plus perinatal nursing support in the prevention of preterm birth among high-risk patients has been demonstrated by several studies. Other reports with less stringent guidelines and less intensive nursing contact have questioned the contribution of home uterine activity monitoring and perinatal nursing support to a preterm birth prevention program. In this large, prospective, randomized multicenter study, patients were assigned to receive either daily monitoring and nursing contact or a preterm birth prevention program including intensive education and more frequent prenatal visits. Among the monitored patients, there was a significant increase in early detection of preterm labor (2 cm or less), successful tocolysis, and prolongation of pregnancy to term. Thirty-one percent of these diagnoses of preterm labor resulted from evaluation of increased uterine activity without associated patient-perceived symptoms. We conclude that a program of daily uterine activity monitoring and perinatal nursing support results in earlier diagnosis of preterm labor and subsequently more effective tocolysis. The aim of the study was to evaluate home uterine activity monitoring as an intervention in reducing the rate of preterm birth among women treated for preterm labor.
                A total of 186 women were treated in the hospital with magnesium sulfate for preterm labor and were prospectively randomly assigned to study groups; among these, 162 were ultimately eligible for comparison. Eighty-two of these women were assigned to the monitored group and 80 were assigned to an unmonitored control group. Other than monitoring, all women received identical prenatal follow-up, including daily perinatal telephone contact and oral terbutaline therapy. Outcome comparisons were primarily directed toward evaluation of preterm birth at <35 weeks' gestation. Readmissions for recurrent preterm labor and observations lasting <24 hours were evaluated in monitored and unmonitored groups. Compliance with monitoring was also evaluated in the monitored group.
                The monitored and control groups were demographically similar. According to a multivariate logistic regression model, women with cervical dilatation of >/=2 cm were 4 times more likely to be delivered at <35 weeks' gestation (P <.05). Gestational ages at delivery were similar in the monitored and control groups. There was no significant difference in the overall rate of preterm delivery at <35 weeks' gestation between the monitored group (10.9%) and the control group (15.0%). The overall rates of delivery at <37 weeks' gestation were high (48.8% and 60.0% for monitored and control groups, respectively), and the difference was not significant. The numbers of women with >/=1 instance of readmission and treatment for recurrent preterm labor were equal in the monitored and control groups. The numbers of women with >/=1 hospital observation lasting <24 hours were not different between the groups. Compliance with monitoring did not significantly differ for women who were delivered at <35 weeks' gestation, women with >/=2 cm cervical dilatation at enrollment, or for African American women.
                A reduction in the likelihood of preterm delivery at <35 weeks' gestation was not further enhanced by the addition of home uterine monitoring to the outpatient management regimens of women treated for preterm labor. We assessed the effectiveness of ambulatory tocodynamometry in reducing the preterm delivery rate in women at risk of preterm delivery such as women with risk factors and women previously hospitalized and discharged.
                In four public maternity units these women were randomly allocated to two groups: 84 had home uterine activity monitoring and daily midwife contact and 84 were given the standard care for high-risk women, which generally includes home visits by community midwives.
                The proportion of deliveries before 37 weeks' gestation was slightly higher in the monitored group than in the control group (32% vs 22%). The corresponding odds ratio was 1.7 (95% confidence interval: 0.9 to 3.5).
                Although the sample was small, these results suggest that home uterine activity monitoring was probably not beneficial to the population studied, or at least that any benefit would have been too small to justify extending this monitoring in this high-risk population. Our purpose was to determine the efficacy of a home uterine activity monitoring system for early detection of preterm labor and reduction of preterm birth.
                A randomized, controlled, double-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 activity monitoring with either active (data revealed) or sham (data concealed) devices. Study end points included mean cervical dilatation and its mean change from a previous visit at preterm labor diagnosis, preterm birth rate, and infant outcomes. Analysis of variance or logistic models including terms for site and group-by-site interaction effects were constructed for all variables.
                Of 1355 patients enrolled, 1292 were randomized, 1165 used home uterine activity monitoring devices, and 842 (72.3%) completed the study. Both device groups had similar demographics, enrollment and delivery gestational ages, discontinuation rates, risk factors, birth weights, cervical dilatation at enrollment and at preterm labor diagnosis, change in cervical dilatation at preterm labor diagnosis, rates of preterm labor and birth, and neonatal intensive care requirements. Power to detect a difference in cervical dilatation > or = 1 cm at diagnosis of preterm labor was 0.99 for all risk factors.
                Uterine activity data obtained from home uterine activity monitoring, when added to daily nursing 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. A total of 394 patients were enrolled in a study to assess the effectiveness of an educational preterm delivery prevention program and to determine whether the addition of home uterine monitoring to the program improved results in patients at high risk of preterm labor. Both the educational program and home uterine monitoring were found to increase the percentage of women with preterm labor who sought care while still favorable for long-term suppression, resulting in a decreased incidence of preterm births and improved outcome when compared with similar high-risk patients who did not participate in these programs. In a randomized, prospective study, addition of home uterine monitoring to the educational program was found to significantly improve outcome in twin gestations but not in singleton gestations. However, the number of singleton pregnancies was too small to rule out possible benefit from home uterine monitoring in that group. Care of women with preterm labor has been reported by Katz et al to be enhanced by use of an electronic uterine contraction monitor. We enrolled 76 women with singleton gestations who had been successfully treated for preterm labor into a prospective randomized trial, assigning subjects in a ratio of 1:2 to a group of 27 receiving education and self-palpation (EP) or to a group of 49 receiving education and an ambulatory monitor (EM). Subjects in both groups received an intensive education session at entry and were contacted frequently (5 days/week in EP and daily in EM) thereafter to report symptoms and frequency of contractions. Physicians were advised to adjust the dosage of oral tocolytic to maintain fewer than four contractions per hour. Rates of recurrent preterm labor and preterm delivery did not differ between the groups. Although the sample size in this study is too small to exclude entirely the possibility of alpha error, our inability to demonstrate a difference suggests that the improvement reported by others in pregnancy outcome associated with use of an electronic ambulatory contraction monitor may be the result of daily attention to symptoms and signs of preterm labor. In a prospective trial we enrolled 157 women at increased risk of preterm birth, randomly assigning women in a ratio of 1:2 to receive either frequent (greater than or equal to 5 days/wk) nursing contact, education in preterm labor symptoms, and self-palpation of uterine activity (group E, n = 50), or daily nursing contact, preterm labor education, and the Term Guard home uterine activity monitor (group EM, n = 107). Comparison of the rate of preterm birth, the incidence of preterm labor and successful tocolysis, and the mean birth weight and gestational age revealed no significant differences and suggested that beneficial effects previously attributed to monitored contraction data may in fact be the result of frequent (five or more times per week) nursing contact and careful attention to preterm labor symptoms and perceived contractions. To evaluate the effectiveness of home uterine activity monitoring in the early detection of preterm labor among women with a history of preterm delivery.
                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.
                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).
                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.
Home uterine monitoring may result in fewer admissions to a neonatal intensive care unit but more unscheduled antenatal visits and tocolytic treatment. There is no impact on maternal and perinatal outcomes such as perinatal mortality or incidence of preterm birth.