Home uterine activity monitoring in France: a randomized, controlled trial. Home uterine activity monitoring is associated with a reduction in preterm birth. The clinical efficacy of oral tocolytic therapy. Multicenter randomized clinical trial of home uterine activity monitoring: pregnancy outcomes for all women randomized. A multicenter randomized controlled trial of home uterine monitoring: active versus sham device. The Collaborative Home Uterine Monitoring Study (CHUMS) Group. Randomized comparison of home uterine activity monitoring and routine care in patients discharged after treatment for preterm labor. A randomized comparison of home uterine activity monitoring in the outpatient management of women treated for preterm labor. A controlled trial of the differential effects of intrapartum fetal monitoring. A prospective random trial of home uterine activity monitoring in pregnancies at increased risk of preterm labor. Prevention of preterm birth by ambulatory assessment of uterine activity: a randomized study. Randomized trial of antibiotics in addition to tocolytic therapy to treat 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. 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. Our purpose was to determine whether maintenance oral tocolytic therapy after preterm labor stabilization decreases uterine activity, reduces the rate of recurrent preterm labor and subsequent preterm birth, or improves neonatal outcome.
                Women with documented idiopathic preterm labor stabilized with acute tocolytic therapy were randomized to three groups: placebo, terbutaline 5 mg, or magnesium chloride 128 mg, all given orally every 4 hours. Patients and providers were blinded to group assignment. All subjects were enrolled in a comprehensive system of preterm birth prevention that included preterm labor education, weekly clinic visits, home uterine contraction assessment, daily phone contact, and 24-hour perinatal nurse access.
                Of the 248 patients who were randomized, 39 were delivered before discharge and 4 were lost to follow-up, leaving 205 for final analysis: 68 placebo, 72 terbutaline, and 65 magnesium. The terbutaline group had significantly more side effects than the placebo group did. All groups had otherwise similar perinatal outcomes when confounding variables were controlled for. Overall, the three groups had a preterm birth rate < 37 weeks of 55.6% delivery, < 34 weeks of 15.6%, a 20.4% rate of newborn intensive care unit admission, and a mean neonatal length of stay of 6.3 days.
                Maintenance oral tocolytic therapy did not decrease uterine activity, reduce the rate of recurrent preterm labor or preterm birth, or improve perinatal outcome. Overall improvement in perinatal outcome may be achieved with a comprehensive program of preterm birth prevention without the use of maintenance oral tocolytic therapy. 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. 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. 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. 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. A controlled prospective study of the differential effects of intrapartum fetal monitoring on mothers and infants has been conducted at Denver General Hospital, Denver, Colorado. A total of 690 high-risk obstetric patients in labor were randomly assigned to one of three monitoring groups--auscultation, electronic fetal monitoring alone, or electronic monitoring with the option to scalp sample. There were no differences in immediate infant outcomes in any measured category (Apgar scores, cord blood gases, neonatal death, neonatal morbidity, nursery course) among the three groups. There were no differences in rates of infant or maternal infections. The cesarean section rate was markedly increased in the electronically monitored groups, especially in the electronically monitored alone (18%) as compared with the auscultated (6%) (P less than 0.005). In this controlled trial electronic monitoring did not improve neonatal outcomes and the mothers were at increased risk of cesarean section. 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. 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 objective of this study was to assess whether antibiotic therapy plus tocolysis given to women in preterm labor would prolong pregnancy compared with tocolysis alone.
                A randomized, double-blind trial of intravenous mezlocillin and oral erythromycin therapy vs. placebo was used in addition to tocolysis among women in preterm labor < or =34 weeks gestation with intact membranes. Amniocentesis was performed, and chorioamnionic membranes were examined histologically and cultured for microorganisms after delivery.
                Clinical characteristics including gestational age at enrollment, frequency of contractions, cervical Bishop's score, and white blood cell count on admission were similar in the 2 groups. Antibiotic therapy was well tolerated. No significant differences in the interval to delivery, birth weight, and neonatal outcomes were observed between the 2 groups. Women in the antibiotic group had a significantly lower incidence of postpartum infections compared with women in the placebo group. Patients with evidence of upper genital tract infection in either group had a significantly shorter interval to delivery, lower gestational age at delivery, lower mean birth weight, and increased neonatal hospitalization time.
                Lack of an antibiotic effect on the gestational age at delivery may be due to the low prevalence of upper genital tract infection among unselected women in preterm labor, to advanced preterm labor unresponsive to antibiotic therapy, or to an inability of antibiotics given alone to inhibit the cytokine response. Further work is needed to identify markers of upper genital tract infection among women in preterm labor and to evaluate other potential therapeutic interventions.
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.