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A multicenter randomized controlled trial of home uterine monitoring: active versus sham device. The Collaborative Home Uterine Monitoring Study (CHUMS) Group.

OBJECTIVE: 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. STUDY DESIGN: 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. RESULTS: 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. CONCLUSIONS: 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.

Adult↗

Prevention of preterm birth in high-risk patients: the role of education and provider contact versus home uterine monitoring.

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.

Female↗

Surveyed use of fetal and uterine monitoring during maternal surgery.

The goal of this study was to determine the frequency and methods of intraoperative fetal and uterine monitoring during maternal surgery in the United States. Maternal surgery was defined as nonobstetric surgery during pregnancy that required general or regional anesthesia. We mailed a 21-item questionnaire to the perioperative nurse managers of US hospitals at which more than 2,000 babies are delivered annually (n = 579). Nearly 60% of responding hospitals routinely used some form of fetal monitoring during maternal surgery; more than 40% of responding hospitals did not use intraoperative fetal and uterine monitoring routinely during maternal surgery.

Chi-Square Distribution↗

Use of echosonography to monitor uterine placement of intrauterine devices after immediate postpartum insertions.

A study designed to monitor uterine placement of IUDs inserted immediately postpartum using echosonography was conducted at the Hospital de Gineco Obstetricia No. 23, "Dr. Ignacio Morones Prieto" in Monterrey, Mexico. TCu220 and Delta T IUDs were randomly assigned to, and inserted in women immediately following a normal vaginal delivery. Ultrasound examinations were to be performed within 60 min postinsertion, at 24 h postinsertion and at 1- and 3-month follow-up visits. There were no differences in the expulsion rates of the two device groups. Data are presented on the readings taken at the ultrasound examinations of the distance between the fundus and the upper part of the stem of the T. These differences differed significantly between the two device groups at the first ultrasound reading only (P less than or equal to 0.01). No relationship was found between the incidence of expulsion and the distance between the IUD and the fundus at any of the readings.

Female↗

Monitoring uterine activity.

Uterine activity may be monitored by methods ranging from gentle palpation of the uterine fundus to the most sophisticated electronic intrauterine pressure monitoring system. The form of monitoring required depends largely on the clinical situation. The relationship between fetal oxygenation and uterine contractions has ensured the continued place of cardiotocographic monitoring.

Female↗

A method for monitoring uterine activity in induced labour.

A system for the quantitative assessment of uterine activity during an oxytocin-induced labour has been developed. This has been achieved using relatively simple analogue techniques and can easily be used in the labour ward alongside existing monitoring equipment. Initial results indicate that a plateau of uterine activity can be easily recognised from the display and maintained at oxytocin dosage levels below those that might normally be used.

Female↗

CA 125, NB/70K, and lipid-associated sialic acid in monitoring uterine papillary serous carcinoma.

Ninety-four plasma samples from 18 women with uterine papillary serous carcinoma were analyzed for three circulating tumor markers: CA 125, NB/70K, and lipid-associated sialic acid. Tumor marker values were correlated with the patients' clinical status. Preoperatively, CA 125, NB/70K, and lipid-associated sialic acid were elevated in 62, 64, and 67%, respectively. The distribution of clinical stages was I -- 56%, II -- 28%, III -- 6%, and IV -- 11%. The distribution of surgical stages was I -- 28%, II -- 17%, III -- 0%, and IV -- 56%. Nine of ten patients with an elevated tumor marker had extrauterine disease confirmed surgically. Eight of nine patients with elevated levels of two markers had extrauterine disease. Four of four patients with three elevated markers had extrauterine disease. There were two false-positive elevations, both in patients who had occult surgical stage II disease. Rising and falling tumor marker levels correlated with progression and regression of disease, respectively. A doubling of CA 125 predicted clinical recurrence in four of six women an average of 17 weeks before clinical confirmation. Lipid-associated sialic acid levels that increased by 25% or by five units predicted recurrence or rapid progression in three of six patients in an average of 5 weeks, and a 50% elevation in NB/70K predicted recurrence in two of three patients by 5 and 3 weeks before clinical confirmation. Although the number of patients in this series is small, preoperative elevated tumor markers in patients known to have uterine papillary serous carcinoma correlate closely with the presence of extrauterine disease. This information should influence surgical management and may be useful in postsurgical treatment assessment.

Aged↗

Use of hospital discharge data to monitor uterine rupture--Massachusetts, 1990-1997.

Uterine rupture (UR), a potentially life-threatening condition for both mother and infant, occurs in <0.1% of all pregnant women and <1% of women attempting vaginal birth after cesarean section (VBAC) (1-4). During 1990-1997, the proportion of vaginal deliveries among women who had previous cesarean sections (CS) in Massachusetts increased 50%, from 22.3% to 33.5% (5). Concern about a corresponding increase in UR prompted the Massachusetts Department of Public Health and CDC to initiate a state-wide investigation that included an assessment of the validity and reliability of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) (6), codes in hospital discharge data to identify UR cases. This report summarizes the results of the investigation, which indicate that ICD-9-CM codes related to UR, designed before increased concern about UR, lack adequate specificity for UR surveillance and have not been applied consistently over time.

Disease↗

Intrapartum use of fetal heart rate monitoring, contraction monitoring, and amnioinfusion.

Fetal heart rate monitoring, uterine contraction monitoring, and amnioinfusion are procedures used commonly during labor that have also improved our understanding of intrapartum physiology, although there are limitations to the ability of these procedures to improve pregnancy outcome. The current status of intrapartum fetal heart rate monitoring, uterine contraction monitoring, and amnioinfusion is reviewed.

Amnion↗

Evaluation of the cost-effectiveness of home monitoring of uterine contractions.

In 1988, the major health insurance carrier in the state of Hawaii initiated a prospective study to determine the cost-effectiveness of ambulatory uterine activity monitoring. At the end of the study, 79 patients had completed 3189 days on the monitor. Thirty-six patients (45.6%) did not have preterm labor; the daily monitoring resulted in an average loss to the insurance carrier of $3300 per patient, or $118,800. Forty-three patients (54.4%) experienced preterm labor and were found to have benefited from the monitoring system. Earlier detection of preterm labor and better management of oral tocolysis in this group resulted in earlier initiation of maternal tocolytic therapy, which ultimately decreased the preterm birth rate and hospitalization days in the neonatal intensive care unit. Cost analysis of this group demonstrated an average savings of $24,000 per patient, or an overall savings of $1,032,000. The total group of high-risk patients (79) resulted in a net savings to the insurance carrier of $913,200, or $11,500 per patient, suggesting that use of the ambulatory uterine activity monitoring system significantly reduced the cost associated with preterm labor and early delivery.

Adult↗

Multicenter randomized clinical trial of home uterine activity monitoring for detection of preterm labor.

Home uterine activity monitoring has been described as an effective means of detecting uterine contractions, but controversy exists whether it is home uterine activity monitoring or increased nursing support in conjunction with it that contributes to earlier detection of preterm labor. In this study 377 women at risk for preterm labor from three centers were prospectively, randomly assigned to high-risk prenatal care alone (not monitored) or to the same care with twice-daily home uterine activity monitoring without increased nursing support (monitored). The two groups were medically and demographically similar at entry into the study. Routine visits, nonroutine visits, and gestational age at diagnosis of preterm labor were similar in both groups. Preterm labor occurred in 41 of 198 monitored and 39 of 179 not monitored patients. Mean cervical dilatation was 1.4 cm in 41 monitored compared with 2.5 cm for 37 not monitored (p = 0.0006); 73.1% of monitored and 27.5% of not monitored had preterm labor detected before 2 cm dilatation (p = 0.00009). Neonatal outcome of singleton pregnancies showed greater birth weight, fewer days in the neonatal intensive care unit, and fewer babies requiring oxygen therapy and mechanical ventilation in the monitored group. The better outcomes are probably due to the increased likelihood of diagnosis of preterm labor before advanced cervical dilatation with home uterine activity monitoring, thus providing the clinician with a better chance to initiate tocolytic therapy directed at improving pregnancy outcome.

Birth Weight↗

Randomized controlled trials of home uterine activity monitoring: a review and critique.

Home uterine activity monitoring has been proposed as an effective technique for reducing the incidence of preterm birth by early recognition of incipient labor. Five randomized controlled trials evaluating this technique have been published in peer review journals. As judged by accepted criteria for such trials, all have serious methodologic deficiencies. Four of the five trials demonstrated no significant benefit from this monitoring. Two other trials not published in peer review journals support the hypothesis that home uterine activity monitoring is no more effective than daily nursing contact. Until the efficacy of this technology has been established, home uterine activity monitoring should not be used clinically.

Evaluation Studies as Topic↗

Preventing preterm birth in twin gestation: home uterine activity monitoring and perinatal nursing support.

In this investigation, 45 women with twin gestations in four centers were randomly assigned to either daily home uterine activity monitoring and perinatal nursing support (19) or an education group (26). Patients in the home uterine activity monitoring and perinatal nursing support group monitored uterine activity twice daily, transmitted the data each day, and had 24 hour-a-day access to nursing support. Education patients were counseled regarding the common signs and symptoms of preterm labor. Both groups had scheduled prenatal visits at least every 2 weeks. Sixteen (62%) of the education group and 14 (74%) of the home uterine activity monitoring and perinatal nursing support group developed preterm labor, values that were not significantly different. Of the monitored group who experienced preterm labor, all 14 were dilated 3 cm or less at diagnosis of the first preterm labor, compared with ten of 16 in the education group (P = .01; one-tailed Fisher test). The mean cervical dilatation at the first preterm labor episode in the group receiving daily monitoring and contact (1.6 cm) was significantly less (P = .01) than that in the education group (2.9 cm). Thus, fewer preterm births were recorded in the home uterine activity monitoring and perinatal nursing support group and significantly fewer patients delivered because of failed tocolysis (P = .03).

Adult↗