Home monitoring of uterine activity: a response from Tokos Medical Corporation

Article Abstract:

In the November 7, 1991 issue of The New England Journal of Medicine, a group of physicians and scientists criticizes the use of the home uterine activity monitor (HUAM), recently approved by the Food and Drug Administration (FDA) for women who have previously given birth to a premature infant. The device permits physicians and technicians in a remote monitoring site to view readings of the activity of a pregnant woman's uterine muscles taken at home. The intent is to identify the earliest stages of premature labor with the hope of intervening and preventing a premature birth. The device is only approved for use among women who are at especially high risk for premature labor (a previous premature birth). In the present editorial, presented by a physician from the Tokos Medical Corporation, which manufactures the device, answers the objections of the physicians and scientists. In addition to many details concerning the interpretation of the scientific research, there is also the consideration of the point of the device. The critical authors are concerned about whether the device actually prevents premature births, although the evidence does, indeed, suggest that monitored women in one study gave birth an average of 1.7 weeks later. However, questions about the prevention of premature birth involve not only the monitoring device, but also the effectiveness of subsequent treatment. The device was not approved to prevent premature labor, although it is hoped that this will result. The device was approved as a monitor of uterine contractions and the early stages of labor, and clearly, a monitoring device can never be expected to prevent anything. Extensive research suggests that the HUAM does, indeed, function effectively in the monitoring of uterine contractions. As gynecologists and obstetricians gain more experience with the device and its use, improvements in the prevention of premature birth may well ensue. (Consumer Summary produced by Reliance Medical Information, Inc.)

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Home monitoring of uterine activity: does it prevent prematurity?

Article Abstract:

Premature birth continues to be an important medical problem in the United States, where about 7 percent of all infants weigh less than 2,500 grams (about 5.5 pounds) at birth. Prematurity is an underlying factor in about one-third of the almost 40,000 deaths per year of infants less than one year of age. US infant mortality is 9.4 deaths per 1,000 live births, one of the highest infant mortality rates of any industrialized country. Recently, the Food and Drug Administration (FDA) approved a device to monitor uterine activity at home. The hope is that the early detection of uterine contractions may permit the use of drugs to prevent premature labor. The device, called the Genesis Home Uterine Activity Monitor (HUAM), is expensive, and its use costs about $5,000 per pregnancy. The device has only been approved for use by women with a history of premature birth. It is attached to the abdomen twice daily; electronic circuits then transmit signals over the telephone lines to a central monitoring facility. The authors suggest, however, that the device fails to measure up to claims. One study only correlated the findings of the HUAM with the signs of cervical dilation in the pregnant mother. There was not enough evidence to determine whether the device actually resulted in the reduction of the number of premature births. The authors express the fear that, although the device is approved only for women with a history of premature birth, it will be used for other women as well. This use would not only add to the cost of medical care, but may result in many women being inappropriately treated. (Consumer Summary produced by Reliance Medical Information, Inc.)

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Intrapartum fetal monitoring - a disappointing story

Article Abstract:

Intrapartum (during delivery) monitoring of the fetal heart rate was initially considered promising for the improvement of infant mortality and morbidity, since it allows the clinician to intervene at the first signs of oxygen deprivation. Early studies showed that electronically monitored fetuses were in better health than fetuses whose heart rates had been monitored by stethoscope. Later reports of studies that had randomly assigned patients to be monitored by means of either the electronic method or the stethoscope failed to find a difference in death rates, Apgar scores (measures of several aspects of newborn function) or acidosis. No advantage of fetal heart monitoring for premature babies was found, either, or when babies were followed-up 18 months after birth. The failure of this technique to improve outcome is puzzling and may be due to the facts that most hypoxic damage (damage from too little oxygen) occurs before labor, that it happens too rapidly for a warning to be helpful, or that hypoxia is not a direct result of neurological abnormality, making intervention pointless. Before reaching a final conclusion on intrapartum fetal heart monitoring, however, it should be kept in mind that the randomized studies were performed with nurses in essentially constant attendance, a condition that is not duplicated in many clinics. It is possible that the monitor will prove to be more beneficial in cases where nurses cannot observe women in labor at least every 15 minutes in the first stage, and every 5 minutes in the second stage. (Consumer Summary produced by Reliance Medical Information, Inc.)

Fetal heart rate monitoring, Electronic fetal monitoring, editorial

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