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Policies toward medical technology: the case of electronic fetal monitoring.

Electronic fetal monitoring (EFM) is an example of a medical technology that has been widely accepted since its introduction in the mid-1960s. However, review of the literature does not provide convincing evidence of EFM efficacy, and four recent, controlled, clinical trails show little if any benefit in terms of preventing death or long-term disability of the baby. Public and private policies have largely acted to encourage use of EFM, and none have acted to slow or prevent its spread. This need for mechanisms to assure the timely evaluation of new medical technologies before they are accepted as a medical practice has led to a new medical devices program in the Food and Drug Administration, consensus development groups at the National Institutes of Health, and congressional legislation to establish a new National Center for Health Care Technology.

Equipment and Supplies

The current status of intrapartum fetal monitoring.

Intensive intrapartum fetal monitoring, using direct fetal EKG leads and intrauterine pressure sensing transducers, seems to add another level of care for the fetus. As with other laboratory aids or devices, fetal monitoring data should not be exclusively relied on in decision making processes. When used with other modern monitor aids, such as scalp pH, it can aid immensely in the management of both normal and complicated labors. When fetal heart rate patterns remain normal throughout labor there can be a high degree of confidence that the fetal outcome will be good. If abnormal patterns occur, however, great care should be taken in interpreting these data, and it should be combined with the overall status of the mother and the fetus, and used together with the clinical acumen of the physician in determining a method of approach to the management of intrapartum situations. Continuous monitoring techniques can and should be applied in the neonatal nursery for intensive neonatal management and care (79,80). As experience is gained in clinical fetal monitoring and as new techniques and methods become available, intensuve intrapartum fetal monitoring will become an increasingly important and significant technique for management of labor (4, 139).

Acid-Base Imbalance

Psychological responses to the use of the fetal monitor during labor.

Fetal monitoring, a major advance in obstetrical care, transforms the labor room into an intensive care setting. The psychological effects of this new technology were investigated by means of structured interviews with 25 postpartum women. The multiplicity of psychological responses obtained are described. The relationship of demographic, obstetrical, and psychosocial variables to women's overall positive or negative reaction to the monitor was investigated. Personality characteristics and life experiences with pregnancy and childbirth were factors that shaped the manner in which the monitor was experienced. The effect of fetal monitoring on maternal anxiety is discussed. The impact of mechanization on the total experience of childbirth is noted.

Anxiety

A computerized fetal monitoring system.

A computerized fetal monitoring system has been developed at the Cedars-Sinai Medical Center in Los Angeles, California. It utilizes unmodified fetal monitors feeding fetal heart rate and uterine pressure data into a minicomputer. The overall accuracy on internal monitoring is 91%. The concept of on-line computer analysis of fetal monitoring records has met with clinical acceptance and is utilized for all patients in labor at the Cedars-Sinai Medical Center.

Blood Pressure

["Fetal monitoring" within the framework of actual obstetric monitoring].

The introduction of fetal monitoring and its use in high-risk patients was followed in the period 1971-1973 by the first-ever drop in perinatal mortality below 2%. Total monitoring brought about a further reduction in perinatal mortality to 0.95% (1974-1975). This decrease is statistically highly significant. It suggests that among all intensive care methods continuous fetal heart-rate monitoring plays the main contributory role in the early detection of fetal distress. We found that selection of high-risk patients was not sufficient to achieve a drastic reduction in the incidence of acidosis. Only with total fetal monitoring was it possible to effect a significant decrease (from 2.41% to 0.51%) in the number of infants with acidosis (pH less than 7.10).

Acidosis

Experience with fetal monitoring in a university teaching hospital.

Fetal monitoring during labour may be expected to decrease perinatal losses and the number of infants born with brain damage. In a prospective study of intrapartum fetal monitoring in selected high-risk pregnancies in a Winnipeg hospital the monitoring rate was 26.5% and the cesarean section rate in the monitored group was 22.0%. The fetal outcome in the monitored group was better than in the unmonitored group. The establishment of a fetal intensive care unit is believed to be strongly desirable in improving fetal surveillance during labour. Fetal monitors should be stationed in the delivery room as well as in the first-stage room.

Delivery, Obstetric

Evaluation of fetal monitoring by telemetry.

A radiotelemetry system for the direct monitoring of fetal heart rate and intrauterine pressure during labor has been evaluated at 5 different institutions. A conventional fetal scalp electrode and a special intrauterine pressure sensor are connected to a radio transmitter placed on the patient's thigh. The receiver can be located up to 50 feet away from the transmitter and is either a self-contained monitor or a unit that converts a conventional fetal monitor to a telemetric one. The telemetry recordings are of similar quality to those obtained from conventional monitors. Telemetry allows for greater patient comfort and mobility as well as greater convenience to the clinical staff. Continuous data can be obtained from patients while they are ambulatory or sitting in a chair as well as while they are in bed.

Electrodes

Osteomyelitis and sepsis: severe complications of fetal monitoring.

Sophisticated modern methods of fetal monitoring during labor have improved the prognosis for high-risk infants, but the possible adverse side effects have not yet been fully documented. One infant with osteomyelitis and one with streptococcal sepsis are reported. In the future, greater attention should be paid to such potential complications and new noninvasive techniques of fetal monitoring should be developed.

Cellulitis

Microfilm storage of fetal monitoring records: a practical solution.

Microfilming of fetal monitoring records has, at our institution, been found to be a practical method for storage of recording papers from fetal monitoring. This system permits a reduction of the records by a factor of 20:1 and up to 7.64 hours of fetal monitroing records will fit into a 4 x 6 inch film jacket. This microfilm record can easily be placed into a patient's chart and can thus easily be retrieved.

Fetal Monitoring

The effect of fetal monitoring on the incidence of cesarean section.

To determine whether routine fetal monitoring inevitably increases the cesarean section rate, we studied the pertinent literature and analyzed the cesarean sections performed at Evanston Hospital during the last 8 years. Many authors have found a slight to moderate increase in cesarean section rates, whereas others have found no change or a decrease. At Evanston Hospital, the primary cesarean section rate has increased from 2.6% in 1968-1969 to 6.9% in 1974-1975. Only 19.2% of this increase is due to increased fetal distress; the magnitude of the increase is due to changes in other factors, notably, breech deliveries (29.5% of the increase) and "dystocia" (60.2% of the increase). The incidence of cesarean section is controlled by several complex variables, only one of which is fetal monitoring. To describe the fetal monitors as the cause of the increased cesarean section rate is to ignore these other equally profound changes in obstetric technic and philosophy.

Breech Presentation

A controlled trial of the differential effects of intrapartum fetal monitoring.

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.

Apgar Score

Electronic fetal monitoring during labor.

Intrapartum electronic fetal monitoring tracings from 620 women monitored internally over 60 minutes were analyzed. Fetal heart rate patterns were statistically analyzed against four variables of labor: 1) the presence of meconium; 2) fetal acidosis; 3) 1-minute Apgar score; and 4) clinical correlates considered as etiologic factors in FHR decelerations. No significant etiologic correlation was found between these clinical correlates and FHR deceleration patterns. Statistically significant correlations were established between poor neonatal outcome and fetal acidosis (P less than 0.01) and the presence of meconium (P less than 0.05). No correlation was found between FHR patterns and fetal acidosis. Variable deceleration showed no significant relation to low Apgar score (less than or equal to 6). Late deceleration showed a significant correlation with depressed infants. FHR patterns are best used as an alarm system of fetal difficulty than as an absolute measure of fetal distress.

Acidosis

Fetal monitoring: psychologic consequences and management recommendations.

The psychologic consequences of fetal monitoring were investigated by means of structured interviews with 35 postpartum women. Both beneficial and detrimental effects associated with the use of fetal monitors were identified. Personality characteristics and past experiences with pregnancy and labor were found to be factors shaping the manner in which the monitor was experienced. Areas of prepartum and intrapartum care indentified in which the potential for maximizing the beneficial aspects of monitoring and reducing the detrimental ones exist. Specific management recommendations are given.

Adolescent

Xerox telecopier transmission of fetal monitor tracings: a 4-year experience.

A telephone consultation system using the Xerox 400 Telecopier has been established to transmit fetal monitor data to a tertiary center from regional hospitals with limited experience in interpreting this data. This report reviews a 4-year experience with this consultative device, discusses both the advantages and disadvantages of such a program, and recommends the establishment of similar services in other tertiary centers. We believe that the establishment of such services can be of diagnostic and therapeutic benefit to inexperienced medical personnel when first confronted with the concept of fetal monitoring. Hopefully, by so doing, hospital use of fetal monitoring will increase.

Copying Processes