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AHCPR Health Technology Reviews. Rockville (MD): Agency for Health Care Policy and Research (US); 1992-1995. 

                        - This publication is provided for historical reference only and the information may be out of date.

**This publication is provided for historical reference only and the information may be out of date.**

## AHCPR Health Technology Reviews.

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Agency for Health Care Policy and Research (US)

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#  1Home Uterine Monitoring

Thomas V Holohan, MD and Ira Green, MD.

Published: July 1992.

## Report

The national infant mortality rate in the United States is one of the highest in                Western industrialized countries, and diseases associated with premature births                account for about one third of all the causes of these infant deaths.(1). Thus preterm labor is an important                medical problem. The management of this condition includes risk assessment,                detection, monitoring, and when deemed to be clinically indicated, the                administration of one or more drugs that inhibit uterine smooth muscle contraction                    (tocolysis).(2-8). The three principal tocolytic agents currently used in                the United States are ritodrine, terbutaline, and magnesium salts.

The increased uterine contractile activity that may be associated with preterm labor                can be measured by a device called an external tocodynamometer(4). (Price P, Center for Drug Evaluation and Research, Food                and Drug Administration, personal communication, 1991). These devices provide                estimates of the frequency and duration of contractions as well as some indication                of intensity. Because patterns or frequencies of low-grade uterine activity may                serve as indicators of impending preterm labor, the use of external tocodynamometers                to assess this risk and/or to diagnose such labor at an early stage has been an                attractive concept. Manufacturers have developed portable monitoring devices                suitable for home use that allow the transmission of digitized tracings over                telephone lines to a remote site for interpretation. Thus, women at high risk for                preterm labor can be monitored at home and the attending physician thereby provided                information that may aid in the treatment of the patient. The Food and Drug                Administration (FDA) has approved one of these devices, the Genesis home uterine                activity monitoring (HUAM) system (manufactured by Physiologic Diagnostic Services),                for use in detecting preterm labor in certain circumstances. The device is labeled                for use in women with high-risk pregnancies, whose fetuses are of more than 24                weeks' gestation, and who have a history of preterm birth.

The clinical utility of home uterine monitoring is controversial. The American                College of Obstetricians and Gynecologists has stated:

Thus, when the use of home uterine activity monitoring devices is part of a preterm                birth prevention program, it has not been shown to add independently to the value of                frequent provider-initiated phone contact. Electronic home uterine activity                monitoring is still under study, but at this time it cannot be recommended for                independent use in women at increased risk for preterm birth.(9).

A National Institutes of Health (NIH) workshop on "Home Monitoring of Uterine                Contractility" was held in March 1989. The workshop summary included the following                statement: 

However, evidence that monitoring per se contributes importantly either to assessing                the risk of preterm labor or to the prevention of preterm birth was felt by most                participants to be less than fully convincing. It appears, therefore, that further                work is needed both to optimize our ability to conduct home uterine activity                monitoring, as well as to demonstrate unequivocally that, in its current form, it                adds to our ability to prevent preterm birth.(10).

The senior NIH scientist at the workshop has indicated that the evidence regarding                the effectiveness of home monitoring has not significantly changed since that                conference was held (McNellis D, National Institutes of Health, personal                communication, 1991). OHTA also sought the opinion of other experienced clinicians                in the federal health care system. A senior official of the Maternal-Fetal Medicine                Department, National Naval Medical Center, has indicated that simpler methods such                as close monitoring of a patient at home by visiting nurses and/or by phone is                sufficient to prevent preterm labor and that monitoring devices are not necessary                (Thomas R, personal communication, 1991).

The FDA approval for marketing of a home uterine monitoring device was based on a                multicenter clinical study which demonstrated that the device could detect uterine                contractions indicative of the onset of preterm labor, utilizing cervical dilation                as the primary endpoint.(11). In that                study, Mou et al(12). selected patients                believed to have an increased risk of preterm labor, based on a Creasy risk score of                10 or greater; 198 were randomized to a monitored group and 179 to an unmonitored                group. The authors reported no statistically significant demographic or medical                differences between the two groups. However, slightly greater proportions of                unmonitored than monitored patients had histories of alcohol use (7.3 vs. 5.1),                cocaine use (8.9 vs. 5.6), cigarette smoking (27.9 vs. 21. 2) and previous preterm                birth (54.8 vs. 45, respectively). All patients received instruction in the signs                and symptoms of preterm labor and in uterine self-palpation techniques. No regular                health care professional-initiated telephone contact was scheduled for any patient.                There was a significant difference in cervical dilation at the time of diagnosis of                preterm labor between the study groups: mean dilation for the monitored group was                1.4 cm, and for the unmonitored group, 2.5 cm. The authors concluded that home                uterine monitoring of high-risk pregnancies allows detection of preterm labor at an                earlier stage of cervical dilation. Although not designated as study endpoints, a                longer duration of gestation after diagnosis of preterm labor and a higher                gestational week at delivery (36.6 vs. 34.9 weeks) were noted in the monitored                group. In addition, the monitored group delivered infants of higher birth weights;                those neonates had less need for intensive care, oxygen therapy, and mechanical                ventilation. Assessments of cervical dilation were performed by "senior residents or                attending physicians," but the accuracy and interobserver reliability of such                measurements were not evaluated in this study. In addition, home monitoring was not                directly compared with frequent provider-initiated patient contact, an approach that                has been considered to be an intervention capable of reducing the incidence of                preterm birth (vide supra).

Moreover, a group of clinician-researchers from several academic medical centers                reviewed this study, as well as other pertinent studies of home uterine monitoring,                and found the data wanting. They concluded that:

It is well known that assessment of cervical dilation is poorly ... We believe the                scientific evidence is insufficient to warrant the clinical use of home                uterine-activity monitoring except for research purposes... its so-called                effectiveness relates not to the prevention of premature births but to the claim of                earlier identification of premature labor, as evidenced by cervical dilation, with                this system.... Home uterine-activity monitoring is a high-cost, ineffective                approach to the all-important problem of prematurity. Daily contact, initiated by                providers, is a lower-cost approach that is equally efficacious in preventing                prematurity and should therefore be supported.(13).

Other published studies of home uterine monitoring techniques do not permit a                determination that this technology results in improved treatment of preterm labor or                a reduction in premature birth. Morrison et al(14). studied 67 patients at high risk for preterm labor who were                randomly assigned to self-palpation or home uterine monitoring techniques. Patient                care was managed by house officers supervised by attending staff. Subjects in the                unmonitored group were contacted by telephone at least twice weekly. In this group                of 33 patients, 22 (67) had documented preterm labor; of the 22,15 (68) were found                to have cervical dilation of 3 cm or greater. In the monitored group of 34 patients,                24 (71) were diagnosed as having preterm labor. Two (8) of the 24 had 3 cm or more                cervical dilation. The difference in gestational age at the time of diagnosis of                preterm labor was significant, although the proportion of patients reaching 36                completed gestational weeks was significantly different in the control (55) and                monitored (85) groups.

Iams et al(15). reported a 2-year study of                266 patients, randomly assigned to either labor education, self-palpation teaching,                and daily telephone contact ("EP group") or to labor education, telephone contact,                and home monitoring ("EM group"). Random assignment to the EP and EM groups with                stratification for risk factors was not performed, and a significantly greater                proportion of patients with multiple gestation were assigned to the EP group, which                consequently may have led to a higher risk of preterm birth. Notwithstanding, there                were no significant differences in rates of preterm labor or preterm delivery, mean                birth weight, or gestational age at delivery between the groups. The authors                concluded that frequent contact and symptom recognition are key in addressing the                problem of preterm labor and in improving pregnancy outcome.

Dyson et al(16). evaluated 247 patients at                risk for preterm labor, all of whom were provided an educational program addressing                the recognition of preterm labor and self-palpation techniques at 24 weeks'                gestation. Patients were then randomized to either a home monitoring (n=120) or                education-palpation (n=127) group. All patients were contacted by a study nurse at                least 5 days each week. A third group of 143 patients with the same risk factors who                had delivered in that hospital during the preceding 30 months was designated a                "standard care" group; attention was paid to selection of this group on the basis of                risk factors and not pregnancy outcome. In singleton gestations, there was not a                statistically significant difference in preterm births between the                education-palpation and home monitoring groups. The incidence of preterm birth was                significantly lower in the education-palpation than the standard care group; the                monitored group was superior to the standard care group only for preterm births at                less than 34 weeks. No significant differences between the education-palpation and                home monitoring groups were noted for neonatal outcome in terms of birth weight,                respiratory distress syndrome, intensive care admission, or infant hospital stay.                For twin gestations (109 cases), the monitored group had fewer very low (<1500g)                birth weight infants, fewer intensive care admissions, and shorter infant hospital                stays than the education-palpation group. Both the education-palpation and monitored                groups were superior to the standard care group in terms of the incidence of                respiratory distress syndrome, intensive care admission, and neonatal death. The                authors concluded that both education and home monitoring approaches are effective                in improving the outcome in high-risk pregnancies; they believed that in twin                pregnancies, home monitoring resulted in higher success rates for tocolytic                therapy.

Other published studies have evaluated home monitoring with respect to detection of                preterm labor, prevention of preterm birth, and cost and cost-effectiveness of this                technology. These reports do not provide additional information sufficient to permit                a logical and defensible conclusion as to the clinical effectiveness of home uterine                    monitoring.(17-20).

The American Medical Association conducted a Diagnostic and Therapeutic Technology                Assessment (DATTA) review of home monitoring of uterine activity. With regard to the                question of the effectiveness of this technology, 50 of the DATTA panelists surveyed                believed it to be "investigational," and 32 believed it to be "indeterminate. " Only                14 classified effectiveness as "established."(21).

In sum, published data provide mixed support for the clinical utility of home uterine                monitoring. Some studies did not compare the outcomes of monitored patients with                those of clinically and demographically similar groups of unmonitored patients.                Moreover, in prospective controlled studies, the unmonitored group was subject to a                variety of alternative interventions, including education programs of varying                intensity and provider-initiated telephone contact on variable schedules (e.g., from                no such contact to a frequency as high as 5 days weekly). As a result, conclusions                as to the effectiveness of HUAM must be tempered by the fact that this technique has                not been adequately compared with simpler approaches applied with equivalent vigor.                The opinions of experts and of professional and specialty groups tend to reflect                these data. Therefore, while the use of HUAM devices may result in detection of                preterm labor at an earlier stage of cervical dilation, it has not been established                that use of this technology results in a reduction in the incidence of preterm                birth, nor that it is superior to patient education coupled with frequent                provider-initiated contact with patients.

## Summary

The use of home uterine monitoring as a central element in programs directed at the                prevention of preterm birth is highly controversial. Current published data do not                clearly demonstrate it to be more effective than alternative, simpler methods nor                provide adequate support to conclude that this technology is appropriate for                widespread use, particularly in patient subsets other than those specified in the                FDA-approved labeling of the HUAM device. Clinical studies directed at the                determination of the effect of home uterine monitoring on net health outcome (e.g.,                diagnosis of preterm labor and reduction in premature births) in direct comparison                with comparably intensive programs of education and provider-initiated contact                should be encouraged. The FDA has stated that any claim for, or promotion of, the                approved HUAM device "...that goes beyond the approved indication would be illegal                and a cause for regulatory action by the FDA."(11).

## References

                        - 1.
                        - National Center for Health Statistics Advance report of                        final natality statistics  Monthly Vital Statistics                        Report 1988 Vol. 39, No. 4, Suppl, Hyattsville, MD:                    Public Health Service, 1990.
                        - 2.
                        - Beall MH, Edgan Edgar BW, Paul RH, et al. A comparison of ritodrine, terbutaline, and magnesium sulfate for                        the suppression of preterm labor.  Am J Obstet Gynecol.  1985;153:854–859. [PubMed: 4073155]
                        - 3.
                        - Caritis N, Toig G, Heddinger A, et al. Double blind study comparing ritodrine and terbutaline in                        treatment of preterm labor.  Am J Obstet Gynecol.  1984;150:7–14. [PubMed: 6383045]
                        - 4.
                        - Lam F, Gill PJ, Smith M, et al. Use of the subcutaneous terbutaline pump for long-term                        tocolysis.  Obstet Gynecol.  1988;72:810–813. [PubMed: 3173932]
                        - 5.
                        - Katz M, Robertsons Robertson PA, Creasy RK. Cardiovascular complications associated with terbutaline                        treatment for preterm labor.  Am J Obstet Gynecol.  1981;139:605–608. [PubMed: 7468724]
                        - 6.
                        - Laros RK, Kitterman JA, Heilbron DA, et al. Outcome of very low-birth weight infants exposed to                        beta-sympathetics in utero.  Am J Obstet Gynecol.  1991;164(6 pt 1):1657–1664. [PubMed: 2048614]
                        - 7.
                        - Ridgway LE, Muise K, Wright JW, et al. A prospective randomized trial comparison of oral terbutaline and                        magnesium oxide for the maintenance of tocolysis.  Am J Obstet Gynecol.  1990;163:879–882. [PubMed: 2206076]
                        - 8.
                        - Taslimi CK, Sibai BM, Amon E, et al. A national survey on preterm labor.  Am J Obstet Gynecol.  1989;160:1352–1357. [PubMed: 2567573]
                        - 9.
                        - American College of Obstetricians and Gynecologists American College                        of Obstetricians and Gynecologists, Committee Opinion, Committee on                        Obstetrics  Maternal and Fetal                        Medicine No. 74 November                    1989.
                        - 10.
                        - Rhoads G, McNellis D, Kessel S. Summary of a Workshop: Home Monitoring of Uterine Contractility.                        National Institute of Child Health and Human Development.  Am J Obstet Gynecol, in press.  [PubMed: 1677235]
                        - 11.
                        - Yin L. A response from the FDA.  N Engl J Med.  1991;325:–. [PubMed: 1922242]
                        - 12.
                        - Mou SM, Shirazali Sunderji GS, Gall S, et al. Multicenter randomized clinical trial of home uterine activity                        monitoring for detection of preterm labor.  Am J Obstet Gynecol.  1991;165:858–866. [PubMed: 1951544]
                        - 13.
                        - Sachs BP, Hellerstein S, Freeman R, et al. Home monitoring of uterine activity: Does it prevent                        prematurity?  N Engl J Med.  1991;325:1374–1377. [PubMed: 1922241]
                        - 14.
                        - Morrison JC, Martin JN, Martin RW, et al. Prevention of preterm birth by ambulatory assessment of uterine                        activity.  Am J Obstet Gynecol.  1987;156:536–540. [PubMed: 3826196]
                        - 15.
                        - Iams JD, Johnson FF, O'Shaugnessy RW. A prospective random trial of home uterine activity monitoring in                        pregnancies at increased risk of preterm labor.  Am J Obstet Gynecol.  1988;159:595–603. [PubMed: 3421258]
                        - 16.
                        - Dyson DC, Crites YM, Ray DA, et al. Prevention of preterm birth in high-risk patients. The role of                        education and provider contact versus home uterine                        monitoring.  Am J Obstet Gynecol.  1991;164:756–762. [PubMed: 2003537]
                        - 17.
                        - Hill WC, Fleming AD, Martin RW, et al. Home uterine monitoring is associated with a reduction in preterm                        birth.  Obstet Gynecol.  1990;76 (1 suppl):13S–18S. [PubMed: 2359574]
                        - 18.
                        - Watson DL, Wech Welch RA, Mariona FG, et al. Management of preterm labor patients at home: Does daily uterine                        activity monitoring and nursing support make a difference?  Obstet Gynecol.  1990;76 (1 suppl):32S–35S. [PubMed: 2359576]
                        - 19.
                        - Kosasa TS, Abou-Sayf FK, Li-Ma G, et al. Evaluation of the cost-effectiveness of home monitoring of                        uterine contractions.  Obstet Gynecol.  1990;76 (1 suppl):71S–75S. [PubMed: 2113662]
                        - 20.
                        - Morrison JC, Pittman KP, Marin RW, et al. Cost/health effectiveness of home uterine activity monitoring in                        a Medicaid population.  Obstet Gynecol.  1990;76 (1 suppl):76S–81S. [PubMed: 2113663]
                        - 21.
                        - Diagnostic and Therapeutic Technology Assessment: Home monitoring of uterine activity.  JAMA.  1989;261:3027–3029. [PubMed: 2716135]

                        - 
AHCPR Pub. No. 92-0064

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Bookshelf ID: NBK63968

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