Maternity Section - Home Uterine Activity Monitoring (HUAM)

IMPORTANT REMINDER

Regence Medical Policies are developed to provide guidance for members and providers regarding coverage in accordance with contract terms. Benefit determinations are based in all cases on the applicable contract language. To the extent there may be any conflict between the Medical Policy and contract language, the contract language takes precedence.

PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that are considered investigational or cosmetic. Providers may bill members for services or procedures that are considered investigational or cosmetic. Providers are encouraged to inform members before rendering such services that the members are likely to be financially responsible for the cost of these services.

DESCRIPTION

The home uterine activity monitor (HUAM) is a device intended to provide early detection of preterm labor (PTL) in women at high risk of developing PTL and preterm birth (PTB). The monitoring device consists of a guard-ring tocodynamometer (worn as a belt around the abdomen), a data recorder, and a data transmitter. Usually, the patient is instructed to use the device daily for two 1-hour periods. After monitoring, the patient transmits the recordings by telephone modem link to a remote base station. Base station nurses facilitate transmission and analysis of the monitor tracings, maintain daily telephone contact with the patient to assess signs and symptoms, and provide advice and counseling.

Nurses employed in HUAM services look for evidence of the onset of PTL, either on the basis of uterine activity exceeding a threshold level, or from the findings of a telephone interview with the patient. Signs and symptoms of PTL include back pain, increased vaginal discharge, menstrual-like cramps, and pelvic pressure or heaviness. The threshold number of uterine contractions signaling the possible onset of PTL is usually 4 to 6 per hour. If signs and symptoms are present or the uterine activity exceeds a certain threshold, patients are instructed to perform the following: empty the bladder, hydrate orally, and assume the left lateral recumbent position. The patient is also instructed to remonitor for 1 additional hour. If uterine activity still exceeds threshold or signs and symptoms persist, the patient is instructed to see her physician immediately for a cervical examination. The cervical examination would then play a pivotal role in diagnosing whether PTL is occurring and whether to initiate tocolytic therapy.

HUAM has been used in both secondary and tertiary prevention of preterm birth:

1. Secondary prevention involves the identification of patients at high risk for PTB with a goal of attempting to diagnose early and treat preterm labor. High-risk factors include a history of PTL or PTB in a previous pregnancy, multiple gestations, uterine anomalies, history of spontaneous abortions, and exposure to diethylstilbestrol.
2. Tertiary prevention involves monitoring of patients who have already experienced preterm labor in the current pregnancy and who have experienced successful arrest of labor with tocolytic drugs. In tertiary prevention, HUAM is used to monitor contractions and manage treatment such as tocolytic therapy.

POLICY/CRITERIA

Home uterine activity monitoring (HUAM) with or without nursing contact is considered not medically necessary for all indications, including but not limited to secondary and tertiary prevention of preterm birth.

SCIENTIFIC BACKGROUND ^[1]

Secondary Prevention

The above policy is based on a 1996 BlueCross BlueShield Association Technology Evaluation Center (TEC) assessment ^[2], which offered the following conclusions:

• Although many randomized controlled trials of HUAM have been published, many contain methodological weaknesses.
• Several meta-analyses have been published, pooling the data from randomized controlled trials; 3 of the 4 concluded that the data were insufficient to support clinical use of HUAM. A fourth meta-analysis did not specifically address whether HUAM or nursing contact, alone or combined, achieved better health outcomes than standard care. None of the meta-analyses identified significant effects of monitoring on referral to neonatal intensive care units (NICUs), the intermediate outcome most related to neonatal morbidity.
• Additional randomized trials, published after the meta-analyses, also failed to validate any effectiveness of HUAM, particularly in the critical outcome of NICU admissions.
• Several organizations have published policy statements indicating there is inadequate data supporting the clinical use of HUAM. These organizations include the American College of Obstetrics and Gynecology (1996), the U.S. Preventive Services Task Force (1993), the Agency for Health Research and Quality(1992), and the National Institute of Child Health and Human Development (1991).

Since publication of the 1996 TEC assessment, another clinical trial has been published that randomized 2,422 pregnant women at high risk for PTL to receive either: weekly contact with a nurse, daily contact with a nurse, or daily contact with a nurse plus HUAM. ^[3] This study was designed to determine whether adding HUAM to nursing contact would improve clinical outcomes. However, there were no significant differences among the groups for the primary endpoint of birth at less than 35 weeks' gestation. The authors concluded that women who have daily contact with a nurse, with or without home monitoring of uterine activity, have no better pregnancy outcomes than women who have weekly contact with a nurse.

In a report by Corwin and colleagues, data from a previous randomized trial were reanalyzed. ^[4] The initial report of this 1991 clinical trial, which randomized 339 women to receive either HUAM or standard care, was criticized because the outcome data were only analyzed among those women who actually experienced PTL. ^[5] The reanalysis included all women, and showed that the beneficial effects reported in the first analysis, including preterm birth rate, increasing birth weight, and referral to NICU, were maintained in the subsequent analysis.

Rittenberg et al published a retrospective study in 2009 comparing outcomes in high-risk pregnant women who received weekly nursing visits with injections of 17 alpha-hydroxyprogresterone caproate (17P) versus daily perinatal nursing surveillance including HUAM twice a day. ^[6] Eligibility criteria included a singleton pregnancy, less than 27 weeks’ gestation, previous spontaneous preterm delivery and no current signs or symptoms of preterm labor. Patients receiving 17P and HUAM patients were matched on a one-to-one basis; 342 matched pairs were included in the analysis. Primary and secondary study outcomes are summarized in the table:

SPTD=Spontaneous pre-term delivery
* Per Dr. Rittenberg (personal communication, October 2009). Table III in the published article contained an error in the reporting of data on SPTD before 37 weeks in the 17P group.

The rate of spontaneous recurrent preterm delivery (SRPD), the primary outcome, did not differ significantly between the two groups when calculated as before 37, 35 or 32 weeks’ gestation. The authors concluded that there is no difference in recurrent SPTD between women treated with 17P and daily surveillance with HUAM. However, it is not valid to draw this conclusion for several reasons. First of all, there were statistically significant differences between groups on three of four reported secondary outcomes. Women in the 17P group experienced significantly less tocolysis, were diagnosed less often with preterm labor and had fewer hospitalizations for suspected preterm labor. Moreover, the study was not randomized and it is not certain that they were equivalent at baseline; there may have been demographic or clinical differences between the groups that affected study outcomes. Furthermore, as noted elsewhere in this summary, it is also difficult to separate the impact of HUAM from that of nurse visits. In addition to HUAM, patients in this group received daily rather than weekly nursing contact. Also, because the study was retrospective, it is not certain that a consistent protocol was followed. Finally, a company that provides in-home prenatal care including 17P and HUAM supplied the study data, and two authors were employees of the company.

The National Institute of Child Health and Human Development Network reported analysis of HUAM recordings from 11 centers with 59 twin and 306 singleton gestations. ^[7] Although twins had higher uterine contraction frequency than singletons, maximum contraction frequency was not predictive of spontaneous preterm birth.

One additional published study of note addressed the scientific basis of HUAM. Iams and colleagues assessed the frequency of uterine contractions as a predictor of the risk of spontaneous preterm delivery before 35 weeks gestation. ^[8] The authors obtained 34,098 hours of successful monitoring from 306 women. Although more contractions were recorded from women who delivered before 35 weeks than from women who delivered at 35 weeks or later, the authors were unable to identify a threshold frequency that effectively identified women who delivered preterm infants.

Tertiary Prevention

Four published trials focused on the use of HUAM in the tertiary prevention of preterm birth (women with preterm labor in current pregnancy):

• In 1990 Iams and colleagues conducted a trial specifically looking at HUAM in 76 women who had been successfully treated for PTL. ^[9] Women were randomized to receive either HUAM, or a program of education and uterine self-palpation. Both groups also received nursing contact five days per week. Rates of recurrent preterm labor and preterm delivery did not differ between the groups.

• Blondel and colleagues conducted a trial that randomized 74 women with successfully treated PTL to either undergo HUAM and nursing contact, or weekly or biweekly home nursing visits. ^[10] There was no significant difference in the rate of preterm deliveries between the 2 groups. 

• In 1993, Nagey and colleagues reported on a study that randomized 56 women with a history of successfully treated PTL to receive either HUAM or standard treatment. ^[11] There was no difference in the incidence of preterm birth between the 2 groups. 

• Brown and colleagues reported on the results of a trial that randomized 162 women who had experienced an episode of PTL in the current pregnancy to undergo HUAM plus standard care, or standard care alone. ^[12] There were no differences in outcomes between the 2 groups, including percentage of women delivered at less than 35 weeks gestation, the term delivery rate, neonatal intensive care admissions, and percentage of women receiving corticosteroid treatment for prevention of neonatal complications.

Specialty Society and Professional Review Organization Statements

• The American College of Obstetricians and Gynecologists ^[13]
  
  “Although the U.S. Food and Drug Administration has approved a HUAM device for women with a prior preterm birth, there is no demonstrated role for HUAM in the prevention of preterm birth. Data are insufficient to support a benefit from HUAM in preventing preterm birth; therefore, this system of care is not recommended.”

• The U.S. Preventive Services Task Force ^[14]
  
  “Home uterine monitoring is no longer considered a part of standard obstetrical care and is not relevant to clinical practice.” The USPSTF will not update its 2006 recommendation.

• The Agency for Healthcare Research and Quality ^[15]
  
  “Finally, we advise against further research on maintenance tocolytics or home uterine activity monitoring. The research to date has made adequately clear that the use of …home uterine activity monitoring confers no maternal, fetal, or neonatal benefits”.

• The National Institute of Child Health and Human Development ^[16]
  
  The NICHD issued a press release stating that their study “confirms earlier findings that the monitors are not useful for predicting or preventing preterm birth.”  (see reference #13 for the NICHD study)

Summary

REFERENCES

1. BlueCross BlueShield Association Medical Policy Reference Manual "Home Uterine Activity Monitoring." Policy No. 4.01.09
2. TEC Assessment 1996. "Home Uterine Activity Monitoring for Secondary Prevetion of Preterm Birth." BlueCross BlueShield Association Technology Evaluation Center, Vol. 11, Tab 15.
3. Dyson, DC, Danbe, KH, Bamber, JA, et al. Monitoring women at risk for preterm labor. N Engl J Med. 1998 Jan 1;338(1):15-9.  PMID: 9414326
4. Corwin, MJ, Mou, SM, Sunderji, SG, et al. Multicenter randomized clinical trial of home uterine activity monitoring: pregnancy outcomes for all women randomized. Am J Obstet Gynecol. 1996 Nov;175(5):1281-5.  PMID: 8942501
5. Mou, SM, Sunderji, SG, Gall, S, et al. Multicenter randomized clinical trial of home uterine activity monitoring for detection of preterm labor. Am J Obstet Gynecol. 1991 Oct;165(4 Pt 1):858-66.  PMID: 1951544
6. Rittenberg, C, Newman, RB, Istwan, NB, Rhea, DJ, Stanziano, GJ. Preterm birth prevention by 17 alpha-hydroxyprogesterone caproate vs. daily nursing surveillance. J Reprod Med. 2009 Feb;54(2):47-52.  PMID: 19301566
7. Newman, RB, Iams, JD, Das, A, et al. A prospective masked observational study of uterine contraction frequency in twins. Am J Obstet Gynecol. 2006 Dec;195(6):1564-70.  PMID: 16769014
8. Iams, JD, Newman, RB, Thom, EA, et al. Frequency of uterine contractions and the risk of spontaneous preterm delivery. N Engl J Med. 2002 Jan 24;346(4):250-5.  PMID: 11807149
9. Iams, JD, Johnson, FF, O'Shaughnessy, RW. Ambulatory uterine activity monitoring in the post-hospital care of patients with preterm labor. Am J Perinatol. 1990 Apr;7(2):170-3.  PMID: 2331280
10. Blondel, B, Breart, G, Berthoux, Y, et al. Home uterine activity monitoring in France: a randomized, controlled trial. Am J Obstet Gynecol. 1992 Aug;167(2):424-9.  PMID: 1497046
11. Nagey, DA, Bailey-Jones, C, Herman, AA. Randomized comparison of home uterine activity monitoring and routine care in patients discharged after treatment for preterm labor. Obstet Gynecol. 1993 Sep;82(3):319-23.  PMID: 8355927
12. Brown, HL, Britton, KA, Brizendine, EJ, et al. A randomized comparison of home uterine activity monitoring in the outpatient management of women treated for preterm labor. Am J Obstet Gynecol. 1999 Apr;180(4):798-805.  PMID: 10203647
13. ACOG Practice Bulletin.  Clinical management guidelines for Obstetricians-Gynecologists.  Assessment of Risk Factors for Preterm Birth.  Number 31, October 2001.
14. U.S. Preventive Services Task Force, Screening Home Uterine Activity Monitoring, 1996.   [cited 10/2009]; Available from: http://www.ahcpr.gov/clinic/uspstf/uspshuam.htm
15. Management of Preterm Labor. Summary, Evidence Report/Technology Assessment: Number 18. AHRQ Publication No. 01-E020, October 2000.   [cited 06/23/2008]; Available from: www.ahrq.gov/clinic/epcsums/pretermsum.htm
16. Home Uterine Monitors Not Useful For Predicting Premature Birth. National Institute of Child Health and Human Development. National Institute of Health. January 23, 2002.   [cited 07/25/2006]; Available from: http://www.nichd.nih.gov/news/releases/uterine.cfm

CROSS REFERENCES

None

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