Large randomized controlled trials have demonstrated that the use of a home uterine monitor is not associated with a decrease in the incidence of preterm birth. This analysis is supported by policy statements by the American College of Obstetricians and Gynecologists (1997; 2001; 2003) and the U.S. Preventive Services Taskforce (1996). An evidence report prepared for the Agency for Healthcare Research and Quality (AHRQ) (2000) concluded that "home uterine activity monitoring was found to confer no maternal or fetal/neonatal benefits".

Reichmann (2008) stated that the current paradigm in obstetrics has shifted toward evidence-based medicine, and yet in clinical practice physicians continue to use interventions for which there exists no credible evidence. The author examined the United States Food and Drug Administration (FDA) status of home uterine activity monitoring (HUAM) and the published clinical trials examining HUAM for the management of current preterm labor. The use of HUAM was introduced into clinical practice and heavily marketed without benefit of scientific rigor. Gradually, HUAM use migrated primarily for patients diagnosed (or mis-diagnosed) with preterm labor in the current pregnancy who are stabilized and sent home with or without a tocolytic. This clinical intervention has not been cleared by the FDA, has virtually no scientific support, and constitutes a gross deviation from evidence-based medicine. As obstetricians accept the role of medical evidence steering clinical practice, HUAM clearly has no clinical value and therefore should not be used to manage patients outside of a randomized controlled clinical trial.

In a Cochrane review, Urquhart et al (2012) examined if HUAM is effective in improving the outcomes for women and their infants considered to be at high-risk of preterm birth, when compared with conventional or other care packages that do not include HUAM. These investigators searched the Cochrane Pregnancy and Childbirth Group's Trials Register (November 30, 2011), CENTRAL (The Cochrane Library 2011, Issue 4 of 4), MEDLINE (1966 to November 30, 2011), EMBASE (1974 to November 30, 2011), CINAHL (1982 to November 30, 2011) and scanned reference lists of retrieved studies. Randomized control trials of HUAM, with or without patient education programs, for women at risk for preterm birth, in comparison to the same care package without HUAM were selected for analysis. Two review authors independently assessed trials for inclusion, extracted data and assessed risk of bias. Data were checked for accuracy. These researchers did not attempt to contact authors to resolve queries. There were 15 included studies (total number of enrolled participants 6,008); 13 studies contributed data. Women using HUAM were less likely to experience preterm birth at less than 34 weeks (risk ratio (RR) 0.78; 95 % confidence interval (CI): 0.62 to 0.99; 3 studies, n = 1,596; fixed-effect analysis). However, this significant difference was not evident when the authors carried out a sensitivity analysis, restricting the analysis to studies at low-risk of bias based on study quality (RR 0.75; 95 % CI: 0.57 to 1.00, 1 study, 1,292 women). There was no significant difference in the rate of perinatal mortality (RR 1.22; 95 % CI: 0.86 to 1.72; 2 studies, n = 2,589). There was no significant difference in the number of preterm births at less than 37 weeks (average RR 0.85; CI: 0.72 to 1.01; 8 studies, n = 4,834; random effects, T(2) = 0.03, I(2) = 68 %). Infants born to women using HUAM were less likely to be admitted to neonatal intensive care unit (average RR 0.77; 95 % CI: 0.62 to 0.96; 5 studies, n = 2,367; random-effects, T(2) = 0.02, I(2) = 32 %). Although this difference was not statistically significant when only high-quality studies were included (RR 0.86; 95 % CI: 0.74 to 1.01; 1 study, n = 1,292). Women using HUAM made more unscheduled antenatal visits (mean difference (MD) 0.49; 95 % CI: 0.39 to 0.62; 2 studies, n = 2,807). Women using HUAM were also more likely to have prophylactic tocolytic drug therapy (average RR 1.21; 95 % CI: 1.01 to 1.45; 7 studies, n = 4,316; random-effects. T(2) = 0.03, I(2) = 62 %); but this difference was no longer significant when the analysis was restricted to high-quality studies (average RR 1.22; 95 % CI: 0.90 to 1.65, 3 studies, n = 3,749,random effects, T(2) = 0.05, I(2) = 76 %). One small study reported that the HUAM group spent fewer days in hospital antenatally. No data on maternal anxiety or acceptability were found. The authors concluded that HUAM may result in fewer admissions to a neonatal intensive care unit but more unscheduled antenatal visits and tocolytic treatment. There is no impact on maternal and perinatal outcomes such as perinatal mortality or incidence of preterm birth.

An UpToDate review on "Management of pregnant women after inhibition of acute preterm labor" (Caritis and Simhan, 2015) states that "Home uterine activity monitoring – We agree with the American College of Obstetricians and Gynecologists and other expert organizations that recommend not using home uterine activity monitors to monitor women at risk for pre-term labor (PTL) or recurrent PTL. In a 2015 systematic review and meta-analysis of trials of standard care with versus without home uterine activity monitoring, the intervention had no impact on maternal and perinatal outcomes such as perinatal mortality or incidence of preterm birth".

Scope of Policy

This Clinical Policy Bulletin addresses home uterine activity monitoring.

Medical Necessity

In its discretion, Aetna may consider HUAM medically necessary upon review of each circumstance and consideration of

of the following criteria: