Blue Cross and Blue Shield of Montana (BCBSMT) considers home uterine activity monitoring (HUAM) through a monitoring device and/or daily nursing contact experimental, investigational and unproven.
* Correction provided by study author, Dr. Rittenberg, 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, 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 PTL, and had fewer hospitalizations for suspected PTL. Moreover, the study was not randomized, and we cannot be certain that they were equivalent at baseline; there may have been demographic or clinical differences between the groups, which 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, we cannot be 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.
There is less evidence on the use of HUAM for the tertiary prevention of preterm delivery. Most trials on HUAM included only patients who were considered “at risk” for PTL, and many specifically excluded those patients who had a history of PTL in the current pregnancy. Four trials were identified that evaluated the use of HUAM for tertiary prevention; none of these found that HUAM improved health outcomes. The trials are briefly summarized below:
- Iams and colleagues conducted a trial looking at HUAM in 76 women who had been successfully treated for preterm labor. (7) Women were randomly assigned 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 PTL and preterm delivery did not differ between the groups.
- Blondel and colleagues randomly assigned 74 women with successfully treated PTL to either undergo HUAM and nursing contact or weekly or biweekly home nursing visits. (8) There was no significant difference in the rate of preterm deliveries between the two groups.
- Nagey and colleagues reported on a study that randomly assigned 56 women with a history of successfully treated PTL to receive either HUAM or standard treatment. (9) There was no difference in the incidence in preterm birth between the two groups.
- Brown and colleagues reported on the results of a trial that randomly assigned 162 women who had experienced an episode of PTL in the current pregnancy to undergo HUAM plus standard care or standard care alone. (10) There were no differences in outcomes between the two 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.
Technology Assessments, Guidelines, and Position Statements
- The U.S. Preventive Services Task Force (USPSTF) current topic page on HUAM states, “Home uterine monitoring is no longer considered a part of standard obstetric care and is not relevant to clinical practice. The USPSTF will not update its 1996 recommendation.” (11)
- In 2002, the National Institute of Child Health and Human Development (NICHD) issued a news release declaring that home uterine monitors are not useful for predicting premature birth. (12) The news release describes a study sponsored by the NICHD which found that ambulatory monitoring of uterine contractions did not identify women most likely to have preterm delivery.
- In 2003, an American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin included the following statement: “No evidence exists to support the use of tocolytic therapy, HUAM, elective cerclage, or narcotics to prevent preterm delivery in women with contractions but no cervical change. “ (13) The position statement was affirmed in 2008.
There is a substantial literature on home uterine activity monitoring for reducing preterm birth in high-risk pregnant women. Numerous RCTs have been performed prior to the year 2000. The trials that were the largest in size and highest in quality have not reported a benefit for HUAM, and systematic reviews of the available trials have not concluded that health outcomes are improved. The available evidence suggests that HUAM does not improve health outcomes, and HUAM is not recommended by national organizations such as the ACOG and the USPSTF. Thus, HUAM is considered experimental, investigational and unproven.