Research Activities February 2013, No. 390
Using a terbutaline pump to prevent preterm birth may be beneficial, but evidence suggests caution
Although it is considered an off-label use, terbutaline sulfate can be given to pregnant women to prevent uterine contractions for extended periods to prevent preterm birth. The infusion is given by a pump after the patient receives primary therapy with first-line agents. The efficacy and safety of this approach, however, remains uncertain. Researchers recently conducted a literature review and meta-analysis to evaluate these issues. While evidence suggested that pump therapy may be beneficial, the strength of the evidence was deemed low.
The final analysis consisted of 2 randomized trials (low and high risk of bias), 1 non-randomized trial (medium to high risk of bias, depending on outcome), and 11 observational studies (medium to high risk of bias). More than 70 percent of the included studies had at least 200 patients. The two small randomized control trials were considered underpowered to detect any differences in outcomes of effectiveness and harm.
Evidence was only of low strength to suggest that the pump may decrease the risk of neonatal death compared with oral medications in those patients with recurrent preterm labor and twin gestation. Observational studies tended to favor the pump at reducing the odds of delivering at less than 32 weeks in these women.
The pump was also favored at preventing any preterm delivery at less than 37 weeks compared with oral agents or no treatment in women with recurrent preterm labor. Benefits were also observed for the pump for birth weight and neonatal intensive care unit admission. No evidence was available for bronchopulmonary dysplasia, death within initial hospitalization, incidence of delivery less than 28 or less than 34 weeks, and withdrawal due to adverse effects.
Based on postmarketing surveillance reports of maternal deaths and cardiovascular events, the FDA issued a warning in February 2011 against the use of terbutaline in general, and as an injection in particular, as maintenance tocolysis in pregnant women. The original review and analysis on which the journal article was based was supported by the Agency for Healthcare Research and Quality (Contract No. 290-07-10059). See "Effectiveness of terbutaline pump for the prevention of preterm birth. A systematic review and meta-analysis," by Laura M. Gaudet, M.D., Kavita Singh, R.Ph., M.P.H., Laura Weeks, Ph.D., and others in the February 2012 PLoS ONE 7(2), pp. e31679 [open access].