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confirmed preterm labor. As with all other performing an up-to-date search of the literature,
contemporary tocolytics, the use of terbutaline for synthesizing evidence in the context of specific
maintenance tocolysis is off-label. The Food and Drug populations of women, addressing confounding by level
Administration (FDA) has approved terbutaline for the of maternal activity and level of care, and grading the
management of acute and chronic obstructive strength of evidence for important outcomes to help
pulmonary disease only. When administered through decisionmakers develop evidence-based
the subcutaneous (SQ) route, terbutaline may be recommendations and policies.
administered by a pump that provides a steady
continuous infusion with allowance for boluses. Objectives
Compared with the oral route of administration, the SQ
terbutaline pump uses lower doses (usual basal rate is The objectives of this review were to examine the
0.03–0.05 mg/hr with an intermittent bolus of 0.25 mg efficacy, effectiveness, and safety of the SQ terbutaline
every 4 to 6 hours) and has less potential for pump as prolonged maintenance tocolysis for inhibiting
tachyphylaxis. 4 progression of parturition in women with arrested acute
preterm labor. The SQ terbutaline pump was compared
The effectiveness and safety of the SQ terbutaline pump
with placebo, conservative treatment, or any other
for maintenance tocolytic therapy was examined in two
active intervention in the following specific
systematic reviews. One review, which was based on
populations: women delivering at various gestational
two small randomized controlled trials (RCTs),
ages, classified as extremely preterm (<28 weeks of
concluded that the SQ terbutaline pump offers no
gestation), very preterm (28 weeks to 31 weeks of
advantages compared with the saline pump or oral
gestation), preterm (32 weeks to 33 weeks of gestation),
terbutaline. The second review found contradictory
4
and later preterm (34 weeks to 36 weeks of gestation);
results among RCTs and observational studies; the
women with multiple gestation; women of different
RCTs found no difference between the SQ terbutaline
racial or ethnic backgrounds; women with previous
pump and comparators, although the observational
preterm birth; women with history of preeclampsia; and
studies demonstrated positive effect estimates in favor
women with recurrent preterm labor (RPTL) during the
of the pump. 5
same pregnancy. Clinical endpoints, which included
Despite previous systematic reviews, uncertainty neonatal health outcomes and maternal/neonatal harms,
surrounding the use of terbutaline and other tocolytics were assessed in addition to several surrogate
as maintenance therapy to prevent recurrent episodes of outcomes, such as birth weight and prolongation of
preterm labor still exists. No clear first-line pregnancy. The potential confounding effects of
maintenance tocolytic therapy has yet emerged. The maternal activity and maternal care on the above
possibility of maternal side effects and unclear evidence endpoints were explored. Lastly, the pump device was
on perinatal outcomes contribute to the ambiguity of evaluated by examining the incidence of pump-related
terbutaline’s role in obstetrical practice. Moreover, in a outcomes, such as missed doses, dislodgment, and
recent cost analysis of four tocolytic agents, overdose.
subcutaneous terbutaline had the highest cost. The
6
These objectives were framed in the following Key
expense is due not only to the device, but also to the
Questions:
need for increased monitoring and management of
adverse events associated with this therapy. 6 In women with arrested preterm labor, does
treatment with an SQ infusion of terbutaline
Given the importance and associated uncertainty about
delivered by a pump, in comparison with placebo,
the appropriateness of ongoing use of the terbutaline
conservative treatment, or other interventions:
pump for maintenance tocolysis for clinicians, patients,
and policymakers, a review about the effectiveness and Key Question 1: improve neonatal health outcomes,
safety of SQ terbutaline pump was commissioned by including bronchopulmonary dysplasia, neonatal
the Agency for Healthcare Research and Quality death, death within initial hospitalization, significant
(AHRQ) to address six Key Questions. This evidence intraventricular hemorrhage (grade III/IV),
report will add to previous systematic reviews by necrotizing enterocolitis, periventricular

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