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compared with either no treatment or oral terbutaline retrospective cohort and a nonrandomized trial,
(mean difference = 0.41, 95% CI: 0.26, 0.56; and 0.14, demonstrated nonsignificant differences between the
95% CI: 0.02–0.26). SQ terbutaline pump and oral terbutaline in the
incidence of gestational diabetes, though type II error
Need for assisted ventilation. One cohort study from
cannot be excluded. No data were available on heart
the Matria database reported a nonsignificant difference
failure, myocardial infarction, refractory hypotension,
between the SQ terbutaline pump and oral tocolytics in
and hypokalemia.
requirement for ventilator among infants with NICU
admission. 18 Until 2009, 16 maternal deaths and 12 cases of
maternal cardiovascular events (hypertension,
NICU admission. Incidence of NICU Admission:
myocardial infarction tachycardia, arrhythmias, and
Statistically significant differences in favor of the SQ
pulmonary edema) in association with terbutaline
terbutaline pump compared with oral tocolytics or no
tocolysis were reported to the FDA. Of these, at least
treatment were reported in cohort studies of women
three maternal deaths and three cardiovascular adverse
with RPTL and single or twin gestation (OR range
events were clearly reported to be in association with
0.28–0.72, 95% CI range: 0.08–0.58, 0.63–0.97). 13,15-19
the use of the SQ terbutaline pump. 24
Again, most of these studies were Matria-based. 15-19 One
small RCT (n=52), which did not pertain to any of the
Neonatal Harms (Key Question 4)
populations of interest, reported a nonsignificant
difference between the SQ terbutaline pump and Neonatal harms data were very sparse. Neonatal
placebo. 10 hypoglycemia was reported in only one RCT that
compared the SQ terbutaline pump with placebo and
NICU length of stay: Statistically significant
11
oral terbutaline. Differences between the SQ
differences in favor of the SQ terbutaline pump
terbutaline pump and placebo or oral terbutaline were
compared with oral tocolytics or no treatment were also
nonsignificant. However, given the small number of
reported for NICU length of stay in mostly Matria-
events and limited sample size (n=42), the RCT was
based cohort studies of women with RPTL and single
underpowered and the results are inconclusive. No
or twin gestation (range of mean difference in days:
studies reported neonatal hypocalcemia or ileus.
-3.50 to -17.90, 95% CI range: -5.26 to -32.88, -1.74 to
-3.54). 13,15,18,19 Another small RCT (n=42), which did not Assessment of Confounding by Level of
address any of the subgroups of interest, reported a Activity and Level of Care (Key Question 5)
nonsignificant difference between the SQ terbutaline
pump and placebo or oral terbutaline. 11 Only a small number of studies could be rated for level
of activity and level of care. Therefore, we could not
Maternal Harms (Key Question 3) carry out meta-regressions to explore the effect of these
variables on maternal and neonatal outcomes.
The strength of evidence is insufficient for Withdrawal-
Furthermore, we could not even explore the impact of
AE (Table B). One prospective cohort in women with
level of activity on effect estimates in a qualitative
singleton gestation and RPTL demonstrated highly
manner because all studies that could be rated were
unreliable odds favoring no treatment compared with
designated as having “low” level of activity. No
the pump for tachycardia/nervousness (OR=25.48, 95%
apparent trends in effect estimates according to level of
CI:1.23, 526.6). Underpowered studies demonstrated
13
care based on qualitative assessments were observed.
indeterminate results for the outcomes of mortality,
pulmonary edema, and therapy discontinuation (i.e.,
type II error cannot be excluded). 10,18,19 Two studies, a

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