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Incidence of Pump Failure (KQ6) Applicability

Two case series and one RCT reported outcomes related In Table C below, we summarize the overall
to the pump device. 11,22,23 In a case series of 51 women, applicability of the evidence base, according to the
one participant had dislodgment of catheter (2 percent, domains of population, intervention, comparison,
exact central CI: 0.5%, 10%) and there was one pump outcomes, timing, and setting.
that malfunctioned (2 percent, exact central CI: 0.5%,
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10%). No infusion site infections or mechanical
failures were observed in a case series of nine women. 23
An underpowered RCT demonstrated indeterminate
results for the outcomes of local pain and local skin
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irritation. No data were available for missed doses or
overdoses.

Table C. Overall applicability of the body of evidence

Population The majority of evidence pertained to women with recurrent preterm labor and
singleton gestation in the United States. Very little information was reported about the
study populations’ demographic and clinical characteristics. Nine of 14 studies (64
percent) included women judged to be in labor on account of persistent contractions
and cervical change. The definition of labor was unclear in other studies. Among the
studies that suggested that the pump was efficacious, 50 percent reported cervical
change and contractions as part of the definition of labor while 50 percent did not
report how labor was defined.
Intervention Although there were gaps in reporting, the intervention generally did not pose any
serious limitations to applicability. Very few details were reported on cointerventions
that could modify the effectiveness of therapy, such as administration of corticosteroids.
In several studies, participants received specialized outpatient services from Matria
Healthcare.

Comparison Comparators included oral tocolytics, no treatment, and placebo.
Outcomes Surrogate outcomes were the most commonly reported. Data on clinical outcomes,
neonatal/maternal harms, and pump-related outcomes were sparse. Long-term outcomes
have not been reported at all.
Timing of Outcomes The absence of followup beyond delivery is a major limitation because important long-
Measurement term outcomes have not been evaluated.
Setting All studies were from the United States and participant data were acquired from a
national database (Matria) or from single center sites. Women from the Matria database
generally received a high level of care from an outpatient perinatal program. However,
the distribution of regions from which patient data were included into the national
database is unknown and information about the standards followed by the individual
practice sites that provided obstetrical care was not reported. Similarly, for those studies
that took place at single center sites, the standards of care followed at these sites are
unclear.

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