Structured Abstract
Please note: In 2003, the CTF updated its Grades of
Recommendations to include an "I Recommendation" for situations where
insufficient evidence exists to allow a recommendation to be made.
(Formerly, these situations were captured under a "C
Recommendation".) This change is not retroactive, and all
"C Recommendations" made prior to 2003 have not been
reevaluated in light of the new "I" recommendation grade. For a
discussion of these recommendation grades, please link to the 2003 article in
the Canadian Medical Association Journal here.
The Use of Home Uterine Activity Monitoring to Prevent Preterm Birth
Adapted by Geoffrey Anderson, MD, PhD, Institute for Clinical Evaluative
Sciences and Department of Health Administration, University of Toronto,
from the report prepared for the US Preventive Services Task
Force by Steven H. Woolf, MD, MPH
These recommendations were finalized by the Task Force in June 1993
Contents
Objective
To make recommendations for the use of home uterine activity monitoring
for preventing preterm birth in Canadian women.
Burden
of Suffering
Birth before 36 or 37 weeks of gestation is defined as preterm birth.
The incidence of preterm birth is about 6 percent of total deliveries in
Canada. Such births account for 75-85% percent of perinatal mortality,
and about 10-15% percent of survivors having major handicaps.
Options
Options include no monitoring and monitoring with a home uterine activity
monitor with a tocodynamometer plus telephone data transfer and analysis.
Telephone reassurance was also given. Prevention of preterm labour includes
detection of labour (defined as consistent contractions with cervical change)
at an early enough stage to allow for use of tocolytic drugs. Both normal
pregnancy and high-risk pregnancies (previous preterm deliveries, multiple
gestations, uterine anomalies, and other risk factors) were studied.
Outcomes
Neonatal mortality, gestational age at birth, birth weight, time spent
in the hospital and neonatal intensive care unit, need for oxygen therapy
and mechanical ventilation, development of respiratory distress syndrome,
term delivery, hospitalization for preterm labour, and cervical changes.
Equipment and monitoring costs were considered.
Evidence
These recommendations were adapted from a report prepared for the U.S.
Preventive Services Task Force. MEDLINE was searched up to1993 using
the keywords monitoring, physiological; home care services; fetal monitoring,
and home.
Recommendations were graded as:
|
A
|
Good evidence to support the recommendation that the condition
be specifically considered in a PHE. |
|
B
|
Fair evidence to support the recommendation that the condition
be specifically considered in a PHE. |
|
C
|
Poor evidence regarding inclusion or exclusion of the condition
in a PHE, but recommendations may be made on other grounds. |
|
D
|
Fair evidence to support the recommendation that the condition
be specifically excluded from consideration in a PHE. |
|
E
|
Good evidence to support the recommendation that the condition
be specifically excluded from consideration in a PHE. |
Quality of evidence was rated according to 5 levels:
|
I
|
Evidence from at least 1 properly randomized controlled
trial (RCT). |
|
II-1
|
Evidence from well-designed controlled trials without randomization. |
|
II-2
|
Evidence from well-designed cohort or case-control analytic
studies, preferably from more than 1 centre or research group. |
|
II-3
|
Evidence from comparisons between times or places with
or without the intervention. Dramatic results in uncontrolled experiments
could also be included here. |
|
III
|
Opinions of respected authorities, based on clinical experience,
descriptive studies or reports of expert committees. |
Values
The 13-member Task Force of experts in family medicine, geriatric medicine,
pediatrics, psychiatry and epidemiology used an evidence-based method for
evaluating the effectiveness of preventive health care interventions. Recommendations
were not based on cost-effectiveness of options. Patient preferences were
not discussed.
Background papers providing critical appraisal of the evidence and tentative
recommendations prepared by the chapter author were pre-circulated to the
members. Evidence for this topic was presented and deliberated upon in
1- to 2-day meetings from March 1993 to June 1993. Consensus was reached
on final recommendations.
Benefits,
Harms, and Costs
6 RCTs have studied women with high-risk pregnancies and none have studied
low-risk pregnancies. The control group women generally received usual
care (often telephone calls and education). The home uterine monitoring
group received training in the use of the equipment and they monitored
contractions for 1 hour 2 to 3 times per day. If 4 contractions per hour
occurred, they monitored contractions again for an hour while lying down.
Data were transmitted by telephone to tocographs and analyzed; telephone
support was provided by a study nurse.
2 studies by the same group (total 309 patients) found no differences
between the groups for incidence of preterm labour, preterm deliveries,
gestational age at delivery, or mean birth weight. A French study of 94
high-risk women also found no differences in rate of hospital admission
for threatened preterm labour, incidence of preterm births or birth weight<
2500 g. One study (251 women) in California found that most differences
were in the subgroups of women with twins and with preterm labour before
43 weeks' gestation. One study of 69 women found an average of 4 weeks
longer gestation in the monitoring group. Another study with a large number
of women not included in the analysis found monitored babies weighed more,
needed fewer days in the neonatal intensive care unit, and had less need
for oxygen therapy or mechanical ventilation. All studies had design flaws
or unequal control groups.
Cost was approximately $90/d Cdn for equipment and monitoring charges
($630 to $7560 per monitored pregnancy).
Recommendations
Recommendation grade [A, B, C, D, E] and level of evidence
[I, II-1, II-2, II-3, III] are indicated after each recommendation. Citations
in support of individual recommendations are identified in the guideline
text.
-
Insufficient evidence exists to recommend for or against using home uterine
activity monitors as a screening tool for high-risk pregnancies [C,
I]. (High-risk pregnancies were defined as previous
preterm deliveries, multiple gestations, uterine anomalies, and other risk
factors.)
-
Because of lack of evidence of benefit and high costs, fair evidence exists
to exclude home uterine activity monitoring in low-risk pregnancies [D,
III].
Validation
This report was externally peer reviewed. The 1989 U.S. Preventive Services
Task Force recommended against use of home uterine activity monitors in
low-risk pregnancies and found insufficient evidence of clinical effectiveness
to recommend for or against home uterine activity monitors as a screening
test in high-risk pregnancies. The British Columbia Office of Health Technology
Assessment does not recommend use of home uterine activity monitoring even
for high-risk pregnancies. The Society of Obstetricians and Gynecologists
of Canada has not made an official recommendation on their use.
Sponsors
The Canadian Task Force on Preventive Health Care
developed this guideline with funding from Health Canada.
Selected
References
Source Document
Other
-
U.S. Preventive Services Task Force. Home uterine activity monitoring for
preterm labor: Review article. JAMA. 1993;270:369-70.
Link to Full Text of this
review
Link to Summary Table of Recommendations of this review
Link to Selected References list of this review
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