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striction or hypertensive disease of pregnancy would<br />

the use of Doppler velocimetry reduce the number of<br />

perinatal deaths and unnecessary obstetric interventions.<br />

Two other meta-analyses of trials of umbilical artery<br />

velocimetry in low-risk pregnancies have been<br />

performed. Goffinet and colleagues [30] conducted a<br />

meta-analysis of four randomized trials of umbilical<br />

Doppler in unselected or low-risk pregnancies with a<br />

total population of 11,375 women. Three other studies<br />

were not included because they did not meet the inclusion<br />

criteria or they had methodological problems.<br />

Screening Doppler umbilical artery velocimetry did<br />

not influence perinatal deaths (overall perinatal<br />

deaths OR 0.90, 95% CI 0.50±1.60) or stillbirth (overall<br />

stillbirths OR 0.94, 95% CI 0.42±1.98), antenatal<br />

hospitalization (OR 1.04, 95% CI 0.95±1.15), obstetric<br />

outcome, or perinatal morbidity.<br />

A subsequent meta-analysis of five trials on routine<br />

Doppler ultrasound in unselected and low-risk<br />

pregnancies with a total population of 14,338 women<br />

also concluded that routine Doppler ultrasound examination<br />

in low-risk or unselected populations did<br />

not confer benefit on mother or infant [31]. Umbilical<br />

Doppler examination cannot be recommended as a<br />

routine test in low-risk or unselected populations.<br />

Unfortunately, the many systematic reviews of<br />

trials on the effect of umbilical artery Doppler velocimetry<br />

have been based on essentially the same 12<br />

trials that were evaluated in the first meta-analysis by<br />

Alfirevic and Neilson [26] with some modifications.<br />

Thornton has been critical of this pattern of repeated<br />

analysis, and believes that ªrepeated analysis of the<br />

same data set can at best only generate hypotheses<br />

for future researchers to testº [49]. He suggested the<br />

need for trials of the effect of umbilical artery Doppler<br />

velocimetry where there is a clearly defined<br />

group and a defined delivery timing policy to follow.<br />

Alternatively, trials with well-defined groups and different<br />

delivery timing policies should be addressed.<br />

It is of interest to note that none of the existing<br />

modalities of fetal surveillance are based on affirmative<br />

evidence derived from clinical trials and systematic<br />

meta-analytic reviews. The benefit of the antepartum<br />

nonstress test was investigated in four randomized<br />

clinical trials [50±53]. None of the studies demonstrated<br />

any benefit. Moreover, a meta-analysis of<br />

these studies failed to show any benefit (Table 26.5).<br />

No randomized trial has ever been reported for the<br />

contraction stress test. There were two quasi-randomized<br />

trials on the fetal biophysical profile in the 1980s<br />

[55, 56]; neither demonstrated any difference in outcome<br />

after use of the test. Subsequent meta-analytic<br />

review also showed no benefit [57]. Two additional<br />

trials [58, 59] on the biophysical profile published in<br />

the 1990s were included in the meta-analysis by Ala<br />

Chapter 26 Doppler Velocimetry for Fetal Surveillance: Randomized Clinical Trials and Implications for Practice 397<br />

Table 26.4. Meta-analysis of Doppler randomized clinical<br />

trials performed on high-risk pregnancies utilizing the random<br />

effects model of DerSimonian and Laird [44]. The<br />

analysis shows the effect on perinatal mortality<br />

First author Doppler Control Odds Ratio<br />

(95% CI)<br />

Trudinger, 1987 1/127 5/162 0.25 (0.03±2.16)<br />

McParland, 1988 6/254 20/255 0.28 (0.11±0.72)<br />

Tyrrell, 1990 3/250 3/250 1.00 (0.20±5.00)<br />

Hofmeyr, 1991 4/438 8/459 0.52 (0.16±1.74)<br />

Newnham, 1991 9/275 9/270 0.98 (0.38±2.51)<br />

Burke, 1992 4/241 3/235 1.31 (0.29±5.90)<br />

Almstrom, 1992 0/214 3/212 0.14 (0.01±2.72)<br />

Biljan, 1992 1/338 4/336 0.25 (0.03±2.22)<br />

Johnstone, 1993 12/1,132 16/1,197 0.79 (0.37±1.68)<br />

Pattinson, 1994 6/108 8/104 0.71 (0.24±2.11)<br />

Neales, 1995 11/236 14/231 0.76 (0.34±1.71)<br />

Nienhuis, 1995 2/74 3/76 0.68 (0.11±4.17)<br />

Total 59/3,687 96/3,787 0.64 (0.46±0.90)<br />

CI 0.50±1.01) especially in pregnancies complicated<br />

by hypertension or presumed impaired fetal growth.<br />

In addition, there were fewer inductions of labor (OR<br />

0.83, 95% CI 0.74±0.93) and fewer hospital admissions<br />

(OR 0.56, 95% CI 0.43±0.72) without adverse<br />

perinatal effects. Moreover, there was no difference<br />

for fetal distress in labor (OR 0.81, 95% CI 0.59±1.13)<br />

or cesarean deliveries (OR 0.94, 95% CI 0.82±1.06).<br />

The investigators concluded that the use of Doppler<br />

ultrasound appeared promising in helping to reduce<br />

perinatal deaths.<br />

Westergaard and colleagues [29] reanalyzed randomized<br />

controlled trials on the use of umbilical artery<br />

Doppler velocimetry in 8,633 high-risk pregnancies<br />

in order to determine which high-risk pregnancies<br />

benefit from the use of Doppler velocimetry.<br />

They divided 13 randomized controlled trials (including<br />

two unpublished studies) into ªwell-defined studies,º<br />

when there was a strict definition of suspected<br />

intrauterine growth restriction or hypertensive disease<br />

of pregnancy, and ªgeneral risk studies.º The<br />

ªwell-defined studiesº showed a significant reduction<br />

in antenatal admissions (OR 0.56, 95% CI 0.43±0.72),<br />

inductions of labor (OR 0.78, 95% CI 0.63±0.96), elective<br />

deliveries (OR 0.73, 95% CI 0.61±0.88), and cesarean<br />

deliveries (OR 0.78, 95% CI 0.65±0.94). No significant<br />

difference was found in perinatal mortality<br />

(OR 0.66, 95% CI 0.36±1.22). The perinatal deaths<br />

were audited by a panel of 32 international experts<br />

who found that more perinatal deaths in the ªwell-defined<br />

studiesº were potentially avoidable by use of<br />

Doppler velocimetry (50% controls versus 20% Doppler<br />

velocimetry group). The ªgeneral risk studiesº<br />

did not show significant differences in the variables<br />

studied. These investigators concluded that only in<br />

pregnancies with suspected intrauterine growth re-

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