The effect of introduction of umbilical Doppler recordings to obstetric practice. Screening for fetal well-being in a high-risk pregnant population comparing the nonstress test with umbilical artery Doppler velocimetry: a randomized controlled clinical trial. Use of a decision aid for prenatal testing of fetal abnormalities to improve women's informed decision making: a cluster randomised controlled trial [ISRCTN22532458]. The value of antenatal cardiotocography in the management of high-risk pregnancy: a randomized controlled trial. Randomized comparison of routine vs highly selective use of Doppler ultrasound and biophysical scoring to investigate high risk pregnancies. Effect of topical anesthesia and age on pain scores during retinopathy of prematurity screening. Screening with a uterine Doppler in low risk pregnant women followed by low dose aspirin in women with abnormal results: a multicenter randomised controlled trial. Randomised comparison of routine versus highly selective use of Doppler ultrasound in low risk pregnancies. Treatment of severe preeclampsia with antithrombin concentrate: results of a prospective feasibility study.
To assess the effect on obstetric practice of clinician access to umbilical artery Doppler ultrasound results.
                Randomised controlled trial.
                A large teaching hospital.
                Two thousand two hundred and eighty-nine pregnancies defined as being at risk by referral for Doppler or fetal monitoring.
                Continuous wave Doppler studies of umbilical artery. Results immediately available to clinicians.
                Fetal outcome: perinatal mortality, Apgar score and admission to the neonatal unit. Obstetric intervention: admission to hospital, induction of labour and caesarean section. Use of of fetal well being: cardiotocography, biophysical profile and ultrasound biometry.
                The treatment and control groups were comparable in age, parity, gestation at point of entry and risk features. There were no overall differences in perinatal outcome, obstetric intervention or use of fetal monitoring. Examination of a subset recruited only because of hypertension or suspected intrauterine growth retardation (n = 754) similarly showed no difference attributable to group randomisation. Comparison of only those pregnancies retrospectively defined as low risk and high risk showed more use of cardiotocography in the high risk group with access to Doppler (P = 0.007) but no difference in the low risk group.
                Doppler umbilical artery recording has been shown to perform well in prediction power of antenatal fetal compromise. What has been examined in this study is the response of clinicians to the test. The results suggest that obstetricians do not use the test to modify their risk assessment, and, therefore, the need for fetal monitoring in particular pregnancies. There is a real need for accumulation of information from very large data sets, particularly in the prediction power of Doppler for antenatal fetal compromise from apparently chronic utero-placental cause to guide use of monitoring resources. If simply added to existing fetal monitoring techniques in a hospital where these are widely used, then umbilical artery Doppler recordings may at present simply involve extra resources of staff and expenses, without benefit. The purpose of this study was to evaluate the ability of two different modes of antepartum fetal testing to screen for the presence of peripartum morbidity, as measured by the cesarean delivery rate for fetal distress in labor.
                Over a 36-month period, all patients who were referred to the Fetal Assessment Unit at BC Women's Hospital because of a perceived increased fetal antepartum risk at a gestational age of > or =32 weeks of gestation were approached to participate in this study. Fetal surveillance of these women was allocated randomly to either umbilical artery Doppler ultrasound testing or nonstress testing as a screening test for fetal well-being. If either the umbilical artery Doppler testing or the nonstress testing was normal, patients were screened subsequently with the same technique, according to study protocol. When the Doppler study showed a systolic/diastolic ratio of >90th percentile or the nonstress testing was equivocal (ie, variable decelerations), an amniotic fluid index was performed, as an additional screening test. When the amniotic fluid index was abnormal (<5th percentile), induction and delivery were recommended. When the Doppler study showed absent or reversed diastolic blood flow or when the nonstress test result was abnormal, induction and delivery were recommended to the attending physician. Statistical comparisons between groups were performed with an unpaired t test for normally distributed continuous variables and chi(2) test for categoric variables.
                One thousand three hundred sixty patients were assigned randomly to groups in the study; 16 patients were lost to follow up. Six hundred forty-nine patients received Doppler testing and 691 received nonstress testing. The mean number of visits for the Doppler test and nonstress test groups was two versus two, respectively. The major indications for fetal assessment included postdates (43%), decreased fetal movement (22%), diabetes mellitus (11%), hypertension (10%), and intrauterine growth restriction (7%). The incidence of cesarean delivery for fetal distress was significantly lower in the Doppler group compared with the nonstress testing group (30 [4.6%] vs 60 [8.7%], respectively; P <.006). The greatest impact on the reduction in cesarean deliveries for fetal distress was seen in the subgroups in which the indication for testing was hypertension and suspected intrauterine growth restriction.
                Umbilical artery Doppler as a screening test for fetal well-being in a high-risk population was associated with a decreased incidence of cesarean delivery for fetal distress compared to the nonstress testing, with no increase in neonatal morbidity. To evaluate the effectiveness of a decision aid for prenatal testing of fetal abnormalities compared with a pamphlet in supporting women's decision making.
                A cluster randomised controlled trial.
                Primary health care.
                Women in early pregnancy consulting a GP.
                GPs were randomised to provide women with either a decision aid or a pamphlet. The decision aid was a 24-page booklet designed using the Ottowa Decision Framework. The pamphlet was an existing resource available in the trial setting.
                Validated scales were used to measure the primary outcomes, informed choice and decisional conflict, and the secondary outcomes, anxiety, depression, attitudes to the pregnancy/fetus and acceptability of the resource. Outcomes were measured at 14 weeks of gestation from questionnaires that women completed and returned by post.
                Women in the intervention group were more likely to make an informed decision 76% (126/165) than those in the control group 65% (107/165) (adjusted OR 2.08; 95% CI 1.14-3.81). A greater proportion of women in the intervention group 88% (147/167) had a 'good' level of knowledge than those in the control group 72% (123/171) (adjusted OR 3.43; 95% CI 1.79-6.58). Mean (SD) decisional conflict scores were low in both groups, decision aid 1.71 (0.49), pamphlet 1.65 (0.55) (adjusted mean difference 0.10; 95% CI -0.02 to 0.22). There was no strong evidence of differences between the trial arms in the measures of psychological or acceptability outcomes.
                A tailored prenatal testing decision aid plays an important role in improving women's knowledge of first and second trimester screening tests and assisting them to make decisions about screening and diagnostic tests that are consistent with their values. The value of routine regular antenatal cardiotocography (CTG) in the management of high-risk pregnancy was assessed in a prospective randomized controlled study of 353 patients. All patients had a weekly CTG trace during the last 6 weeks of pregnancy and according to the random allocation the tracings were concealed from, or available to, the clinicians. Other methods of assessing fetal welfare were available to both groups. There was no significant difference between the concealed and revealed groups in the timing and mode of delivery, birthweights, Apgar score and neonatal morbidity. No apparent effect from the routine use of antenatal CTG in high-risk pregnancy was shown. To compare routine versus highly selective use of Doppler ultrasound and biophysical scoring in higher risk pregnancy.
                A pragmatic randomized trial.
                St James's University Hospital, Leeds.
                500 pregnant women at high risk of intrauterine growth retardation or still birth.
                Regular monitoring with biophysical profile assessment and Doppler velocity waveform recording in umbilical and uteroplacental arteries. Results immediately available to clinicians.
                Gestational age at delivery, obstetric intervention rates and short-term neonatal morbidity.
                Risk factors were distributed very evenly between the 250 patients in the study and control groups respectively. A total of 902 biophysical profile and Doppler assessments were done in the 250 study group patients and only in 12 patients in the control group. In the study group, absent end-diastolic flow was found in only 2.7% of all 902 measurements. A persistently abnormal biophysical score was always associated with absence of end-diastolic flow. The mean gestational age at induction of labour was statistically and clinically similar in the two groups and there was no overall statistically significant difference in intervention rates between the two groups. There was a statistically significant lower frequency of depressed 5-min Apgar scores in the study group. Serious neonatal morbidity was also statistically significantly more common in the control group than in the study group.
                The use of Doppler ultrasound in higher risk pregnancies does not lead to an increase in iatrogenic preterm delivery. The total rate of positive tests on Doppler ultrasound is very low and persistently abnormal biophysical scores are unlikely to be found in patients where umbilical end-diastolic blood flow is present. Surrogate measures for fetal damage seem to be improved when clinicians have access to Doppler ultrasound assessments. The efficacy of topical anesthesia during retinopathy of prematurity (ROP) screening has been a controversial issue. To determine the efficacy of proparacaine eye drops (0.5%), we compared the Premature Infant Pain Profile (PIPP) scores in 40 preterm infants undergoing ROP screening.
                Prospective randomized double masked cross-over clinical trial. The study was conducted in the neonatal intensive units for infants undergoing routine ROP screening exams. Baseline PIPP scores and post-examination PIPP scores at 1 and 5 min were compared for: (1) those receiving saline vs proparacaine eye drops (2) first ROP screening vs second ROP screening, regardless of the type of eye drops used. Wilcoxon signed-ranks test was used to pair pain scores.
                Forty preterm infants were included in the study. Mean gestational age (GA) at first and second examinations was 33.3 and 35.3 weeks, respectively. Proparacaine use significantly lowered mean PIPP scores (P=0.027) and delta scores (P=0.013) at 1 min after examination, but there was no difference at 5 min after examination. Second examinations showed significantly lower mean PIPP scores after examination (1 min (P=0.003) and 5 min (P=0.025)), regardless of the type of drop used.
                Proparacaine eye drops offer significant relief of pain that is apparently short lived. Significantly lower PIPP scores at second ROP examinations suggested that infants of older GA may have a greater ability to tolerate ROP screening. We recommend the use of proparacaine eye drops for the short term, immediate relief of pain during ROP screening in preterm infants of lesser GA. To assess whether systematic screening with an uterine artery Doppler in low risk pregnant women followed by the prescription of low dose aspirin in cases with abnormal results reduced the incidence of intrauterine growth restriction and pre-eclampsia.
                A multicentre randomised trial.
                3,317 low risk pregnant women. In the Doppler group, the uterine artery Doppler was performed between 20 and 24 weeks. Women with abnormal results received 100 mg of aspirin daily until the 35th week.
                Intrauterine growth restriction was defined as birthweight below the tenth and the third centile according to gestational age. Pre-eclampsia was defined as hypertension associated with proteinuria > 0.5g/L.
                Intrauterine growth restriction, whether defined by the third or tenth centile, did not differ significantly between the two groups (RR = 1.22 [0.73 - 2.04] and 1.18 [0.93 - 1.51] respectively). Screening with uterine artery Doppler did not affect birthweight or any of the criteria of perinatal morbidity. There was no effect on the incidence of pre-eclampsia (RR = 1.99 [0.97 - 4.09]) or hypertensive disorders. These results were the same for nulliparae and multiparae.
                There is no justification for screening with uterine artery Doppler in a low risk population, even if abnormal results are followed by aspirin treatment and increased prenatal surveillance. Future studies must assess predictive tests that can be performed early in pregnancy and can identify populations at very high risk of pre-eclampsia and intrauterine growth restriction. Only when all of these conditions are fulfilled, aspirin or other treatments may prove its efficacy. To help answer the question: should Doppler ultrasound of the umbilical circulation be made available to all pregnant women as part of their routine antenatal care?
                A randomised trial.
                St James's University Hospital, Leeds.
                2025 low risk primigravid women.
                Obstetric intervention rates and short term neonatal morbidity.
                The incidence of abnormal Doppler was low (1.7%) with complete absence of end diastolic flow in only 0.3% of cases. No significant differences could be demonstrated between control and study women in any of the outcomes measured.
                This study did not demonstrate any benefit or harm from Doppler ultrasound as a routine screening test for all low risk women, whereas our previous studies have suggested that it is useful in high risk pregnancies. Any marginal returns on extending access to Doppler ultrasound from high risk to all women must be small. Since this test has excellent performance characteristics (sensitivity and specificity) for the prediction of fetal hypoxia and acidosis our results call into question the cost to benefit ratio of all tests designed to predict these outcomes in low risk women. The prospective feasibility study was designed to determine whether treatment with antithrombin (AT) concentrates could be used for patients with severe preeclampsia to provide clinical efficacy without the full systemic antihypertensive drug. Twenty-nine severe preeclamptic patients (24 to 36 weeks of gestation, gestosis index [GI] >/= 6 points) were randomized to receive AT (1500 U/day) or not. AT was given intravenously once daily for 7 consecutive days. Twenty-four hours of continuous infusion of 5000 U/day of unfractionated heparin was given simultaneously in both groups. There were no statistical differences in the clinical profiles of the two groups. Maternal symptoms were evaluated from the difference of GI before and after treatment, and fetal findings were evaluated from the changes of the biophysical profile score. Improvement was significantly greater in the AT group for both the GI ( P = 0.046) and the biophysical profile score ( P = 0.022). The improvement of coagulation parameters was also evaluated. The improvement of plasmin-plasmin inhibitor complex (PPIC), D-dimer levels, and platelet counts was observed in the AT group compared with the non-AT group. The coagulation index as a composite coagulation test parameter showed a significantly improvement in the AT group. No adverse events related to AT were observed. Given that AT plus heparin was significantly better than treatment with heparin alone for improvement of both GI and biophysical profile of infant, it is suggested that therapy with AT alone might be effective enough for severe preeclampsia.
At present, there is insufficient evidence from randomised trials to support the use of BPP as a test of fetal wellbeing in high-risk pregnancies.
[Note: The three citations in the awaiting classification section of the review may alter the conclusions of the review once assessed.]