Monitoring of in vitro fertilization-embryo transfer cycles by ultrasound versus by ultrasound and hormonal levels: a prospective, multicenter, randomized study. Ultrasound-guided hydrosalpinx aspiration during oocyte collection improves pregnancy outcome in IVF: a randomized controlled trial. Randomized comparison of routine vs highly selective use of Doppler ultrasound and biophysical scoring to investigate high risk pregnancies. Routine ultrasound fetal examination in pregnancy: the 'Alesund' randomized controlled trial. The effect of introduction of umbilical Doppler recordings to obstetric practice. Ultrasound guidance during embryo transfer: a prospective, single-operator, randomized, controlled trial. Intrapartum management of nonreassuring fetal heart rate patterns: a randomized controlled trial of fetal pulse oximetry. Randomised comparison of routine versus highly selective use of Doppler ultrasound in low risk pregnancies. Doppler flow velocity waveform analysis in high risk pregnancies: a randomized controlled trial.
To determine whether cycle monitoring using both serum E(2) and ultrasound findings yields superior clinical pregnancy rates during IVF-embryo transfer (ET) compared to monitoring with ultrasound alone.
                Prospective, randomized, multicenter, patient-blinded study.
                Four assisted conception units in the United Kingdom.
                Two hundred ninety-seven women believed to be normal responders undergoing IVF treatment.
                Patients were randomly allocated on day 7 of stimulation to one of the two hCG administration criteria: [1] the E(2)-to-follicle > or =11 mm ratio was between 250 and 500 pmol/L/follicle and at least 2 follicles reached a mean diameter of 18 mm or [2] at least 2 follicles reached a mean diameter of 18 mm and the endometrium thickness was > or =8 mm.
                Duration and cumulative dose of recombinant human FSH, total number of growing follicles, oocytes retrieved, number and quality of embryos, pregnancy rates, and ovarian hyperstimulation syndrome (OHSS) rates.
                Two hundred ninety-seven patients were randomized to one of the two criteria groups. Of these, 288 (97%) received urinary (u)-hCG (143 in group A and 145 in group B). One hundred three women in group A (72%) met both criteria for hCG administration. Pregnancy and OHSS rates were similar (34.3% vs. 31.4% and 4.9% vs. 4.1%, respectively).
                The addition of E(2)/follicle criteria to ultrasound monitoring of IVF cycles in normal responders seldom changes the timing of hCG, and does not increase pregnancy rates or the risk of OHSS. Hydrosalpinges have adverse effects on IVF outcomes. Salpingectomy is effective in improving outcomes, but it is not always practical or safe. Ultrasound-guided aspiration of hydrosalpinges at oocyte collection is an option for those who develop hydrosalpinges during controlled ovarian stimulation; however, there is no randomized evidence to show whether this practice is effective.
                Between October 1999 and June 2003, consenting women of age <or=39 years with an ultrasound diagnosis of hydrosalpinx were randomized before oocyte collection to transvaginal aspiration of hydrosalpinx under antibiotics cover or no aspiration. Third-party randomization was performed using a computer algorithm, and allocation concealment was achieved with opaque sealed envelopes. Outcomes were biochemical and clinical pregnancies, implantation, spontaneous abortion, ectopic pregnancy and pelvic infection rates. Analysis was by intention to treat.
                Sixty-six women were recruited to the trial, 32 to the aspiration group and 34 to the no-aspiration group. Aspiration resulted in a greater biochemical pregnancy rate [14/32 (43.8%) versus 7/34 (20.6%), relative risk (RR) = 2.1 (1.02, 4.6), P = 0.04]. Clinical pregnancy rates for aspiration versus control groups were 31.3% (10/32) and 17.6% (6/34), respectively [RR = 1.8 (0.8, 4.3), P = 0.20]. There were no changes in implantation rate or spontaneous abortion risk with aspiration and no differences between the groups in infection or ectopic pregnancy rates.
                In women who are identified to have hydrosalpinges during controlled ovarian stimulation during IVF, aspiration of hydrosalpinges during oocyte collection may be effective in improving pregnancy rates (Trial Registration Number: NCT00566956). 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. To evaluate the possible benefits of the routine use of ultrasound screening in pregnancy.
                A randomized controlled trial was designed to detect a 50% difference in the incidence of induction for apparent post-term pregnancies between women who were screened with ultrasound and unscreened women. A total of 1628 pregnant women from the general population were included. Eight hundred and twenty-five were allocated to an ultrasound examination at the 18th and 32nd week of pregnancy in addition to receiving routine antenatal care. The remaining 803 women received standard antenatal care, but could only be referred for ultrasound examination on clinical indication.
                The incidence of induced labor due to apparent post-term pregnancies was approximately 70% lower in the ultrasound-screened group. Inductions from all causes were also less frequent among ultrasound-screened women. There were six perinatal deaths among the screened and seven among the controls after excluding three lethal malformations among the controls. There was no difference in Apgar score after 1 min, but the proportion with Apgar score less than 8 after 5 min was lower among the screened group (P = 0.04). The need for positive pressure ventilation for more than 1 min was lower among the screened group (P = 0.02). Birth weight was slightly higher in the screened group (39 g), but the difference was not statistically significant. Among the controls three pairs of twins remained undiagnosed until the mothers were admitted to the hospital in labor at between 36 and 38 weeks gestation.
                These results suggest that for women who were screened with ultrasound, obstetricians were less likely to induce labor due to apparent post-term pregnancy, than for women who were not screened. All 10 pairs of twins in the screened group were diagnosed at the routine examination. These data also suggest that perinatal morbidity might be slightly lower in the screened group. 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. To determine whether the implementation of ultrasound (US) guidance will improve the clinical outcomes of ET compared with the standard clinical touch method of embryo catheter placement.
                Prospective, single-operator, randomized, controlled trial.
                Saudi Center for Assisted Reproduction.
                Three hundred seventy-three women.
                Transcervical, intrauterine ET with or without US guidance.
                Primary outcomes were the live-birth/ongoing pregnancy and clinical pregnancy rates per randomized woman. Secondary outcomes were the incidences of difficult transfers, blood and/or mucus on the catheter tip, spontaneous miscarriages, and ectopic pregnancies.
                Demographics and cycle characteristics were not different between the two groups. The live-birth/ongoing pregnancy rate was significantly higher in the US ET group (68 of 183, 40.98%) than in the clinical touch ET group (50 of 190, 28.42%) (odds ratio = 1.66, 95% confidence interval 1.07-2.57). In addition, there was a significantly higher number of clinical pregnancies in the US ET group (75 of 183, 40.98%) than in the clinical touch ET group (54 of 190, 28.42%) (odds ratio = 1.75, 95% confidence interval 1.14-2.69). Secondary outcomes were not significantly different between the two groups.
                Ultrasound-guided ET significantly increases ongoing pregnancy/live-birth and clinical pregnancy rates compared with the clinical touch method. We tested if fetal pulse oximetry in addition to electronic fetal monitoring (CTG) and scalp blood sampling improves the accuracy of fetal assessment and allows safe reduction of operative deliveries (-50%) and scalp blood sampling (-50%) performed because of nonreassuring fetal status. Study design A randomized controlled trial was conducted in 146 patients with term pregnancies in active labor and abnormal fetal heart rate patterns: 73 had electronic fetal heart rate monitoring (CTG) and fetal scalp blood sampling (control group), 73 had CTG, fetal scalp blood sampling, and continuous fetal pulse oximetry (study group).
                There was a reduction of -50% in operative deliveries and fetal scalp blood sampling performed because of nonreassuring fetal status in the study group: operative deliveries, study versus control 25/49 (P </= .001); fetal scalp sampling, study versus control 32/64 (P </= .001). An increase in cesarean sections because of dystocia in the study group did not change the net number of operative deliveries. There was no difference between the 2 groups in adverse maternal or neonatal outcomes, as well as for the end points of metabolic acidosis and need for resuscitation.
                There was a safe reduction in operative deliveries (-50%) and scalp blood sampling (-50%) performed because of nonreassuring fetal status. The increase in cesarean sections because of dystocia in the study group was a well-documented arrest of labor, but it did not change the total number of operative deliveries in this group. 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. To test whether the introduction of Doppler waveform analysis into the ultrasound department of a tertiary level hospital reduces neonatal morbidity and improves obstetric management.
                A randomized controlled trial.
                Department of Ultrasound, King Edward Memorial Hospital, Perth, Western Australia.
                505 women with pregnancy abnormalities referred to an ultrasound department for fetal investigation during the third trimester.
                Continuous wave Doppler studies of umbilical and uteroplacental arterial circulations. Results were revealed to patients and clinicians.
                Principal end point was the duration of neonatal stay in hospital; other end points included the number and type of fetal heart rate monitoring studies, obstetric interventions, frequency of fetal distress, birthweight, Apgar scores and need for neonatal intensive care.
                There was no effect on the duration of neonatal stay in hospital. Small trends in obstetric management were observed with study group patients having fewer contraction stress tests, less likelihood of antepartum fetal distress, and more likelihood of fetal distress after induction of labour leading to emergency caesarean section. Depressed Apgar scores were more frequent in the study group.
                Introduction of Doppler waveform studies did not result in reduced neonatal morbidity but did have a small effect on obstetric management. For each institution the role of Doppler studies in late pregnancy will be influenced by the usage of other tests of fetal welfare already entrenched in clinical practice.
There is no evidence from randomised trials to support cycle monitoring by ultrasound plus serum estradiol as more efficacious than cycle monitoring by ultrasound only on outcomes of live birth and pregnancy rates. A large well-designed randomised controlled trial is needed that reports on live birth rates and pregnancy, with economic evaluation of the costs involved and the views of the women undergoing cycle monitoring. A randomised trial with sufficiently large sample size to test the effects of different monitoring protocols on OHSS, a rare outcome, will pose a great challenge. Until such a trial is considered feasible, cycle monitoring by transvaginal ultrasound plus serum estradiol may need to be retained as a precautionary good practice point.