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| 2. |
- Amer-Wåhlin, I, et al.
(författare)
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Swedish randomized controlled trial of cardiotocography only versus cardiotocography plus ST analysis of fetal electrocardiogram revisited : analysis of data according to standard versus modified intention-to-treat principle.
- 2011
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Ingår i: Acta Obstetricia et Gynecologica Scandinavica. - : John Wiley & Sons Ltd.. - 0001-6349 .- 1600-0412. ; 90:9, s. 990-996
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To undertake a renewed analysis of data from the previously published Swedish randomized controlled trial on intrapartum fetal monitoring with cardiotocography (CTG-only) vs. CTG plus ST analysis of fetal electrocardiogram (CTG+ST), using current standards of intention-to-treat (ITT) analysis and to compare the results with those of the modified ITT (mITT) and per protocol analyses. METHODS: Renewed extraction of data from the original database including all cases randomized according to primary case allocation (n=5 049). MAIN OUTCOME MEASURE: Metabolic acidosis in umbilical artery at birth (pH <7.05, base deficit in extracellular fluid >12.0 mmol/l) including samples of umbilical vein blood or neonatal blood if umbilical artery blood was missing. RESULTS: The metabolic acidosis rates were 0.66% (17 of 2 565) and 1.33% (33 of 2 484) in the CTG+ST and CTG-only groups, respectively [relative risk (RR) 0.50; 95% confidence interval (CI) 0.28-0.88; p=0.019]. The original mITT gave RR 0.47, 95%CI 0.25-0.86 (p=0.015), mITT with correction for 10 previously misclassified cases RR 0.48, 95%CI 0.24-0.96 (p=0.038) and per protocol analysis RR 0.40, 95%CI 0.20-0.80 (p=0.009). The level of significance of the difference in metabolic acidosis rates between the two groups remained unchanged in all analyses. CONCLUSION: Re-analysis of data according to the ITT principle showed that regardless of the method of analysis, the Swedish randomized controlled trial maintained its ability to demonstrate a significant reduction in metabolic acidosis rate when using CTG+ST analysis for fetal surveillance in labor.
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| 3. |
- Ayres-de-Campos, D., et al.
(författare)
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A randomised clinical trial of intrapartum fetal monitoring with computer analysis and alerts versus previously available monitoring
- 2010
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Ingår i: BMC Pregnancy and Childbirth. - : BioMed Central Ltd.. - 1471-2393 .- 1471-2393. ; 10:71
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Tidskriftsartikel (refereegranskat)abstract
- Background: Intrapartum fetal hypoxia remains an important cause of death and permanent handicap and in a significant proportion of cases there is evidence of suboptimal care related to fetal surveillance. Cardiotocographic (CTG) monitoring remains the basis of intrapartum surveillance, but its interpretation by healthcare professionals lacks reproducibility and the technology has not been shown to improve clinically important outcomes. The addition of fetal electrocardiogram analysis has increased the potential to avoid adverse outcomes, but CTG interpretation remains its main weakness. A program for computerised analysis of intrapartum fetal signals, incorporating real-time alerts for healthcare professionals, has recently been developed. There is a need to determine whether this technology can result in better perinatal outcomes. Methods/design: This is a multicentre randomised clinical trial. Inclusion criteria are: women aged ≥ 16 years, able to provide written informed consent, singleton pregnancies ≥ 36 weeks, cephalic presentation, no known major fetal malformations, in labour but excluding active second stage, planned for continuous CTG monitoring, and no known contra-indication for vaginal delivery. Eligible women will be randomised using a computer-generated randomisation sequence to one of the two arms: continuous computer analysis of fetal monitoring signals with real-time alerts (intervention arm) or continuous CTG monitoring as previously performed (control arm). Electrocardiographic monitoring and fetal scalp blood sampling will be available in both arms. The primary outcome measure is the incidence of fetal metabolic acidosis (umbilical artery pH < 7.05, BDecf > 12 mmol/L). Secondary outcome measures are: caesarean section and instrumental vaginal delivery rates, use of fetal blood sampling, 5-minute Apgar score < 7, neonatal intensive care unit admission, moderate and severe neonatal encephalopathy with a marker of hypoxia, perinatal death, rate of internal monitoring, tracing quality, and signal loss. Analysis will follow an intention to treat principle. Incidences of primary and secondary outcomes will be compared between groups. Assuming a reduction in metabolic acidosis from 2.8% to 1.8%, using a two-sided test with alpha = 0.05, power = 0.80, and 10% loss to follow-up, 8133 women need to be randomised. Discussion: This study will provide evidence of the impact of intrapartum monitoring with computer analysis and real-time alerts on the incidence of adverse perinatal outcomes, intrapartum interventions and signal quality. (Current controlled trials ISRCTN42314164)
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| 4. |
- Babucci, G., et al.
(författare)
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3D evaluation of fetal brain structures: reference values and growth curves
- 2021
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Ingår i: Journal of Maternal-Fetal and Neonatal Medicine. - : Informa UK Limited. - 1476-7058 .- 1476-4954. ; 34:21, s. 3546-3551
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Tidskriftsartikel (refereegranskat)abstract
- Background: The development of the fetal central nervous system is one of the most important fields of research in perinatology. Since the early 1980s, 3 D ultrasound has become one of the major research tools in obstetrics and gynecology. Objective: The aim of this study was to reconstruct thalamus, cerebellum and Cortex volumes of fetal brain and generate, for these volumes, growth curves related to gestational age. Methods: We enrolled 344 pregnant women. Using “Tomographic Ultrasound Imaging” (TUI), in all cases we obtained a satisfying 3 D acquisition of fetal brain. We reconstructed offline thalamus, cerebellum and cortex volumes using “Virtual Organ Computer-Aided AnaLysis” (VOCAL) or 4 D View (GE Healthcare). Results: Among the 344 fetuses examined, we obtained 314 thalamus volumes, 252 cerebellum volumes and 261 cortex volumes and we constructed the reference growth curves. Conclusion: Our study confirms the reliability of cerebral volumes evaluation using 3 D technology and how these cerebral structures grow through gestation. © 2019, © 2019 Informa UK Limited, trading as Taylor & Francis Group.
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| 5. |
- Blad, Sofia, et al.
(författare)
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ECG and heart rate variability changes in preterm and near-term fetal lamb following LPS exposure.
- 2008
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Ingår i: Reproductive sciences (Thousand Oaks, Calif.). - : Springer Science and Business Media LLC. - 1933-7205 .- 1933-7191. ; 15:6, s. 572-83
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Tidskriftsartikel (refereegranskat)abstract
- The aim of this study is to evaluate the myocardial response in the preterm and near-term fetal lamb with infection. Chronically instrumented fetal lambs were exposed to lipopolysaccharide (LPS), and the fetal electrocardiogram (FECG) ST waveform was examined using STAN. Fetal heart rate variability (FHRV) was automatically analyzed by adapting a polynomial function to the RR sequence in the FECG. Preterm fetuses exposed to >90 ng/kg LPS died within 8 hours of LPS administration, a response not seen in near-term fetuses. In both surviving and nonsurviving preterm fetuses, cardiovascular responses were characterized by decreased arterial pressure, negative T waves, and tachycardia accompanied by an increase in FHRV. Similar changes were not observed in the near-term fetuses after LPS. The study shows that preterm lambs are more sensitive to LPS in terms of myocardial/cardiovascular response than the more mature fetuses are. High FHRV and negative ST waveform seem to characterize the LPS-induced stress response in preterm fetuses.
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| 7. |
- Hafström, Maria, 1962, et al.
(författare)
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Developmental Outcome at 6.5 Years After Acidosis in Term Newborns : A Population-Based Study
- 2012
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Ingår i: Pediatrics. - : American Academy of Pediatrics. - 0031-4005 .- 1098-4275. ; 129:6, s. 1-7
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVES: Infants who develop encephalopathy after perinatal asphyxia have an increased risk of death and adverse neurologic outcome. Conflicting results exist concerning outcome in healthy infants with metabolic acidosis at birth. The aim of the current study was to evaluate whether metabolic acidosis at birth in term infants who appear healthy is associated with long-term developmental abnormalities. METHODS: From a population-based cohort (14 687 deliveries), 78 infants were prospectively identified as having metabolic acidosis (umbilical artery pH , 7.05 and base deficit in the extracellular fluid .12.0 mmol/L). Two matched controls per case were selected. The child health and school health care records were scrutinized for developmental abnormalities. RESULTS: Outcome measures at 6.5 years of age for 227 of 234 children (97%) were obtained. No differences were found concerning neurologic or behavioral problems in need of referral action or neurodevelopmental diagnosis in comparison of control children with acidotic children who had appeared healthy at birth, ie, had not required special neonatal care or had no signs of encephalopathy. CONCLUSIONS: Infants born with cord metabolic acidosis and who appear well do not have an increased risk for neurologic or behavioral problems in need of referral actions or special teaching approaches at the age of 6.5 years. Pediatrics 2012;129:1–7
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| 8. |
- Kjellmer, Ingemar, 1935, et al.
(författare)
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ST analysis of the fetal electrocardiogram - Comments on recent experimental data
- 2019
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Ingår i: Plos One. - : Public Library of Science (PLoS). - 1932-6203. ; 14:8
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- In their paper, Andriessen at al present a validation of fetal ECG analysis and the clinical STAN device in midgestation fetal lambs exposed to 25 minutes of umbilical cord occlusion. The study presents results that contrast remarkably from previously published experimental data which raises a number of questions and comments. The most striking finding of Andriessen et al is the recording of an extremely high number of alarms from the STAN equipment during control conditions when no alarms at all are expected. These patterns have never been seen, neither in the clinical situation nor in our own fetal sheep studies. The reason for this becomes apparent when their way of recording the FECG is scrutinized. In their assessment of STAN, Andriessen at al use an assumed negative aVF lead with the assumption that it will reflect the FECG in the same way as the unipolar scalp lead used clinically. The signal used for disqualification of STAN is itself not qualified to properly represent the fetal scalp lead signal that STAN is designed for. To question a proven technology is fully accepted but those attempting would be asked to argue along fully validated data and related analysis including questioning of their own data.
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| 9. |
- Kro, G A B, et al.
(författare)
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A new tool for the validation of umbilical cord acid-base data.
- 2010
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Ingår i: BJOG : an international journal of obstetrics and gynaecology. - : Wiley. - 1471-0528 .- 1470-0328. ; 117:12, s. 1544-52
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Tidskriftsartikel (refereegranskat)abstract
- To identify the distribution of carbon dioxide tension (pCO(2) ) relative to pH in validated umbilical cord acid-base data.
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| 10. |
- Luttkus, Andreas, et al.
(författare)
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Fetal scalp pH and ST analysis of the fetal ECG as an adjunct to CTG. A multi-center, observational study
- 2004
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Ingår i: J Perinat Med. ; 32:6, s. 486-94
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To evaluate the relationships between scalp-pH and CTG plus ST waveform analysis of the fetal ECG (STAN) clinical guidelines as indicators of intrapartum hypoxia in term fetuses born with cord artery acidemia. STUDY DESIGN: Data from 6999 term deliveries monitored by the STAN (R) S 21 as part of an EU multi-center study on clinical implementation of the STAN methodology for intrapartum fetal surveillance were analyzed. We identified 911 cases where a scalp-pH was obtained, including 53 cases with cord artery acidemia (pH < 7.06). Lag times between ST events and scalp-pH and time to delivery were related to cord artery metabolic and respiratory acidosis and neonatal outcome. RESULTS: 43 fetuses were identified by CTG plus ST as being in need of intervention 31 (25-46) minutes before delivery (median, 95% Cl). In five, no indications were given and in another five there were inadequate data. Fifteen cases with metabolic acidosis required special neonatal care, all 14 cases adequately monitored on STAN had indications to intervene for 19 minutes or more. In 30 adequately recorded cases, fetal blood sampling (FBS) was obtained within the last hour of labor. In 22 cases, FBS was obtained 13 (7-24) minutes after STAN guidelines had indicated abnormality and in eight no ST changes had occurred at time of FBS. The corresponding FBS data were pH 7.10 (7.01-7.15) and pH 7.21 (7.08-7.31), respectively, P = 0.01. In cases of metabolic acidosis, scalp-pH fell 0.01 units per minute after a baseline T/QRS rise was recorded during the second stage of labor. Apart from one newborn that died at 2 h from E. Coli septicemia, none of the neonates were affected neurologically. CONCLUSION: Cardiotocography plus ST analysis provides accurate information about intrapartum hypoxia similar to that obtained by scalp-pH.
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