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1.  A randomised clinical trial of intrapartum fetal monitoring with computer analysis and alerts versus previously available monitoring 
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)
doi:10.1186/1471-2393-10-71
PMCID: PMC2987886  PMID: 21029466
2.  Randomised controlled trial of cardiotocography versus Doppler auscultation of fetal heart at admission in labour in low risk obstetric population 
BMJ : British Medical Journal  2001;322(7300):1457-1462.
Objective
To compare the effect of admission cardiotocography and Doppler auscultation of the fetal heart on neonatal outcome and levels of obstetric intervention in a low risk obstetric population.
Design
Randomised controlled trial.
Setting
Obstetric unit of teaching hospital
Participants
Pregnant women who had no obstetric complications that warranted continuous monitoring of fetal heart rate in labour.
Intervention
Women were randomised to receive either cardiotocography or Doppler auscultation of the fetal heart when they were admitted in spontaneous uncomplicated labour.
Main outcome measures
The primary outcome measure was umbilical arterial metabolic acidosis. Secondary outcome measures included other measures of condition at birth and obstetric intervention.
Results
There were no significant differences in the incidence of metabolic acidosis or any other measure of neonatal outcome among women who remained at low risk when they were admitted in labour. However, compared with women who received Doppler auscultation, women who had admission cardiotocography were significantly more likely to have continuous fetal heart rate monitoring in labour (odds ratio 1.49, 95% confidence interval 1.26 to 1.76), augmentation of labour (1.26, 1.02 to 1.56), epidural analgesia (1.33, 1.10 to 1.61), and operative delivery (1.36, 1.12 to 1.65).
Conclusions
Compared with Doppler auscultation of the fetal heart, admission cardiotocography does not benefit neonatal outcome in low risk women. Its use results in increased obstetric intervention, including operative delivery.
What is already known on this topicThe admission cardiotocogram is a short recording of the fetal heart rate immediately after admission to the labour wardOpinion varies about its value in identifying a potentially compromised fetusIn low risk women, the incidence of intrapartum fetal compromise is lowWhat this study addsCompared with Doppler auscultation of the fetal heart, admission cardiotocography has no benefit on neonatal outcome in low risk womenAdmission cardiotocography results in increased obstetric intervention, including operative delivery
PMCID: PMC32308  PMID: 11408301
3.  Cardiotocography in the Prognosis of Perinatal Outcome 
Medical Archives  2014;68(2):102-105.
ABSTRACT
Aim:
The objective of the study was to examine whether cardiotocography can (CTG) predict asphyxia of the embryo, manifested as hypoxic-ischemic encephalopathy (HIE), and to what extent one can rely on CTG record.
Material and methods:
Retrospective research was carried out at the Clinic for Gynecology and Obstetrics UKC Tuzla and medical documentation from the history of mothers and newborns was used. The study group consisted of 68 pregnancies and newborns who developed HIE. The control group consisted of 40 pregnancies, which resulted in birth of healthy newborns – without signs of asphyxia. CTG records were analyzed, Apgar score, the ways of finishing delivery.
Results:
Pathological CTG records (bradycardia 100, tachycardia 180, silent type of curve, late decelerations) were found in 45 (66,17%) cases of the study group in comparison to 11 (27,5%) in the control group. In the study group Apgar score in 5th minute lower than 7 had 17,46% newborns and the highest incidence of the normally finished deliveries. We conclude that cardiotocography is one of the reliable methods of fetal monitoring in pregnancy and delivery, and that pathological CTG record very likely indicates the possible presence of perinatal asphyxia.
Conclusion:
Achieving a low degree of correlation between pathological intrapartum cardiotocography findings and long-term outcome of children can be achieved by rapid and adequate obstetric intervention and the relatively short duration of fetal acidosis, and optimal procedures during intensive care of newborns.
doi:10.5455/medarh.2014.68.102-105
PMCID: PMC4272492  PMID: 24937932
cardiotocography; perinatal outcome
4.  The long-term cost-effectiveness of fetal monitoring during labour: a comparison of cardiotocography complemented with ST analysis versus cardiotocography alone 
Bjog  2008;115(13):1676-1687.
Objective
To assess the cost-effectiveness of the use of cardiotocography (CTG) complemented with fetal electrocardiography and ST analysis compared with the use of CTG alone in term deliveries when a decision has been made to use fetal monitoring with a scalp electrode.
Design
A cost-effectiveness analysis based on a probabilistic decision model incorporating relevant strategies and lifelong outcomes.
Setting
Maternity wards in Sweden.
Population
Women with term fetuses after a clinical decision had been made to apply a fetal scalp electrode for internal CTG.
Methods
A decision model was used to compare the costs and effects of two different treatment strategies. Baseline estimates were derived from the literature. Discounted costs and quality-adjusted life years (QALYs) were simulated over a lifetime horizon using a probabilistic model.
Main outcome measures
QALYs, incremental costs, and cost per QALY gained expressed as incremental cost-effectiveness ratio (ICER).
Results
The analysis found an incremental effect of 0.005 QALYs for ST analysis compared with CTG; the ST analysis strategy was also moreover associated with a €56 decrease in costs, thus dominating the CTG strategy. The probability that ST analysis is cost-effective in comparison with CTG is high, irrespective of the willingness-to-pay value for a QALY.
Conclusions
Compared with CTG alone, ST analysis is cost-effective when used in term high-risk deliveries in which there is a need for internal fetal monitoring.
doi:10.1111/j.1471-0528.2008.01935.x
PMCID: PMC2659360  PMID: 19035942
Cardiotocography; cerebral palsy; cost-effectiveness; fetal monitoring; ST analysis
5.  Fetal electrocardiogram: ST waveform analysis in intrapartum surveillance 
Bjog   2007;114(10):1191-1193.
ST waveform analysis of fetal electrocardiogram (ECG) for intrapartum surveillance (STAN) is a newly introduced method for fetal surveillance. The purpose of this commentary is to assist in the proper use of fetal ECG in combination with cardiotocography (CTG) during labour. Guidelines and recommendations concerning CTG and ST waveform interpretation and classification are stated that were agreed on by the European experts on ST waveform analysis for intrapartum surveillance during a meeting in Utretcht, the Netherlands in January 2007.
doi:10.1111/j.1471-0528.2007.01479.x
PMCID: PMC2239304  PMID: 17877671
Fetal ECG; guidelines; intrapartum surveillance; ST waveform analysis
6.  Full-term-pregnancy effects of antenatal betamethasone administration on short-term variation as assessed by computerized cardiotocography 
Journal of Prenatal Medicine  2012;6(2):18-21.
Summary
Objective
to verify whether there are other than transitory effects of antenatal betamethasone (administered for fetal lung maturity [FLM] enhancement) on fetal heart rate (FHR) variability detected by computerized cardiotocography (cCTG) in cases where formerly steroid-treated fetuses reached term.
Materials and methods
cCTG of one hundred sixty-four women (study group) exposed to antenatal betamethasone for risk of preterm delivery in third trimester period were compared to controls (pregnancies who presented risk of preterm labour in the same period of cases, although with no steroids administration). cCTG was performed weekly as of standard schedule when pregnancies reach term from 37–40 weeks’ gestation for cases and controls.
Results
regarding data concerning cCTG at term for cases and controls, no significant difference was found for FHR, Acc (accelerations) 10 min, and FM (fetal movements) between groups. LV (low variation)/min and LV/msec were absent in cCTG parameters of fetuses in the study group.
Instead, for all weeks studied (37 to 40), cCTG parameters were higher for HV (high variation)/msec, STV(short term variation)/msec, and Acc 15 in cases with respect to controls.
Conclusion
interestingly, maternal corticosteroid administration may be related to higher fetal reactivity when fetuses exposed to steroid therapy reach term. Our observation may help in the interpretation of a “more reactive” CTG trace in babies whose mothers previously received steroid therapy for FLM enhancement.
PMCID: PMC3421949  PMID: 22905307
computerized cardiotocography; betamethasone; intrauterine long-term effects
7.  Open access intrapartum CTG database 
Background
Cardiotocography (CTG) is a monitoring of fetal heart rate and uterine contractions. Since 1960 it is routinely used by obstetricians to assess fetal well-being. Many attempts to introduce methods of automatic signal processing and evaluation have appeared during the last 20 years, however still no significant progress similar to that in the domain of adult heart rate variability, where open access databases are available (e.g. MIT-BIH), is visible. Based on a thorough review of the relevant publications, presented in this paper, the shortcomings of the current state are obvious. A lack of common ground for clinicians and technicians in the field hinders clinically usable progress. Our open access database of digital intrapartum cardiotocographic recordings aims to change that.
Description
The intrapartum CTG database consists in total of 552 intrapartum recordings, which were acquired between April 2010 and August 2012 at the obstetrics ward of the University Hospital in Brno, Czech Republic. All recordings were stored in electronic form in the OB TraceVue®;system. The recordings were selected from 9164 intrapartum recordings with clinical as well as technical considerations in mind. All recordings are at most 90 minutes long and start a maximum of 90 minutes before delivery. The time relation of CTG to delivery is known as well as the length of the second stage of labor which does not exceed 30 minutes. The majority of recordings (all but 46 cesarean sections) is – on purpose – from vaginal deliveries. All recordings have available biochemical markers as well as some more general clinical features. Full description of the database and reasoning behind selection of the parameters is presented in the paper.
Conclusion
A new open-access CTG database is introduced which should give the research community common ground for comparison of results on reasonably large database. We anticipate that after reading the paper, the reader will understand the context of the field from clinical and technical perspectives which will enable him/her to use the database and also understand its limitations.
doi:10.1186/1471-2393-14-16
PMCID: PMC3898997  PMID: 24418387
Cardiotocography; Intrapartum; CTG; Database; Signal processing; Fetal heart rate
8.  Reducing stillbirths: screening and monitoring during pregnancy and labour 
BMC Pregnancy and Childbirth  2009;9(Suppl 1):S5.
Background
Screening and monitoring in pregnancy are strategies used by healthcare providers to identify high-risk pregnancies so that they can provide more targeted and appropriate treatment and follow-up care, and to monitor fetal well-being in both low- and high-risk pregnancies. The use of many of these techniques is controversial and their ability to detect fetal compromise often unknown. Theoretically, appropriate management of maternal and fetal risk factors and complications that are detected in pregnancy and labour could prevent a large proportion of the world's 3.2 million estimated annual stillbirths, as well as minimise maternal and neonatal morbidity and mortality.
Methods
The fourth in a series of papers assessing the evidence base for prevention of stillbirths, this paper reviews available published evidence for the impact of 14 screening and monitoring interventions in pregnancy on stillbirth, including identification and management of high-risk pregnancies, advanced monitoring techniques, and monitoring of labour. Using broad and specific strategies to search PubMed and the Cochrane Library, we identified 221 relevant reviews and studies testing screening and monitoring interventions during the antenatal and intrapartum periods and reporting stillbirth or perinatal mortality as an outcome.
Results
We found a dearth of rigorous evidence of direct impact of any of these screening procedures and interventions on stillbirth incidence. Observational studies testing some interventions, including fetal movement monitoring and Doppler monitoring, showed some evidence of impact on stillbirths in selected high-risk populations, but require larger rigourous trials to confirm impact. Other interventions, such as amniotic fluid assessment for oligohydramnios, appear predictive of stillbirth risk, but studies are lacking which assess the impact on perinatal mortality of subsequent intervention based on test findings. Few rigorous studies of cardiotocography have reported stillbirth outcomes, but steep declines in stillbirth rates have been observed in high-income settings such as the U.S., where cardiotocography is used in conjunction with Caesarean section for fetal distress.
Conclusion
There are numerous research gaps and large, adequately controlled trials are still needed for most of the interventions we considered. The impact of monitoring interventions on stillbirth relies on use of effective and timely intervention should problems be detected. Numerous studies indicated that positive tests were associated with increased perinatal mortality, but while some tests had good sensitivity in detecting distress, false-positive rates were high for most tests, and questions remain about optimal timing, frequency, and implications of testing. Few studies included assessments of impact of subsequent intervention needed before recommending particular monitoring strategies as a means to decrease stillbirth incidence. In high-income countries such as the US, observational evidence suggests that widespread use of cardiotocography with Caesarean section for fetal distress has led to significant declines in stillbirth rates. Efforts to increase availability of Caesarean section in low-/middle-income countries should be coupled with intrapartum monitoring technologies where resources and provider skills permit.
doi:10.1186/1471-2393-9-S1-S5
PMCID: PMC2679411  PMID: 19426468
9.  IUGR Management: New Perspectives 
Journal of Pregnancy  2014;2014:620976.
Aim of the Study. Analyzing velocimetric (umbilical artery, UA; ductus venosus, DV; middle cerebral artery, MCA) and computerized cardiotocographic (cCTG) (fetal heart rate, FHR; short term variability, STV; approximate entropy, ApEn) parameters in intrauterine growth restriction, IUGR, in order to detect early signs of fetal compromise. Population Study. 375 pregnant women assisted from the 28th week of amenorrhea to delivery and monitored through cCTG and Doppler ultrasound investigation. The patients were divided into three groups according to the age of gestation at the time of delivery, before the 34th week, from 34th to 37th week, and after the 37th week. Data were analyzed in relation to the days before delivery and according to the physiology or pathology of velocimetry. Statistical analysis was performed through the t-test, chi-square test, and Pearson correlation test (P < 0.05). Our results evidenced an earlier alteration of UA, DV, and MCA. The analysis between cCTG and velocimetric parameters (the last distinguished into physiological and pathological values) suggests a possible relation between cCTG alterations and Doppler ones. The present study emphasizes the need for an antenatal testing in IUGR fetuses using multiple surveillance modalities to enhance prediction of neonatal outcome.
doi:10.1155/2014/620976
PMCID: PMC4274670  PMID: 25548677
10.  Must we press on until a young mother dies? Remifentanil patient controlled analgesia in labour may not be suited as a “poor man’s epidural” 
Background
The epidural route is still considered the gold standard for labour analgesia, although it is not without serious consequences when incorrect placement goes unrecognized, e.g. in case of intravascular, intrathecal and subdural placements. Until now there has not been a viable alternative to epidural analgesia especially in view of the neonatal outcome and the need for respiratory support when long-acting opioids are used via the parenteral route. Pethidine and meptazinol are far from ideal having been described as providing rather sedation than analgesia, affecting the cardiotocograph (CTG), causing fetal acidosis and having active metabolites with prolonged half-lives especially in the neonate. Despite these obvious shortcomings, intramuscular and intravenously administered pethidine and comparable substances are still frequently used in delivery units.
Since the end of the 90ths remifentanil administered in a patient-controlled mode (PCA) had been reported as a useful alternative for labour analgesia in those women who either don’t want, can’t have or don’t need epidural analgesia.
Discussion
In view of the need for conversion to central neuraxial blocks and the analgesic effect remifentanil has been demonstrated to be superior to pethidine. Despite being less effective in terms of the resulting pain scores, clinical studies suggest that the satisfaction with analgesia may be comparable to that obtained with epidural analgesia. Owing to this fact, remifentanil has gained a place in modern labour analgesia in many institutions.
However, the fact that remifentanil may cause harm should not be forgotten when the use of this potent mu-agonist is considered for the use in labouring women. In the setting of one-to-one midwifery care, appropriate monitoring and providing that enough experience exists with this potent opioid and the treatment of potential complications, remifentanil PCA is a useful option in addition to epidural analgesia and other central neuraxial blocks. Already described serious consequences should remind us not refer to remifentanil PCA as a “poor man’s epidural” and to safely administer remifentanil with an appropriate indication.
Summary
Therefore, the authors conclude that economic considerations and potential cost-savings in conjunction with remifentanil PCA may not be appropriate main endpoints when studying this valuable method for labour analgesia.
doi:10.1186/1471-2393-13-139
PMCID: PMC3700797  PMID: 23815762
Remifentanil; Epidural Analgesia; Labour Pain; Labour Analgesia; Patient Controlled Analgesia; Patient Satisfaction; Healthcare Cost; Healthcare Economics
11.  Admission cardiotocography: Its role in predicting foetal outcome in high-risk obstetric patients 
The Australasian Medical Journal  2012;5(10):522-527.
Background
Routine and continuous electronic monitoring of foetal heart rate (FHR) in labour has become an established obstetric practice in high-risk pregnancies in industrialised countries. However, the same may not be possible in non-industrialised countries where antenatal care is inadequate with a large number of high-risk pregnancies being delivered in crowded settings and inadequate health care provider to patient ratios.
Aims
The objective of this study was to evaluate the predictive value of the admission cardiotocogram (CTG) in detecting foetal hypoxia at the time of admission in labour and to correlate the results of the admission CTG with the perinatal outcome in high-risk obstetric cases.
Method
This was a prospective observational study conducted in the labour and maternity ward of a hospital in Gangtok, India, during the period 2008 to 2010. The study included high-risk pregnant women, admitted via the emergency or outpatient department with a period of gestation ≥36 weeks, in first stage of labour with foetus in the cephalic presentation. All women were subjected to an admission CTG, which included a 20 minute recording of FHR and uterine contractions.
Results
One hundred and sixty patients were recruited. The majority of women were primigravida in the 21-30 years age group. About 42% patients were postdated pregnancy followed by pregnancy-induced hypertension (PIH) (15.6%) and premature rupture of membranes (PROM) (11.3%) as the major risk factors. The admission CTG were ‘reactive’ in 77%, ‘equivocal’ in 14.4% and ‘ominous’ in 8.7% women. Incidence of foetal distress, moderate-thick meconium stained liquor and neonatal intensive care unit (NICU) admission was significantly more frequent among patients with ominous test results compared with equivocal or reactive test results on admission. Incidence of vaginal delivery was more common when the test was reactive.
Conclusion
The admission CTG appears to be a simple non-invasive test that can serve as a screening tool in ‘triaging’ foetuses of high-risk obstetric patients in non-industrialised countries with a heavy workload and limited resources.
doi:10.4066/AMJ.2012.1267
PMCID: PMC3494822  PMID: 23173014
Cardiotocography; admission test; foetal distress; foetal hypoxia; perinatal outcome.
12.  Treatments of pelvic girdle pain in pregnant women: adverse effects of standard treatment, acupuncture and stabilising exercises on the pregnancy, mother, delivery and the fetus/neonate 
Background
Previous publications indicate that acupuncture is efficient for the treatment of pelvic girdle pain, PGP, in pregnant women. However, the use of acupuncture for PGP is rare due to insufficient documentation of adverse effects of this treatment in this specific condition. The aim of the present work was to assess adverse effects of acupuncture on the pregnancy, mother, delivery and the fetus/neonate in comparison with women that received stabilising exercises as adjunct to standard treatment or standard treatment alone.
Methods
In all, 386 women with PGP entered this controlled, single-blind trial. They were randomly assigned to standard treatment plus acupuncture (n = 125), standard treatment plus specific stabilising exercises (n = 131) or to standard treatment alone (n = 130) for 6 weeks. Acupuncture that may be considered strong was used and treatment was started as early as in the second trimester of pregnancy. Adverse effects were recorded during treatment and throughout the pregnancy. Influence on the fetus was measured with cardiotocography (CTG) before-during and after 43 acupuncture sessions in 43 women. A standardised computerized method to analyze the CTG reading numerically (Oxford 8000, Oxford, England) was used. After treatment, the women rated their overall experience of the treatment and listed adverse events if any in a questionnaire. Data of analgesia and oxytocin augmentation during labour, duration of labour, frequency of preterm birth, operative delivery, Apgar score, cord-blood gas/acid base balance and birth weight were also recorded.
Results
There were no serious adverse events after any of the treatments. Minor adverse events were common in the acupuncture group but women rated acupuncture favourably even despite this. The computerized or visually assessed CTG analyses of antenatal recordings in connection with acupuncture were all normal.
Conclusion
This study shows that acupuncture administered with a stimulation that may be considered strong led to minor adverse complaints from the mothers but had no observable severe adverse influences on the pregnancy, mother, delivery or the fetus/neonate.
doi:10.1186/1472-6882-8-34
PMCID: PMC2467402  PMID: 18582370
13.  Management of reported decreased fetal movements for improving pregnancy outcomes 
Background
Clinical observations indicate that mothers commonly perceive a reduction in, or absence of, the baby’s movements for some days preceding a baby’s death. For this reason, fetal movement monitoring is advised by caregivers and used spontaneously by mothers to assess the baby’s well-being. However, it is possible that the harmful effects of interventions may outweigh the benefits of such testing. Evidence of effectiveness of fetal movement screening to improve outcomes is limited, though indirect evidence suggests a potential benefit. A secondary question is whether any specific management response to perceived decreased fetal movements (DFM) improves clinical outcome.
Objectives
To determine, from the best available evidence, the effectiveness of various management strategies for DFM.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (28 February 2012) and bibliographies of included studies.
Selection criteria
Randomised clinical trials comparing various management strategies for DFM, including delivery, expectant management, cardiotocography (visual and computerised), ultrasound examination including Doppler ultrasound, and fetal arousal tests (cardiotocographic or clinical).
Data collection and analysis
Two assessors evaluated potentially eligible trials for inclusion, and extracted data onto a purpose-designed form. Where DFM was one among a number of inclusion criteria for the trial, we contacted trial authors for information on outcomes specific to the DFM subgroups.
Main results
No randomised trials of management of DFM were found. Of 13 randomised trials of management strategies for pregnancies with risk factors for fetal compromise including DFM, data on the DFM subgroups could only be provided by the authors of one trial. The numbers were too small for meaningful analysis (there were 28 cases of DFM).
Authors’ conclusions
There are insufficient data from randomised trials to guide practice regarding the management of DFM. Based on the results of other systematic reviews of management strategies for women whose babies are thought to be at risk of compromise for various reasons, the following strategies show promise and may be prioritised for further research: Doppler ultrasound studies, computerised cardiotocography, and fetal arousal to facilitate cardiotocography.
For settings where electronic fetal assessment methods are not available, clinical fetal arousal tests should be investigated.
doi:10.1002/14651858.CD009148.pub2
PMCID: PMC4058897  PMID: 22513971
*Fetal Movement; *Pregnancy Outcome; Fetal Distress [*therapy]; Fetal Monitoring; Female; Humans; Pregnancy
14.  UK study of intrapartum care for low risk primigravidas: a survey of interventions 
STUDY OBJECTIVE: To determine the extent of intrapartum intervention received by primigravidas. DESIGN: Cross sectional survey of NHS hospitals in the UK. SETTING: One hundred and one randomly selected hospital maternity units. PARTICIPANTS: Forty consecutive primigravid women, judged to be at low risk at the start of labour, in each hospital. MAIN OUTCOME MEASURES: Seven groups of interventions or monitoring procedures were identified from the first, second, and third stages of labour: fetal monitoring, vaginal examinations, artificial rupture of membranes, augmentation of labour, pain relief, type of delivery, and episiotomy. Data were collected during 1993. MAIN RESULTS: Ninety eight hospitals took part in the study and data were collected on 3160 low risk primigravidas. Seventy four per cent of these women had continuous cardiotocography. The proportion of women having restrictive or invasive fetal monitoring showed appreciable geographical variation for both the first and second stages of labour. Using the criterion of a vaginal examination every four hours and allowing for the length of each woman's labour, 72% had more vaginal examinations than expected; there was a significant geographical variation in the number of women receiving more than five examinations. Fifty three per cent had artificial rupture of membranes; the procedure was performed over a wide range of cervical dilatations (0 cm-10 cm). Thirty eight per cent of labours were augmented, most commonly by intravenous syntocinon; the procedure showed significant geographical variation. Twenty eight per cent had a spinal block or epidural analgesia for the relief of pain; this intervention varied by geographical region only for the second stage of labour. Over one quarter of the women required instrumental delivery. Forty six per cent had an episiotomy; the frequency of this intervention varied substantially by region. There were no infant deaths. Twelve babies were recorded at birth as having a congenital anomaly. CONCLUSIONS: The rates of several interventions seem high for this low risk group and there was substantial geographical variation in the use of six interventions. Clinical trials are needed to evaluate the optimum criteria for using these interventions from which guidelines should be drawn up by local groups and the Royal College.
 
PMCID: PMC1756743  PMID: 9876360
15.  Fetal distress and the condition of newborn infants. 
In a prospective audit of the obstetric management of 1210 consecutive deliveries the association was investigated between the need for operative delivery for fetal distress during labour and the condition of the newborn infant. Operative delivery was performed for only 11.5% of the newborn infants with severe acidosis at birth (umbilical artery pH less than 7.12, base deficit greater than 12 mmol (mEq)/1), 24.1% of those with an Apgar score less than 7 at one minute, and 15.8% of those with both severe acidosis and a one minute Apgar score less than 7. Most of the infants delivered operatively were in a vigorous condition at birth and did not have severe acidosis. Fetal blood sampling was done in 4.0% of labours. As none of the fetal blood values were less than 7.20 and only three of the infants sampled in utero suffered severe acidosis at birth, fetal blood sampling would have had to be performed much more often to provide a useful guide to metabolic state at birth. While the large majority of "at risk" fetuses had continuous fetal heart rate monitoring in labour, this had not been provided in 48.7% of the labours of infants with severe acidosis, 38.7% of infants with a one minute Apgar score less than 7, and 47.4% of infants with both severe acidosis and a one minute Apgar score less than 7. Continuous fetal heart rate monitoring was associated with a much higher incidence of operative delivery for fetal distress than was intermittent fetal heart rate auscultation. These results suggest an urgent need to review present methods for assessing the intrapartum condition of the fetus, making the diagnosis of fetal distress, and assessing the condition of the infant at birth.
PMCID: PMC1549216  PMID: 6412897
16.  Use of Continuous Electronic Fetal Monitoring in a Preterm Fetus: Clinical Dilemmas and Recommendations for Practice 
Journal of Pregnancy  2011;2011:848794.
The aim of intrapartum continuous electronic fetal monitoring using a cardiotocograph (CTG) is to identify a fetus exposed to intrapartum hypoxic insults so that timely and appropriate action could be instituted to improve perinatal outcome. Features observed on a CTG trace reflect the functioning of somatic and autonomic nervous systems and the fetal response to hypoxic or mechanical insults during labour. Although, National Guidelines on electronic fetal monitoring exist for term fetuses, there is paucity of recommendations based on scientific evidence for monitoring preterm fetuses during labour. Lack of evidence-based recommendations may pose a clinical dilemma as preterm births account for nearly 8% (1 in 13) live births in England and Wales. 93% of these preterm births occur after 28 weeks, 6% between 22–27 weeks, and 1% before 22 weeks. Physiological control of fetal heart rate and the resultant features observed on the CTG trace differs in the preterm fetus as compared to a fetus at term making interpretation difficult. This review describes the features of normal fetal heart rate patterns at different gestations and the physiological responses of a preterm fetus compared to a fetus at term. We have proposed an algorithm “ACUTE” to aid management.
doi:10.1155/2011/848794
PMCID: PMC3172974  PMID: 21922045
17.  How often is a low Apgar score the result of substandard care during labour? 
Bjog  2010;117(8):968-978.
Objective
To increase our knowledge of the occurrence of substandard care during labour.
Design
A population-based case–control study.
Setting
Stockholm County.
Population
Infants born in the period 2004–2006 in Stockholm County.
Methods
Cases and controls were identified from the Swedish Medical Birth Register, had a gestational age of ≥33 complete weeks, had planned for a vaginal delivery, and had a normal cardiotocographic (CTG) recording on admission. We compared 313 infants with an Apgar score of <7 at 5 minutes of age with 313 randomly selected controls with a full Apgar score, matched for year of birth.
Main outcome measure
Substandard care during labour.
Results
We found that 62% of cases and 36% of controls were subject to some form of substandard care during labour. In half of the cases and in 12% of the controls, CTG was abnormal for ≥45 minutes before birth. Fetal blood sampling was not performed in 79% of both cases and controls, when indicated. Oxytocin was provided without signs of uterine inertia in 20% of both cases and controls. Uterine contractions were hyperstimulated by oxytocin in 29% of cases and in 9% of controls, and the dose of oxytocin was increased despite abnormal CTG in 19% and 6% of cases and controls, respectively. Assuming that substandard care is a risk factor for low Apgar score, we estimate that up to 42% of the cases could be prevented by avoiding substandard care.
Conclusions
There was substandard care during labour of two-thirds of infants with a low Apgar score. The main reasons for substandard care were related to misinterpretation of CTG, not acting on an abnormal CTG in a timely fashion and incautious use of oxytocin.
doi:10.1111/j.1471-0528.2010.02565.x
PMCID: PMC2901517  PMID: 20545673
Asphyxia; delivery; fetal surveillance; hyperstimulation; labour; oxytocin; substandard care; vacuum extraction.
18.  Use of wind-up fetal Doppler versus Pinard for fetal heart rate intermittent monitoring in labour: a randomised clinical trial 
BMJ Open  2015;5(1):e006867.
Objectives
In resource-poor settings, the standard of care to inform labour management is the partograph plus Pinard stethoscope for intermittent fetal heart rate (FHR) monitoring. We compared FHR monitoring in labour using a novel, robust wind-up handheld Doppler with the Pinard as a primary screening tool for abnormal FHR on perinatal outcomes.
Design
Prospective equally randomised clinical trial.
Setting
The labour and delivery unit of a teaching hospital in Kampala, Uganda.
Participants
Of the 2042 eligible antenatal women, 1971 women in active term labour, following uncomplicated pregnancies, were randomised to either the standard of care or not.
Intervention
Intermittent FHR monitoring using Doppler.
Primary outcome measures
Incidence of FHR abnormality detection, intrapartum stillbirth and neonatal mortality prior to discharge.
Results
Age, parity, gestational age, mode of delivery and newborn weight were similar between study groups. In the Doppler group, there was a significantly higher rate of FHR abnormalities detected (incidence rate ratio (IRR)=1.61, 95% CI 1.13 to 2.30). However, in this group, there were also higher though not statistically significant rates of intrapartum stillbirths (IRR=3.94, 0.44 to 35.24) and neonatal deaths (IRR=1.38, 0.44 to 4.34).
Conclusions
Routine monitoring with a handheld Doppler increased the identification of FHR abnormalities in labour; however, our trial did not find evidence that this leads to a decrease in the incidence of intrapartum stillbirth or neonatal death.
Trial registration number
Clinical Trails.gov (1000031587).
doi:10.1136/bmjopen-2014-006867
PMCID: PMC4316429  PMID: 25636792
NEONATOLOGY; PRIMARY CARE
19.  Reducing risk by improving standards of intrapartum fetal care 
Confidential Enquiries into Stillbirths and Deaths in Infancy (CESDI) have pointed to a high frequency of suboptimal intrapartum fetal care of a kind that, in the event of an adverse outcome, is hard to defend in court. In an effort to minimize liability, various strategies were applied in a district hospital labour ward—guidelines, cyclical audit, monthly feedback meetings and training sessions in cardiotocography (CTG). The effects of these interventions on quality of care was assessed by use of the CESDI system in all babies born with an Apgar score of 4 or less at 1 min and/or 7 or less at 5 min.
540 babies (4.3%) had low Apgar scores, and neither the percentage nor gestational age differed significantly between audit periods. In the baseline audit, care was judged suboptimal (grade II/III) in 14 (74%) of 19 cases, and in the next four periods it was 23%, 27%, 27% and 32%. In the latest audit period, after further educational interventions, it was 9%. Many of the failures to recognize or act on abnormal events were related to CTG interpretation. After the interventions there was a significant increase in cord blood pH measurement. There were no differences between audit periods in the proportion of babies with cord pH <7.2.
These results indicate that substantial improvements in quality of intrapartum care can be achieved by a programme of clinical risk management.
PMCID: PMC1281454  PMID: 11385089
20.  Intelligent Structured Intermittent Auscultation (ISIA): evaluation of a decision-making framework for fetal heart monitoring of low-risk women 
Background
Research-informed fetal monitoring guidelines recommend intermittent auscultation (IA) for fetal heart monitoring for low-risk women. However, the use of cardiotocography (CTG) continues to dominate many institutional maternity settings.
Methods
A mixed methods intervention study with before and after measurement was undertaken in one secondary level health service to facilitate the implementation of an initiative to encourage the use of IA. The intervention initiative was a decision-making framework called Intelligent Structured Intermittent Auscultation (ISIA) introduced through an education session.
Results
Following the intervention, medical records review revealed an increase in the use of IA during labour represented by a relative change of 12%, with improved documentation of clinical findings from assessments, and a significant reduction in the risk of receiving an admission CTG (RR 0.75, 95% CI, 0.60 – 0.95, p = 0.016).
Conclusion
The ISIA informed decision-making framework transformed the practice of IA and provided a mechanism for knowledge translation that enabled midwives to implement evidence-based fetal heart monitoring for low risk women.
doi:10.1186/1471-2393-14-184
PMCID: PMC4070350  PMID: 24884597
Intermittent auscultation; Fetal heart rate monitoring; Decision-making; Clinical; Knowledge translation; Mixed methods
21.  Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT 
Background
Around 80% of intrauterine growth restricted (IUGR) infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management is controversial, in particular the decision whether to induce labour or await spontaneous delivery with strict fetal and maternal surveillance. We propose a randomised trial to compare effectiveness, costs and maternal quality of life for induction of labour versus expectant management in women with a suspected IUGR fetus at term.
Methods/design
The proposed trial is a multi-centre randomised study in pregnant women who are suspected on clinical grounds of having an IUGR child at a gestational age between 36+0 and 41+0 weeks. After informed consent women will be randomly allocated to either induction of labour or expectant management with maternal and fetal monitoring. Randomisation will be web-based. The primary outcome measure will be a composite neonatal morbidity and mortality. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs. Moreover, we aim to assess neurodevelopmental and neurobehavioral outcome at two years as assessed by a postal enquiry (Child Behavioral Check List-CBCL and Ages and Stages Questionnaire-ASQ). Analysis will be by intention to treat. Quality of life analysis and a preference study will also be performed in the same study population. Health technology assessment with an economic analysis is part of this so called Digitat trial (Disproportionate Intrauterine Growth Intervention Trial At Term). The study aims to include 325 patients per arm.
Discussion
This trial will provide evidence for which strategy is superior in terms of neonatal and maternal morbidity and mortality, costs and maternal quality of life aspects. This will be the first randomised trial for IUGR at term.
Trial registration
Dutch Trial Register and ISRCTN-Register: ISRCTN10363217.
doi:10.1186/1471-2393-7-12
PMCID: PMC1933438  PMID: 17623077
22.  Midwife managed delivery unit: a randomised controlled comparison with consultant led care. 
BMJ : British Medical Journal  1994;309(6966):1400-1404.
OBJECTIVE--To examine whether intrapartum care and delivery of low risk women in a midwife managed delivery unit differs from that in a consultant led labour ward. DESIGN--Pragmatic randomised controlled trial. Subjects were randomised in a 2:1 ratio between the midwives unit and the labour ward. SETTING--Aberdeen Maternity Hospital, Grampian. SUBJECTS--2844 low risk women, as defined by existing booking criteria for general practitioner units in Grampian. 1900 women were randomised to the midwives unit and 944 to the labour ward. MAIN OUTCOME MEASURES--Maternal and perinatal morbidity. RESULTS--Of the women randomised to the midwives unit, 647 (34%) were transferred to the labour ward antepartum, 303 (16%) were transferred intrapartum, and 80 (4%) were lost to follow up. 870 women (46%) were delivered in the midwives unit. Primigravid women (255/596, 43%) were significantly more likely to be transferred intrapartum than multi-gravid women (48/577, 8%). Significant differences between the midwives unit and labour ward were found in monitoring, fetal distress, analgesia, mobility, and use of episiotomy. There were no significant differences in mode of delivery or fetal outcome. CONCLUSIONS--Midwife managed intrapartum care for low risk women results in more mobility and less intervention with no increase in neonatal morbidity. However, the high rate of transfer shows that antenatal criteria are unable to determine who will remain at low risk throughout pregnancy and labour.
PMCID: PMC2541316  PMID: 7819846
23.  Fetal Vibroacoustic Stimulation in Computerized Cardiotocographic Analysis: The Role of Short-Term Variability and Approximate Entropy 
Journal of Pregnancy  2012;2012:814987.
The aim of this study was to evaluate the impact of vibroacoustic stimulation (VAS) on computerized cardiotocography short-term variability (STV) and approximate entropy (ApEn) in both low- and high-risk pregnancies. VAS was performed on 121 high- and 95 low-risk pregnancies after 10 minutes of continuous quiet, while their FHR parameters were monitored and recorded by cCTG analysis. Fetal heart rate was recorded using a computer-assisted equipment. Baseline FHR, accelerations, decelerations, STV, long-term irregularity (LTI), ApEn, and fetal movements (FMs) were calculated for defined observational periods before VAS and after 10 minutes. Data were also investigated in relationship with the perinatal outcome. In each group of patients, FHR after VAS remained almost unmodified. Fetal movements significantly increased after VAS in both groups. Results show that only in the high-risk pregnancies, the increase of STV and the decrease of ApEn after VAS were significantly associated with favorable perinatal outcomes.
doi:10.1155/2012/814987
PMCID: PMC3265125  PMID: 22292120
24.  The Role of 4D Ultrasound in the Assessment of Fetal Behaviour 
Mædica  2011;6(2):120-127.
ABSTRACT
Fetal behavior is defined as any fetal action seen by the mother or fetus diagnosed by objective methods such as cardiotocography (CTG) or ultrasound. Analysis of the dynamics of the fetal behavior with morphological studies has lead to the conclusion that fetal behavior patterns are directly reflecting development and maturation of the central nervous system. The assessment of fetal behavior by 4D ultrasound could allow distinction between normal and abnormal fetal behavior patterns which might make possible the early recognition of fetal brain impairment.
Aim: Assessment of fetal movements throughout the pregnancy using 4D ultrasound.
Material and Method: The study group included 144 healthy pregnant women with single pregnancies between 7-38 weeks of gestation. For the first trimester of pregnancy we assessed eight types of fetal movements and for the second and third trimesters 14 types of fetal movements and facial expressions. The analyzed parameters for each trimester of pregnancy can be used for performing antenatal neurodevelopment test, used the first time by Professor Kurjak.
Results: After 15-20 minutes 4D ultrasound examination, we found a pattern of fetal behavior for each trimester of pregnancy.
Conclusions: Dynamic evaluation of fetal behavior reflects directly the processes of maturation and development of the central nervous system. This can make the difference between normal and abnormal brain development and may be used for early diagnosis of neurological disorders that become manifest in perinatal and postnatal periods.
PMCID: PMC3239390  PMID: 22205894
fetal behavior; 4D ultrasound; fetal movements
25.  Reliability of admission cardiotocography for intrapartum monitoring in low resource setting 
Background
To evaluate the role of admission cardiotocography in intrapartum patients in detecting fetal hypoxia already present and to correlate the results of admission cardiotocography with perinatal outcome.
Materials and Methods:
It was a cross-sectional study conducted in the Labor and Maternity ward during the period 2007-2009. The study included 176 pregnant women (both high risk and low risk), admitted to the emergency department or through the outpatient department with period of gestation ≥36 weeks, in first stage of labor with fetus in cephalic presentation. All of them were subjected to an admission test, a 20 min recording of fetal heart rate and uterine contractions on cardiotocograph machine at the time of admission.
Results:
The results of the admission test were ‘reactive’ in 82.38%, ‘equivocal’ in 10.22%, and ‘ominous’ in 7.38% women. Women with the reactive admission test had low risk of intrapartum fetal distress (6.9%) as compared to 39.9% in the equivocal and 84.6% in the ominous group (P<0.001). Incidence of moderate to thick meconium stained liqor were more in ominous (61.5%) and equivocal group (33.3%) in compared to reactive group (4.8%) (P<0.001). Incidence of NICU admission was also significantly high (62%) in babies delivered from mother with ominous test group compared to those with equivocal (28%) and reactive test (3.45%) group babies. Neonatal mortality was also seen in babies born to mothers with equivocal (5.5%) and ominous (7.6%) admission test groups. Operative delivery for fetal distress was required in only 5.5% (8 of 145) woman of the reactive group, in 27.8% (5 of 18) woman of the equivocal group and in 84.6% (11 of 13) women of the ominous group.
Conclusion:
The admission cardiotocography is a simple non-invasive test that can serve as screening tool to detect fetal distress already present or likely to develop and prevent unnecessary delay in intervention. The test has high specificity and can help in ‘triaging’ fetuses in obstetric wards of developing countries with a heavy workload and limited resources.
doi:10.4103/0300-1652.104384
PMCID: PMC3531034  PMID: 23293415
Admission test; cardiotocograph; fetal distress; fetal hypoxia; perinatal outcome

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