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1.  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
2.  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
3.  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
4.  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
5.  Antepartum fetal heart rate feature extraction and classification using empirical mode decomposition and support vector machine 
Background
Cardiotocography (CTG) is the most widely used tool for fetal surveillance. The visual analysis of fetal heart rate (FHR) traces largely depends on the expertise and experience of the clinician involved. Several approaches have been proposed for the effective interpretation of FHR. In this paper, a new approach for FHR feature extraction based on empirical mode decomposition (EMD) is proposed, which was used along with support vector machine (SVM) for the classification of FHR recordings as 'normal' or 'at risk'.
Methods
The FHR were recorded from 15 subjects at a sampling rate of 4 Hz and a dataset consisting of 90 randomly selected records of 20 minutes duration was formed from these. All records were labelled as 'normal' or 'at risk' by two experienced obstetricians. A training set was formed by 60 records, the remaining 30 left as the testing set. The standard deviations of the EMD components are input as features to a support vector machine (SVM) to classify FHR samples.
Results
For the training set, a five-fold cross validation test resulted in an accuracy of 86% whereas the overall geometric mean of sensitivity and specificity was 94.8%. The Kappa value for the training set was .923. Application of the proposed method to the testing set (30 records) resulted in a geometric mean of 81.5%. The Kappa value for the testing set was .684.
Conclusions
Based on the overall performance of the system it can be stated that the proposed methodology is a promising new approach for the feature extraction and classification of FHR signals.
doi:10.1186/1475-925X-10-6
PMCID: PMC3033856  PMID: 21244712
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.  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
8.  Intrauterine Extremity Gangrene and Cerebral Infarction at Term: A Case Report 
Case Reports in Pediatrics  2011;2011:363517.
Intrauterine extremity gangrene in combination with cerebral infarction is a serious and rare event. We present a case with a healthy mother who gave birth to a child with this condition. At term, the mother presented at the antenatal clinic with decreased fetal movements. Cardiotocography (CTG) showed signs of fetal distress and a caesarean section was performed. The left arm of the newborn was found gangrenous. Amputation of the arm was necessary and the child was subsequently treated with anticoagulant therapy due to thrombosis and cerebral infarction in the left hemisphere found by magnetic resonance imaging (MRI). At one year of age the boy was doing well and had prosthesis as a left arm. He had no signs of further complications. Despite thorough examination of the parents and the child, the reason for the thrombosis is still unknown.
doi:10.1155/2011/363517
PMCID: PMC3350222  PMID: 22606511
9.  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
10.  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
11.  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
12.  Home Labour Induction with Retrievable Prostaglandin Pessary and Continuous Telemetric Trans-Abdominal Fetal ECG Monitoring 
PLoS ONE  2011;6(11):e28129.
Objective
To evaluate the feasibility of continuous telemetric trans-abdominal fetal electrocardiogram (a-fECG) in women undergoing labour induction at home.
Study Design
Low risk women with singleton term pregnancy undergoing labour induction with retrievable, slow-release dinoprostone pessaries (n = 70) were allowed home for up to 24 hours, while a-fECG and uterine activity were monitored in hospital via wireless technology. Semi-structured diaries were analysed using a combined descriptive and interpretive approach.
Results
62/70 women (89%) had successful home monitoring; 8 women (11%) were recalled because of signal loss. Home monitoring lasted between 2–22 hours (median 10 hours). Good quality signal was achieved most of the time (86%, SD 10%). 3 women were recalled back to hospital for suspicious a-fECG. In 2 cases suspicious a-fECG persisted, requiring Caesarean section after recall to hospital. 48/51 women who returned the diary coped well (94%); 46/51 were satisfied with home monitoring (90%).
Conclusions
Continuous telemetric trans-abdominal fetal ECG monitoring of ambulatory women undergoing labour induction is feasible and acceptable to women.
doi:10.1371/journal.pone.0028129
PMCID: PMC3225384  PMID: 22140522
13.  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
14.  Outcome of deliveries in healthy but obese women: obesity and delivery outcome 
BMC Research Notes  2013;6:50.
Background
Obesity among fertile women is a global problem. 25% of pregnant Swedish women are overweight at admission to the antenatal clinic and 12% of them are considered as obese. Previous studies have shown an increased risk of delivery complications with an elevated maternal BMI. The aim of this study was to evaluate delivery outcomes in relation to maternal BMI on admission to the antenatal clinic.
A healthy group of 787 women with full-term pregnancies and spontaneous onset of labor were included in the study. Delivery outcome was assessed in relation to maternal BMI when attending the antenatal clinic.
Results
The results indicated that in deliveries where the maternal BMI was >30 a high frequency of abnormal CTG trace during the last 30 minutes of labor was shown. A blood sample for evaluation of risk of fetal hypoxia was performed in only eight percent of these deliveries. A spontaneous vaginal delivery without intervention was noted in 85.7%, and 12% of neonates were delivered with an adverse fetal outcome compared to 2.8% in the group with a maternal BMI<30 (p<0.001).
Conclusion
These results indicate an increased risk at delivery for healthy, but obese women in labor. Furthermore, the delivery management may not always be optimal in these deliveries.
doi:10.1186/1756-0500-6-50
PMCID: PMC3573993  PMID: 23388378
Obesity; Fetal outcome; Delivery outcome
15.  The Bristol third stage trial: active versus physiological management of third stage of labour. 
BMJ : British Medical Journal  1988;297(6659):1295-1300.
OBJECTIVE--To compare the effects on fetal and maternal morbidity of routine active management of third stage of labour and expectant (physiological) management, in particular to determine whether active management reduced incidence of postpartum haemorrhage. DESIGN--Randomised trial of active versus physiological management. Women entered trial on admission to labour ward with allocation revealed just before vaginal delivery. Five months into trial high rate of postpartum haemorrhage in physiological group (16.5% v 3.8%) prompted modification of protocol to exclude more women and allow those allocated to physiological group who needed some active management to be switched to fully active management. Sample size of 3900 was planned, but even after protocol modification a planned interim analysis after first 1500 deliveries showed continuing high postpartum haemorrhage rate in physiological group and study was stopped. SETTING--Maternity hospital. PARTICIPANTS--Of 4709 women delivered from 1 January 1986 to 31 January 1987, 1695 were admitted to trial and allocated randomly to physiological (849) or active (846) management. Reasons for exclusion were: refusal, antepartum haemorrhage, cardiac disease, breech presentation, multiple pregnancy, intrauterine death, and, after May 1986, ritodrine given two hours before delivery, anticoagulant treatment, and any condition needing a particular management of third stage. INTERVENTIONS--All but six women allocated to active management actually received it, having prophylactic oxytocic, cord clamping before placental delivery, and cord traction; whereas just under half those allocated to physiological management achieved it. A fifth of physiological group received prophylactic oxytocic, two fifths underwent cord traction and just over half clamping of the cord before placental delivery. ENDPOINT--Reduction in incidence of postpartum haemorrhage from 7.5% under physiological management to 5.0% under active management. MEASUREMENTS AND MAIN RESULTS--Incidence of postpartum haemorrhage was 5.9% in active management group and 17.9% in physiological group (odds ratio 3.13; 95% confidence interval 2.3 to 4.2), a contrast reflected in other indices of blood loss. In physiological group third stage was longer (median 15 min v 5 min) and more women needed therapeutic oxytocics (29.7% v 6.4%). Apgar scores at one and five minutes and incidence of neonatal respiratory problems were not significantly different between groups. Babies in physiological group weighed mean of 85 g more than those in active group. When women allocated to and receiving active management (840) were compared with those who actually received physiological management (403) active management still produced lower rate of postpartum haemorrhage (odds ratio 2.4;95% CI1.6 to 3.7). CONCLUSIONS--Policy of active management practised in this trial reduces incidence of postpartum haemorrhage, shortens third stage, and results in reduced neonatal packed cell volume.
PMCID: PMC1834913  PMID: 3144366
16.  Oxytocin infusion during second stage of labour in primiparous women using epidural analgesia: a randomised double blind placebo controlled trial. 
BMJ : British Medical Journal  1989;299(6713):1423-1426.
OBJECTIVE--To determine whether the high rate of forceps delivery associated with the use of epidural analgesia could be reduced through giving an intravenous infusion of oxytocin during the second stage of labour. DESIGN--A randomised, double blind, placebo controlled trial. SETTING--Delivery suites in three hospitals. SUBJECTS--226 Primiparous women with adequate epidural analgesia in whom full dilatation of the cervix had been achieved without prior stimulation with oxytocin. INTERVENTION--An infusion of oxytocin or placebo starting at the diagnosis of full cervical dilatation at an initial dose rate of 2 mU/min increasing to a maximum of 16 mU/min. MAIN OUTCOME MEASURES--The outcome of labour was assessed in terms of the duration of the second stage, mode of delivery, fetal condition at birth, postpartum blood loss, and the incidence of perineal trauma. RESULTS--Treatment with oxytocin was associated with a shorter second stage (p = 0.01), a reduction in the number of non-rotational forceps deliveries (p = 0.03), and less perineal trauma (p = 0.03) but was not associated with any reduction in the number of rotational forceps deliveries performed for malposition of the occiput. No adverse effects on fetal condition at birth or in the early puerperium were seen in association with the use of oxytocin. CONCLUSIONS--The use of an oxytocin infusion may reduce the high rate of operative delivery associated with epidural analgesia provided that the fetal occiput is in an anterior position at the onset of the second stage of labour but within the dose range studied does not seem to correct malposition of the fetal occiput.
PMCID: PMC1838287  PMID: 2514824
17.  IMOP: randomised placebo controlled trial of outpatient cervical ripening with isosorbide mononitrate (IMN) prior to induction of labour – clinical trial with analyses of efficacy, cost effectiveness and acceptability 
Background
There is increasing interest in carrying out pre-induction cervical ripening on an outpatient basis. However, there are concerns about the use of prostaglandins, the agents commonly used in hospital settings for this indication, because prostaglandins induce uterine contractions that may lead to fetal hypoxia. Indeed, in a recent study we demonstrated abnormalities in 9% of fetal heart rate tracings performed following prostaglandin induced cervical ripening at term. In contrast, we confirmed in the same study that isosorbide mononitrate (IMN) (administered on an inpatient basis) was both effective in inducing cervical ripening at term, and was associated with no associated fetal heart rate abnormalities.
Methods/design
The aim of this study is to determine whether IMN self administered by women on an outpatient basis improves the process of induction of labour. Specifically, we hypothesise that the use of outpatient IMN will result in a shorter inpatient stay before delivery, decreased costs to the health service and greater maternal satisfaction with ripening and induction of labour, compared with placebo treatment.
In the study described here (the "IMOP" study), women scheduled for induction of labour at term, and who require pre-induction cervical ripening will be randomised to self-administer at home either IMN 40 mg, or a placebo, each vaginally, at 48 hours, 32 hours and 16 hours before scheduled hospital admission.
After admission to hospital, treatment will revert to the usual induction of labour protocol. We will compare the primary outcomes of the elapsed time interval from hospital admission to vaginal delivery, the costs to the health service of induction of labour, and women's experience of induction of labour in the two groups.
Discussion
This trial will provide evidence on the efficacy of outpatient IMN for pre-induction cervical ripening at term. We will study a formulation of IMN which is cheap and widely available. If the treatment is effective, acceptable to women, and cost effective, it could be implemented into obstetric practice worldwide.
Trial registration
The trial has been registered on the International Standard Randomised Controlled Trial Number Register (ISRCTN) and given the registration number ISRTN39772441.
doi:10.1186/1471-2393-6-25
PMCID: PMC1569865  PMID: 16869966
18.  Professionals’ views of fetal monitoring during labour: a systematic review and thematic analysis 
Background
Current recommendations do not support the use of continuous electronic fetal monitoring (EFM) for low risk women during labour, yet EFM remains widespread in clinical practice. Consideration of the views, perspectives and experiences of individuals directly concerned with EFM application may be beneficial for identifying barriers to and facilitators for implementing evidence-based maternity care. The aim of this paper is to offer insight and understanding, through systematic review and thematic analysis, of research into professionals’ views on fetal heart rate monitoring during labour.
Methods
Any study whose aim was to explore professional views of fetal monitoring during labour was considered eligible for inclusion. The electronic databases of MEDLINE (1966–2010), CINAHL (1980–2010), EMBASE (1974–2010) and Maternity and Infant Care: MIDIRS (1971–2010) were searched in January 2010 and an updated search was performed in March 2012. Quality appraisal of each included study was performed. Data extraction tables were developed to collect data. Data synthesis was by thematic analysis.
Results
Eleven studies, including 1,194 participants, were identified and included in this review. Four themes emerged from the data: 1) reassurance, 2) technology, 3) communication/education and 4) midwife by proxy.
Conclusion
This systematic review and thematic analysis offers insight into some of the views of professionals on fetal monitoring during labour. It provides evidence for the continuing use of EFM when caring for low-risk women, contrary to current research evidence. Further research to ascertain how some of these views might be addressed to ensure the provision of evidence-based care for women and their babies is recommended.
doi:10.1186/1471-2393-12-166
PMCID: PMC3549751  PMID: 23270400
Fetal monitoring; Pregnancy; Labour; Views
19.  Fetal cardiotocography before and after water aerobics during pregnancy 
Reproductive Health  2010;7:23.
Objective
To evaluate the effect of moderate aerobic physical activity in water on fetal cardiotocography patterns in sedentary pregnant women.
Method
In a non-randomized controlled trial, 133 previously sedentary pregnant women participated in multiple regular sessions of water aerobics in a heated swimming pool. Cardiotocography was performed for 20 minutes before and just after the oriented exercise. Cardiotocography patterns were analyzed pre- and post-exercise according to gestational age groups (24-27, 28-31, 32-35 and 36-40 weeks). Student's t and Wilcoxon, and McNemar tests were used, respectively, to analyze numerical and categorical variables.
Results
No significant variations were found between pre- and post-exercise values of fetal heart rate (FHR), number of fetal body movements (FM) or accelerations (A), FM/A ratio or the presence of decelerations. Variability in FHR was significantly higher following exercise only in pregnancies of 24-27 weeks.
Conclusions
Moderate physical activity in water was not associated with any significant alterations in fetal cardiotocography patterns, which suggests no adverse effect on the fetus.
doi:10.1186/1742-4755-7-23
PMCID: PMC2936287  PMID: 20807417
20.  Induction of labour versus expectant management for prelabour rupture of the membranes at term: an economic evaluation 
BACKGROUND: As the interval between rupture of the fetal membranes at term and delivery increases, so may the risk of fetal and maternal infection. Recently the TERMPROM (Term Prelabor Rupture of the Membranes) Study Group reported the results of a randomized controlled trial comparing 4 management strategies: induction with oxytocin (IwO), induction with prostaglandin (IwP), and expectant management and induction with either oxytocin (EM-O) or prostaglandin (EM-P) if complications developed. The study found no statistically significant differences in neonatal infection and cesarean section rates between any of the 4 groups. OBJECTIVE: To conduct an economic evaluation comparing the cost of (a) IwO and EM-O, (b) IwP and EM-P and (c) IwO and IwP. DESIGN: An economic analysis, conducted alongside the clinical trial, using a third-party payer perspective. Analysis included all treatment costs incurred for both the mother and the baby. Information on health care utilization and outcomes was collected for all study participants. Three countries (Canada, the United Kingdom and Australia), corresponding to the largest study recruitment, were chosen for calculation of unit costs. For each country, the base, low and high estimates of unit cost for each service item were generated. Intention-to-treat analysis. Extensive statistical and sensitivity analyses were performed. RESULTS: The median cost of IwO per patient was significantly lower statistically than that of EM-O and IwP. This result held in all 3 countries compared -$114 and -$46 in Canada, -113 Pounds and -63 Pounds in the UK, and -A$30 and -A$49 in Australia) and after an extensive sensitivity analysis. There was no statistically significant difference in median cost per patient between IwP and EM-P. CONCLUSION: Although the clinical results of the TERMPROM study did not find IwO to be preferable to the other treatment alternatives, the economic evaluation found it to be less costly. However, these cost differences, even though statistically significant, are not likely to be important in many countries. When this is the case, the authors recommend that women be offered a choice between management strategies.
PMCID: PMC1228562  PMID: 9400406
21.  Comparison of outcome of low-risk labour in an isolated general practice maternity unit and specialist maternity hospital 
The outcome of labour of 185 low-risk pregnancies at an isolated general practitioner maternity unit was compared with that for 185 comparable low-risk pregnancies at a specialist maternity hospital. No difference was found in mode of delivery or in the proportion of women requiring no analgesia, although significantly more women in the general practice group received analgesia beyond nitrous oxide. There was a significantly higher level of intervention in labour in the maternity hospital group in the form of fetal monitoring and augmentation of labour. The duration of first stage of labour was longer and meconium staining less frequent in the general practice group. Fourteen (7.6%) of the general practice group were transferred in labour to the specialist unit.
The results suggest that where considerations for selection of low-risk pregnancy permit, the general practice maternity unit can provide a distinctive style of intrapartum care with minimum intervention.
PMCID: PMC1711124  PMID: 3505637
22.  Monitoring Fetal Electrocortical Activity during Labour for Predicting Worsening Acidemia: A Prospective Study in the Ovine Fetus Near Term 
PLoS ONE  2011;6(7):e22100.
Background
Severe fetal acidemia during labour with arterial pH below 7.00 is associated with increased risk of hypoxic-ischemic brain injury. Electronic fetal heart rate (FHR) monitoring, the mainstay of intrapartum surveillance, has poor specificity for detecting fetal acidemia. We studied brain electrical activity measured with electrocorticogram (ECOG) in the near term ovine fetus subjected to repetitive umbilical cord occlusions (UCO) inducing FHR decelerations, as might be seen in human labour, to delineate the time-course for ECOG changes with worsening acidemia and thereby assess the potential clinical utility of fetal ECOG.
Methodology/Principal Findings
Ten chronically catheterized fetal sheep were studied through a series of mild, moderate and severe UCO until the arterial pH was below 7.00. At a pH of 7.24±0.04, 52±13 min prior to the pH dropping <7.00, spectral edge frequency (SEF) increased to 23±2 Hz from 3±1 Hz during each FHR deceleration (p<0.001) and was correlated to decreases in FHR and in fetal arterial blood pressure during each FHR deceleration (p<0.001).
Conclusions/Significance
The UCO-related changes in ECOG occurred in advance of the pH decreasing below 7.00. These ECOG changes may be a protective mechanism suppressing non-essential energy needs when oxygen supply to the fetal brain is decreased acutely. By detecting such “adaptive brain shutdown,” the need for delivery in high risk pregnant patients may be more accurately predicted than with FHR monitoring alone. Therefore, monitoring fetal electroencephalogram (EEG, the human equivalent of ECOG) during human labour may be a useful adjunct to FHR monitoring.
doi:10.1371/journal.pone.0022100
PMCID: PMC3137606  PMID: 21789218
23.  "GINEXMAL RCT: Induction of labour versus expectant management in gestational diabetes pregnancies" 
Background
Gestational Diabetes (GDM) is one of the most common complications of pregnancies affecting around 7% of women. This clinical condition is associated with an increased risk of developing fetal macrosomia and is related to a higher incidence of caesarean section in comparison to the general population. Strong evidence indicating the best management between induction of labour at term and expectant monitoring are missing.
Methods/Design
Pregnant women with singleton pregnancy in vertex presentation previously diagnosed with gestational diabetes will be asked to participate in a multicenter open-label randomized controlled trial between 38+0 and 39+0 gestational weeks. Women will be recruited in the third trimester in the Outpatient clinic or in the Day Assessment Unit according to local protocols. Women who opt to take part will be randomized according to induction of labour or expectant management for spontaneous delivery. Patients allocated to the induction group will be admitted to the obstetric ward and offered induction of labour via use of prostaglandins, Foley catheter or oxytocin (depending on clinical conditions). Women assigned to the expectant arm will be sent to their domicile where they will be followed up until delivery, through maternal and fetal wellbeing monitoring twice weekly. The primary study outcome is the Caesarean section (C-section) rate, whilst secondary measurement4s are maternal and neonatal outcomes. A total sample of 1760 women (880 each arm) will be recruited to identify a relative difference between the two arms equal to 20% in favour of induction, with concerns to C-section rate. Data will be collected until mothers and newborns discharge from the hospital. Analysis of the outcome measures will be carried out by intention to treat.
Discussion
The present trial will provide evidence as to whether or not, in women affected by gestational diabetes, induction of labour between 38+0 and 39+0 weeks is an effective management to ameliorate maternal and neonatal outcomes. The primary objective is to determine whether caesarean section rate could be reduced among women undergoing induction of labour, in comparison to patients allocated to expectant monitoring. The secondary objective consists of the assessment and comparison of maternal and neonatal outcomes in the two study arms.
Trial Registration
The study protocol has been registered in the ClinicalTrials.gov Protocol Registration System, identification number NCT01058772.
doi:10.1186/1471-2393-11-31
PMCID: PMC3108319  PMID: 21507262
24.  Management of fetal growth restriction 
Fetal growth restriction (FGR) is challenging because of the difficulties in reaching a definitive diagnosis of the cause and planning management. FGR is associated not only with a marked increased risk in perinatal mortality and morbidity but also with long‐term outcome risks. Combinations of fetal biometry, amniotic fluid volume, heart rate patterns, arterial and venous Doppler, and biophysical variables allow a comprehensive fetal evaluation of FGR. However, no evidence supports that the use of cardiotocography or the biophysical profile improves perinatal outcome. Therefore, obstetricians aim to identify fetuses with early FGR so delivery can be planned according to gestational age and severity of the condition. The balance of risks and the need for the availability of services mean that the involvement of neonatologists in FGR management is vital. In this review, the focus is on the pathophysiology and management of FGR caused by placental diseases.
doi:10.1136/adc.2005.082297
PMCID: PMC2675309  PMID: 17185432
25.  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.

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