Dataset Information

Use of wind-up fetal Doppler versus Pinard for fetal heart rate intermittent monitoring in labour: a randomised clinical trial.

ABSTRACT:

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).

SUBMITTER: Byaruhanga R

PROVIDER: S-EPMC4316429 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Use of wind-up fetal Doppler versus Pinard for fetal heart rate intermittent monitoring in labour: a randomised clinical trial.

Byaruhanga R R Bassani D G DG Jagau A A Muwanguzi P P Montgomery A L AL Lawn J E JE

BMJ open 20150130 1

<h4>Objectives</h4>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.<h4>Design</h4>Prospective equally randomised clinical trial.<h4>Setting</h4>The labour and delivery unit of a teaching hospital in Kampala, Uga ...[more]

PMID: 25636792

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Project description:BackgroundContinuous electronic fetal heart-rate monitoring is widely used during labour, and computerised interpretation could increase its usefulness. We aimed to establish whether the addition of decision-support software to assist in the interpretation of cardiotocographs affected the number of poor neonatal outcomes.MethodsIn this unmasked randomised controlled trial, we recruited women in labour aged 16 years or older having continuous electronic fetal monitoring, with a singleton or twin pregnancy, and at 35 weeks' gestation or more at 24 maternity units in the UK and Ireland. They were randomly assigned (1:1) to decision support with the INFANT system or no decision support via a computer-generated stratified block randomisation schedule. The primary outcomes were poor neonatal outcome (intrapartum stillbirth or early neonatal death excluding lethal congenital anomalies, or neonatal encephalopathy, admission to the neonatal unit within 24 h for ≥48 h with evidence of feeding difficulties, respiratory illness, or encephalopathy with evidence of compromise at birth), and developmental assessment at age 2 years in a subset of surviving children. Analyses were done by intention to treat. This trial is completed and is registered with the ISRCTN Registry, number 98680152.FindingsBetween Jan 6, 2010, and Aug 31, 2013, 47 062 women were randomly assigned (23 515 in the decision-support group and 23 547 in the no-decision-support group) and 46 042 were analysed (22 987 in the decision-support group and 23 055 in the no-decision-support group). We noted no difference in the incidence of poor neonatal outcome between the groups-172 (0·7%) babies in the decision-support group compared with 171 (0·7%) babies in the no-decision-support group (adjusted risk ratio 1·01, 95% CI 0·82-1·25). At 2 years, no significant differences were noted in terms of developmental assessment.InterpretationUse of computerised interpretation of cardiotocographs in women who have continuous electronic fetal monitoring in labour does not improve clinical outcomes for mothers or babies.FundingNational Institute for Health Research.

Project description:BackgroundFetal stethoscopes are mainly used for intermittent monitoring of fetal heart rate (FHR) during labor in low-income countries, where perinatal mortality is still high. Handheld Dopplers are rarely available and are dependent on batteries or electricity. The objective was to compare the Pinard stethoscope versus a new wind-up handheld Doppler in the detection of abnormal FHR.Materials and methodsWe conducted a randomized controlled study at Muhimbili National Hospital, Tanzania, from April 2013 to September 2015. Women with gestational age ≥37 weeks, cephalic presentation, normal FHR on admission, and cervical dilatation <7 cm were included. Primary outcome was abnormal FHR detection (<120 or >160 beats/min). Secondary endpoints were time to delivery, mode of delivery, and perinatal outcomes. χ2, Fisher's exact test, Mann-Whitney test, and logistic regression were conducted. Unadjusted and adjusted odds ratios were calculated with respective 95% confidence interval.ResultsIn total, 2,844 eligible women were assigned to FHR monitoring with Pinard (n=1,423) or Doppler (n=1,421). Abnormal FHRs were more often detected in the Doppler (6.0%) versus the Pinard (3.9%) arm (adjusted odds ratio =1.59, 95% confidence interval: 1.13-2.26, p=0.008). Median (interquartile range) time from abnormal FHR detection to delivery was comparable between Doppler and Pinard, ie, 80 (60,161) and 89 (52,165) minutes, respectively, as was the incidence of cesarean delivery (12.0% versus 12.2%). The incidence of adverse perinatal outcomes (fresh stillbirths, 24-hour neonatal admissions, and deaths) was similar overall; however, among newborns with abnormal FHR delivered vaginally, adverse outcomes were less incident in Doppler (7 of 43 births, 16.3%) than in the Pinard arm (10 of 23 births, 43.5%), p=0.021.ConclusionIntermittent FHR monitoring using Doppler was associated with an increased detection of abnormal FHR compared to Pinard in a low-risk population. Time intervals from abnormal FHR detection to delivery were longer than recommended in both arms. Perinatal outcomes were better among vaginally delivered newborns with detected abnormal FHR in the Doppler arm.

Project description:BackgroundIntermittent auscultation (IA) is the technique of listening to and counting the fetal heart rate (FHR) for short periods during active labour and continuous cardiotocography (CTC) implies FHR monitoring for longer periods. Although the evidence suggests that IA is the best way to monitor healthy women at low risk of complications, there is no scientific evidence for the ideal device, timing, frequency and duration for IA. We aimed to give an overview of the field, identify and describe methods and practices for performing IA, map the evidence and accuracy for different methods of IA, and identify research gaps.MethodsWe conducted a systematic scoping review following the Joanna Briggs methodology. Medline, EMBASE, Cinahl, Maternity & Infant Care, Cochrane Library, SveMed+, Web of Science, Scopus, Lilacs and African Journals Online were searched for publications up to January 2019. We did hand searches in relevant articles and databases. Studies from all countries, international guidelines and national guidelines from Denmark, United Kingdom, United States, New Zealand, Australia, The Netherlands, Sweden, Denmark, and Norway were included. We did quality assessment of the guidelines according to the AGREEMENT tool. We performed a meta-analysis assessing the effects of IA with a Doppler device vs. Pinard device using methods described in The Cochrane Handbook, and we performed an overall assessment of the summary of evidence using the GRADE approach.ResultsThe searches generated 6408 hits of which 26 studies and 11 guidelines were included in the review. The studies described slightly different techniques for performing IA, and some did not provide detailed descriptions. Few of the studies provided details of normal and abnormal IA findings. All 11 guidelines recommended IA for low risk women, although they had slightly different recommendations on the frequency, timing, and duration for IA, and the FHR characteristics that should be observed. Four of the included studies, comprising 8436 women and their babies, were randomised controlled trials that evaluated the effect of IA with a Doppler device vs. a Pinard device. Abnormal FHRs were detected more often using the Doppler device than in those using the Pinard device (risk ratio 1.77; 95% confidence interval 1.29-2.43). There were no significant differences in any of the other maternal or neonatal outcomes. Four studies assessed the accuracy of IA findings. Normal FHR was easiest to identify correctly, whereas identifying periodic FHR patterns such as decelerations and saltatory patterns were more difficult.ConclusionAlthough IA is the recommended method, no trials have been published that evaluate protocols on how to perform it. Nor has any study assessed interrater agreements regarding interpretations of IA findings, and few have assessed to what degree clinicians can describe FHR patterns detected by IA. We found no evidence to recommend Doppler device instead of the Pinard for IA, or vice versa.

Project description:Although being the golden standard for intrapartum fetal surveillance, cardiotocography (CTG) has been shown to have poor specificity for detecting fetal acidosis. Non-invasive near-infrared-spectroscopy (NIRS) monitoring of placental oxygenation during labour has not been studied yet. The objective of the study was to determine whether changes in placental NIRS values during labour could identify intrapartum fetal hypoxia and resulting acidosis. We included 43 healthy women in active stage of labour at term. CTG and NIRS parameters in groups with vs. without neonatal umbilical artery pH ? 7.20 were compared using Mann-Whitney-U. Receiver-operating-characteristics (ROC) curves were used to estimate predictive value of CTG and NIRS parameters for neonatal pH ? 7.20. A computer-based statistical classification was also performed to further evaluate predictive values of CTG and NIRS for neonatal acidosis. Ten (23%) neonates were born with umbilical artery pH ? 7.20. Compared to group with pH > 7.20, fetal acidosis was associated with more episodes of placental NIRS deoxygenation (9 (range 2-37) vs. 2 (range 0-65); p<0.001), higher velocity of placental NIRS deoxygenation (2.31 (range 0-22) vs. 1 (range 0-49) %/s; p = 0.03), more decelerations on CTG (25 (range 3-91) vs. 10 (range 10-60); p = 0.02), and more prolonged decelerations on CTG (2 (range 0-4) vs. 1 (range 0-3); p = 0.04). Number of placental deoxygenations had the highest prognostic value for fetal/neonatal acidosis (area under the ROC curve 0.85 (95% confidence interval 0.70-0.99). Computer-based classification also identified number of placental deoxygenations as the most accurate classifier, with 25% false positive and 93% true positive rate in the training dataset, with 100% accuracy when applied to the testing dataset. Placental deoxygenations during labour measured by NIRS are associated with fetal/neonatal acidosis. Predictive value of placental NIRS for neonatal acidosis was superior to that of CTG.

Project description:BackgroundDespite medical advances, major surgery remains high risk with up to 44% of patients experiencing postoperative complications. Early recognition of postoperative complications is crucial in reducing morbidity and preventing long-term disability. The current standard of care is intermittent manual vital signs monitoring, but new wearable remote monitors offer the benefits of continuous vital signs monitoring without limiting the patient's mobility. The aim of this study was to evaluate the feasibility, acceptability and clinical outcomes of continuous remote monitoring after major surgery.MethodsThe study was a randomised, controlled, unblinded, parallel group, feasibility trial. Adult patients undergoing elective major surgery were randomly assigned to receive continuous remote monitoring and normal National Early Warning Score (NEWS) monitoring (intervention group) or normal NEWS monitoring alone (control group). Continuous remote monitoring was achieved using the SensiumVitals® wireless patch which is worn on the patient's chest and monitors heart rate, respiratory rate and temperature continuously, and alerts the nurse when there is deviation from pre-set physiological norms. Feasibility was assessed by evaluating recruitment rate, adherence to protocol and randomisation and the amount of missing data. Clinical outcomes included time to antibiotics in cases of sepsis, length of hospital stay, number of critical care admissions and rate of hospital readmission within 30 days of discharge.ResultsOne hundred and thirty-six patients were randomised between October 2018 and April 2019: 67 to the control group and 69 to the intervention group. Recruitment was completed prior to the 12 month target with a high rate of eligibility and consent. Missing data was limited only to questionnaire responses; no participants were lost to follow-up and only one participant was withdrawn due to loss of capacity. The number of patients classed as 'drop-out' due to design (8.1%) were less than anticipated, and there were no participants who crossed over into the alternative trial allocation group. Seventeen participants in the intervention group (28%) did not adhere to the monitoring protocol. No formal comparisons between arms was undertaken; however, participants had fewer unplanned critical care admissions (1 versus 5) and had a shorter average length of hospital stay (11.6 days (95% confidence interval 9.5-13.7 days) versus 16.2 days (95% confidence interval 11.3-21.2 days)) in the continuous vital signs monitoring group. The time taken to receive antibiotics in cases of sepsis was similar in both arms. A cost-utility analysis indicated that the remote monitoring system was cost-saving when compared to standard NEWS monitoring alone.ConclusionsIt is feasible to perform a large-scale randomised controlled trial of continuous remote monitoring after major surgery. Progression to a definitive multicentre randomised controlled trial would be appropriate, taking consideration of factors, such as patient adherence, that might mask the potential benefit of additional monitoring.Trial registrationISRCTN registry with study ID ISRCTN16601772 . Registered 30 August 2017.

Project description:One dimensional Doppler Ultrasound (DUS) is a low cost method for fetal auscultation. However, accuracy of any metrics derived from the DUS signals depends on their quality, which relies heavily on operator skills. In low resource settings, where skill levels are sparse, it is important for the device to provide real time signal quality feedback to allow the re-recording of data. Retrospectively, signal quality assessment can help remove low quality recordings when processing large amounts of data. To this end, we proposed a novel template-based method, to assess DUS signal quality. Data used in this study were collected from 17 pregnant women using a low-cost transducer connected to a smart phone. Recordings were split into 1990 segments of 3.75 s duration, and hand labeled for quality by three independent annotators. The proposed template-based method uses Empirical Mode Decomposition (EMD) to allow detection of the fetal heart beats and segmentation into short, time-aligned temporal windows. Templates were derived for each 15 s window of the recordings. The DUS signal quality index (SQI) was calculated by correlating the segments in each window with the corresponding running template using four different pre-processing steps: (i) no additional preprocessing, (ii) linear resampling of each beat, (iii) dynamic time warping (DTW) of each beat and (iv) weighted DTW of each beat. The template-based SQIs were combined with additional features based on sample entropy and power spectral density. To assess the performance of the method, the dataset was split into training and test subsets. The training set was used to obtain the best combination of features for predicting the DUS quality using cross validation, and the test set was used to estimate the classification accuracy using bootstrap resampling. A median out of sample classification accuracy on the test set of 85.8% was found using three features; template-based SQI, sample entropy and the relative power in the 160 to 660 Hz range. The results suggest that the new automated method can reliably assess the DUS quality, thereby helping users to consistently record DUS signals with acceptable quality for fetal monitoring.

Dataset Information

Use of wind-up fetal Doppler versus Pinard for fetal heart rate intermittent monitoring in labour: a randomised clinical trial.

Objectives

Design

Setting

Participants

Intervention

Primary outcome measures

Results

Conclusions

Trial registration number

Publications

Use of wind-up fetal Doppler versus Pinard for fetal heart rate intermittent monitoring in labour: a randomised clinical trial.

Similar Datasets

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