Intrapartum fetal scalp lactate sampling for fetal assessment in the presence of a non-reassuring fetal heart rate trace.

BACKGROUND Fetal scalp blood sampling for lactate estimation may be considered following identification of an abnormal or non-reassuring fetal heart rate pattern. The smaller volume of blood required for this test, compared with the more traditional pH estimation, may improve sampling rates. The appropriate use of this practice mandates systematic review of its safety and clinical effectiveness prior to widespread introduction. OBJECTIVES To evaluate the effectiveness and risks of fetal scalp lactate sampling in the assessment of fetal well-being during labour, compared with no testing or alternative testing. SEARCH METHODS We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 January 2015). SELECTION CRITERIA All published and unpublished randomised and quasi-randomised trials that compared fetal scalp lactate testing with no testing or alternative testing to evaluate fetal status in the presence of a non-reassuring cardiotocograph during labour. DATA COLLECTION AND ANALYSIS We used the standard methodological procedures of the Cochrane Pregnancy and Childbirth Group. Two review authors independently assessed the studies. MAIN RESULTS The search identified two completed randomised controlled trials (RCTs) and two ongoing trials. The two published RCTs considered outcomes for 3348 mother-baby pairs allocated to either lactate or pH estimation of fetal blood samples when clinically indicated in labour. Overall, the published RCTs were of low or unclear risk of bias. There was a high risk of performance bias, because it would not have been feasible to blind clinicians or participants.No statistically significant between-group differences were found for neonatal encephalopathy (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.32 to 3.09, one study, 2992 infants) or death. No studies reported neonatal seizures. We had planned to report death with other morbidities, for example, neonatal encephalopathy; however, the data were not available in a format suitable for this, therefore death due to congenital abnormality was considered alone. The three reported neonatal deaths occurred in babies with diaphragmatic hernias (n = 2) or congenital cardiac fibrosis (n = 1). All three babies had been randomised to the pH group and were not acidaemic at birth.There were no statistically significant differences for any of the pre-specified secondary fetal/neonatal/infant outcomes for which data were available. This included low Apgar score at five minutes (RR 1.13, 95% CI 0.76 to 1.68, two studies, 3319 infants) and admission to neonatal intensive care units (RR 1.02, 95% CI 0.83 to 1.25, one study, 2992 infants), or metabolic acidaemia (RR 0.91, 95% CI 0.60 to 1.36, one study, 2675 infants) considered within the studies, either overall or where data were available for those where fetal blood sampling had occurred within 60 minutes of delivery.Similar proportions of fetuses underwent additional tests to further evaluate well-being during labour, including scalp pH if in the lactate group or scalp lactate if in the pH group (RR 0.22, 95% CI 0.04 to 1.30, two studies, 3333 infants;Tau² 1.00, I² = 58%). Fetal blood sampling attempts for lactate and pH estimation were successful in 98.7% and 79.4% of procedures respectively in the one study that reported this outcome.There were no significant between-group differences in mode of birth or operative birth for non-reassuring fetal status, either for all women, or within the group where the fetal blood sample had been taken within 60 minutes of delivery (for example, caesarean section for all enrolled, RR 1.09, 95% CI 0.97 to 1.22, two studies, 3319 women; operative delivery for non-reassuring fetal status for all enrolled RR 1.02, 95% CI 0.93 to 1.11, one study, 2992 women).Neither study reported on adverse effects of fetal scalp lacerations or maternal anxiety. AUTHORS' CONCLUSIONS When further testing to assess fetal well-being in labour is indicated, fetal scalp blood lactate estimation is more likely to be successfully undertaken than pH estimation. Further studies may consider subgroup analysis by gestational age, the stage of labour and sampling within a prolonged second stage of labour. Additionally, we await the findings from the ongoing studies that compare allocation to no fetal blood sample with sampling for lactate and address longer-term neonatal outcomes, maternal satisfaction with intrapartum fetal monitoring and an economic analysis.

[1]  P. Reif,et al.  Validation of a point-of-care (POC) lactate testing device for fetal scalp blood sampling during labor: clinical considerations, practicalities and realities , 2014, Clinical chemistry and laboratory medicine.

[2]  Gynecologists ACOG Committee Opinion. Number 326, December 2005. Inappropriate use of the terms fetal distress and birth asphyxia. , 2005, Obstetrics and gynecology.

[3]  J. Dudenhausen,et al.  Predictive value of pulse oximetry for the development of fetal acidosis , 2010, Journal of perinatal medicine.

[4]  D. Young,et al.  Fetal health surveillance: antepartum and intrapartum consensus guideline. , 2007, Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC.

[5]  The Predictive Value of Abnormal Fetal Heart Rate Patterns in Early Labour , 1993, The Australian & New Zealand journal of obstetrics & gynaecology.

[6]  S J Payne,et al.  Phase‐rectified signal averaging for intrapartum electronic fetal heart rate monitoring is related to acidaemia at birth , 2014, BJOG : an international journal of obstetrics and gynaecology.

[7]  C. East,et al.  Fetal pulse oximetry for fetal assessment in labour. , 2014, The Cochrane database of systematic reviews.

[8]  G. Bogdanovic,et al.  Cardiotocography in the Prognosis of Perinatal Outcome , 2014, Medical archives.

[9]  Byerich Saling,et al.  BIOCHEMICAL SUPERVISION OF THE FOETUS DURING LABOUR , 1967, The Journal of obstetrics and gynaecology of the British Commonwealth.

[10]  Douglas G. Altman,et al.  Systematic Reviews in Health Care: Meta-Analysis in Context: Second Edition , 2008 .

[11]  Comparing fetal scalp lactate and umbilical cord arterial blood gas values , 2014, The Australian & New Zealand journal of obstetrics & gynaecology.

[12]  Omid Azizi Farzan Modarresi,et al.  Published by John Wiley & Sons Ltd , 2015 .

[13]  F. Borruto,et al.  Prevention of cerebral palsy during labour: role of foetal lactate , 2008, Archives of Gynecology and Obstetrics.

[14]  F. Sharp,et al.  Fetal scalp blood lactate as an indicator of intrapartum hypoxia , 1983, British journal of obstetrics and gynaecology.

[15]  M Westgren,et al.  Role of lactate measurements during labor. , 1999, Obstetrical & gynecological survey.

[16]  I. Ingemarsson,et al.  Scalp blood lactate: a new test strip method for monitoring fetal wellbeing in labour , 1995, British journal of obstetrics and gynaecology.

[17]  George A. Macones,et al.  Intrapartum fetal heart rate monitoring: nomenclature, interpretation, and general management principles , 2009 .

[18]  B Hallberg,et al.  Predictive value of fetal scalp blood lactate concentration and pH as markers of neurologic disability. , 1999, American journal of obstetrics and gynecology.

[19]  J. Neilson Fetal electrocardiogram (ECG) for fetal monitoring during labour. , 2012, The Cochrane database of systematic reviews.

[20]  A. Herbst,et al.  Lactate concentration in umbilical cord blood is gestational age‐dependent: a population‐based study of 17 867 newborns , 2008, BJOG : an international journal of obstetrics and gynaecology.

[21]  A. Pachydakis,et al.  Persistent scalp bleeding due to fetal coagulopathy following fetal blood sampling , 2006, International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics.

[22]  Z. Alfirevic,et al.  Continuous cardiotocography (CTG) as a form of electronic fetal monitoring (EFM) for fetal assessment during labour. , 2017, The Cochrane database of systematic reviews.

[23]  C. East,et al.  Women's evaluations of their experience in a multicenter randomized controlled trial of intrapartum fetal pulse oximetry (The FOREMOST Trial). , 2006 .

[24]  C. East,et al.  Vibroacoustic stimulation for fetal assessment in labour in the presence of a nonreassuring fetal heart rate trace. , 2013, The Cochrane database of systematic reviews.

[25]  A. Herbst,et al.  Determination of pH or lactate in fetal scalp blood in management of intrapartum fetal distress: randomised controlled multicentre trial , 2008, BMJ : British Medical Journal.

[26]  Douglas G. Altman,et al.  Statistical Methods for Examining Heterogeneity and Combining Results from Several Studies in Meta‐Analysis , 2008 .

[27]  A. Maclennan A template for defining a causal relation between acute intrapartum events and cerebral palsy: international consensus statement , 1999, BMJ.

[28]  R. Ramanah,et al.  Fetal Scalp Lactate Microsampling for Non-Reassuring Fetal Status during Labor: A Prospective Observational Study , 2009, Fetal Diagnosis and Therapy.

[29]  J. Orsonneau,et al.  Suitability of POC lactate methods for fetal and perinatal lactate testing: considerations for accuracy, specificity and decision making criteria , 2012, Clinical chemistry and laboratory medicine.

[30]  A. C. Primavesi ? Labor after Previous Cesarean: Influence of Prior Indication and Parity , 2000 .

[31]  Tiina Luukkaala,et al.  Intrapartum cardiotocography – the dilemma of interpretational variation , 2006, Journal of Perinatal Medicine.

[32]  W. Benitz Benefits of introducing universal umbilical cord blood gas and lactate analysis into an obstetric unit , 2011 .

[33]  U. Ungerstedt,et al.  Effect of Perinatal Asphyxia on Systemic and Intracerebral pH and Glycolysis Metabolism in the Rat , 1997, Experimental Neurology.

[34]  F. M. Wolf,et al.  Near-infrared spectroscopy for fetal assessment during labour. , 2000, The Cochrane database of systematic reviews.

[35]  P. Colditz,et al.  A cost‐effectiveness analysis of the intrapartum fetal pulse oximetry multicentre randomised controlled trial (the FOREMOST trial) , 2005, BJOG : an international journal of obstetrics and gynaecology.

[36]  N. Bashan,et al.  The effect of the duration of the second stage of labour on the acid‐base state of the fetus , 1987, British journal of obstetrics and gynaecology.

[37]  I. Ingemarsson,et al.  Lactate in fetal scalp blood and umbilical artery blood measured during normal labor with a test strip method , 1994, Acta obstetricia et gynecologica Scandinavica.

[38]  D. Sahota,et al.  Computerised analysis of the fetal heart rate and relation to acidaemia at delivery , 2001, BJOG : an international journal of obstetrics and gynaecology.

[39]  Determining the fetal scalp lactate level that indicates the need for intervention in labour , 2004, The Australian & New Zealand journal of obstetrics & gynaecology.

[40]  Lactate in Scalp and Cord Blood From Fetuses With Ominous Fetal Heart Rate Patterns , 1998, Obstetrics and gynecology.

[41]  D. Devane,et al.  Midwives' visual interpretation of intrapartum cardiotocographs: intra- and inter-observer agreement. , 2005, Journal of advanced nursing.

[42]  Fetal haemorrhage after fetal scalp blood sampling , 1990, The Lancet.

[43]  Intérêt de la mesure des lactates au scalp fœtal au cours du travail. Étude comparative avec le pH au scalp , 2005 .

[44]  C. East,et al.  The effect of intrapartum fetal pulse oximetry, in the presence of a nonreassuring fetal heart rate pattern, on operative delivery rates: a multicenter, randomized, controlled trial (the FOREMOST trial). , 2006, American journal of obstetrics and gynecology.

[45]  F. Mecacci,et al.  Comparison of five classification systems for interpreting electronic fetal monitoring in predicting neonatal status at birth , 2013, The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians.

[46]  H. Jordaan,et al.  Intrapartum fetal heart rate monitoring. III. Association of meconium with abnormal fetal heart rate patterns. , 1980, American journal of obstetrics and gynecology.

[47]  S. Arulkumaran,et al.  Quality assessment of two lactate test strip methods suitable for obstetric use , 1998, Journal of perinatal medicine.

[48]  B Persson,et al.  Lactate compared with pH analysis at fetal scalp blood sampling: a prospective randomised study , 1998, British journal of obstetrics and gynaecology.

[49]  J. Milley Uptake of exogenous substrates during hypoxia in fetal lambs. , 1988, The American journal of physiology.

[50]  S. Arulkumaran,et al.  Fetal and maternal lactate increase during active second stage of labour , 2001, BJOG : an international journal of obstetrics and gynaecology.

[51]  M. Morgan,et al.  Predictive factors for neonatal morbidity in neonates with an umbilical arterial cord pH less than 7.00. , 1997, American journal of obstetrics and gynecology.

[52]  C. East,et al.  Intrapartum fetal scalp lactate sampling for fetal assessment in the presence of a non-reassuring fetal heart rate trace. , 2010, The Cochrane database of systematic reviews.

[53]  G. Visser,et al.  Cerebrospinal Fluid Leakage, an Uncommon Complication of Fetal Blood Sampling: A Case Report and Review of the Literature , 2011, Obstetrical & gynecological survey.

[54]  A. Perales,et al.  Intrapartum fetal invasive procedures and perinatal transmission of HIV. , 1999, European journal of obstetrics, gynecology, and reproductive biology.

[55]  Outcome of severe intrapartum acidemia diagnosed with fetal scalp blood sampling , 2011, Journal of perinatal medicine.

[56]  S. Cnattingius,et al.  Cardiotocography patterns and risk of intrapartum fetal acidemia , 2015, Journal of perinatal medicine.