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A comparative evaluation of Electronic fetal monitoring vs intermittent auscultation after an initial screening admission test Dr Neeru Talwar, Dr Chitra

Raghunandan Lady Hardinge Medical College and associated hospitals ABSTRACT Aims and objectives: 1. To perform an Admission test in early labour to identify patients who are at risk of developing intrapartum fetal hypoxia in low and high risk pregnancy.2.To study in these patients at risk the benefits and risks associated with electronic fetal monitoring as compared to intensive intermittent auscultation. Material and methods 213 patients.were subjected to electronic fetal monitoring for 20 minutes using electronic cardiotocographic machine at admission in early labor. Patients with abnormal(equivocal and ominous admission test) were randomly divided into two groups. Group I were monitored with intensive intermittent auscultation with stethoscope and group II with continuous electronic fetal monitoring. The detection of intra partum fetal hypoxia was comparatively evaluated in the two groups. Results 13% of low risk pregnancies showed an abnormal admission test and thus became high risk in labor. No significant difference was found in the perinatal morbidity and mortality in the two groups. Although Operative intervention for fetal distress was marginally higher in electronic fetal monitoring group but it was not a statistically significant difference. Conclusion An admission test followed by intermittent auscultation with stethoscope during and after uterine contractions should be the mainstay of fetal monitoring in labor and is the best way of using the limited number of fetal monitors available in developing countries with economic constraints.

FULL TEXT Introduction Fetal evaluation in the intrapartum period is increasing in our quest to improve perinatal morbidity and mortality rates. Currently routine electronic fetal monitoring in labor has become an established obstetric practice in the western world and is being used in 3 out of every 4 labor patients in the USA (Thacker et al 1995). It is presumed to be a superior method of screening for fetal hypoxia as it detects subtle changes in the fetal heart, which can be missed on auscultation. It has been found that under clinical conditions, the overwhelming majority of compromised fetuses will reflect their status during labor by some abnormality in the FHR pattern Assessment of possible benefits of continuos electronic fetal monitoring is pertinent since this technique requires capital expenditure, educational programs for its correct interpretation and decision making and increased patient surveillence (Neafe 96). In countries like India, where only a few cardiotocography machines are available even in the tertiary level hospitals, it is imperative to select patients who require intensive intrapartum fetal surveillance and also to study the benefits if any of continuos electronic fetal monitoring over intensive intermittent auscultation with stethoscope during labor.. Fetal heart rate (FHR) changes and fetal acidosis may occur in the low as well as in the high-risk pregnancies. So it is imperative to select fetuses at risk of developing fetal distress for intensive intrapartum monitoring not only from the high risk but also in the low risk pregnancies. Hence some form of risk assessment at the beginning of labor or an ADMISSION TEST might detect intrauterine fetal hypoxia already present at admission and might have some predictive value for fetal hypoxia that may develop in

labor. The admission test is a screening test for detecting patients at risk of developing intra partum fetal hypoxia.It is a short 20 minutes external electronic recording of the fetal heart and uterine contractions on the electronic cardiotocography machine at admission in labor (Ingemarsson et al al 1993) To meet the optimal utilization of the few cardiotocography monitors available, we performed an admission test and endeavored to find out if after an initial 20 min. electronic recording of the fetal heart, auscultation could be substituted for electronic fetal monitoring for intrapartum fetal surveillance even in the high risk group. Since continous electronic fetal monitoring (EFM) requires massive capital expenditures, technical expertise and teaching programmes , it was endeavoured to find the difference in perinatal morbidity and mortality and operative intervention for fetal distress rates in patients in labor undergoing fetal surveillance with continous EFM or intermittent auscultation of fetal heart. Aims and objectives: 1. To perform an Admission test in early labour to identify patients who are at risk of developing intrapartum fetal hypoxia in low and high risk pregnancy. 2.To study in these patients at risk the benefits and risks associated with electronic fetal monitoring as compared to intensive intermittent auscultation. Material and methods 213 patients were subjected to electronic fetal at monitoring for 20 minutes using electronic cardiotocographic machine

admission in early labor in the main labor room of our Smt. Sucheta Kriplani H o s p i t a l . The study population consisted of 108 cases of low risk and 105 cases of high-risk pregnancy. The high risk pregnancies included PIH (BP >140/90 at admission with or without Proteinurea and Edema), Prolonged pregnancy (40-42 weeks) and Unexplained Intra- uterine growth retardation (IUGR) All the patients included in the study were Primigravidas, between 20 to 30 years of age, with gestational age between 37 to 42 weeks and with Cephalic presentation. Patients with complications -Ante partum hemorrhage, previous bad obstetric history, Malpresentations, Premature rupture of membranes, Multiple pregnancy, Rh negative pregnancy, Diabetes Mellitus, Hypertension, Heart disease, Moderate or severe anemia, UTI, and Collagen Vascular disease were excluded from the study.

All the patients were subjected to a detailed history, physical examination and routine investigations. All patients were subjected to an Admission Test - a 20 minutes recording of fetal heart and uterine contractions using electronic cardiotocographic machine (Hewlett Packard 50 A series[M 1351 A]) at admission in labor.
Interpretation of the Admission Test i. Reactive /Normal Presence of at least 2 accelerations greater than 15 beats lasting for more than 15

seconds in 20 minutes, Baseline heart rate between 110 to 160 beats per minute, Baseline variability between 10 to 25 beats per minute, Absence of any deceleration. ii. Equivocal / Suspicious. Normal baseline rate with no accelerations in 20 minutes and reduced baseline variability (5-10 beats / minute), Abnormal baseline rate ( more than 160 beats per minute) with no acceleration, Variable deceleration < 60 beats per minute for < 60 seconds.

iii.

Ominous. Baseline variability of < 5 beats per minute and abnormal base line rate,. Repeated late

decelerations,Variable decelerations with any one of the following ominous signs : duration > 60 secs and decelerating > 60 beats per minute from the baseline FHR ,rebound tachycardia, slow recovery, reduced variability between decelerations, late component. Patients with abnormal(equivocal and ominous admission test) were randomly divided into two groups.: GroupI subjected to intra partum fetal surveillance by intensive intermittent auscultation with stethoscope. GroupII subjected to intra partum fetal surveillance by continous electronic fetal monitoring. Intermittent auscultation of the fetal heart was performed during and 30 seconds after contractions in accordance with ACOG recommendations, which are as follows: Stage of labor First stage of labor Second stage of labor High risk patients Every 15 minutes Every 5 minutes

The details of progress of labor were recorded. The mode of delivery whether spontaneous vaginal or any operative intervention - LSCS , forceps or vacuum and the indication for its use was noted. The condition of the neo nate at birth was recorded in detail. Any need for resuscitation endotracheal suction, oxygen, Bag &mask ventilation, intubation and intermittent positive pressure ventilation was taken note of . Admission to neonatal nursery or neonatal intensive care unit , indication for admission, duration of stay and condition at discharge were also recorded. The data was computerized. Statistical analysis of the observations and the results of the above study was carried out using the two standard test of significance in order to find if the results of the study were statistically significant. Continuos data such as age, height, weight etc. were compared by students t-test. Categorical data such as FHR pattern, type of delivery etc were compared with Chi-square test. OBSERVATIONS AND RESULTS TABLE I. THE RESULT OF THE ADMISSION TEST IN THE STUDY POPULATION Reactive Equivocal Ominous Total No. 171 25 17 42 % 80.28 11.73 7.98 19.72 171 patients (80.28%) who had a reactive admission test were considered low risk for development of intrapartum fetal asphyxia. 42 patients who had an abnormal(equivocal and ominous )admission test were considered high risk. TABLE II . INDICATORS OF INTRAPARTUM FETAL HYPOXIA IN THE TWO GROUPS

Sno 1 2 3 4

Parameter Abnormal FHR pattern in 1st stage Abnormal FHR pattern in 2nd stage MSL Abnormal FHR pattern & MSL

Group I IIA No % (n=21) 6 3 12 5 28.57 14.28 57.14 23.80

Group II Continous EFM No % 12 5 9 6 (n=21) 57.14 23.80 42.86 42.86

Statistical analysis 0.06 0.43 0.35 0.91

The detection of abnormal FHR pattern in the first stage was higher in the EFM group 12 (57.14%) as compared to the IIA group 6 (28.57%), the difference almost reaching statistical significance (p=0.06).
TABLE III. MODE OF DELIVERY IN THE TWO GROUPS

Mode of delivery

Group I (n=21) IIA No 9 3 8 3 3 0 9 9 0 21

Group II (n=21) Continous EFM No % 6 28.57 1 4.76 5 23.80 4 19.05 4 19.05 0 0.00 11 52.38 11 52.38 0 0.00 21

Statistical Analysis

Spontaneous Fetal distress No fetal distress Forceps & Vacuum Fetal Distress Other indications Cesarean Section Fetal distress Other indicators Total (N) (%)

% 42.86 14.28 38.10 14.28 14.28 0.00 42.86 47.62 0.00

P=0.34 P=0.29 P=0.31 P=0.67 P=0.67 P=0.54 P=0.54

Operative vaginal delivery for the indication of fetal distress was used in 3 (14.28%) cases in intensive intermittent auscultation group and in 4 (19.05%) cases in the continuos electronic fetal monitoring group.Cesarean section for the indication of fetal distress was performed in 9 (47.62%) cases in the intensive intermittent auscultation group 11 (52.38%) cases in the continuos electronic fetal monitoring group.

TABLE IV. PERINATAL OUTCOME IN THE GROUPS I AND II. Sr No Parameter Group I (n=21) IIA % Group II (n=21) Continous EFM No % Statistical analysis

No 1 Apgar Score <7 a - at 1 m 6

28.57

19.04

P=0.12

b - at 5 m

9.52

0.00

P=0.15

Resuscitation a)Endotracheal suction b)Oxygen c)Bag & Mask d)Intubation & IPPV e)cardiac message Perinatal death a-Asphyxia b- Other causes Perinatal Morbidity due to birth Aspyxia a) MAS 2 1 9.52 0.91 2 0 9.52 0.00 P=1.0 P=0.31 b) Neneonatal seizures Admission to nursery/NICU a-asphxia b-other causes 5 0 23.81 0.00 23.81 42.86 47.62 0 71.43 3 0 3 6 8 0 11 14.29 0.00 14.29 28.57 38.10 0 52.38 0.43 0.34 0.53 1.0 0.20 0.43 12 8 3 4 1 1 0 57.14 38.10 14.28 19.05 4.76 0.91 0.00 9 5 3 1 0 1 0 42.86 23.80 14.28 4.76 0 0.91 0.00 P=1.0 P=0.35 P=0.32 P=1.0 P=0.15 P=0.31

Cord blood (venous) PH <7.20 Base excess >8 Bicarbonate <19 PO2 <22 PCO2 >40 5 9 10 0 15

There was no statistically significant difference in the perinatal outcome in the intensive intermittent auscultation and the continuos electronic fetal monitoring groups as shown in the table IV. Discussion Electronic fetal monitoring , brought hope that there could be a way of detecting, in utero, an already compromised fetus, as well as a fetus in the process of deterioration during labor and delivery. Presumed to be a superior method of screening for fetal asphyxia as compared with intensive intermittent auscultation, electronic fetal monitoring provided continuos data with written documentation on the fetal response to labor and was considered especially helpful in the management of labor with attendant risk factors. Miller et al (1984) asked experienced labor and delivery physicians to ascertain the presence of decelerations and other features of the fetal heart rate pattern from the fetal heart beats recorded on tape. Not only were these clinicians unable to reliably identify certain obvious decelartions or features of

baseline rate and variabilty, they could not match auscultatory findings with simultaneous electronic fetal monitoring tracings. Inspite of the several limitations of auscultation, the results of several recent clinical trials of electronic fetal monitoring purportedly support the notion that auscultation is comparable to electronic fetal monitoring (McDonald ,1985, Luthy,1987). On the basis of these Randomized clinical trials the guidelines for perinatal care published by the ACOG and the American Academy of Paediatrics 1992 permit auscultation without electronic fetal monitoring backup, for evaluation of fetal well being during labor, irrespective of the risk status of the mother or fetus. To meet the optimal utilization of the few cardiotocography monitors available, we performed an admission test and endeavored to find out if after an initial 20 min. electronic recording of the fetal heart, auscultation could be substituted for electronic fetal monitoring for intrapartum fetal surveillance even in the high risk group. In the present prospective study 213 patients both low risk(108) and high risk(105) were subjected to an admission test. In a previous study by Hobel et al in 1973, it has been estimated that upto 20% of low risk pregnancies become high risk in labor, some of them probably being missed as high pregnancies.In the present study the corresponding incidence was 13%. We identified 12 Radomized control trials that addressed the safety of electronic fetal monitoring . Nine of the 12 randomized control trials addressed the comparitive efficacy of continuos electronic fetal monitoring and auscultations are summarized in tableVI. Our study population had patients from both high and low risk pregnancies who showed an equivocal or ominuos admission test result. In randomized control trial by Renou et al 1976, Haverkammp AD et al al 1976, Luthy DA et al 1987, high risk pregnancies were studied. Kelso et al 1978, Wood et al 1981, Herbst et al 1994 included only low risk pregnancies in their study. Fetal scalp blood Sampling as a backup method and / or patient crossover from one group to other was used in studies by Renou et al 1976, Haverkamp et al 1979, Wood C et al 1981, Neldam S et al, MacDonald et al 1985, Luthy DA et al , Herbst A et al 1994. In this study the use of Fetal scalp blood Sampling or patient crossover was not permitted. A higher number of patients in the electronic fetal monitoring group showed abnormal fetal heart rate pattern in the first and second stage - 12 (57.14%) and 6 (28.57%) respectively as against 6 (28.57%) and 3 (14.28%) in the intensive intermittent auscultation group respectively. The difference in the abnormal FHR pattern detection in first stage almost reached statistical significance (P=0.06 respectively). This may have been because electronic fetal monitoring can detect subtle abnormalities in fetal heart pattern, which are missed by auscultation. (Schifrin et al 1994). The presence of non reassuring FHR patterns was higher in the EFM group in other studies: 23.4% in EFM versus 10.7% in IA group (Vintzileous et al 1993), 5.9% in EFM versus 1.1% in IA group (Mcdonald et al 1985). However in the trial by HaverKamp et al 1976 this finding was not observed. However, frequency of meconium stained liquor was higher in the intensive intermittent auscultation

group, 12(57.14%) as compared to 9(42.86%) in the electronic fetal monitoring group although the difference was not statistically significant (P=0.35). Incidence of meconium in the Dublin trial was 11.3 % in the IA group compared to 10% in the EFM group. The incidence of meconium in the Athens trial was 12.3% in IA and 15% in the EFM group. Miller et al 1975 and Steer et al 1989 concluded that the presence of meconium is associated with a higher chance of baby being born acidotic and asphyxiated. It has been seen in a number of studies that when the fetal heart rate pattern was normal, there was no difference in scalp and cord blood pH or neonatal outcome between fetuses who had or had not passed mecnium (Miller et al 1975, Shaw et al 1988, Baker et al 1992). There was no statistically significant difference in the intensive intermittent auscultation and electronic fetal monitoring group as regards to presence of MSL and abnormal fetal heart rate pattern in our study (P=0.91). Vintzileus et al 1995 reported that cesarean section rate for suspected fetal distress was increased in the electronic fetal monitoring group in four of the nine trials (Haverkamp 76, Haven 79, Mcdonald 1985, Vintzileos 1993) but not in other randomized control trials. In our study the incidence of cesarean section for fetal disterss was higher in EFM (52.38%) as compared to IA (42.86%) group. The difference was not statistically significant. In the above 4 trials the incidence of operative vaginal delivery was also higher in the EFM group as compared to IA group. In our study rate of forceps in the EFM group was 19.055 versus 14.28% in IA group but difference was not statistically significant. Thacker et al 1995 in their meta analysis of randomized control trial summarized the outcome of published randomized control trial. Eight randomized control trials reported 1 minute Apgar score less than 7. Electronic fetal monitoring showed no beneficial effect overall . In our study, Apgar score was less than 7 at 1 min is 6 (28.57%) and 4 (19.04%) patients in the intensive intermittent auscultation and electronic fetal monitoring groups respectively but the difference was not statistically significant. In the 7 studies that reported 1 minute apgar score less than 4 electronic fetal monitoring showed a slight protective effect overall. In our study 1 minute apgar score < 4 was seen in 1 new born in the intensive intermittent auscultation and none in the electronic fetal monitoring group. This difference was not statistically significant. Neutra et al 1981 studied the relationship between electronic fetal heart monitoring and the Apgar score and found that simple comparison of Apgar scores in monitored and unmonitored babies showed no difference at 5 minutes. When they controlled for gestational age and other potential confounders, a different pattern emerged. In a group of obviously high-risk pregnancies, monitored babies had a more favorable distribution of 5-minute Apgar scores (3.8% instead of 7.2% with a score below 6, P = 0.020). The only case of neonatal seizures in our study was in the IA group but the difference was not statistically significant. The study by Renon et al 1976 found a 2.3% incidence of neonatal seizures in the IA group compared to none in the EFM group. They reported that EFM is associated with improved neurological outcome.

Electronic fetal monitoring was associated with a reduction in the rate of neonatal seizures which is especially significant in the 1985 Dublin trial. However, the long time impact of this effect is less clear. The only two follow up studies (Grant A 1987, Shy et al al 1990) have indicated that the long term neurologic effects of these seizures have been minimal. However , Pancta et al 1993 pointed out that none of these studies had the power to determine whether infant brain damage was avertable. Unfortunately, we have yet to determine how many infants are injured during or before labour and what role if any, electronic fetal monitoring or intervention plays in detection and prevention of injury. In our study 4(19.05) infants in the IA group and 1(0.91%) babies in IA and EFM group respectievely required intubation and IPPV.but difference was not statistically significant (p=0.15). NICU admissions for birth asphyxia were 5 (23.81%) I intensive intermittent auscultation group and 3 (14.29%) in the electronic fetal monitoring group (p=0.43). Meta analysis from the nine randomized control trials (Thacker et al al 1995, Vintzilios at al 1995) showed no beneficial effect on electronic fetal monitoring with regards to need for IPPV or NICU admissions in any of these trials. In our study, cord blood analysis showed no statistically significant increase in the incidence of acidemia in the electronic fetal monitoring group (14.28%) versus intensive intermittent auscultation group (23.81%). In their study Vintzileos et al al 1993 found a decreased perinatal mortality in the electronic fetal monitoring group. Other randomized control trials did not have any such finding. In our study on Perinatal mortality, only two perinatal deaths occurred 0ne each in both the groups. There were no stillbirths in our study and both the perinaal deaths were early neonatal deaths. Page et al 1985 and Low et al 1981 found that 44% and 48% cases of high risk pregnancies with abnormal fetal tracings showed fetal metabolic acidosis. In our study, a total of 8 (19.05%) cases with high risk admission test (Equivocal and Ominous) showed umblical cord (venous) acidemia at birth. All of them showed metabolic acidosis. MSL was present in 5 (62.5%) of babies with acidemia. Operative intervention for fetal distress (cesarean section or forceps) was required in all these cases. 6 (75%) of these babies required admission to Nursery/NICU for birth asphyxia The correlation of acidemia with 1 min apgar score was excellent in all the patients with acidemia having 1 minute apgar score less than 7. 2 (25%) patients had Apgar Score less than 7at 5 minutes. Page et al 1985 found that 75% of infants with significant acidosis had an apgar score less than 7.Birth asphyxia is a relatively rare cause of major neurologic morbidity in children despite the fact that it is the most commonly alleged cause in the courtroom. Recent studies estimate that less than 8% of cerebral palsy in children is actually related to birth asphyxia. New born depression is not a specific indicator of birth asphyxia. It is generally agreed that umblical cord blood acidemia is the most sensitive indicator of birth asphyxia at the time of delivery. Most authorities agree that it is extremely important to obtain umblical cord blood pH samples in the presence of new born depression since it will rule out birth asphyxia in approximately 80%

of cases. However the value of umblical cord blood PH and gas measurement in the vigorous new born is not clearly established (Thorp et al 1989) Conclusion An admission test followed by intermittent auscultation with stethoscope during and after uterine contractions should be the mainstay of fetal monitoring in labor and is the best way of using the limited number of fetal monitors available in developing countries with economic constraints.

The false-positive rate of electronic fetal monitoring (EFM) for predicting adverse outcomes is high. The use of EFM is associated with an increase in the rate of operative interventions (vacuum, forceps, and cesarean delivery). The use of EFM does not result in a reduction of cerebral palsy rates. With persistent variable decelerations, amnioinfusion reduces the need to proceed with emergent cesarean delivery and should be considered.

The following recommendations are based on limited or inconsistent scientific evidence (Level B):

The labor of parturients with high-risk conditions should be monitored continuously. Reinterpretation of the fetal heart rate (FHR) tracing, especially knowing the neonatal outcome, is not reliable. The use of fetal pulse oximetry in clinical practice cannot be supported at this time.