Who Is Prescribed Epidural Anesthesia - Research Proposal Example

Background: Pregnancy is a physiological process but in due of time it may change to a pathological situation when some complication arises. To be aware of the progress of pregnancy and to screen for some conditions so that a complicated scenario could be avoided, World Health Organization (WHO) has recommended at least four antenatal visits during which a pregnant woman should have a contact with some qualified health care provider in relevant speciality. Most of the time, in the UK, health care providers take more than required measures and implement interventions, which may not be needed at that time. To look for whether these interventions are implemented appropriately for low risk clients or more than the required level, we carried out a survey. Methodology: We carried out a cross-sectional survey in Great Britain during February 1993 through January 1994 with a sample size of 1490 pregnant women. Results: Seventy five percent women had normal uneventful delivery. Out of a range of interventions implemented during the management of labour, three interventions were strongly associated with low risk women as compared to high risk clients, these interventions are: episiotomy (aOR=24.93, 95%CI: 11.81-52.65), vaginal examination for 6-10 times (aOR= 3.85, 95% CI: 2.03-7.33) and pain relief at stage II (aOR=10.50, 95%: 6.34-17.38). Conclusions & Recommendations: In the UK, low risk pregnant women are aggressively managed with interventions, which may not be required at that time as compared to high-risk group. An index of required interventions and guidelines to follow should be developed to be used universally in the country. A good provider-client liaison with continuous link should be established. Provider should reassure their clients and use effective management to deal if complicated cases arise. PART 1 BACKGROUND LITERATURE REVIEW PART II RESEARCH METHODOLOGY A) RESEARCH DESIGN B) SAMPLING SIZE C) RECRUITMENT D) EXCLUSION CRITERIA E) TIME SCALE G) QUESTIONNAIRE DESIGN F) DATA ANALYSIS PART III DATA HANDLING AND DATA ENTRY ORIGINAL DATABASE +AMENDED DATABASE (CD ATTACHED) LABELLING THE DATABASE PART IV ANALYSIS OF DATA A) INTRODUCTION B) DESCRIPTIVE STATISTICS OF THE VARIABLE C) INTERVENTION: AUGMENTATION BY DRUGS D) INTERVENTION: EPISIOTOMY E) INTERVENTION: FETAL MONITORING STAGE-I F) INTERVENTION: FETAL MONITORING STAGE-II D) INTERVENTION: PAEDIATRICIAN D) INTERVENTION: FREQUENCY OF VAGINAL EXAMINATION RERFERANCE Background Literature Pregnancy is a physiological process but this physiological process may change to a pathological one at any time during the course of antenatal period. Although this sudden change to a pathological process is rare and is unpredictable. World Health Organization (WHO) recommends at least four antenatal visits over the course of whole pregnancy. (1) To be on the safe side, most of the obstetricians or other medical staff takes every effort to detect any minor chance of complication. In this effort these health professionals may go beyond normal or recommended frequency of some of the procedures or interventions at the time of delivery. In normal labor the package of routine care becomes very flexible one. These interventions depend upon the place of delivery; at home most of the time moral support and attachment are the major interventions while at a well-equipped health facility the staff utilizes more interventions in the management of any pregnant women. (2) In the UK, the routine practice at the time of delivery is carrying out various activities related to any task of maternal and fetal care. Usually, the intensity and frequency of these activities crosses any line or level recommended. Most of the time these activities are carried out without any supportive evidence and at times these may become dangerous instead of beneficial. Findings from the study carried out by Hofmeyr stressed on the inconclusive evidence of routine use of oxytocin, routine amniotomy, continuous electronic fetal heart rate, etc (2). Use of analgesia has got its own untoward effects. Epidural analgesia may convert the normal labor to a prolonged labor at one end; further, it may also increases the probability of performing other interventions, as they are needed due to the long duration of labor. So after getting epidural analgesia which results in prolonged labor eventually results in exhaustion on the side of the woman with weaker and infrequent labor pains fro which drugs for augmentation are required supported by episiotomy. (3) The frequency and types of interventions used during intrapartum period in the UK especially in low risk women has not been looked for and estimated. (4) There are strong recommendations not to overuse interventions when they are not indicated. (5) There is a common agreement of obstetricians and midwives that most of the obstetric interventions cannot be explained. (6) Therefore, as is well known that these interventions are at times dangerous especially when used in excess and at the same time the frequency of use of these interventions is not available. To get reliable information on the utilization of these interventions appropriately a study is proposed with a research question of are low risk women in normal labor receiving too many interventions Objectives To look for level of intrapartum interventions used in normal labor in the UK. Methodology Study design A cross sectional survey will be carried out to reach the objective of this study. Sampling frame A sampling frame of all the consultant maternity units in Great Britain was obtained from the annual returns to the Royal College of Obstetricians and Gynecologist (RCOG). This list contains the data, which is believed to be almost complete. Aim was to complete data collection in one year. The sampling frame captured 237 hospitals but the final number of hospital to be included in the study was 226. The hospitals with less than 1000 births per annum were excluded from the list. Sample size determination To get an appropriate number of women to capture all major interventions, a sample size of 4040 women was finalized. It was decided to collect information from 40 women from each hospital to complete the data collection in an appropriate time without putting extra burden on the hospitals. For this purpose, 101 hospitals were randomly selected from the sampling frame and from each hospital at least 40 consecutive cases of delivery were proposed to be selected for further work on data collection. (7) So there were total of 4040 (101*40=4040) pregnant women. Entry criteria All the pregnant women entered into the study at the onset of the labor if they were delivering in hospital after an uneventful antenatal periods, at 37>= weeks of pregnancy and with the fetal head presenting. Study Setting This study was carried out in maternity units in Great Britain. Study Period This study was conducted during February 1993 through January 1994 Data Collection and management To maintain the quality of data collection, the principal investigator checked completed questionnaires daily. Any missing and inconsistent information in the questionnaires or any other problem during the process of data collection was discussed with the data collectors and remediable solutions sought. Final editing was done after the completion of whole process of data collection. Statistical Analyses EPI INFO version 6.04 (8) was used for the double entry of the data from questionnaires and analysis was performed in SPSS software version 14.0 (9). Plan of analysis We took the variable of type of delivery with three categories as the main point of focus. We planned to look for the associated factors especially interventions with the normal delivery. For this purpose first we recoded the variable of type of delivery into dichotomous variable and ran the analysis. Table 1: Sociodemographic, personal and medical charateristics Variable Normal Delivery (1112) Frequency (%) Abnormal Delivery (378) Frequency (%) Age of Mother 16-19 years 20-24 years 25-29 years 30-34 years 193 (17.6) 356 (32.5) 374 (34.2) 172 (15.7) 43 (11.6) 90 (24.3) 156 (42.0) 82 (22.1) Gestational Age 37-37.9 weeks 38-38.9 weeks 39-39.9 weeks 40-40.9 weeks 41-41.9 weeks >= 42 weeks 59 (5.4) 115 (10.5) 275 (25.2) 451 (41.3) 178 (16.3) 15 (1.4) 8 (2.2) 31 (8.4) 79 (21.4) 149 (40.3) 88 (23.8) 15 (4.1) Family Type One parent Two parents 329 (29.9) 773 (70.1) 71 (19.0) 302 (81.0) Size of the Hospital < 3000 Deliveries >= 3000 Deliveries 728 (65.5) 384 (34.5) 224 (59.2) 154 (40.7) Type of Hospital Teaching Non-teaching 152 (13.7) 960 (86.3) 67 (17.7) 311 (82.3) Vaginal Examination 1-5 times 6-10 times Mean (SD) 1041 (93.6) 71 (6.4%) 3.11 1.44 262 (69.3) 116 (30.7) 4.83 1.83 Durationof 1st stage of labour Up to 8 hours 8-12 hours 12-16 hours > 16 hours 616 (55.4) 316 (28.4) 133 (12.0) 47 (4.2) 142 (37.6) 75 (19.8) 72 (19.0) 89 (23.5) Durationof 2nd stage of labour Up to 1 hour 1-3 hours 3-4 hours >4 hours 707 (63.6) 351 (31.6) 7 (0.6) 47 (4.2) 87 (23.0) 168 (44.4) 19 (5.0) 104 (27.5) Birth Weight of the Infant < 2000 grams >= 2500 grams 18 (2.1) 837 (97.9) 1 (0.3) 300 (99.0) Descriptive Analysis A total of 1490 pregnant women's information was collected around their delivery. Almost three fourths (1112) of these women delivered normally without any notable event while remaining (378) had some abnormality or an event present which resulted in some type of intervention to successfully deliver a baby (Table 1). Results show that in women who delivered normally, about 66% were in the middle age group of 20-29 years while both ends of the extremes were almost equally distributed with 16 % on both the ends. On the other hand, women who had eventful delivery had more representation on the older age group of 25-29 years where about two-fifths (42%) were accumulated. Although 25-29 years age group is not that much on extremes but the probability of complicated delivery increases if we move toward either of the extreme ends. While in both the groups gestational age varied to some extent among same categories except group of 40-40.9 weeks which reflected highest proportion of 40% and was similar on both the sides. Gestational age is also an indicator of normal delivery. As the gestational age crosses the full term mark the chances of ending up in any complication around delivery are increased many fold as the time passes. A similar situation was found in this study when about 10 % more women in abnormally delivered group were of equal to or more than 40 weeks of gestational age as compared to the women from the other group. Progress of labour can be assessed retrospectively through a review of the duration of first stage of labour, which may give some idea about the type of delivery. In our study, more than 80% of the deliveries were conducted with duration of first stage of labour being within 12 hours in normally delivered category while slightly more than half (56%) of the women passed through this duration to complete the process of delivery in abnormal delivery category. In abnormally delivered category, around one fifths (24%) of the women passed the first stage with duration of more than 16 hours. This delay in first stage reflects some elements of obstructed labour, which may end up in abnormally, delivered or assisted delivery and this has supported our results. Duration of the second stage of labour also provides some hints about the complexity of the case. Longer the duration more complex the case is! Again, table 1 shows that more than 95% of the women delivered their babies within 3 hours of the second stage of labour in normally delivered category while about two-thirds (68%) of the women delivered their babies during this time interval in the other group. Additionally, more than a quarter of women (28%) took more than 4 hours to deliver their babies in the abnormal delivery category in contrast to only 4 % women in the normally delivered category. More women were proportionately single who delivered normally (30%) as compared to those women whose delivery was eventful (19%). Difference between parentage reflected that those women who were single, majority of them delivered normally (30 vs. 19) while the situation is opposite on the other side; those women who represented two parents family, out of those women more deliveries conducted showed some type of event or abnormality. The distribution of type of delivery was not much different across the hospitals with different levels of turn over of clients as far as delivery services are concerned. Around two third of the women delivered with both normal or abnormal delivery circumstances were from the hospitals where the annual turn over was less than 3000 deliveries as compared to the other group which had similar distribution but with higher turn over. Similarly, the type of hospitals based on teaching and non-teaching criterion also did not show much difference of proportions of delivery in the two groups. There were 13 % normal deliveries and 17 % abnormal deliveries conducted in teaching hospitals and remaining proportions were conducted in non-teaching hospitals. As maternity services are available more frequently and which do not require, always, a teaching hospital but a non-teaching appropriately equipped hospital can also serve the purpose; this might be one reason for more deliveries in non-teaching hospitals because they exist in much higher number than teaching hospitals. Interestingly, abnormal deliveries could not affect the situation of the foetus/newborn as almost all newborns from the abnormally delivered category were equal to or of more than 2500 grams weight; very small number from normally delivered babies were of low birth weight at the time of delivery. To monitor the progress of labour vaginal examination is carried out. More favourable the progress of labour less frequent is the examination. It has been the case in our study which shows that women who had abnormal delivery they undergone vaginal examination more frequently (30%) as compared to normally delivered women (6.4%). The situation further gets clearer when a comparison is made between the mean number of vaginal examinations performed across the two groups. We can see, again, the mean number of vaginal examinations performed is more for abnormal delivery category (4.83) when it is compared to normally delivered category (3.11). Figure 1 provides us some information on the use of drugs for augmenting the process of labour when it was found necessary. In about 80% of the deliveries, augmentation was not required across the two groups collectively; it means in spite of the abnormality of delivery in some cases augmentation was not introduced. In less than 20% of cases, drugs were introduced during first stage of labour and even in half of those cases the drugs were used during second stage of labour. On very rare occasions drugs were used during the first and second stages of labour. Figure 2 presents the status of frequency of episiotomy performed on women in both the categories jointly. In our study, there were two thirds of the deliveries during which episiotomy was performed. Episiotomy is performed in the situation of simple vaginal delivery during the second stage of labour to expedite the process and make the task easier for both the mother and the neonate. Univariate Analysis: To answer the primary question of whether low risk pregnant women are receiving much interventions even if the delivery is uneventful we performed univariate analysis. Through this analysis we could identified the association between independent and dependant variables at the individual level. Table 2 provides information on various factors associated individually at univariate analysis level with the outcome variable i.e.; type of delivery. We can see that almost all the interventions are significantly associated at the univariate level. This analysis gives some idea about the interventions being offered to the normal low risk pregnant women. Table 2: Univariat analysis Variable Odds Ratio (OR) 95 % CI Episiotomy No Yes 1 22.79 13.54-38.36 Pain relief measures at stage II No Any type 1 15.54 10.24-23.58 Pain relief measures at stage I No Any type 1 6.60 3.16-13.80 Vaginal examination 1-5 6-10 1 6.56 4.74-9.08 Drugs used for augmenting the labor No During stage 1 During stage 2 Both stages 1 4.27 4.30 6.51 3.03-6.02 2.70-6.88 3.62-11.72 Fetal Monitoring at day 2 No Any type 1 2.38 1.83-3.10 Episiotomy came as a very strongly associated factor with the normal or low risk labour group. Those women who were in low risk category, normal labour, were about 23 times more likely to undergo episiotomy procedure as compared to those women who were in the high risk category. This association was statistically significant. Usually, some steps are taken to ease the process of labour and minimize the agony of the woman to be delivered; a range of services available to get this objective. In our study, analgesia was provided during the first as well as the second stage of labour to give some relief to the woman undergoing labour. Again, those women who delivered without any event were given this analgesia more frequently in both the stages when compared to the women in the other category. These women received pain relief services during first stage of labour about 6 times more frequently than women in high-risk group. Pain relief services during second stage of labour were even more frequent. During second stage of labour, women in normal/low risk category were 15 times more likely to receive the services of pain relief as compared to the women in the group with high risk. Vaginal examination was also performed more frequently in normally delivered women than the high-risk group. The odds of undergoing vaginal examination by 6-10 times among women of low risk category were 6.56 times the odds of undergoing vaginal examination by 6-10 times of women in high risk category. Use of drug to augment the process of labour is also a frequent activity carried out to expedite the process when it is necessary. This augmentation can be induced in either or both the stages simultaneously. Our results show (table 2) that women with low risk category were again more likely to be given this trial as compared to women in the abnormal delivery category. Among various categories where the augmentation was induced, the category of both stages was strongly associated than the other two categories. Use of augmenting drugs was 6.51 times more likely during both first and second stages of labour among women of normal/low risk category as compared to women with eventful delivery category. Foetal monitoring is another intervention, which is carried out to assess and monitor the well being of the foetus usually with the help of cardiotocograph. Again, this factor was associated with low risk women than the high-risk group; this association is statistically significant. Multivariat analysis All those variables which show association with the dependant variable with as high p-value as 0.25low and all those, which have got biological plausibility, were selected for multivariate analysis. In this analysis, the variables with the strongest association with the dependant variable will be taken first in the model and then followed by another variable in the model. Our aim is to prepare parsimonious model. At the multivariate analysis level three factors kept their strong association. Three variables were: episiotomy, pain relief at the time of deliveries and vaginal examinations during delivery. While the other factors although, they showed strong association with the outcome variable, normal delivery, but they lost their association when put together with other variables in the multivariate model through a step by step procedure. Table 3: Multivariate analysis Variable Odds Ratio (OR) 95 % CI Episiotomy No Yes 1 24.93 11.81-52.65 Vaginal examination 1-5 6-10 1 3.85 2.03-7.33 Pain relief measures at stage II No Any type 1 10.50 6.34-17.38 We could see that in normal labour more of the women were being examined during labour. Similarly the association of those women who asked for the drugs during labour to get pain relief was significant with normal delivery. This way three out of six interventions being utilized during labour have shown significant association when they were put together simultaneously in a multivariate model. These models also control the confounding effect of the variables. We also did check any interaction term to be associated significantly but it was not. These findings strongly support the answer that low risk pregnant women in normal labour receive more interventions. Conclusions: Our data suggest that low risk women are intervene more frequently with a higher number of interventions as compared to high risk group Among the various factors, episiotomy, vaginal examination and pain relief measures during second stage emerged as the most strongly associated factors with the women with normal delivery/low risk group. At times, these are not required interventions, which may result in wastage of resources. Recommendations: An index of interventions should be formulated based on the risk level of pregnant women. Risk management guidelines should be developed to be followed accordingly. Close liaison between the health care providers and the clients should be established with continuous contact in situations where more complex cases arise. Patient should be reassured and measures be taken to minimize the wastage of time, money, human and other resources. Efficient ways of management should be incorporated. RERFERANCES 1. Villar J, Ba'aqeel H, Piaggio G, Lumbiganon P, Belizan MJ, Farnot U, et al. WHO antenatal care randomized trial for the evaluation of a new model of routine antenatal care. Lancet 2001; 357:1551-64. 2. Hofmer GJ. Evidence-based intrapartum care. Best Prec Res Clin Obstet Gynaecol. 2005; 19:103-15 3. Alder BB, Bonder K, Kimberger O, Wagenbichler P, Kaider A, Husslein P, et al. The effect of epidural analgesia on the occurrence of obstetric lacerations and on the neonatal outcome during spontaneous vaginal delivery. Arch Gynecol Obstet 2002; 267:81-4 4. Williams FL, Florey Cdu, Ogston SA, Patel NB, Howie PW and Tindall VR. UK Study of intrapartum care for low risk primigravidas: a survey of interventions. J Epidemiol Community Health 1998;52:494-500. 5. Health Committee. Maternity services. London: HMSO. 6. Tindall VR (Chair). Women in normal labour: a report of a CSAG Committee on women in normal labour. London: HMSO, 1995. 7. Scheaffer RL, Mendenhall III W, Ott L. Elementary survey sampling. 5th ed. New York: Duxbury press; 1996. 8. Epi Info version (6.04): A word processing, database and statistics program for Public Health [computer program]. Atlanta, GA: Centers for Disease Control and Prevention, 1995. 9. SPSS (14.0) for windows. Chicago, IL: SPSS Inc, 2006. Read More