Fetomaternal Outcomes in Epidural Analgesia during Labour: A Double-Arm Randomised Control Study

: Background: Childbirth is undoubtedly one of the most challenging experiences a woman will ever go through. The use of analgesia during labor that is effective and safe has always been a topic of debate, alongside misconceptions and discussions about labor pain management. The objective of this study was to assess the impact of Epidural Analgesia (EA) on both the woman and the fetus during labor, as well as to compare the fetomaternal outcomes between the control and epidural groups. Materials and Methods: This study was a two-year, double-arm, randomized controlled trial conducted at the Department of Obstetrics and Gynecology, VIMSAR, Burla, between November 2018 and October 2020. Prior to participating in the study, all participants provided written informed consent, and strict confidentiality was maintained for all patient-related data throughout the investigation. Results: The results indicated that epidural pain management had no effect on the duration of the second stage of labor, which was similar in both groups (p=0.1). Cesarean section was performed for 7.3% of the analgesia group. Prolonged labor was observed in 50% of the women, fetal distress in 25%, and deep transverse arrest in 25%. Due to fetal jeopardy, three out of 55 expectant women in the control group underwent emergency caesarean sections. Conclusion: In conclusion, lumbar epidural analgesia, when administered by a skilled practitioner, offers a safe analgesic technique. This study supports its use as a recommendation for all women undergoing normal labor.


I. INTRODUCTION
Birth is undoubtedly one of the most painful experiences a woman will undergo in her lifetime. Due to the longstanding myths and debates surrounding the management of labor pain, providing effective and reliable analgesia during labor has remained a persistent challenge. Various pharmacological and non-pharmacological approaches have been employed. Given the complexity of labor, it is crucial to strike a balance between pain relief and other factors such as physical, emotional, psychological, social, and sometimes even religious considerations.
Epidural analgesia (EA) stands as a popular and effective method for alleviating labor pain. Numerous studies investigating the impact of ongoing EA on labor progression have yielded inconsistent results [1]. Thus, the present study was conducted to assess the effects of EA administered during labor on both the mother and the fetus, and to compare the fetomaternal outcomes between the control and epidural groups.

II. MATERIALS AND METHODS
The current two-year, double-arm, randomized controlled trial was conducted at the Department of Obstetrics and Gynecology, VIMSAR, Burla, from November 2018 to October 2020. The secondary outcomes compared delivery methods and labor durations between the two groups. Ethical approval was obtained from the Institutional Ethics Committee of VIMSAR prior to the commencement of the study. All participants provided written informed consent before being enrolled in the experiment, and strict confidentiality was maintained for all relevant patient data throughout the study. The investigation adhered to ICH-GCP and Helsinki Declaration guidelines.
The study population consisted of pregnant women admitted to the labor room at VIMSAR who met the inclusion and exclusion criteria. Primigravida/virtual primigravida VOLUME 22, ISSUE 1, Pages 34-37 (G4A3/ G3A2 / G2A1) with a gestational age beyond 37 weeks, vertex presentation, a viable singleton pregnancy, and a cervical dilation of at least 4 cm were eligible for the study. Pregnant women with pre-eclampsia, eclampsia, diabetes, heart conditions, coagulopathies, or fetal congenital abnormalities were excluded. Once they entered active labor and had at least 4 cm of cervical dilation confirmed through a vaginal examination, patients were randomly assigned to either the epidural or control group. EA was administered in the epidural group using 8 ml of injectable bupivacaine 0.125%. The placement of an intrathecal catheter was suspected if hypotension, motor block in the legs, warm upper foot, and rapid disappearance of labor signs were observed (epidurals usually take 10 minutes to take effect). A drop of 20% or more in mean blood pressure from pre-operative levels indicated hypotension. Motor function was assessed by having the patient rise from the bed and straighten her knees, and sensory block was determined using the pinprick test. Following the onset of contractions, pregnant women were asked to rate their pain level using a visual analog scale. Side effects such as metallic aftertaste, tingling lips, dizziness, ringing in the ears, a heart rate increase of more than 30 beats per minute within a minute, and complete cardiovascular shutdown were reported. Fetal heart rate, uterine contractions, and other vital signs were monitored every 5 minutes for the first 60 minutes after the loading dose, and then every 30 minutes until delivery. A partograph was used to assess and visualize labor progress. Pain intensity, sensory block, motor block, and potential side effects such as nausea, vomiting, hypotension, headache, urinary retention, fever, and fetal heart rate anomalies were monitored every 5 minutes for the first 60 minutes after the loading dose, and then every 30 minutes until delivery. Time from epidural administration to complete cervical dilation was recorded. The second stage (SS) of labor was defined as the time between full cervical dilation and the birth of the baby. Postpartum complications, as well as the incidence of instrumental and cesarean deliveries, were documented and analyzed. The newborns were assessed using APGAR scores at one and five minutes after birth.
The collected data on the case record form was transferred to a Microsoft Excel spreadsheet. SPSS 20.0 was utilized for the analysis of all the data. The mean and standard deviation were employed to present the data. Categorical data were assessed using frequency (n) and percentage (%). Any change with a p value less than 0.05 was considered statistically significant using appropriate statistical methods.

III. OBSERVATIONS AND RESULTS
The study encompassed 110 individuals who fulfilled the inclusion and exclusion criteria; 55 were allocated to the study group and the remaining 55 were assigned to the control group. The average gestational age of the study participants ranged between 37 and 39 weeks (see Table 1). The vast majority of pregnant women (84%) attended their first prenatal appointment.  The maternal vital signs were reported as mean standard deviation, including pulse rate, blood pressure, fetal heart rate (FHR), and the time taken for complete cervical dilation. The median duration of the second stage (SS) of labor is presented in Table 2. All pregnant women were able to perceive uterine contractions and relaxations. Those who received spinal pain relief exhibited a higher average heart rate. Epidural analgesia (EA) did not impact FHR changes. FHRs for both groups remained within a similar range, differing by 0.67. Discomfort was further alleviated with EA, and no pregnant woman reported a pain score between 8 and 10 indicating severe pain. In contrast, without spinal pain relief, 98% of participants experienced excruciating pain. Consequently, EA significantly reduced the pain score (p value = 0.01). The comparison of pain scores was similar for both groups (p = 0.1), regardless of the use of epidural pain treatment. Cesarean delivery was performed on 7.3% of women in the epidural group. Among them, 50% encountered prolonged labor, 25% experienced fetal distress, and 25% faced a substantial transverse blockage. Due to fetal jeopardy, three out of 55 pregnant mothers in the control group underwent hospital transfers for caesarean sections.
There was no significant difference between the study and control groups in terms of newborn outcomes, including AP-GAR score and NICU admissions. This suggests that the use of Epidural Analgesia (EA) did not result in any observable adverse effects on the developing fetus. A comparison of fetal outcomes between the study arms was performed using unpaired T-test (*) and Chi-square test (#). A p value is considered significant at <0.05, as shown in Table 3.

IV. DISCUSSION
In the present study, we evaluated 110 pregnant women for fetomaternal outcomes of 0.125% injection of bupivacaine and compared the results with those of a control group. Epidural Analgesia (EA) has been demonstrated to be more effective than other treatments in relieving discomfort [2]. However, concerns persist regarding whether it might prolong labor, increase the likelihood of surgical deliveries, and lead to adverse side effects. Various factors, including changes in vital signs, fetal heart rate, drug side effects, visual analog scale-assessed analgesia intensity, duration of the first stage of labor, duration of the second stage of labor, mode of VOLUME    Pain is a subjective and individual experience, making it challenging to quantify. In our study, we utilized a visual analog scale to assess pain. Notably, none of the EA recipients in the study reported severe pain (VAS score 8-10), a contrast to the 98% of participants in the control group (chi-square test, p=0.01). This finding aligns with a 2018 investigation wherein patients receiving EA reported less pain than those receiving analgesics. The EA recipients also reported higher proportions of "excellent or very good" pain relief [3].
Our study demonstrated a significantly longer average duration of the first stage of labor in the epidural group compared to the control group (T-test, p=0.02). Studies by Tsen et al. and Bhagwat et al. in 2008 [4], [5] reported increased cervical dilatation rates associated with combined spinal-epidural (CSE) anesthesia. CSE recipients exhibited twice the mean cervical dilation rate and reduced first stage labor time when compared to EA recipients. Contrarily, Lipschuletz Michal et al. in 2020 found no significant difference in the duration of labor stages or instrumental delivery rate based on the timing of EA administration [6].
Our findings also showed that administering bupivacaine during the second stage of labor did not prolong it. There was no statistically significant difference in the average duration of the second stage of labor between the control and epidural groups (Mann-Whitney U test, p=0.1), consistent with a 2020 study by ShengXing Zheng et al. [7]. However, Anat Shmueli et al. indicated that women with EA had a longer second stage of labor [8]. According to a 2015 study by Sadia Anwar et al., EA increased the likelihood of instrumental delivery and extended the duration of the second stage of labor. Nevertheless, babies exhibited favorable outcomes, and EA led to minimal intrapartum complications [9].
Our findings indicate that the utilization of Epidural Analgesia (EA) does not significantly elevate the rate of instrumental or cesarean deliveries when compared to the control group (Chi-square test, p=0.4). These outcomes align with those of Lian et al., who observed that Combined Spinal-Epidural (CSE) analgesia had no impact on cesarean section VOLUME 22, ISSUE 1, Pages 34-37 rates relative to the control group, as the administration procedure was consistent for both groups [10]. Additionally, CSE analgesia led to a lower cesarean section rate compared to the control group in a different study [11]. Similarly, another Iranian study found that the prevalence of EA-associated cesarean deliveries was comparable to the control group (p=0.26) [12]. Eriksson et al. [13] discovered no association between epidural blocks, cesarean sections, and instrumental births. While labor EA was linked to prolonged first and second labor stages, it did not impact the incidence of instrument-assisted births or the risk of adverse infant outcomes, as indicated by Kestutis Rimaitis et al. [14]. Qian Wang et al. (2018) reported that the application of EA during labor elevated the proportion of vaginal births while maintaining safety for both mother and fetus [15].
Similarly, our study's findings suggest that the administration of epidural analgesia has no detrimental effects on fetal outcomes when compared to the control group. These results are consistent with a 2020 study by ShengXing Zheng et al., who found no significant distinction in infant APGAR scores at 5 minutes between the EA and control groups [16].

V. CONCLUSION
Labor analgesia aims to enhance the childbirth experience. Our study demonstrates that EA does not pose risks to either the mother or the infant. In conclusion, we recommend lumbar EA administered by experienced professionals as a safe analgesic technique, suitable for use by all women undergoing regular childbirth.