Background: Childbirth is without a doubt the most horrific process a woman will ever go through. Analgesia during labor that is both effective and safe has always been a source of contention, as have misconceptions and debates surrounding labor pain management. The goal of this study was to determine the effects of EA on the woman and embryo during labor, as well as to compare the fetomaternal outcomes of the control and epidural groups. Materials and procedures: The current study was a two-year, double-arm, randomized control trial that took place in the Department of Obstetrics and Gynecology, VIMSAR, Burla, between November 2018 and October 2020. Before joining in the experiment, all participants provided written informed consent, and strict confidentiality was maintained over all relevant patient data throughout the inquiry. Results: The results showed that epidural pain treatment had no effect on the length of the second stage of labor, which was the same in both groups (p=0.1). Cesarean section was used by 7.3% of the analgesic cohort. 50% of the women had prolonged labor, 25% had fetal discomfort, and 25% had a deep transverse stop. Because their newborns were in danger, three of the 55 expecting women in the control group were taken to the hospital for emergency caesarean sections. Conclusion: We may conclude that lumbar EA in the hands of a skilled expert provides a technique of safe analgesia, allowing us to recommend for its use in all women experiencing ordinary labor.
Birth is without a doubt the most agonizing process a woman will go through in her lifetime. Because the treatment of labor pain has long been veiled in myths and disputes, providing efficient and trustworthy analgesia during labor has remained a recurrent challenge. A variety of pharmacological and non-pharmacological treatment approaches have been used. Because work is so complex, it is vital to strike a balance between pain alleviation and other aspects such as physical, emotional, psychological, societal, and, in some cases, religious considerations.
Epidural analgesia (EA) is a popular and effective means of relieving labor pain. Numerous investigations on the impact of ongoing EA on labor progress have yielded inconsistent results [1]. As a result, the current study was carried out to determine the effects of EA delivered during labor on the mother and embryo, as well as to compare the fetomaternal results of the control and epidural groups.
From November 2018 to October 2020, the current study was a two-year, double-arm, randomized control trial at the Department of Obstetrics and Gynecology, VIMSAR, Burla. The secondary findings compared the delivery procedures and labor durations of the two groups. The Institutional Ethics Committee of VIMSAR got ethical permission prior to the start of the inquiry. All participants submitted written informed consent before being included in the experiment, and strict confidentiality was maintained over all pertinent patient information throughout the inquiry. The investigation adhered to ICH-GCP and Helsinki Declaration guidelines.
The study population consisted of pregnant women admitted to the labor room at VIMSAR as well as those who matched the inclusion and exclusion criteria. Primigravida/virtual primigravida (G4A3/ G3A2 / G2A1) with a gestational age greater than 37 weeks, vertex presentation, a viable singleton pregnancy, and a cervical diameter of at least 4 cm were eligible for the study. The study excluded pregnant women with pre-eclampsia, eclampsia, diabetes, heart illness, coagulopathies, or fetal congenital abnormalities. Patients were randomly randomized to either the epidural or control group once they reached active labor and a per vaginal exam confirmed at least 4 cm of cervical dilation. EA was administered in the epidural group using 8 ml of injectable bupivacaine 0.125%.
The placement of an intrathecal catheter may be suspected in the presence of hypotension, motor block in the legs, a warm upper foot, and the fast absence of labor signs (epidurals normally take 10 minutes to take action). When the mean blood pressure dropped by 20% or more from pre-operative levels, hypotension was identified. The patient’s motor function was assessed by having her rise from the bed and straighten her knees, and sensory block was determined using the pinprick test.
Following the commencement of contractions, the pregnant women were asked to rate their level of distress using a visual analog scale. Patients complained of a metallic aftertaste, tingling lips, dizziness, ringing in the ears, a heart rate increase of more than 30 beats per minute in less than one minute, and a full shutdown of the cardiovascular system. Fetal heart rate, uterine contractions, and other vital signs were monitored every 5 minutes for the first 60 minutes after the loading dosage, and then every 30 minutes until delivery.
A partograph is used to evaluate and visualize labor progression. Pain intensity, sensory blockage, motor blockade, and possible side effects such as nausea, vomiting, hypotension, headache, urine retention, fever, and FHR anomalies were monitored every 5 minutes for the first 60 minutes following the loading dosage, and then every 30 minutes until delivery. Time was recorded from the time the epidural was delivered until the cervical dilatation was complete. The second stage (SS) of labor was defined as the time between when the cervix was fully dilated and when the baby was born. Postpartum problems, as well as the prevalence of instrumental and caesarean deliveries, were also documented and studied. The newborns were evaluated using the APGAR scores one and five minutes after birth.
The gathered data on the case record form was transferred to a Microsoft Excel spreadsheet. SPSS 20.0 was used to analyze all of the data. The mean and standard deviation were used to depict the data. Categorical data were analyzed using frequency (n) and percentage (%). Any change at p0.05 was determined to be statistically significant using the appropriate statistical methods.
It included 110 people who met the inclusion and exclusion criteria; 55 were assigned to the study group and the other 55 were assigned to the control group. The study participants’ average gestational age ranged between 37 and 39 weeks (Table 1). The vast majority of pregnant women (84%) have their first prenatal appointment.
Characteristics | n(%) |
---|---|
Age in years (Mean \(\pm\) SD) | 24.39 \(\pm\) 2.8 |
Parity | |
Primi | 98 (89 %) |
Virtual primi | 12 (11%) |
Gestational Age | |
37-39 weeks | 89 (81%) |
>39 weeks | 21 (19%) |
Booking status | |
Booked | 92 (84%) |
Unbooked | 18 (16%) |
The mother’s vital indicators were expressed as mean standard deviation, including pulse rate, blood pressure, fetal heart rate [FHR], and time to completely open the cervix. The middle number in Table 2 represents the average length of the SS of work. All pregnant women were able to see their uteruses contract and relax. Women who obtained spinal pain alleviation had a greater average heart rate. The EA had no effect on the FHR adjustments. The FHRs of both groups fell within the same range, with a difference of 0.67. The discomfort was reduced even further with EA, and not a single pregnant woman earned a score between 8 and 10 for severe pain. Without spinal pain relief, 98% of the trial participants were in excruciating agony. As a result, EA significantly reduced the pain score (p value = 0.01). It was the same for both groups (p=0.1), whether or not epidural pain treatment was used. Cesarean delivery was performed on 7.3% of women in the epidural cohort. 50% experienced extended labor, 25% experienced fetal distress, and 25% experienced a significant transverse stop. Because their babies were in danger, three of the 55 pregnant mothers in the control group were sent to the hospital for caesarean sections.
Maternal outcomes | Epidural group (n=55) | Control group(n=55) | p-value |
---|---|---|---|
Pulse (per min) | 77.31 \(\pm\) 6.62 | 69.5 \(\pm\) 5.08 | <0.001* |
Blood pressure (mm /Hg) | |||
SBP | 120.6 \(\pm\)7.63 | 117 \(\pm\) 8.7 | 0.017* |
DBP | 79 \(\pm\) 7.82 | 76 \(\pm\) 8 | 0.09* |
FHR (per min) | 140.3 \(\pm\) 13.7 | 140.3 \(\pm\) 10.5 | 0.77* |
Pain score | |||
Mild (0-3) | 38 (69%) | 0 | <0.01# |
Moderate (4-7) | 17 (31%) | 1 (2%) | |
Severe (8-10) | 0 | 54 (98%) | |
Time for full dilatation (min) | 267.4 \(\pm\)91.2 | 225 \(\pm\)98.7 | 0.02* |
Duration of SS of labour (min) | 28 | 25 | 0.1$ |
Mode of delivery | |||
Spontaneous | 46 (82.7%) | 49 (89%) | 0.4# |
Instrumental (ventouse) | 5 (10%) | 3 (5.5%) | |
Cesearean section | 4 (7.3%) | 3 (5.5%) | |
Indication for cesearean section | |||
Prolonged labour | 2 (50%) | 0 | |
Fetal distress | 1 (25%) | 3 (100%) | |
Deep transverse arrest | 1 (25%) | 0 | |
Total | 4 | 3 | |
Os Dilatation (cm) | |||
4-6 | 47 (85.5%) | 34 (61.8%) | 0.005# |
7-9 | 8 (14.5%) | 21 (38.2%) |
There was no significant difference between the study and control groups in terms of newborn outcomes such as APGAR score and NICU admissions. This means that the usage of EA had no discernible negative consequences on the growing fetus.
Fetal outcomes | Epidural group (n=55) | Control group(n=55) | p-value |
---|---|---|---|
Baby weight (kg) | 2.85\(\pm\) 0.65 | 2.93 \(\pm\)0.63 | 0.55* |
APGAR at 1 min | |||
0-3 | 0 | 0 | |
4-6 | 10 (18%) | 0 | |
7-10 | 45 (82%) | 55 (100%) | |
APGAR at 5 min | |||
0-3 | 0 | 0 | |
4-6 | 00 | ||
7-10 | 55 (100%) | 55 (100%) | |
NICU admission | |||
Present | 9 (16.3%) | 4 (7.2%) | 0.23# |
Absent | 46 (83.6%) | 51 (92.7%) |
In the current study, 110 pregnant women were evaluated for fetomaternal outcomes of 0.125% inj. bupivacaine and compared to the results of a control group. EA has been demonstrated to be more effective than other treatments in relieving discomfort [2]. However, there are serious concerns about whether it would lengthen labor, increase the likelihood of surgical deliveries, and create unpleasant side effects. Changes in vital signs, fetal heart rate, drug side effects, the grade of analgesia based on a visual analog scale, the duration of the first stage of labor, the duration of the second stage of labor, the mode of delivery, the baby’s health, the need for NICU admission, and any other complications were all examined in this study.
Pain is unique in that it is arbitrary and varies from person to person. This is a subjective and difficult to define occurrence. In our study, we used a visual analog scale to assess pain. Unlike 98% of control group participants, none of the EA recipients in the study reported severe pain (VAS score 8-10) (chi-square test, p=0.01). This was consistent with the findings of a 2018 investigation by Patients who received EA reported less pain than those who received analgesics (standardized mean difference: -2.64, 95% CI: -4.56 to -0.73; 1133 women; 5 studies; I2: 98%; low-quality evidence), and a higher proportion of patients (average) reported "excellent or very good" pain relief [3].
In our study, the average duration of the first stage of labor was substantially longer in the epidural group than in the control group (T-test, p=0.02). Tsen et al. and Bhagwat et al. observed in 2008 [4, 5] that combined spinal-epidural (CSE) anesthesia is associated with an increased incidence of cervical dilatation. When compared to patients receiving EA, participants randomly assigned to CSE analgesia had a doubling of the mean cervical dilation rate and a reduction in the time of the first stage of labor. Lipschuetz et al. [6] discovered no link between the administration of EA early or late in labor and substantial differences in the duration of labor stages or the rate of instrumental delivery in a 2020 trial. As a result, EA can be given throughout the early stages of labor [6]. According to our findings, giving 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). We discovered no statistically significant difference in the duration of the second stage of labor (SS) between the study and control groups. Women with an EA8 had a considerably longer SS of labor, according to Shmueli et al. [7]. The EA increases the likelihood of instrumental delivery and lengthens the duration of the second stage of labor. Furthermore, it was shown that babies had a satisfactory prognosis and that EA causes little intrapartum problems.
Our findings reveal that, as compared to the control group, the use of EA does not substantially increase the rate of instrumental or caesarean deliveries (Chi-square test, p=0.4). These findings agree with those of Lian and Ye [8], who discovered that CSE analgesia had no effect on caesarean section rates when compared to the control group. The administration procedure was the same for both groups. CSE analgesia resulted in a lower caesarean section rate than the control group, according to [9]. A further study (p=0.26) [10] discovered that the prevalence of EA caesarean deliveries was equivalent to the control group. Eriksson et al. [11] discovered no link between epidural blocks, caesarean sections, and instrumental births. Labor EA was related with protracted first and second labor phases, but had no effect on the incidence of instrument-assisted births or the risk of bad infant outcomes, according to a research by Rimaitis et al. [12]. According to Zheng et al. [13], the use of EA during labor increased the proportion of vaginal births while remaining safe for both the mother and the fetus.
When compared to the control group, the administration of an epidural analgesic had no harmful effects on fetal outcomes, according to the findings of our study. Consistent with the findings of a 2020 study by Zheng et al. who found no discernible difference between infant APGAR scores at 5 minutes with EA and the control group [12], these findings revealed no discernible difference between infant APGAR scores at 5 minutes with EA and the control group.
Labor analgesia is intended to make childbirth more bearable. EA is not dangerous to either the mother or the infant. We may conclude that lumbar EA in the hands of experienced personnel is a technique of safe analgesia, allowing us to recommend for its use in all women experiencing regular childbirth.
The authors declare no conflict of interests.