Introduction
Labour pain is one of the most intense forms of physiological pain experienced by women during their reproductive lives. It results from uterine contractions, cervical dilatation, and perineal distension, and its intensity varies substantially among individuals. Effective management of intrapartum pain is an important component of high-quality obstetric care, influencing not only maternal comfort but also labour progression, mode of delivery, and the overall childbirth experience [1].
Epidural labour analgesia is widely regarded as the gold standard for intrapartum pain management. It achieves superior analgesia compared with systemic opioids and non-pharmacological methods, while allowing the parturient to remain conscious and participate actively in the birthing process [2,3]. Modern low-dose epidural techniques, combining dilute local anaesthetic agents with lipophilic opioids, have substantially reduced the motor blockade and systemic side-effects associated with earlier, higher-concentration formulations.
Despite the well-established analgesic efficacy of epidural analgesia, concerns persist regarding its potential effects on obstetric outcomes. Specifically, the association between epidural analgesia and increased rates of instrumental vaginal delivery, prolongation of the second stage of labour, and to a lesser extent caesarean section has been a subject of ongoing debate in the obstetric literature. µ⁻⁶ These concerns influence patient and clinician decision-making, particularly in low- and middle-income settings such as India, where utilisation of labour epidural analgesia remains limited relative to high-income countries.
Primigravid women represent a particularly important population in which to evaluate these outcomes, as they are at higher baseline risk of prolonged labour and operative delivery compared with multiparous women. Understanding the true effects of epidural analgesia on maternal and neonatal outcomes in this group is therefore of considerable clinical relevance.
The aim of the present study was to compare maternal outcomes including mode of delivery, duration of labour, and pain relief and immediate neonatal outcomes between low-risk primigravid women who received epidural labour analgesia and those who laboured without epidural analgesia at a tertiary care teaching hospital in Bengaluru, India.
Materials and Methods
Study design and setting
This hospital-based comparative cross-sectional study was conducted in the Department of Obstetrics and Gynaecology, Vydehi Institute of Medical Sciences and Research Centre, Bengaluru, Karnataka, India, over a period of 18 months. The study was approved by the Institutional Ethics Committee (ECR/747/Inst/KA/2015/RR-21) prior to commencement. All procedures were conducted in accordance with the ethical principles of the Declaration of Helsinki. Written informed consent was obtained from every participant before enrolment.
Study population and group allocation
Eligible women were divided into two groups based on their informed choice of labour analgesia following structured counselling by the attending obstetrician and anaesthesiologist: Group A (Epidural Group, n = 46) women who opted for epidural labour analgesia; and Group B (Control Group, n = 46) women who chose to labour without epidural analgesia.
Eligibility criteria
Inclusion criteria: primigravid women aged 18-35 years; singleton pregnancy with cephalic presentation; gestational age 37-42 completed weeks; spontaneous onset of labour; cervical dilatation appropriate for initiation of labour analgesia; willingness to participate and provide written informed consent.
Exclusion criteria: multiple gestation; previous uterine surgery; malpresentation; antepartum haemorrhage; hypertensive disorders complicating pregnancy; diabetes mellitus requiring medical management; intrauterine fetal demise; known fetal congenital anomalies; contraindications to epidural analgesia (coagulopathy, thrombocytopenia, local infection at the puncture site, severe maternal hypovolaemia, neurological disorders, allergy to local anaesthetic agents, patient refusal); and planned elective caesarean delivery.
Sample size
The sample size was calculated based on previously published literature comparing maternal outcomes following epidural labour analgesia, assuming a 95% confidence level and 80% study power. A minimum of 46 participants per group was determined to detect a clinically meaningful difference in operative delivery rates. The total planned sample was therefore 92 women.
Epidural analgesia technique
Women in Group A were evaluated by the anaesthesia team prior to epidural insertion. Following standard aseptic precautions, the epidural catheter was sited at the L3-L4 or L4-L5 intervertebral level using the loss-of-resistance technique. Correct catheter placement was confirmed with an appropriate test dose. Labour analgesia was initiated using a low-concentration local anaesthetic solution combined with a lipophilic opioid according to institutional protocol, and maintained throughout labour with intermittent top-up doses or continuous infusion, titrated to pain scores and labour progression. Maternal blood pressure, heart rate, oxygen saturation, fetal heart rate, and uterine contraction pattern were continuously monitored after epidural administration.
Control group management
Women in Group B received routine obstetric labour management without epidural analgesia. Supportive obstetric care, including pharmacological or non-pharmacological pain relief methods other than epidural analgesia, was administered as clinically indicated.
Outcome measures
Primary maternal outcomes: pain intensity (assessed by the Visual Analogue Scale [VAS], a 10-cm horizontal scale with 0 representing no pain and 10 representing the worst imaginable pain, recorded at the onset of active labour, and at 2 and 4 hours thereafter); maternal satisfaction; mode of delivery (normal vaginal delivery, instrumental vaginal delivery, or caesarean section); duration of the first, second, and third stages of labour; and maternal complications attributable to analgesia.
Secondary neonatal outcomes: APGAR score at 1 and 5 minutes; requirement for neonatal resuscitation; NICU admission and duration; early neonatal complications.
Labour was monitored using the WHO partograph. The mode of delivery was determined by the attending obstetrician on the basis of obstetric indications and fetal condition. Neonatal assessment was performed by a paediatrician who was not involved in administering labour analgesia.
Statistical analysis
Data were entered into Microsoft Excel and analysed using SPSS software (IBM Corp., Armonk, NY, USA). Continuous variables are expressed as mean ± standard deviation (SD); categorical variables as frequency and percentage. Between-group comparisons were performed using the Student’s independent t-test for continuous variables, and the chi-square test or Fisher’s exact test for categorical variables. A two-sided p < 0.05 was considered statistically significant.
Results
Baseline characteristics
A total of 92 low-risk primigravid women were enrolled, 46 in each group. Baseline demographic and obstetric characteristics were comparable between the groups (Table 1). The majority of participants were aged 18–30 years, with no significant between-group difference in age distribution (p = 0.23). Mean gestational age was 38.8 ± 0.9 weeks in the epidural group and 38.6 ± 0.9 weeks in the control group (p = 0.33).
| Variable | Control Group (n = 46) | Epidural Group (n = 46) | p value |
| Age 18-25 years | 22 (47.8%) | 20 (43.5%) | - |
| Age 26-30 years | 19 (41.3%) | 15 (32.6%) | - |
| Age 31-35 years | 5 (10.9%) | 8 (17.4%) | - |
| Age 36-40 years | 0 (0%) | 3 (6.5%) | 0.23 |
| Gestational age, weeks, mean ± SD | 38.6 ± 0.9 | 38.8 ± 0.9 | 0.33 |
SD, standard deviation.
Mode of delivery
Normal vaginal delivery with right mediolateral episiotomy (FTND + RMLE) was significantly more common in the control group (78.3% vs. 50.0%) while operative delivery was more frequent in the epidural group. The overall caesarean section rate was higher in the epidural group (32.6% vs. 17.4%), encompassing emergency (28.3% vs. 17.4%) and elective (4.3% vs. 0%) procedures, but this difference did not achieve statistical significance (p = 0.09). Assisted vaginal delivery (forceps or vacuum) was significantly more frequent in the epidural group (17.4% vs. 4.3%; p = 0.04). Forceps-assisted delivery occurred exclusively in the epidural group (8.7% vs. 0%).
| Outcome | Control Group (n = 46) | Epidural Group (n = 46) | p value |
| Normal vaginal delivery (FTND + RMLE) | 36 (78.3%) | 23 (50.0%) | - |
| Emergency LSCS | 8 (17.4%) | 13 (28.3%) | - |
| Elective LSCS | 0 (0%) | 2 (4.3%) | - |
| Overall caesarean section rate | 8 (17.4%) | 15 (32.6%) | 0.09 |
| Forceps-assisted delivery | 0 (0%) | 4 (8.7%) | - |
| Vacuum-assisted delivery | 2 (4.3%) | 4 (8.7%) | - |
| Overall assisted vaginal delivery | 2 (4.3%) | 8 (17.4%) | 0.04 |
FTND, full-term normal delivery; RMLE, right mediolateral episiotomy; LSCS, lower segment caesarean section.
Indications for operative delivery
The distribution of indications for operative delivery was comparable between groups (p = 0.13). Poor maternal bearing-down effort was a more frequent indication for operative delivery in the epidural group (34.8% vs. 20.0%), while failed induction was observed only in the control group (20.0% vs. 0%). Arrest of descent requiring operative intervention occurred exclusively in the epidural group (17.4%). Fetal distress was the indication in 21.7% and 30.0% of operative deliveries in the epidural and control groups, respectively.
| Indication | Control Group | Epidural Group | p value |
| Arrest of descent | 0 (0%) | 4 (17.4%) | - |
| Failed induction | 2 (20.0%) | 0 (0%) | - |
| Fetal distress | 3 (30.0%) | 5 (21.7%) | - |
| Maternal request | 0 (0%) | 2 (8.7%) | - |
| Non-progression of labour | 3 (30.0%) | 4 (17.4%) | - |
| Poor bearing-down effort | 2 (20.0%) | 8 (34.8%) | 0.13 |
Percentages are of operative deliveries within each group. p value refers to overall distribution.
Pain scores and maternal satisfaction
At the onset of active labour, mean VAS scores were comparable between groups (8.8 ± 0.7 in the epidural group vs. 8.6 ± 0.8 in the control group; p = 0.23). Pain scores diverged significantly at 2 hours (5.6 ± 1.4 vs. 8.9 ± 0.5; p < 0.001) and at 4 hours (4.9 ± 1.4 vs. 9.4 ± 0.5; p < 0.001), confirming the analgesic efficacy of epidural analgesia. Overall maternal satisfaction was significantly higher in the epidural group (p = 0.01). Pain score data beyond 4 hours were not available for tabulation in the current analysis and will be reported in a supplementary report.
| Time point | Control Group (mean ± SD) | Epidural Group (mean ± SD) | p value |
| Onset of active labour | 8.6 ± 0.8 | 8.8 ± 0.7 | 0.23 |
| 2 hours after analgesia/comparable time | 8.9 ± 0.5 | 5.6 ± 1.4 | <0.001 |
| 4 hours after analgesia/comparable time | 9.4 ± 0.5 | 4.9 ± 1.4 | <0.001 |
VAS, Visual Analogue Scale; SD, standard deviation. Complete pain score data beyond 4 hours were not available for tabulation in the current analysis.
Duration of labour
The duration of the first stage of labour was comparable between groups (8.8 ± 3.1 hours in the epidural group vs. 9.9 ± 2.7 hours in the control group; p = 0.09). The second stage was marginally longer in the epidural group (38.4 ± 16.7 minutes vs. 31.3 ± 14.7 minutes), but the difference was not statistically significant (p = 0.06). These findings indicate that epidural analgesia, as administered in this study, did not significantly prolong either stage of labour.
| Stage | Control Group | Epidural Group | p value |
| First stage (hours) | 9.9 ± 2.7 | 8.8 ± 3.1 | 0.09 |
| Second stage (minutes) | 31.3 ± 14.7 | 38.4 ± 16.7 | 0.06 |
SD, standard deviation.
Neonatal outcomes
Neonatal outcomes were comparable between groups. Mean APGAR scores at 1 minute were 7.2 ± 0.8 (epidural) and 7.4 ± 0.8 (control; p = 0.18). APGAR scores at 5 minutes were 8.7 ± 0.5 and 8.9 ± 0.3, respectively (p = 0.18). NICU admission rates were identical in both groups (4.4%; p = 0.41), and no early neonatal complications attributable to epidural analgesia were observed.
| Outcome | Control Group (n = 46) | Epidural Group (n = 46) | p value |
| APGAR score 1 min, mean ± SD | 7.4 ± 0.8 | 7.2 ± 0.8 | 0.18 |
| APGAR score 5 min, mean ± SD | 8.9 ± 0.3 | 8.7 ± 0.5 | 0.18 |
| No NICU admission | 44 (95.6%) | 44 (95.6%) | - |
| NICU admission 2 days | 1 (2.2%) | 0 (0%) | - |
| NICU admission 3 days | 0 (0%) | 1 (2.2%) | - |
| NICU admission 4 days | 0 (0%) | 1 (2.2%) | - |
| NICU admission 5 days | 1 (2.2%) | 0 (0%) | - |
| Overall NICU admission rate | 2 (4.4%) | 2 (4.4%) | 0.41 |
APGAR, Appearance, Pulse, Grimace, Activity, Respiration; NICU, neonatal intensive care unit; SD, standard deviation.
Discussion
The present study evaluated maternal and neonatal outcomes following epidural labour analgesia in a well-defined cohort of low-risk primigravid women at a tertiary care centre in India. The principal findings were: (1) epidural analgesia provided significantly superior pain relief and maternal satisfaction; (2) assisted vaginal delivery was significantly more common in the epidural group; (3) caesarean section rates and duration of labour stages did not differ significantly between groups; and (4) immediate neonatal outcomes were comparable.
The analgesic efficacy demonstrated in this study is consistent with the highest-level evidence in the literature. A Cochrane systematic review by Anim-Somuah et al.,[1] encompassing more than 12,000 women across 40 trials confirmed that epidural analgesia provides superior pain relief compared with all alternative pharmacological methods. Mean VAS scores in our cohort fell from approximately 8.8 at the onset of active labour to 4.9 at 4 hours in the epidural group, against a rise to 9.4 in controls over the same interval, with highly significant between-group differences (p < 0.001). The substantially higher maternal satisfaction observed in the epidural group reflects the clinical importance of adequate intrapartum analgesia as a determinant of childbirth experience [3].
The higher rate of instrumental vaginal delivery in the epidural group (17.4% vs. 4.3%; p = 0.04) is consistent with evidence from randomised controlled trials and meta-analyses. The proposed mechanism is motor blockade of pelvic floor musculature and reduced urge to bear down, impairing active maternal expulsive efforts in the second stage. In the present cohort, poor bearing-down effort was indeed more frequently cited as the indication for assisted delivery in the epidural group (34.8% vs. 20.0%). This association underscores the importance of antenatal counselling regarding the higher likelihood of assisted vaginal delivery, as recommended by the ASA Practice Guidelines for Obstetric Anaesthesia [8].
The absence of a statistically significant difference in caesarean section rates between groups (32.6% vs. 17.4%; p = 0.09) aligns with contemporary evidence. Earlier observational data suggested that epidural analgesia increased caesarean risk, but subsequent randomised trials have consistently refuted this association [1-2]. The 2020 systematic review by Sultan et al.´ and updated ACC/ACOG recommendations [2] confirm that when low-dose epidural techniques are employed by experienced anaesthesia teams, caesarean section rates are not significantly elevated. The numerically higher rate in the epidural group in the present study may reflect the higher proportion of operative deliveries in the epidural group overall, and the study was not powered to detect a statistically significant difference in caesarean rates specifically.
Neither the duration of the first stage (p = 0.09) nor the second stage (p = 0.06) of labour differed significantly between groups, although both trended towards a longer duration in the epidural group. These findings are broadly consistent with a Cochrane review reporting a modest prolongation of the second stage (approximately 13-14 minutes) with epidural analgesia [1] and with the observation that modern low-dose epidural regimens have minimal impact on labour progression compared with older high-concentration formulations [3].
Neonatal outcomes were reassuring. APGAR scores at 1 and 5 minutes and NICU admission rates did not differ significantly between groups. These findings support the safety profile of epidural analgesia for the neonate, consistent with the conclusions of multiple systematic reviews and with current NICE and ASA guideline statements. No immediate neonatal complications attributable to epidural analgesia were observed.
Strengths and Limitations
Strengths of this study include the homogeneous study population (low-risk primigravidae only), the prospective collection of standardised outcome data, and the rigorous application of institutional labour management protocols. The study also addresses a recognised evidence gap regarding labour analgesia outcomes in Indian tertiary care settings, where published data remain limited.
Several limitations must be acknowledged. The non-randomised design, with group allocation determined by patient preference, introduces the possibility of selection bias; women opting for epidural analgesia may differ systematically from those who decline it in ways not fully captured by baseline characteristics. The study was conducted at a single centre with a relatively small sample size (n = 46 per group), limiting statistical power to detect modest differences in caesarean section rates. VAS pain data beyond 4 hours were incomplete and could not be fully analysed. Long-term outcomes including postpartum analgesia requirements, breastfeeding success, postpartum depression, and neonatal neurodevelopment were not evaluated. Future multicentre randomised studies with larger sample sizes and comprehensive follow-up are warranted to confirm and extend these findings.
Conclusion
Epidural labour analgesia provides significantly superior intrapartum pain relief and improves maternal satisfaction in low-risk primigravid women without adversely affecting immediate neonatal outcomes. Although instrumental vaginal delivery was significantly more frequent in the epidural group, caesarean section rates and labour duration did not differ significantly between groups. These findings support the safe use of epidural labour analgesia in appropriately selected low-risk primigravidae. Structured antenatal counselling regarding the analgesic benefits and the higher probability of assisted vaginal delivery is recommended. Wider availability of labour epidural services in Indian tertiary care hospitals, underpinned by collaborative obstetric and anaesthesia teams, has the potential to meaningfully improve intrapartum care quality and maternal childbirth experience.
Declarations
Ethics approval and consent to participate
The study protocol was approved by the Institutional Ethics Committee of Vydehi Institute of Medical Sciences and Research Centre, Bengaluru, India (ECR/747/Inst/KA/2015/RR-21). All procedures were conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from every participant before enrolment.
Availability of data and materials
The datasets used and analysed during the current study are available from the corresponding author on reasonable request.
Competing interests
The authors declare no competing interests.
Funding
This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
Authors’ contributions
NRP: Conceptualization, study design, patient recruitment, data collection, statistical analysis, interpretation of results, manuscript preparation. AN: Supervision, critical revision of the manuscript, final approval. Both authors read and approved the final manuscript.
Acknowledgements
The authors sincerely thank the Departments of Obstetrics and Gynaecology and Anaesthesiology at Vydehi Institute of Medical Sciences and Research Centre, Bengaluru, for their guidance and support. The authors also express gratitude to all participating women and the nursing and midwifery staff for their cooperation during the study and thanks to Dr Venkataraman A P (Healthium Medtech) for drafting the manuscript.