A before and after study to compare an Additional Proactive Respectful Management of labour with routine intrapartum care.

A before and after study to compare an Additional Proactive Respectful Management of labour with routine intrapartum care. | Authorea try { document.documentElement.classList.add('js'); } catch (e) { } var _gaq = _gaq || []; _gaq.push(['_setAccount', 'G-8VDV14Y67G']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(ga, s); })(); Skip to main content Preprints Collections Wiley Open Research IET Open Research Ecological Society of Japan All Collections About About Authorea FAQs Contact Us Quick Search anywhere Search for preprint articles, keywords, etc. Search Search ADVANCED SEARCH SCROLL This is a preprint and has not been peer reviewed. Data may be preliminary. 23 January 2026 V1 Latest version Share on A before and after study to compare an Additional Proactive Respectful Management of labour with routine intrapartum care. Authors : Sharon Sophia S , Evelina Jane K , Shiny Nirupama Boddu , Nitin Alexander Abraham 0009-0005-0852-3038 [email protected] , Divya K , Mintoo Tergestina , Prasanna Samuel Premkumar , and Jiji Elizabeth Mathew Authors Info & Affiliations https://doi.org/10.22541/au.176915360.00828639/v1 99 views 54 downloads Contents Abstract Supplementary Material Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract Objective: An Intrapartum strategy that decreases the duration of labour is always desirable, especially in busy settings. Trials on active management of labour have shown a decrease in the duration of labour and some varying effects on caesarean rates. Therefore, in this study, we compared an additional proactive respectful management of labour strategy (APRML) to the existing routine care in our setting. Design: This was a prospective observational study with a before and after study design. Setting: A large tertiary care centre in South India. Population: Women delivering at or after 22 weeks of gestation until 41 weeks with a birth weight of >500g. Methods: An APRML strategy was formulated and compared with routine care. APRML comprised of early diagnosis of labour, early amniotomy, early augmentation, proactive induction protocol, ambulation, improved hydration, oxytocin refrigeration and respectful maternity care. Main Outcome Measures: Comparison of duration of labour between routine care and APRML Results: Baseline characteristics, especially the Robson TGCS were similar in both groups. The duration of time spent in the delivery room and instrumental delivery was significantly decreased in the APRML group (18.13 hours versus 17.52 hours, p=0.0456) and (19.8% versus 14.1% p<0.001) respectively. There was a significant decrease in infectious morbidities such as wound infection, urinary tract infection and probable neonatal sepsis. Postpartum haemorrhage was also significantly less in the APRML group (10.6% versus 9.02% p=0.02.) Chorioamnionitis and fever were more common in the APRML group. Perinatal and Maternal morbidity and mortality were similar in both groups. Conclusions: APMRL strategy showed better outcomes than routine intrapartum care. Funding: There was no external funding for the research conducted. Keywords: Proactive management, intrapartum care, Labour duration, augmentation, amniotomy, induction INTRODUCTION: The intrapartum phase is the most difficult period, both for the woman and the health care provider (HCP). Therefore, improvement of the overall intrapartum experience and outcomes of the woman has been given substantial emphasis by HCPs in recent times. The challenges faced by HCPs differ according to the setting of the birthing unit. Busy maternity units, especially in low and middle-income countries, would want women to spend the least amount of time in the delivery rooms to optimize the use of health resources. Trials on active management of labour 1,2,3,4,5 and similar strategies that included early amniotomy and early use of oxytocin for augmentation have shown a decrease in duration of labour and some varying effects on caesarean delivery rates. Ambulation and hydration 6,7 of the women in labour have also shown some decrease in the duration of labour. There has also been a great momentum towards ensuring respectful maternity care for all labouring women, especially in our subcontinent. All the above strategies are not followed uniformly by all HCPs, and the effectiveness of some of these outcomes has not been assessed for external validity. Therefore, in this study, we compared an additional proactive, respectful management of labour strategy (APRML) to the existing routine care in our setting. The scientific hypothesis of this study is that there will be a statistically significant reduction in the duration of labour in the APRML group compared to the routine care group. MATERIALS AND METHODS: This prospective observational study with a before-and-after study design was conducted in a large tertiary centre in South India that has around 10,000-12,000 deliveries every year. It was done after institutional review board clearance (IRB No14906 Observe dated 12.10.2022). All women delivering at or after 22 weeks of gestation until 41 weeks with a birth weight of >500g were included in the study. The clinical data captured in an electronic database by office facilitators as part of clinical services in the setting was used for baseline data and data on outcomes. Most of the details of the routine care in our setting have been described in a previous publication8. An APRML strategy was formulated with a consensus of the obstetric team that managed labour in our setting. Several meetings were held with the tenured faculty of the department. Before the implementation of the regimen, data was collected on all women who received routine intrapartum care for a period of 4 months. The APRML strategy was taught to all HCPs who were involved with decision-making in the intrapartum care of the women. These HCPs were senior residents and faculty in the domain of Obstetrics and Gynaecology. Their thoughts, opinions and understanding of the APRML strategy were captured in an electronic questionnaire before the training. After the training period of 8 months, we ensured that all HCPs in the setting were following the APRML strategy. In the routine care group, there were 4085 deliveries, and in the APRML group, there were 3500 deliveries. The APRML strategy for low-risk women comprised the following set of management protocols that were not followed in routine care in our setting. The components of the strategy and the differences from routine care are described below. 1.Assessment at admission : All low-risk women had a pelvic examination and the primigravida women with cervical length of less than 1 cm and multigravida women with cervical length of less than 0.5 cm with labour pains, were diagnosed to be in labour. Those who did not have the above criteria were sent home. They were advised to return if they had increased abdominal pain, or had associated bleeding and/or leaking. In the routine management of this setting, a pelvic examination was deferred and a definite diagnosis of labour was often delayed. 2.Augmentation : Those admitted with the diagnosis of labour had an early amniotomy and early augmentation with oxytocin and this was implemented within an hour of admission. Thus, early amniotomy was performed if the length of the cervix was less than 1cm in a primigravida and less than 0.5cm in a multigravida, irrespective of the cervical dilation when a woman came with a history of labour pains. The regime followed included an increase of oxytocin (5 mIU in 500ml Ringers Lactate) every 15 minutes in nulliparous women and oxytocin (2.5 mIU in 500ml Ringers Lactate) every 15-30 minutes in multiparous women to ensure good uterine contraction lasting for 40 seconds every 3-4 minutes. In routine management, the augmentation policy was conservative, with delayed amniotomy only after cervical effacement and cervical dilatation of more than 4cm. An augmentation process was with slow oxytocin titration. The increase in the rate of oxytocin infusion was only every 30 minutes to 1 hour. 3.Induction of labour : Women requiring misoprostol for induction were given 25μg misoprostol vaginally with up to 2-3 doses every 4 hours instead of the 6- hourly dose in the routine care management 9 . Amniotomy was done after 8 hours of the first misoprostol dose. This was not followed in routine care. An automatic increase in oxytocin infusion every 15 minutes without monitoring contractions if a woman did not complain of pain was implemented in the APRML group. The increase in oxytocin infusion was stopped or titrated carefully once the parturient complained of abdominal pain due to regular uterine contractions. In routine care, uterine contractions were assessed with abdominal palpation every 30 minutes, and an increase in oxytocin was done only if contractions were inadequate. As the setting did not have one-to-one care for intrapartum women by HCP, there was often a delay in oxytocin titration in the routine care group. HCPs involved with medical care and labour management in our setting were junior doctors. 4.Ambulation : Women were encouraged to ambulate or to stay in an upright position and continuous monitoring of labour was done only in active labour when the cervix was 4-5 cm dilated. In routine care, this was not ensured, and continuous monitoring was common as soon as the woman was admitted. This resulted in women being in recumbent positions most of the time. 5.Hydration : Women were given 200 ml of fluids every hour orally or intravenously. In routine care, they were only encouraged to stay hydrated. However, they did not ensure an intake of 200ml of fluid per hour. 6.Refrigeration of oxytocin : Extra care to use only refrigerated oxytocin in APRML strategy was implemented to ensure the potency of oxytocin and this was not being adequately emphasized in the routine care of the setting. 7.Respectful maternity care : The birth companion and the woman were informed of progress every four hours. Routine care had provision for a birth companion but they were not formally informed of progress every four hours. For the period of routine labour management, the data was obtained from Electronic medical records (EMR) for all the women who fulfilled the inclusion criteria (those admitted and delivered in the labour room for the 4 months from November 2022 to February 2023) at the end of each of the four months. The electronic discharge summary for each mother and neonate that were included in the study, was checked to identify outcomes. Following a training period of 8 months, the proactive management of labour was implemented from March 2024 to June 2024. An information sheet was provided to antenatal mothers in English and their vernacular language (refer to annexure 1); they were informed that as part of the study, all low-risk women would have an APRML strategy followed as the intrapartum management protocol. Thus APRML strategy was implemented only in low-risk women. Between March and June 2024, written consent was obtained from all women admitted to the labour ward. The faculty in charge of the woman in labour was allowed to decide if the woman was low-risk and could be managed with the APRML strategy. Details of outcomes of all women who delivered between March 2024 to June 2024 were also captured from EMR, the delivery database and the discharge summary of the mother and child. The outcomes and data chosen for assessment included relevant parameters that are easily available and recorded in the EMR as part of the clinical services and audit systems in the setting. The Primary outcome was to compare the duration from admission to the labour ward to delivery in routine management and APRML groups. This duration was chosen instead of the actual duration of labour to ensure uniformity and accuracy in the data collected, as this was being documented as part of the clinical services. Secondary outcomes were the comparison of the following parameters: 1.Mode of delivery: Primary LSCS rates included caesarean rates in women with an unscarred uterus. Instrumental delivery rates. 2.Perinatal mortality included intrapartum stillbirths and early neonatal death. 3.Perinatal morbidity included low Apgar, of less than 7 at 5 mins and Hypoxic ischemic encephalopathy or birth asphyxia. 4.Infectious morbidity in the neonate is defined per Departmental guidelines as probable sepsis or sepsis, in the background of risk factors for early-onset neonatal sepsis. Probable sepsis was when the baby was symptomatic, the sepsis screen was positive (CRP > 10mg/L), but the blood culture was negative. Sepsis was defined as a symptomatic baby with blood culture positivity. Risk factors for early-onset neonatal sepsis were maternal chorioamnionitis, maternal fever > 100.4F on two occasions or > 102.2F on one occasion, prolonged rupture of membranes (>24 Hours), spontaneous onset preterm labour, preterm prelabour rupture of membranes, more than 3 per vaginal examinations after rupture of membranes, maternal GBS UTI / screen positive, previous baby with invasive GBS disease and untreated maternal UTI. 5.Morbidity in the mother included maternal chorioamnionitis, post-partum haemorrhage, Postoperative/postnatal fever, urinary tract infection, third- or fourth-degree tear, LSCS wound site/episiotomy site infection. 6.Maternal Chorioamnionitis: Temperature recording of >100.4 F on 2 occasions after rupture of membranes and before delivery was considered as maternal chorioamnionitis in this study. Sample size and statistical methods: The sample size for this study was determined based on the objective of detecting a statistically significant difference in the duration of labour between the APRML group and the routine care group. Assuming a significance level of 0.05 and a power of 80%, and for a range of standard deviations between 2 and 7 hours, we required a sample size of 3,500 in each period to detect even small to moderate effects (cohen’s d of 0.2 or less). For SD of 7, this will give the power to detect differences even as small as 15 mins. Mean with SDs were used to summarize the continuous variables (age, and duration); categorical variables were presented with frequencies and percentages. Student’s t-test was used for the comparison of continuous variables between the two periods, and the Chi-2 test or Fisher’s exact test was used for the categorical variables. All analysis was done using SPSS V 21.0. RESULTS: Details of baseline characteristics among 4086 women in the routine management group and 3500 in the post-APRML group were captured in Table S1. The demography, obstetric complications and medical complications were similar in both groups. The ten group classes in both groups were also similar (Table S2). The outcomes have been described in Tables S3 & S4. The primary outcome, which was the duration from admission to delivery, was significantly less in the APRML group. However, the mean difference was only about 36 minutes. The secondary outcomes did not show any difference in the caesarean section rates. However, there was a statistically significant decrease in instrumental deliveries (812 (19.8%) versus 491 (14.1%), p<0.001) in the APRML group, while maternal chorioamnionitis (55(1.6%) versus 91(2.6%) P<0.001) and postnatal fever (192(4.7%) versus 233(6.7%) p<0.001) were more common in the APRML group. Infectious morbidities like wound infections, urinary tract infections and probable neonatal sepsis were less common with APRML. Postpartum haemorrhage was less common with APRML (434 (10.6%) versus 316 (9.02%), p= 0.02. Neonatal asphyxia rates and deaths were similar in both groups. There were no intrapartum stillbirths or maternal deaths. DISCUSSION: Main Findings: This low-cost study was done using a before-and-after study design that has shown some interesting conclusive findings. A large number of cases with diverse patient characteristics could be recruited, and hence, it improved the external validity of the strategy. While the baseline characteristics in both groups were similar, the primary outcome showed a statistically significant trend towards shorter duration spent in the delivery suite, confirming that the implementation of APRML was effective. A reduction of a mean duration of 36 minutes per woman managed with the APRML strategy would definitely contribute to the overall efficiency and improved utilization of health resources. Additionally, the reduction in post-partum haemorrhage, wound infection, urinary tract infection, instrumental delivery and neonatal sepsis support this trend, with a positive result with the use of this APRML strategy. The diagnosis of chorioamnionitis was based on the presence of fever and not based on proven infection and this could explain the discrepancy in findings of increased chorioamnionitis and postpartum fever but decrease in overall infectious morbidity with APRML. Interpretation: There are not many studies on different packages of care. A Cochrane review by Brown et al 2 included seven studies with similar strategies but not identical to our study. They found similar results with a trend towards decreasing the duration of labour with the use of proactive management of labour. Strengths and Limitations: The strength of the study was that a large number of women were included in the study in two distinct time periods but in similar seasons of the year. The HCP managing the intrapartum periods were similar. Outcomes were recorded by office facilitators who were not involved in the study, and therefore, there was no scope for any bias or a Hawthorne effect. An eight-month period was used to assess the thoughts of the HCP and train them in the APRML strategy. There were regular assessments to ensure the strategy was being followed and the outcomes that were studied were prespecified. The results also show that the findings are biologically plausible. The large numbers that could be incorporated in this design have helped to ensure conclusive evidence in this study. The limitations of the study were that it was a low-cost study and data capture was from an electronic database at the end of each month. We did not have information on the use of antibiotics. We did not assess the satisfaction of the mother and family. Importantly we were not sure which component of the strategy was most impactful. However, the study was done in a setting that followed standard protocols with good and accurate documentation of events. We did not have the actual number of women who were managed by the important components of the APRML strategy. CONCLUSION: In conclusion, this low-cost, large study using a before and after study design has shown a decrease in duration of labour, instrumental delivery, infection morbidity and post-partum haemorrhage with an increase in postpartum fever in the mother with the use of the APRML strategy. A before and after study is an inexpensive study design that can be used effectively to find conclusive answers when there is a clinical equipoise, in comparison to randomized controlled trials that are cumbersome to execute. AUTHOR CONTRIBUTIONS: Dr Sharon Sofia S, Dr Evelina Jane, Dr Shiny Nirupama Boddu, Dr Nitin Alexander Abraham, Dr Mintoo Tergestina, Dr Jiji Elizabeth Mathews were involved in the study design, data collection, interpretation and manuscript writing and final approval of the version to be published. Miss. Divya K and Dr Prasanna Samuel Premkumar were involved in the data analysis. All authors agree to be accountable for all aspects of the research work. CONFLICT OF INTEREST: None of the above listed authors have a conflict of interest. FUNDING: There was no external funding obtained for the purpose of this study. ETHICS COMMITTEE APPROVAL: This study was done after obtaining approval from the Institutional Ethical Committee (IRB No14906 Observe dated 12.10.2022). TABLES: TABLE S1 – BASELINE CHARACTERISTICS TABLE S2 – ROBSON’S TEN GROUP CLASSIFICATION SYSTEM TABLE S3 – PRIMARY OUTCOME TABLE S4 – SECONDARY OUTCOMES Supplementary Material File (tables.docx) Download 25.22 KB Information & Authors Information Version history V1 Version 1 23 January 2026 Copyright This work is licensed under a Non Exclusive No Reuse License. Keywords general obstetrics labour: management Authors Affiliations Sharon Sophia S Christian Medical College Vellore View all articles by this author Evelina Jane K Christian Medical College Vellore View all articles by this author Shiny Nirupama Boddu Christian Medical College Vellore View all articles by this author Nitin Alexander Abraham 0009-0005-0852-3038 [email protected] Christian Medical College Vellore View all articles by this author Divya K Christian Medical College Department of Biostatistics View all articles by this author Mintoo Tergestina Christian Medical College Vellore Department of Neonatology View all articles by this author Prasanna Samuel Premkumar Christian Medical College Department of Biostatistics View all articles by this author Jiji Elizabeth Mathew Christian Medical College Vellore View all articles by this author Metrics & Citations Metrics Article Usage 99 views 54 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Sharon Sophia S, Evelina Jane K, Shiny Nirupama Boddu, et al. A before and after study to compare an Additional Proactive Respectful Management of labour with routine intrapartum care.. Authorea . 23 January 2026. DOI: https://doi.org/10.22541/au.176915360.00828639/v1 If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download. For more information or tips please see 'Downloading to a citation manager' in the Help menu . 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