Trends and Determinants of the Use of Episiotomy in a Prospective Population-Based Registry from Central India

doi:10.21203/rs.3.rs-2089297/v1

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Trends and Determinants of the Use of Episiotomy in a Prospective Population-Based Registry from Central India

https://doi.org/10.21203/rs.3.rs-2089297/v1

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published 12 Sep, 2024

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Background: Findings from research and recommendations from the World Health Organization favors restrictive use of episiotomy, but whether this guidance is being followed in India and factors associated with its use are not known.

Methods: We conducted a secondary analysis of data collected by the Maternal Newborn Health Registry, a prospective population-based pregnancy registry established in Central India (Nagpur, Eastern Maharashtra). We examined mode of delivery and use of episiotomy in vaginal deliveries from 2014 to 2018, as well as maternal and birth characteristics, health systems factors, and concurrent obstetric interventions associations with its use with multivariable Poisson regression models.

Results: During the five-year interval, the rate of episiotomy in vaginal birth rose from 13% to 31% despite a decline in assisted vaginal delivery. In the adjusted analysis prior birth, multiple gestations, seven or more years of maternal education, higher gestational age, higher birthweight, delivery by an obstetrician (as compared to midwife or general physician), and birth in hospital (as compared to clinic or health center) were associated with episiotomy. After adjusting for these factors, year over year rise in episiotomy was significant with an adjusted incidence rate ratio (AIRR) of 1.10 [95% confidence interval (CI) 1.08-1.13; p=0.018]. We found an association between episiotomy and several other obstetrics interventions, with the strongest relationship for maternal treatment with antibiotics (AIRR 4.31, 95% CI 3.17 – 5.87; p=0.003).
Conclusions: Episiotomy in this population-based sample from central India steadily rose from 2014 to 2018. This increase over time was observed even after adjusting for patient characteristics, obstetric risk factors, and health system features, such as specialty of the delivery provider. Our findings have important implications for maternal-child health and respectful maternity care given that most women prefer to avoid episiotomy; they also highlight a potential target for antibiotic stewardship as part of global efforts to combat antimicrobial resistance.

Trial Registration: The trial was registered at ClinicalTrials.gov under reference number NCT01073475.

episiotomy

vaginal delivery

birth complications

India

Episiotomy is a surgical procedure to widen the vaginal opening for childbirth. It was once commonly used worldwide. However, because the procedure can cause pain to mothers and place them at risk for infections and serious tears to the vagina, research suggests it should be used sparingly. As such, it is now less often practiced in high-income countries, but whether the same is true in India is not well documented. To answer this question, we used a large population-based pregnancy registry, the Maternal Newborn Health Registry, from Central India (Nagpur) to assess the frequency of episiotomy use between 2014 and 2018 and if there were certain maternal characteristics, features of the health care system, and other pregnancy interventions that were related with its use. Over this five-year period, the use of episiotomy during vaginal delivery rose more than two-fold. It was more often used on women who had never delivered a baby before, were further along in pregnancy, had higher levels of education, had heavier babies, or were carrying more than one baby. Obstetricians were more likely to perform episiotomy than midwives or general physicians and it was more likely to be performed in hospitals than in clinics or primary health centers. This rise during the five-year time frame was significant even when accounting for these patient and provider characteristics, suggesting a shift in medical practice. Because this was an observational study more research is needed to determine if the associations we found are causal.

Episiotomy—the surgical incision of the perineum to enlarge the vaginal outlet at the time of fetal delivery—was once the most common surgical procedure in obstetrics. In 1979, two-thirds of all vaginal deliveries in the United States involved an episiotomy.(1, 2) The theoretical benefits—including prevention of severe perineal injury, faster second stage of labor, and prevention of shoulder dystocia—also led to its routine use in low- and middle-income countries (LMICs) where obstructed labor is a major cause of morbidity and mortality.(3–6) A large study conducted in the mid-1990s in 13 Latin American countries found a median rate of episiotomy in nulliparous women ranging from 69.2% in Mexico to 96.2% in Ecuador.(7, 8) Similarly, a 2003 study from the Global Network for Women and Children’s Research found that rates among nulliparous women neared 100% in many countries, including India.(9)

Despite the theoretical benefits of episiotomy, its true clinical impact remains unclear. There are well documented risks associated with its use, including excessive blood loss, wound dehiscence, infection, and increased risk of severe lacerations in future deliveries.(10–14) A Cochrane systematic review on the topic concluded that restrictive use of episiotomy leads to better clinical outcomes—including a decreased incidence of severe (third- and fourth-degree) lacerations—as compared to routine use.(6) In 2018, the World Health Organization (WHO) recommended against its routine/liberal use.(15) While the American College of Obstetrics and Gynecology (ACOG) recognizes its utility in assisted vaginal delivery (vacuum or forceps delivery), their guideline states that “current data and clinical opinion suggest that there are insufficient objective evidence-based criteria to recommend episiotomy.. .”.(16)

In response to this evidence and the recommendations from professional societies, the rate of episiotomy has significantly declined in many high-income countries, such as United States and Sweden.(5, 17, 18) Less well documented is the recent trend and clinical associations of its use in LMICs. The vast majority of studies identified by a 2019 systematic review and more recent publications—including from India, which accounts for approximately one-fifth of births worldwide—represent data from a single hospital.(19–25) Understanding representative trends in episiotomy use globally is important given mounting evidence that most women prefer to avoid the procedure; its use without full patient consent is a common example of disrespectful and abusive maternity care that can deter women from seeking facility-based delivery, a key strategy to reducing maternal mortality.(26, 27)

The Maternal Newborn Health Registry (MNHR) is a large ongoing prospective population-based pregnancy cohort founded to address gaps in global health research.(28) We used data from the Nagpur (Central India) MNHR site to better understand the pattern of episiotomy use. Our goals were to document trends in use of episiotomy over a five-year period (2014–2018) both overall and as a proportion of vaginal deliveries; to examine its relationship to maternal, pregnancy, and health-system characteristics; and to investigate its association with other obstetric interventions.

Overall study population, setting, and participants

Nagpur is one of eight sites included in the Global Network for Women and Children’s Research funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The Global Network’s goal is to conduct research to improve maternal and newborn outcomes in low-resource settings. MNHR methods have been published elsewhere.(3,28,29) The MNHR enrolls women as early in pregnancy as possible and collects data on pregnancy outcomes, regardless of delivery location, through six weeks (42 days) postpartum. We used observational data of pregnant women and their babies enrolled in the MNHR from 20 government-run primary health centers (PHCs) in rural and semi-urban areas of eastern Maharashtra near Nagpur, India. Each PHC registers 300-500 births yearly with follow-up rates of over 99% for pregnant women and their babies.

MNHR data is derived from two sources: mothers are interviewed by trained auxiliary nurse midwives using standardized data collection forms and medical officers at the PHCs abstract clinical data from hospital and clinic records, such as facility discharge summaries. Information is gathered on maternal characteristics, including age, parity, educational attainment, and BMI (in kg/m² taken at the first antenatal visit). Data collection tools also query key pregnancy and delivery details, including mode of delivery, use of episiotomy, neonatal birth weight, delivery location (hospital versus clinic or PHC), type of delivery provider, and gestational age (calculated based on last menstrual period or, when available, ultrasound) at delivery. Lastly, data are collected on birthing complications, including postpartum hemorrhage and a combined outcome of obstructed/prolonged labor, and other medical interventions including maternal treatment with uterotonics, antibiotics, and blood transfusion. Data from the registry case report forms were entered into a secure electronic database by trained research assistants and verified for accuracy.

Approval by Institutional Review Boards/Ethics Committees was obtained prior to initiation of the MNHR, which is registered in ClinicalTrials.gov (NCT01073475). Individual informed consent is also solicited from each study participant. A Data Monitoring Committee appointed by the NICHD oversees the study and reviews it annually.

Inclusion/Exclusion Criteria

The enrollment diagram for the study is provided in Figure 1. For this secondary analysis aimed at understanding the use of episiotomy, we limited our sample to women who underwent a facility-based delivery with a skilled provider. Exclusion criteria included no documented consent (n=370), spontaneous abortion or medical termination of pregnancy (n= 2,997), home or unskilled delivery (n=177), and missing data for the primary outcome of episiotomy (n=26). After an examination of trends in mode of delivery over the study timeframe in this sample (n=39,789), the remainder of the analysis considered only vaginal deliveries (n=27,614).

Statistical analysis

We computed summary statistics (e.g., proportions) for mode of delivery and use of episiotomy by study year among all births and among the subset of vaginal deliveries. Significance in trends over time were examined using the Cochrane-Armitage test. We obtained unadjusted incidence rate ratios (IRR) and adjusted IRRs (AIRR) with 95% confidence intervals (CIs) from Poisson regression models to assess the relationship of the maternal and pregnancy characteristics with episiotomy using generalized estimating equations to account for clustering of women within PHCs. We excluded 16 cases with extreme values for BMI indicative of data error from this analysis. We built two separate adjusted models with variable inclusion based on clinical relevance. Most variables were considered as categorical, except for year of delivery which was considered continuous. For example, gestational age was classified as preterm (<37 weeks), term (37-40 weeks), or post-dates (>40 weeks). Similarly, maternal age and parity were combined into four categories (<25 years/primiparous, <25 years/multiparous, >=25 years/primiparous, >=25 years/multiparous) consistent with a prior analysis with MNHR data.(30) The first model (presented in Table 1; Forest Plot) explored the relationship between episiotomy and the maternal, pregnancy, neonatal, and health systems characteristics described above. The second model (presented in Table 2) examined associations between episiotomy and labor complications and concurrent maternal interventions queried by the MNHR and was adjusted for all variables included in the first model. We used Benjamini and Hochberg's (BH) procedure to control for the false discovery rate. Statistical significance was set at a two-sided p-value of < 0.05. All analyses were conducted using Stata (StataCorp 2018 release 14.2, College Station, Texas, USA).

Of the 43,359 women screened for participation in the MNHR from 2014-2018, 91.8% (n= 39,789) met our inclusion criteria (Figure 1). During the study period from 2014 to 2018, the proportion of births by esarean delivery rose from 23.8% to 37.3% with a concordant decrease in spontaneous (73.0% to 63%) and assisted (3.2% to 0.2%) vaginal delivery (Figure 2a; p < 0.001 for all trends). While the overall incidence of episiotomy in live births increased 9% (from 10% to 19%) during the five-year study period, as a proportion of vaginal deliveries the frequency of episiotomy rose 2.3-fold from 13% to 31% (Figure 2b; p < 0.001 for all trends). Episiotomy was more commonly used on primiparous women as compared to multiparous across all years of the study, though similar overall increases over time were observed in both groups (Figure 2c; p < 0.001 for all trends).

Among the 27,614 women who had a vaginal delivery, a total of 6,862 (24.8%) underwent episiotomy (Figure 1). The distribution of characteristics of women who delivered vaginally with and without episiotomy are shown in Table 1. Most mothers included in our sample had 7-12 years of formal education, a mean age of 23.9 years (standard deviation 0.018), and had a low BMI (mean BMI 19.4, standard deviation 2.84). In both sub-groups most births were singleton deliveries (99.3%) at term (89.8%) with a low prevalence of neonatal macrosomia (0.40%).

Table 1

The results of the unadjusted regression models examining maternal and pregnancy characteristics are shown in in Table 1 and the results of the adjusted model in the Forest plot displayed in Figure 3. In the multivariable model, episiotomy was significantly more likely in women with multiple gestations (AIRR 1.57, 95% CI 1.25-1.98), higher levels of education (7-12 years AIRR 1.23, 95% CI 1.09-1.39; > 12 years AIRR 1.27, 95% CI 1.12-1.45), term and post-dates pregnancies (AIRR 1.25, 95% CI 1.15-1.36 and AIRR 1.33, 95% CI 1.22-1.46, respectively), and larger neonates (birthweight middle tertile AIRR 1.19, 95% CI 1.12-1.26, and highest tertile AIRR 1.42, 95% CI 1.32-1.53). Multiparous women regardless of age were less likely to undergo episiotomy (multiparous age < 25 AIRR 0.71, 95% CI 0.66-0.77, and multiparous age > 25 AIRR 0.71, 95% CI 0.66-0.77), as were the minority of women who underwent assisted vaginal delivery (AIRR 0.77, 95% CI 0.61-0.97, BH p-value = 0.053).

Figure 3: Adjusted regression model of relationship between episiotomy and maternal, pregnancy, and health system characteristics. Forest plot of adjusted incident rate ratios for Poisson regression model. Overall p-values were generated for each variable; the Benjamini-Hochburg method for multiple comparisons was used to determine significance using a two-sided p < 0.05. Adjusted model adjusts for year of delivery, maternal age-parity group (nulliparous and < 25 years, multiparous and age < 25 years, nulliparous and age > 25 years, and multiparous age > 25 years), use of assisted vaginal delivery, multiple gestations, gestational age (< 37 weeks, 37-40 weeks, > 40 weeks), maternal education (no schooling, 1-6 years, 7-12 years, or > 12 years), maternal body weight index (by tertiles of body mass index), birthweight (tertiles), type of delivery provider (obstetrician, non-obstetrician physician, and midwife), and delivery location (hospital or clinic/primary health center).

Table 2

With regards to health system factors, women who gave birth in hospitals were significantly more likely to receive an episiotomy than those who delivered in clinics and PHCs (AIRR 1.24, 95% CI 1.16 – 1.33). Furthermore, women were 23% less likely to undergo this intervention if delivered by a general physician (AIRR 0.77, 95% CI 0.71-0.82) and 17% less likely if delivered by a nurse midwife (AIRR 0.83, 95% CI 0.78 – 0.88) as compared to those delivered by an obstetrician. The relative risk of episiotomy increased over the study timeframe even when adjusting for other variables (delivery year AIRR 1.10, 95% CI 1.08 – 1.13). The findings of the adjusted analysis are summarized in the Forest plot (Figure 3).

There was a significant relationship between episiotomy and obstructed/prolonged labor in both the unadjusted and adjusted analyses (IRR 1.58, 95% CI 1.34 – 1.86 and AIRR 1.29, 95% CI 1.14 – 1.29, respectively). There was a statistically significant association between episiotomy and receipt of antibiotics (AIRR 4.31, 95% CI 3.17-5.87), uterotonics (AIRR 1.61, 95% CI 1.44 -1.80), and blood transfusion (AIRR 1.52, 95% CI 1.26-1.85) as compared to women who did not receive antibiotics, uterotonics, and blood transfusion, respectively (Table 2).

In this analysis of facility-based births from a prospective population-based pregnancy registry in Central India we found that the use of episiotomy in vaginal delivery more than doubled, from 13–31%, between 2014 and 2018. While the average episiotomy rate of 24.9% over this five-year interval is lower as compared to the estimated incidence from the same study site in 2003 (approximately 45%), it is still notably higher than many high-income countries such as the United States and the 10% threshold that the WHO stated is “a good goal to pursue.”(9, 17, 18, 31) However, the true ideal rate may be even lower: a randomized controlled trial showed no increase in adverse maternal or perinatal outcomes when fewer than 2% of vaginal deliveries utilized episiotomy.(32)

One important strength of our study is that MNHR data reflects deliveries in both public and private hospitals and clinics. As such, it provides a reliable picture of episiotomy incidence, as compared to data derived from individual health facilities that provides biased estimates if extrapolated to the population level. For example, a recent study from 18 academic hospitals in India’s capital New Delhi found that episiotomy was used in 63.4% of vaginal deliveries, much higher than the average from MNHR data published here.(21)

Similar to prior research, we found that primiparous as compared to multiparous mothers, regardless of age, were at higher risk for episiotomy (age < 25 multiparous AIRR 0.71, 95% CI 0.66–0.77; age ≥ 25 AIRR 0.71, 95% CI 0.66–0.77).(19, 33) Other significant maternal or pregnancy characteristics in the adjusted analysis included higher gestational age (37–40 weeks AIRR 1.25, 95% CI 1.15–1.36; > 40 weeks AIRR 1.33, 95% CI 1.22–1.46), multiple gestations (AIRR 1.57, 95% CI 1.25–1.98), and higher fetal weight (middle tertile AIRR 1.19, 95% CI 1.12–1.26; highest tertile AIRR 1.43, 95% CI 1.33–1.54), all of which fit the typical clinical justifications for episiotomy. Interestingly, while assisted vaginal delivery is a more accepted indication for episiotomy—to facilitate placement of a vacuum or forceps—we found it was less likely to be used in these births [AIRR 0.76 (95% CI 0.60–0.96)] though the p-value did not meet the pre-specified cut-off of p < 0.05 when adjusted using the BH procedure.(14, 34–36) We also found an association between episiotomy and obstructed/prolonged labor even when adjusting for use of assisted vaginal delivery and maternal characteristics (AIRR 1.29, 95% CI 0.57–1.59), which could indicate its use as an intervention for obstructed/prolonged labor. While episiotomy has been shown to improve outcomes for obstructed/prolonged labor in women with female genital mutilation, this cultural practice is not common in the population we studied.(37)

Because evidence strongly favors restrictive use of episiotomy, the fact that we found a year over year rise in episiotomy even when adjusting for patient characteristics is concerning. (6) A study from the United States found that provider type was the strongest predictor of episiotomy use in first vaginal delivery, more so than patient demographic and obstetric factors.(33) Similarly, we found that provider type (physician versus midwife), physician specialty (obstetrician versus generalist), and facility type (hospital versus clinic or PHC) were associated with episiotomy use. Nonetheless, the annual rise was still significant when adjusting for these health system features (AIRR 1.11, 95% CI 1.08–1.13, p = 0.010), suggesting not just a shift in workforce but an actual change in practice toward a more interventionalist approach to maternity care. This hypothesis is supported by the concurrent rise in cesarean delivery over the same timeframe. Our data show that in 2018 over one-third of all births were surgical, a trend that is seen across most LMICs.(30, 38, 39) The WHO has recently highlighted the global rise in cesarean delivery without medical indication and the need for effective interventions to address the overmedicalization of childbirth and the resulting iatrogenic harm.(40–42) Despite this movement, there are no recent efforts in the published literature to develop or test interventions to address the overuse of episiotomy.

Prior research has identified a number of maternal risks of episiotomy, such as obstetric anal sphincter injury.(10, 13, 14) We found that women who underwent episiotomy were over four times more likely to be exposed to antibiotics (AIRR 4.31, 95% CI 3.17–5.87) with an overall incidence of 96.9% in this group. Potential risks of antibiotic exposure include Clostridium difficile infection, development of multi-drug resistant organisms, and serious allergic reaction.(43–45) While antibiotics are indicated for third or fourth-degree lacerations, universal prophylaxis for all episiotomies is not recommended.(16, 46) Given the important clinical implications of global emerging antibiotic resistance, this association merits further investigation to establish a causal link and to understand provider reasoning for use of antibiotics in women undergoing episiotomy.(47–49) We also found an association between episiotomy and maternal blood transfusion (AIRR 1.52, 95% CI 1.26–1.85). Prior research has documented high rates of prenatal anemia among women in Nagpur, India, which may explain the need for blood transfusion despite a low incidence of postpartum hemorrhage (0.2%) in our sample.(30)

It is important to note the limitations of our analysis. First, we were unable to distinguish whether the episiotomy performed was midline or mediolateral. As evidence suggest the latter approach is associated with fewer complications, our analysis would be more robust if this variable was available in the MNHR database.(50) Second, the indication for episiotomy is not recorded in the MNHR, which limits our ability to comment on specific clinical rationale for its use. Third, given the large size and diversity of India we cannot extrapolate these findings to the country as a whole. Fourth, given the cross-sectional nature of the data we can only comment on the association between episiotomy and patient characteristics, health systems features, and other medical treatments, thus additional research is needed to establish possible causal links.

Despite increasing pressure by professional societies to abandon routine use of episiotomy in vaginal delivery, we found that its use is becoming more popular in Nagpur, Central India. This rise could not be explained by shifts in patient demographics, obstetric risk factors, or features of the health care system known to influence its use. The increasing popularity of episiotomy without definitive medical benefit has important clinical consequences, as well as implications for patient-centered respectful maternity care. Future research should focus on strategies to de-implement episiotomy, which have the potential to reveal effective approaches to addressing other examples of the overmedicalization of childbirth such as the concurrent rise in cesarean delivery.

ACOG = American College of Obstetrics and Gynecology

AIRR = adjusted incidence rate ratio

BH = Benjamini and Hochberg

CI = confidence interval

IRB = institutional review board

IRR = incidence rate ratio

LMICs = low- and middle-income countries

MNHR = Maternal Newborn Health Registry

NICHD = National Institute of Child Health and Human Development

PHC = primary health center

WHO = World Health Organization

Ethics approval and consent to participate

The MNHR study in Nagpur, India was reviewed and approved by the Lata Medical Research Foundation Institutional Review Board (FWA00012971) and the Partners Human Research Committee, Boston, MA. A Data Monitoring Committee appointed by NICHD reviews the MNH Registry data at least annually. The study was registered at ClinicalTrials.gov (NCT01073475). Research was conduct in concordance with the Declaration of Helsinki. Pregnant women intending to deliver in the study communities or affiliated hospitals were informed about the study and invited to participate in the MNHR if they consented and signed the IRB approved informed consent form.

Consent for publication

Not applicable

Availability of Data

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Competing interests

The authors do not have competing interests to declare.

Funding

This project was funded by grants U01HD058322 and U01HD078439 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the US National Institutes of Health.

Authors’ Contributions

KA, PH, and AP conceived of and designed the study. KA, SR, PH, and AP contributed to the statistical analysis plan. KA conducted the analysis and wrote the first draft of the manuscript, which was revised by SR, PH, and AP. All authors read, revised, and approved the final manuscript.

Acknowledgements

We would like to recognize the auxiliary nurse midwives who collect the MNHR data, the Registry Administrators at each PHC, and the women and families who contribute to the database. In addition, the MNHR would not be possible without the support of RTI International.

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Table 1: Maternal, pregnancy, and newborn characteristics and association with use of episiotomy

Characteristic	Cohort N (%)*	Without episiotomy n (% row)	With episiotomy n (% row)	Unadjusted IRR (95% CI*)	p-value****
Year of delivery				1.14 (1.11 – 1.17)	0.018
2014	4,445 (16.1%)	3,875 (87.2%)	570 (12.8%)	--	--
2015	6,989 (25.3%)	5,242 (75.0%)	1,747 (25.0%)	--	--
2016	6,183 (22.4%)	4,521 (73.1%)	1,662 (26.9%)	--	--
2017	5,549 (20.1%)	4,016 (72.4%)	1,533 (27.6%)	--	--
2018	4,448 (16.1%)	3,098 (69.7%)	1,350 (30.4%)	--	--

Type of vaginal delivery
Spontaneous	27,335 (99.0%)	20,520 (75.1%)	6,815 (24.9%)	Reference	--
Assisted	279 (1.0%)	232 (83.2%)	47 (16.9%)	0.66 (0.50 – 0.86)	0.0028

Age/Parity
Primiparous, < 25 years,	10,838 (39.3%)	7,488 (69.1%)	3,350 (30.9%)	Reference	--
Multiparous, < 25 years	6,451 (23.4%)	5,149 (79.8%)	1,302 (20.2%)	0.64 (0.59 – 0.71)	0.009
Primiparous, > 25 years	2,010 (7.3%)	1,412 (70.3%)	598 (29.7%)	0.98 (0.91 – 1.06)	0.67
Multiparous, > 25 years	8,315 (30.1%)	6,703 (80.6%)	1,612 (19.4%)	0.66 (0.60 – 0.72)	0.006

Multiple gestations	157 (0.6%)	100 (63.7%)	57 (36.3%)	1.34 (1.04 – 1.71)	0.028

Education
None	1,045 (3.8%)	919 (87.9%)	126 (12.1%)	Reference	--
1 – 6 years	1,520 (5.5%)	1,278 (84.1%)	242 (15.9%)	1.08 (0.91 – 1.28)	0.46
7 – 12 years	21,944 (79.6%)	16,402 (74.7%)	5,542 (25.3%)	1.44 (1.24 – 1.67)	0.0045
> 12 years	3,072 (11.1%)	2,132 (69.4%)	940 (30.6%)	1.78 (1.49 – 2.13)	0.0036

Maternal BMI
Lowest tertile (BMI 11.0 – 18.0)	9,313 (33.8%)	6,827 (73.3%)	2,486 (26.7%)	Reference	--
Middle tertile (BMI 18.1 – 20.3)	9,197 (33.3%)	6,907 (75.1%)	2,290 (24.9%)	0.99 (0.94 – 1.04)	0.68
Highest tertile (BMI 20.4 – 55.9)	9,085 (32.9%)	7,003 (77.1%)	2,082 (22.9%)	0.99 (0.94 – 1.04)	0.70

Gestational age at delivery
< 37 weeks	2,809 (10.2%)	2,306 (82.1 %)	503 (17.9%)	Reference	--
37 – 40 weeks	12,811 (46.4%)	9,710 (75.8%)	3,101 (24.2%)	1.42 (1.27 – 1.58)	0.003
> 40 weeks	11,992 (43.4%)	8,734 (72.8%)	3,258 (27.2%)	1.58 (1.40 – 1.78)	0.0026

Neonatal birthweight
Lowest tertile (150g – 2,500g)	10,148 (36.8%)	7,977 (78.6%)	2,171 (21.4%)	Reference	--
Middle tertile (2,501g – 2,800g)	8,600 (31.2%)	6,450 (75.0%)	2,150 (25.0%)	1.21 (1.13 – 1.29)	0.002
Highest tertile (2,801g – 4,500g)	8,808 (32.0%)	6,269 (71.2%)	2,539 (28.8%)	1.45 (1.34 – 1.57)	0.002

Delivery provider
Obstetrician	10,259 (37.2%)	7,292 (71.1%)	2,967 (28.9%)	Reference	--
Other physician	5,805 (21.0%)	5,062 (87.2%)	743 (12.8%)	0.66 (0.60 – 0.73)	0.0018
Nurse midwife	11,548 (41.8%)	8,396 (72.7%)	3,152 (27.3%)	0.62 (0.56 – 0.69)	0.0016

Facility type
Clinic/Health Center	8,830 (32.0%)	7,259 (82.2%)	1,571 (17.8%)	Reference	--
Hospital	18,784 (68.0%)	13,493 (71.9%)	5,291 (28.2%)	1.52 (1.38 – 1.67)	0.0015
Overall percentages exclude missing data IRR = incidence rate ratio CI = confidence interval **Italics denote significant p-values after adjusting for multiple comparisons using the Benjamini-Hochberg method using a two-sided p<0.05

Data presented represent women who underwent skilled facility-based vaginal delivery from 2014-2018 and excludes participants with missing data for the primary outcome of episiotomy. Poisson regression models were used to account for clustering by primary health center.

Table 2: Association of Complications and Other Interventions Peri-Birth with Use of Episiotomy.

Characteristic	Cohort n/N (%)*	Without episiotomy n (% column)	With episiotomy n (% column)	Unadjusted IRR (95% CI*)	p-value****	Adjusted IRR***** (95% CI)	p-value****
Birth complications
Obstructed labor	377/27,614 (1.4%)	257 (1.2%)	120 (1.8%)	1.58 (1.34 – 1.86)	0.010	1.29 (1.14 – 1.29)	0.010
Postpartum hemorrhage	44/27,614 (0.2%)	34 (0.16%)	10 (0.15%)	0.89 (0.51 – 1.57)	0.70	0.95 (0.57 – 1.59)	0.83

Maternal treatments
Uterotonics	22,323/27,608 (80.9%)	16,128 (77.7 %)	6,195 (90.3%)	1.68 (1.48 – 1.91)	0.005	1.61 (1.44 – 1.80)	0.005
Blood transfusion	205/27,614 (0.7%)	111 (0.5%)	94 (1.4%)	1.54 (1.24 – 1.90)	0.003	1.52 (1.26 – 1.85)	0.003
Antibiotics	22,816/27,611 (82.6%)	16,165 (77.9%)	6,651 (96.9%)	5.13 (3.43 – 7.65)	0.003	4.31 (3.17 – 5.87)	0.003
Overall percentages exclude missing data IRR = incidence rate ratio CI = confidence interval Italics denote significant p-values after adjusting for multiple comparisons using the Benjamini-Hochberg procedure using a two-sided p<0.05 ***Adjusted model adjusts for year of delivery, maternal age-parity group (nulliparous and < 25 years, multiparous and age < 25 years, nulliparous and age > 25 years, and multiparous age > 25 years), use of assisted vaginal delivery, multiple gestations, gestational age (< 37 weeks, 37-40 weeks, > 40 weeks), maternal education (no schooling, 1-6 years, 7-12 years, or > 12 years), maternal body weight index (by tertiles of body mass index), birthweight (tertiles), type of delivery provider (obstetrician, non-obstetrician physician, and midwife), and delivery location (hospital or clinic/primary health center).

Results of analysis including Poisson regression models of all facility-based skilled vaginal deliveries from the 2014 – 2018 Maternal Newborn Health Registry conducted in Nagpur, India.

No competing interests reported.

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Trends and Determinants of the Use of Episiotomy in a Prospective Population-Based Registry from Central India

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