Pharmacological and Non-pharmacological Prescribed Methods for Labor and Delivery Pain Relief: a Cross-sectional Study in a Maternity Hospital in Brazil

doi:10.21203/rs.3.rs-3102312/v1

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Pharmacological and Non-pharmacological Prescribed Methods for Labor and Delivery Pain Relief: a Cross-sectional Study in a Maternity Hospital in Brazil

https://doi.org/10.21203/rs.3.rs-3102312/v1

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Improving obstetric outcomes is a global priority. The prescription of non-pharmacological (NPA) or pharmacological analgesia (PA) as well as evidence-based interventions for pain relief are recommended. We conducted a cross-sectional study to evaluate pain and analgesia prescription prevalence among low-risk pregnant women in labor. We used post-labor interviews, assessing pain using Analogue Pain Scale, and medical record reviews, from July to October 2022. Of the 277 participants, 215 (77.61%) were interviewed in the Obstetric Center (OC) and 62 (22.38%) in the midwife-led ward (MLW). In the MLW and OC, the prevalence of NPA prescription was 82.51% and 61.86%, respectively. Mean pain score (PS) in the MLW and OC was 9.09 and 8.93, respectively, on hospital arrival. Severe PS significantly decreased from 84.48% to 61.22% (χ2=21.05) and from 92.16% to 69.50% (χ2=42.04) in the MLW and OC, respectively after NPA. PA prescription rate was 15.81%. Mean PS after PA was 3.41 and severe PS was significantly reduced (χ2=19.05). A significant delay in analgesia prescription was recorded. Request for analgesia was associated with incomplete primary school (OR 0.33, 95% CI 0.13 – 0.84) and severe pain (OR 8.18, 95%CI 1.91 - 35.02). PA prescription was associated with delivery performed by a team of doctors and nurses (OR 2.20, 95%CI 1.08 -4.49, p 0.02) and time of labor >8 hours (OR 7.45, 95%CI 3.27 – 16.99). Both NPA and PA significantly reduced severe pain. Findings underscore the importance of clinical staff training on appropriate analgesia pain management considering patient preferences, timing, and type of analgesia.

Labor Pain

Obstetric Labor

Pregnant Women

Analgesia

Health Personnel

Perinatal healthcare provided to pregnant low-risk women and the complexity and effectiveness of prescribed techniques to treat pain related to labor and delivery.

Negative perinatal outcomes can be reduced through high quality practices, the proper use of preventive measures and technology and interventions performed during labor and delivery assistance¹. Improving obstetric and neonatal indicators has been a global priority since the United Nations established the Millennium Development Goals in 2000². Global efforts to improve these priority indicators have been identified and Brazil has achieved institutional delivery rates higher than 98% ^3,4. Despite recent progress, Brazil continues to have poor indicators, including a maternal mortality rate of 107 per 100.000 live births and an infant mortality rate of 13 per 1.000 live births in 2021. Moreover, Brazil has one of the highest cesarean delivery rates in the world, at 55.7%^5,6,7,8,9. These figures suggest low quality prenatal and perinatal care.

To address these issues, “Stork Network” (SN) was established by the Ministry of Health in 2011 and updated in 2022 to improve the application of standards of care. The SN aims to implement a delivery care model based on women needs. Promotes vaginal delivery, offers technical support for the qualification of health professionals, supports the implementation of monitoring indicators, and provides financial support to improve health facilities across the country^10,11. According to SN guidelines, the management of labor and delivery pain should involve a combination of pharmacological (PA) and non-pharmacological (NPA) interventions, tailored to the needs and preferences of each woman ¹¹. Despite high rates of hospital-based deliveries in Brazil, the use of analgesia during labor and delivery remains low, at only 4%^12,13.

Pain, in addition to representing an important sign of labor, is defined as a subjective, unpleasant, sensitive, and emotional experience that may or may not be associated with tissue damage^14,15,16,17. Factors such as maternal age, parity, ethnicity have been suggested as mediating factors in women´s experience of labor pain^18,19. In addition, pain can also be influenced by anxiety, fear, stress, low sense of security, and environmental factors like type and quality of support provided, furniture noise and restrictiveness of the environment in terms of space among others^20,21,22,23.

The National Guidelines for Assistance for Normal Childbirth, published by the Ministry of Health of Brazil in 2017, recommends that at the place of delivery the pregnant women must have access to pain and suffering relief techniques, including NPA and PA²⁴. In regards to labor pain management, health professionals are advised to assess the pregnant woman’s knowledge about the subject, offer information about the different techniques available, and help them choose the most acceptable and suitable options.

Despite National Guidelines there is a lack of knowledge about the extent to which these guidelines are being implemented. The aim of this study is to evaluate the adoption of recommended evidence-based care during normal labor and birth, specifically focusing on the use of NPA and PA techniques for labor pain relief among women with usual obstetric risk. We hypothesize that despite specialized birthing centers providing care during labor and delivery, the treatment of pain and suffering associated with this special moment is underestimated and undertreated.

We used a prospective, observational, cross-sectional study design to evaluate how practices aligned with recommendations from the National Guidelines for labor care, and to assess the prevalence of prescribed techniques for pain management during labor and delivery assistance for pregnant women at usual obstetric risk. We followed the STROBE statement for reporting observational cross-sectional studies to report our findings²⁵.

Setting

This study was conducted at the Maria da Conceição Maternity Hospital (MMCJ), in Salvador, Bahia, Brazil, between June 15 to October 31, 2022. The MMCJ is a public maternity hospital located in the Suburbio Ferroviário (SF) district, which has a high population density of approximately 25% of the population of the city of Salvador including 22 nighborhoods. Between 2000 and 2015, this district had the highest absolute number of maternal deaths in the city of Salvador. The MMCJ was established in May 2021 and offers obstetric emergency and inpatient units with conventional, intermediate, and intensive neonatal care. The hospital provides care to pregnant women with a complete medical team including obstetric nurses. Women in labor with usual obstetric risk, after an initial risk screening by the nursing team, can choose where to receive labor and delivery assistance. There are two options available: the Obstetric Centre (OC) where women with any risk factors can receive care by obstetric nurses, obstetric medical doctors, or a collaborative team of both and the midwife-led ward (MLW) where obstetric nurses provide exclusive care to healthy women with uncomplicated pregnancies, including free from congenital malformations or fetal/placental disease, and who have attended antenatal care regularly. The MLW uses only NPA techniques for labor pain relief, while the OC can prescribe epidurals or any other PA options. Woman in the MLW needing PA during labor must be transferred to the OC. The medical obstetricians are legally responsible for both MLW and the OC. However, in the MLW obstetric nurses manage the daily care of women during labor and delivery, and the medical obstetricians are consulted only in case of complications.

Participants

To determine the sample size for this study, we used Epi-Info 7.2 to estimate that a convenience sample of 227 participants was needed based on the number of deliveries performed since the hospital’s inauguration and taking into consideration a margin of error of five percent and a confidence interval of 95%. Participant eligibility criteria were postpartum women who were hospitalized in labor for vaginal delivery and attended by either a medical or nursing team in the OC or MLW units.

Excluded were those with high-risk labor, labor with indication for cesarean section, seeking care during delivery, and 42 or more weeks without labor pain.

Data sources/Questionnaire/Data collection tool

A trained researcher collected data using a questionnaire developed by the investigator based on literature review and by reviewing medical records. The questionnaire was administered at bed-side the day after childbirth. The questionnaire consisted of forty multiple-choice questions divided into 6 sections (sociodemographic; obstetric history, comorbidities and past gestational characteristics; labor and delivery history; pain and pain management selected from a list of NPA and PA options; presence of a companion during the childbirth process; and outcoming complications). Race/ skin color was measured using national census classification from the Instituto Brasileiro de Geografia e Estatística (IBGE)²⁶. Data extracted from medical records included time of admission, analgesia management, and documentation of use of evidenced-based interventions. For example, when available we recorded the prescription of oxytocin, prostaglandin, amniotomy, episiotomy, and medical complications.

Sampling technique

A convenience sampling technique was used to select the participants from the patient census of postpartum women, from July to October 2022. The study coordinator reviewed the census from Monday to Friday. All women meeting inclusion criteria were invited to participate.

NPA and PA methods

NPA techniques recorded for pain management throughout labor and delivery include, for example, the freedom to use different positions, ambulation, rhythmic breathing, relaxation techniques, hot shower or immersion baths, massage or the use of a birthing ball. These techniques are intended to reduce pain and the unnecessary administration of drugs that can interfere with the physiological processes that occur during labor and delivery assistance. The PA techniques recorded for pain management include, for example, several ways of administration, such as regional (epidurals, peridural and spinal anesthesia) and intravenous analgesia, and a range of analgesic drug options.

Variables

The following variables were used in the analysis: race/color, maternal age (years); marital status; education level; obstetric history (pregnancies, deliveries, abortions, previous cesarean section); maternal past comorbidities; gestational age at the time of labor (weeks); duration of labor (hours) and birth (minutes); time of admission; presence of a companion of preference during labor and birth; place of delivery; who delivered; pain intensity was measured using the Analogue Pain Scale. The patient was asked to recall the pain intensity before analgesia prescription and after NPA and PA interventions. Pain was categorized by the perceived intensity from: 0-3 mild; 4-7 moderate; and 8-10 severe pain. Fear was measured using a fear intensity scale, rating fear from zero (no fear) to ten (the worst fear). The patient was asked to recall the fear intensity during labor and delivery. Additional data collected included patient request or medical team refusal to fill a prescription of NPA and PA; patient refusal to receive a NPA or PA prescription; time and type of NPA and PA prescriptions. Prescription of more than one type of NPA was categorized as multiple; use of oxytocin, prostaglandin, episiotomy, amniotomy, perineal laceration and lithotomic position; obstetric and neonatal complications; maternal and neonatal deaths.

Statistical methods

We calculated descriptive statistics (mean values, standard deviations, absolute values and proportions). For continuous variables, we used analysis of variance and for categorical variables we used a chi-square test. The prevalence of analgesic prescription orders (NPA and PA) was calculated using the total number of deliveries divided by the total number of deliveries with analgesia multiplied by a coefficient. Comparisons were conducted to assess differences between unit of delivery in participants pain management. Odds Ratios, 95% confidence interval and p<0.05 were used as association variables. Statistical differences in treatment results between patients from the same unit of treatment, before and after analgesia, were calculated using McNemar (one degree of freedom and p<0.05). Univariate and multivariate logistic regressions were used to analyze the determinants of analgesia prescription by medical staff and analgesia request by patients. Multivariate models were constructed using variables found to be significant (p<0.1) in the univariate models. The analysis was performed using Epi-Info 7.2 software.

Socio-demographic characteristics

A total of 277 patients participated, of which 215 (77.61%) were interviewed after labor and delivery assistance in the OC and 62 (22.38%) in the MLW. The mean age in both groups was twenty-five years old (p 0.57). Women between eighteen and thirty-four years old represented 85.20% of the sample. About half (54.88%) of the participants in the OC self-reported as Brown-skinned race/color versus 45.16% in the MLW (OR 0.67, 95%CI 0.38 – 1.19, p 0.17). Black-skinned race/color was more frequent in the MLV (53.23%) when compared to the OC (38.14%). White-skinned race/color was less frequent in both groups. The most frequent level of educational completed in both groups was secondary school (41.40% and 53.22% respectively). Participants attended in the MLW had a higher frequency of higher education completed (17.74%) when compared to the OC (7.44%). Regarding the obstetric history, in both groups, the history of a single pregnancy, a single birth, the absence of previous abortion, and the absence of previous cesarean section were more frequent. The occurrence of comorbidities was 40.00% in the OC versus 11.29% in the MLW. Statistically significant differences between units were identified for black-skinned race/color (OR 1.84, 95%CI 1.04 – 3.26, p 0.03), higher education (OR 3.68, 95%CI 1.17 – 6.13, p 0.01) and the presence of comorbidities (OR 0.31, 95%CI 0.12 – 0.77, p 0.00) (Table 1).

Table 1- Socio-demographic characteristics.

VARIABLES	MLW N= 62 (%)	OC N= 215 (%)	OR (95%CI) – p Value
Race
Brown-skinned women	28 (45.16)	118 (54.88)	0.67 (0.38 - 1.19) – 0.17
Black-skinned women	33 (53.23)	82 (38.14)	1.84 (1.04 – 3.26) – 0.03
White-skinned women	1 (1.61)	15 (6.98)	0.21 (0.02 – 1.68) – 0.11
Educational Level
Illiterate	0 (0.00)	2 (0.93)	--
Incomplete Primary School	8 (12.90)	41 (19.07)	0.62 (0.27 – 1.42) – 0.26
Complete Primary School	0 (0)	4 (1.86)	--
Incomplete Secondary School	9 (14.29)	53 (24.65)	0.51 (0.23 – 1.12) – 0.09
Complete Secondary School	33 (53.22)	89 (41.40)	1.61 (0.91 – 2.84) – 0.09
Incomplete Higher Education*	1 (1.61)	10 (4.65)	--
Complete Higher Education	11 (17.74)	16 (7.44)	3.68 (1.17 – 6.13) – 0.01
Age
Mean Age (min-max)	25.25	25.02	0.57
Marital Status
Married	45 (72.58)	146 (67.91)	1.25 (0.66 – 2.34) – 0.48
Single	17 (27.42)	69 (32.09)	0.79 (0.42 – 1.48) – 0.48
Obstetric History
Single Pregnancy	29 (46.77)	85 (39.53)	1.38 (0.78 – 2.44) – 0.26
Two Pregnancies	18 (29.03)	65 (30.23)	0.94 (0.50 – 1.75) – 0.85
Three Pregnancies	8 (12.90)	35 (15.81)	1.36 (0.67 – 2.74) – 0.39
More Than Three Pregnancies	2 (3.22)	30 (13.90)	--
Single Previous Birth	35 (56.45)	104 (49.77)	1.37 (0.73 – 2.56) – 0.67
Two Previous Births	18 (29.03)	58 (26.98)	1.10 (0.59 – 2.05) – 0.74
Three Previous Births	8 (12.90)	34 (15.81)	0.78 (0.32 – 1.80) – 0.57
More Than Three Previous Births	1 (1.61)	17 (7.91)	--
No Previous Abortion	50 (80.65)	168 (78.14)	1.16 (0.57 – 2.36) – 1.01
Single Previous Abortion	11 (17.74)	38 (17.67)	1.00 (0.47 – 2.10) – 0.99
More Than One Previous Abortion	1 (1.61)	9 (4.19)	--
Whithout C Section	62 (100)	193 (89.77)	--
Comorbidities
Whithout Comorbidities	55 (88.71)	155 (72.09)	0.31 (0.12 – 0.77) – 0.00
With Comorbidities and Types	7 (11.29)	62 (40.00)	--
Maternal Syphilis	1 (14.29)	16 (25.81)	--
Gestational Diabetes	0 (0.00)	11 (17.74)	--
Gestational Hypertension	0 (0.00)	10 (16.13)	--
Anemia	1 (16.67)	9 (15.52)	--
Toxoplasmosis	0 (0.00)	5 (8.06)	--
Urinary Tract Infection	2 (28.57)	3 (4.84)	--
Asthma	2 (28.57)	2 (3.23)	--
Others	2 (28.57)	6 (9.66)	--

*Higher education: university degree. MLW (midwife-led ward). OC (Obstetric Center).

Labor and Delivery assistance characteristics

When considering the current pregnancy, participants in this study arrived at the maternity ward at a median 39 weeks of gestation (p 0.63). Approximately 95.3% of deliveries were registered between 37 and 41 weeks of gestational age (Table 2).

Table 2- Labor (L) and Delivery (D) Characteristics

	MLW N= 62 (%)	OC N= 215 (%)	OR (95%IC) – p Value
Mean Gestational Age	39.08 (37 – 41)	39.99 (33 – 42)	0.63
Mean Total Duration of L and D (h)	17.41 (4 – 73)	14.97 (2 – 61)	0.18
Mean Assisted Time for L and D (h)	9.75 (1 – 48)	8.63 (1 – 42)	0.32
L Assisted Time < 3 (h)	13 (20.97)	70 (32.56)	0.54 (0.27 – 1.07) – 0.07
L Assisted Time 4 – 8 (h)	19 (30.65)	58 (26.98)	1.19 (0.64 – 2.20) – 0.57
L Assisted Time > 8 (h)	30 (48.39)	87 (40.47)	1.37 (0.77 – 2.52) – 0.30
Median Time for D (min)	33.29 (2 – 60)	31.55 (1 – 180)	0.51
Who Delivered
Both (physician and nurse)	7 (11.29)	90 (41.86)	0.17 (0.07 – 0.40) – 0.00
Nurse	52 (83.87)	65 (30.23)	12.00 (5.74 – 26.00) – 0.00
Physician	2 (3.23)	45 (20.93)	--
First Nurse and after Physician	1 (1.61)	15 (6.98)	--
Pain and Fear Scale and Request for Analgesia
Median Pain Scale at Arrival	9.09 (4 – 10)	8.93 (2 – 10)	0.52
Mild Pain (0 – 3)	0 (0.00)	6 (2.79)	--
Moderate Pain (4 – 7)	10 (16.13)	24 (11.16)	1.54 (0.68 – 3.40) – 0.29
Severe Pain (8 – 10)	52 (83.87)	185 (86.05)	0.84 (0.38 – 1.83) – 0.66
Fear Scale (0 – 10)	5.34 (0 – 10)	6.70 (0 – 10)	0.11
Mild Fear (0 – 3)	7 (16.28)	19 (12.50)	0.97 (0.46 – 2.03) 0.93
Moderate Fear (4 – 7)	13 (3.23)	45 (29.61)	0.73 (0.28 – 1.88) 0.51
Severe Fear (8 – 10)	23 (53.49)	88 (57.89)	1.19 (0.60 – 2.36) 0.60
Requested for Analgesia	16 (25.81)	62 (28.84)	0.85 (0.45 – 1.62) 0.64
Team Refused Analgesia Request	6 (42.85)	13 (24.07)	--

MLW (midwife-led ward). OC (Obstetric Center).

The mean duration of labor and delivery (starting from when the symptoms began in the patient´s home until the birth in the unit) was 17.41 hours in the MLW versus 14.97 hours in the OC (p 0.18). The mean elapsed time under the care of the health team during labor until delivery (the duration of supervised labor and delivery assistance in the unit) was 9.75 hours in the MLW and 8.63 in the OC (p 0.32). Considering only primiparous women, the mean elapsed time, in hours, under care was 10.40 for OC patients and 11.74 for MLW patients (p 0.40). In the OC, the percentage of patients who were followed up during labor until delivery for more than eight hours was 40.47% versus 48.39% in the MLW (OR 1.37, 95%CI 0.37 – 2.52, p 0.30). The mean time of delivery in minutes was 33.29 in the MLW versus 31.55 in the OC (p 0.51). When assessing who performed the delivery, nurses were responsible for 80.87% of deliveries in the MLW versus 30.23% in the OC (OR 12.00, 95%CI 5.74 – 26.00, p 0.00). In the OC, deliveries were performed more frequently by a collaborative team of nurses and doctors (41.68%).

Labor and delivery perceived pain and fear

The mean values of labor pain intensity on arrival were 9.09 in the MLW and 8.93 in the OC (p 0.52). Severe pain on arrival was more frequently reported by OC patients (86.04%) when compared with MLV patients (83.87%). Even with severe pain, only 28.84% of the OC patients and 25.81% of the MLW patients requested analgesia (Table 3). In the MLW, 42.85% of patient´s requests for analgesia were refused versus 24.07% in the OC. The mean value for fear scale on arrival was 6.70 in the OC versus 5.36 in the MLV (p 0.11). No differences on mild, moderate or severe fear were identified. No associations were identified between fear and request for analgesia and between fear and the absence of a companion during labor and/or during birth.

Pain management

NPA techniques for pain relief. The prevalence of prescription of multiple NPA techniques for labor pain management was 82.51% in the MLW versus 61.86% in the OC (Table 3).

Table 3. Labor and delivery pain management.

	MLW N= 62 (%)	OC N= 215 (%)	OR (95%IC) – p Value
Prescribed Multiple NPA Methods	52 (82.51)	133 (61.86)	1.56 (0.55 – 4.38) – 0.39
Prescribed Just a Single NPA Method	5 (7.93)	20 (9.30)	0.63 (0.22 – 1.79) – 0.39
Whithout NPA Prescription	4 (6.45)	57 (26.51)	5.30 (1.84 – 15.29) – 0.00
Prescribed but Patient Refused NPA	1 (1.61)	5 (2.32)	--
Prescription Delay for NPA (h)	5.54 (0 – 22)	4.36 (0 – 22)	0.15
Improved Pain After NPA	31 (54.39)	62 (40.52)	1.75 (0.94 – 3.23) – 0.07
Median Pain Scale After NPA	7.54 (1 – 10)	8.12 (1 – 10)	0.10
Mild Pain After NPA (0 – 3)	3 (5.26)	1 (0.66)	--
Moderate Pain After NPA (4 – 7)	24 (42.11)	54 (35.29)	1.33 (0.71 – 2.48) – 0.36
Severe Pain After NPA (8 – 10)	30 (52.63)	98 (64.05)	0.62 (0.33 – 1.15) – 0.13
Pain Scale and Pharmacologic Analgesia (PA)
Whithout PA Prescription	62 (100)	174 (80.93)	--
With PA Prescription	0 (0)	34 (15.81)	--
Prescribed but Patient Refused PA	0 (0)	7 (2.25)	--
Prescription Delay for PA (h)	0 (0)	11.65 (2 -23)	--
Improved Pain After PA	0 (0)	30 (88.23)	--
Whithout Pain Improvment After PA	0 (0)	4 (11.76)	--
Pain Scale After PA	--	3.41 (0 – 10)	--
Mild Pain After PA (0 – 3)	--	21 (38.24)	--
Moderate Pain After PA (4 – 7)	--	9 (26.47)	--
Severe Pain After PA (8 – 10)	--	4 (11.76)	--

MLW (midwife-led ward). OC (Obstetric Center). NPA (Non-Pharmacologic Analgesia). PA (Pharmacologic Analgesia).

In both units, the most frequently prescribed techniques for NPA were warm water shower, breathing techniques, massage, and birthing ball (Table 4).

Table 4. Analgesic Techniques and Evidence-based prescriptions and complications.

Non-Pharmacological Analgesia Methods	MLW N= 62 (%)	OC N= 215 (%)	OR (95%CI) - p Value
Warm Water Shower	54 (94.74)	110 (71.90)	7.03 (2.08 – 23.71) – 0.00
Breathing Techniques	42 (73.68)	105 (68.63)	1.28 (0.64 – 2.52) – 0.47
Massage	44 (77.19)	90 (58.82)	2.36 (1.17 – 4.75) – 0.01
Horse	31 (54.39)	79 (51.63)	1.11 (0.60 – 2.05) – 0.72
Exercises	25 (45.86)	62 (40.52)	1.14 (0.62 – 2.12) – 0.66
Ball	25 (43.86)	36 (23.53)	2.53 (1.33 – 4.28) – 0.00
Music	9 (15.79)	24 (15.69)	1.00 (0.43 – 2.32) – 0.98
Aroma therapy	2 (3.51)	3 (1.96)	--
Pharmacological Analgesia Methods	MLW N= 62 (%)	OC N= 215 (%)	OR (95%CI) - p Value
Raquideana + peridural	--	18 (42.94)	--
Peridural	--	14 (41.18)	--
Others	--	2 (5.88)	--
Non-Pharmacological Variables Associated With Decreasing Severe Pain
	Not With Severe Pain	Severe Pain	OR (95%CI) - p Value
Did Not Receive Massage	22 (28.57)	55 (71.43)	0.49 (0.27 – 0.89) 0.02
Receive massage	60 (44.78)	74 (55.22)
Labor And Delivery Evidence-based Interventions
Induction Oxytocin	16 (26.23)	67 (31.46)	0.77 (0.40 – 1.46) – 0.43
Episiotomy	0 (0.00)	1 (0.46)	--
Amniotomy	12 (19.35)	86 (40.19)	0.35 (0.17 – 0.70) – 0.00
Lithotomy Position	0 (0.00)	(0.00)	--
Labor and Birth Companion of Preference
Companion during L	61 (98.39)	196 (91.16)	5.91 (0.07 – 45.08) – 0.05
Companion during D	61 (98.39)	191 (88.84)	7.63 (1.01 – 57.84) – 0.02
Laceration During Delivery
Laceration	42 (67.74)	142 (66.36)	1.06 (0.58 – 1.94) – 0.83
Tipo 1 Laceration	24 (57.14)	64 (46.04)	1.56 (0.77 – 3.13) – 0.20
Tipo 2 Laceration	17 (40.48)	70 (52.36)	0.67 (0.33 – 1.35) – 0.26
Tipo 3 Laceration	1 (2.38)	5 (3.60)	--
Tipo 4 Laceration	0 (0.00)	0 (0.00)	--
Maternal Complications
Obstetric Complications	4 (6.45)	13 (6.07)	1.06 (0.33 – 3.39) – 0.91
Hemorrage After Delivery	2 (50.00)	11 (76.47)	0.20 (0.01 – 2.38) – 0.19
Outher Obstetric Complications	2 (50.00)	4 (23.53)	--
Neonatal Complication
Neonatal Complication	3 (4.83)	27 (12.56)	0.35 (0.10 – 1.20) – 0.08
Respiratory Discomfort	1 (33.33)	13 (48.00)	--
Congenital Syphilis Risk	--	5 (17.86)	--
Jaundice	2 (66.67)	5 (17.86)	--
Other Neonatal Complications	0 (0.00)	5 (17.86)	--

MLW (midwife-led ward). OC (Obstetric Center).

The application of massage during labor was the only NPA statistically associated with a decrease in the number of women reporting severe pain (OR 0.50, 95%CI 0.27 – 0.91, p 0.02). Considering the time of admission of the patient to the maternity hospital, the delay in prescribing NPA in hours at the MLW was 5.54 and at the OC 4.36 (p 0.15). After prescribing NPA, the mean pain based on the analogic pain scale was 8.12 in the OC and 7.54 in the MLW (p 0.10). Severe pain at arrival was compared with severe pain after NPA. Of a total of 62 patients at MLW, 58 (93.53%) were prescribed NPA. Of those, 49 (84.48%) reported severe pain and 9 (15.51%) mild or moderate pain before treatment. After receiving the treatment, 30 (61.22%) of those who initially referred severe pain continue with the same pain score and 28 (38.78%) reported reduction to mild or moderate pain. Differences between MLW patients reporting severe pain, before and after analgesia prescription, was statistically significant (χ2=21.05 > χc2=3.84). In the OC, of a total of 215 patients, 71.16% were prescribed NPA. Of those, 141 (92.16%) reported severe pain and 12 (7.84%) mild or moderate pain. After the prescription of NPA 98 (69.50%) continued to report severe pain and 43 (30.50%) reported a reduction to mild or moderate pain. One patient (8.33%) with initial mild and moderate pain reported severe pain after NPA. Similarly, differences between OC patients reporting severe pain, before and after NPA prescription, were statistically significant (χ2=42.04 > χc2=3.84). As expected, no patient received PA at the MLW. However, no unit transfer from MLW to the OC was recorded despite patient request for analgesia.

Pharmacological pain relief techniques in the OC. In the OC, PA was prescribed for only 18.10% (of those, 2.25% refused the medication due to concerns about its effects on the progress of labor), and 81.00% were not prescribed PA (Table 3). The delay, in hours, in prescribing PA was 11.65. Of those who received PA, 88.23% reported pain improvement. After NPA, only 34 (15.85%) patients were prescribed and received PA. Of those patients, 23 (67.64%) reported severe pain before PA and 11 (32.36%) reported mild or moderate pain. After PA, severe pain was reported by 6 (26.08%) and 17 (73.92%) reported a reduction to mild or moderate pain. None of the initial eleven patients with moderate and mild pain changed their score to severe pain. The difference between severe pain, before and after pharmacological analgesia prescription, was statistically significant (χ2=19.05 > χc2=3.84). The mean pain scale recorded after pharmacological analgesia was 3.41. No differences were found between race/color and prescription of NPA and PA for pain relief.

Use of Evidence-based interventions

Oxytocin prescription ranged from 26.23% in the MLW to 31.46% in the OC (p 0.43). No lithotomic position was recorded because there are no stretchers available for this purpose in the units and episiotomy was registered only once (0.46%) in the OC. Amniotomy was significantly more frequent in the OC when compared to MLW (0.37 (0.17 – 0.70) – 0,00). Patients in the MLW more frequently had a companion during delivery (98.39%) compared to the OC (88.84%) and the difference was statistically significant (OR 7.63, 95%CI 1.01 – 57.84, p 0.02). The frequency of laceration during childbirth was high in both groups. Type I laceration was more frequent in the MLW (57.14%) compared to the OC (46.04%). Type 2 laceration was more frequent in the OC (52.36%) compared to the MLW (40.48%). No significant differences were found in the percentage of patients with a companion during labor, type 2 laceration and for obstetric and neonatal complications.

Variables associated with labor and delivery pain management

Variables associated with not requesting analgesia for pain management during labor and delivery assistance, prescription of NPA during labor, and prescribing PA are provided in Table 5.

Table 5. Variables Associated Whit Labor and Delivery pain management

	Did not Request for Analgesia N (%)	Resquested for Analgesia	OR (95%CI) - p Value
Complete Primary School	156 (68.42)	72 (31.58)	0.30 (0.12 – 0.74) – 0.00
With Incomplete Primary School	43 (78.39)	6 (12.24)
L Assistance > 3 (h)	132 (68.04)	62 (31.96)	0.50 (0.27 – 0.94) – 0.03
L Assistance < 3 (h)	67 (80.72)	16 (19.28)
L Assistance < 8 (h)	123 (76.88)	37 (23.13)	1.79 (1.05 – 3.04) – 0.02
L Assistance > 8 (h)	76 (64.96)	41 (35.04)
Not a Intense Pain (< 8)	38 (95.00)	2 (5.00)	8.96 (2.10 – 38.15) – 0.00
Intense Pain (8 – 10)	161 (67.93)	76 (32.07)
Not a Moderate Pain at Arrival (<4 - >7)	166 (68.31)	77 (31.69)	0.06 (0.00 – 0.48) – 0.00
Moderate Pain at Arrival (4 – 7)	33 (97.06)	1 (2.94)
	PA Not Offered	Offered PA
D not Performed by Both Physician and Nurse	160 (88.89)	20 (11.11)	2.21 (1.13 – 4.32) – 0.01
D Performed by Both Physician and Nurse	76 (78.35)	21 (21.65)
D Not Performed by Nurse	128 (80.00)	32 (20.00)	0.33 (0.15 – 0.72) – 0.00
D Performed by Nurse	108 (92.31)	9 (7.69)
L Assistance > 3 (h)	154 (79.38)	40 (20.62)	0.04 (0.00 – 0.34) – 0.00
L Assistance < 3 (h)	82 (98.80)	1 (1.20)
L Assistance < 8 (h)	152 (95.00)	8 (5.00)	7.46 (3.29 – 16.89) – 0.00
L Assistance > 8 (h)	84 (71.79)	33 (28.49)
	NPA Not Offered	Offered NPA
L Assistance > 3 (h)	31 (15.98)	163 (84.02)	0.26 (0.14 – 0.46) – 0.00
L Assistance < 3 (h)	35 (42.17)	48 (57.83)
L Assistance < 8 (h)	52 (32.50)	108 (67.50)	3.54 (1.85 – 6.77) – 0.00
L Assistance > 8 (h)	14 (11.97)	103 (88.03)
	Not a Severe Pain After NPA	Severe Pain After NPA
Did Not Received Massage as NPA	22 (28.95)	54 (71.05)	0.50 (0.27 – 0.91) – 0.02
Received Massage as NPA	60 (44.78)	74 (55.22)

NPA (Non-Pharmacologic Analgesia). PA (Pharmacologic Analgesia). L (Labor). D (Delivery)

Patients with incomplete primary school (OR 0.30, 95%CI 0.12 – 0.74, p 0.00), time of labor and delivery assistance of less than three hours (OR 0.50, 95%CI 0.27 – 0.94, p 0.03), and moderate pain at arrival (OR 0.06, 95%CI 0.00 – 0.48, p 0.00) were associated with not requesting any type of analgesia for pain management during labor and delivery assistance.

Variables associated with the prescription of NPA were the time of assistance during labor and delivery of less than three hours (OR 0.26, 95%CI 0.14 – 0.46, p 0.00) and the time of assistance during labor and delivery longer than eight hours (OR 3.54, 95%CI 1.85 – 6.77, p 0.00).

Variables associated with prescribing PA were labor and delivery assistance performed by a collaborative team of doctors and nurses (OR 2.21, 95%CI 1.13 – 4.32, p 0.01), delivery exclusively performed by the nursing team (OR 0.33, 95%CI 0.15 – 0.72, p 0.00), time of labor and delivery assistance less than three hours (OR 0.04, 95%CI 0.00 – 0.34, p 0.00) and time of labor care longer than eight hours (OR 7.46, 95%CI 3.29 – 16.89, p 0.00).

Logistic regression

A logistic regression was performed to assess the association of each independent variable with the patient´s request for analgesia and analgesic prescription during labor and delivery assistance (Table 6 and 7).

Table 6. Logistic Regression for any Analgesia Request for Pain Relief.

Variables	OR	IC (95%)	Valor de P
Incomplete Primary School	0.33	0.13 – 0.84	0.02
Severe Pain (8 – 10)	8.18	1.91 – 35.02	0.00

Table 7. Logistic Regression for Pharmacological Analgesia Prescription for Pain Relief.

Variável	OR	IC (95%)	Valor de P
D Performed by Both Physician and Nurse	2.20	1.08 – 4.49	0.02
L Assisted Time > 8 (h)	7.45	3.27 – 16.99	0.00

Additional Table. Variables Associated with Perineal Laceration.

	No Type I Laceration	Type 1 Laceration
D Not Performed by Nurse	62 (57.94)	45 (42.06)	1.91 (1.04 – 3.48) – 0.03
D Performed by Nurse	31 (41.89)	43 (58.11)

The variables statistically associated with a patient’s request for analgesia included incomplete primary school (OR 0.33, 95%CI 0.13 – 0.84, p 0.02) and severe pain upon arrival (OR 8.18, 95%CI 1.91 - 35.02, p 0.00). The variables statistically associated with analgesic prescription during labor and delivery assistance were delivery performed by a collaborative team of doctors and nurses (OR 2.20, 95%CI 1.08 -4.49, p 0.02) and the time of labor and delivery assistance in the unit greater than eight hours (OR 7.45, 95%CI 3.27 – 16.99, p 0.00).

Our study population demographics, including race/color, age, education, and obstetric history were similar to those reported in a large cohort study conducted by Leal et al conducted in the Northeast region of Brazil, which included 23,532 postpartum women ²⁷. In our study, less than five percent of the pregnant women reported a gestational age different from the 37 to 41 weeks. In contrast to a large transversal retrospective study by Simoes et al. in 2022, found that only 43.91% patients fell within the normal gestational range²⁸. Differences are likely due to our study population focusing exclusively on low-risk pregnant women.

Our study found that women were more frequently attended by nurses in the MLW or by a collaborative team of nurses and doctors in the OC. Only 21% of deliveries were solely attended by doctors. These findings contrast with those of a large cross-sectional study by Granado et al. in 2017 which included 571 maternity hospitals across Brazil. In the Northeast region the proportion of vaginal births attended by doctors ranged from 64.7% to 70.6%²⁹. However, our study focused on low-risk pregnant women, which could explain the higher rates of nurse delivery identified.

In this study, we observed that despite the availability of medical staff and multiple options to help women cope with pain, the majority of women did not request PA or NPA (OC 71,16% versus MLW 74,19%). The request for analgesia was found to be associated with pain intensity, labor progression time, and educational level. In a cross-sectional study conducted by Adebayo et al at a tertiary hospital in Nigeria, 38.9% of patients with severe pain did not desire pain relief, and women with no formal education had higher risk of severe pain compared to those with primary and tertiary level of education³⁰.This finding may indicate a failure in guidance and education during prenatal care and during hospital admission about the available techniques for analgesia to ensure women were aware of the options for pain relief during labor.

In our study, massage was the only NPA method associated with reduction of severe pain. NPA techniques, referred to as mind-body interventions, are designed to induce calm and to distract and alleviate pain³¹. Our findings were consistent with a Cochrane systematic review (CSR) which identified that massage significantly reduces labor pain and improved the emotional experience of labor. However, it is important to note that the evidence supporting the efficacy was rated as low and very low-quality³². Nonetheless, the high prevalence of prescription of NPA in our study is noteworthy, with over 90% of women in the MLW and over 72% in the OC receiving such prescriptions. This is in contrast to the findings of a cross-sectional study with 768 postpartum women from eleven maternity hospitals conducted in the Northeast region of Brazil, where only 26.1% received a NPA prescription for pain relief³³.

In our study, despite the prescription of NPA, a high percentage of patients continued to experience severe pain and no physicians were called by MLW nurses to transfer patients with severe pain for PA prescription. This finding is consistent with a qualitative descriptive study conducted in a hospital in Tanzania which found that healthcare providers often do not offer pharmacological pain relief during labor pain and after childbirth. The authors suggested that reasons for this may include a shortage of staff, lack of equipment, and fear regarding the effect of opioids on the patient and baby³⁴.

PA is an effective form of pain relief during labor^35,36. However, concerns regarding its safety may be a reason for refusing or not requesting PA. In our study, the prescription of PA was low and frequently prescribed after eight hours of labor. A CSR, evaluating early versus late initiation of analgesia for labor, found that there was no clinically significant difference in maternal and neonatal outcomes for early and late initiation³⁷. It is worth noting that various forms of NPA were prescribed prior to PA, which is in line with current guidelines recommending NPA as a first-line treatment for labor pain. Additionally, it is important to consider that PA it is not always associated with a positive birth experience as it could decrease women´s feelings of control. Furthermore, PA is more expensive than NPA, can delay second stage of labor, and increase the likelihood of further interventions such as instrumental birth, and caesarean section^31,38.

Physiological concepts related to labor must also be considered. Labor support, such as reassurance and touch, facilitate release of oxytocin, which stimulates uterine myometrial contractions and labor progress ^39,40. However, this physiological pattern can be modified by specific interventions such as oxytocin infusion⁴¹. In this study, the mean follow-up labor time (time from arrival in labor to birth) was 10.40 hours in the OC and 11.74 hours in the MLW. The prevalence of oxytocin prescription was less than 31% and it was more frequent at the OC. These findings differed from those presented in a randomized controlled trial by Stjernholm et al in Sweden which compared primiparous women with spontaneous labor. The use of oxytocin was 79% by women who received continued support by midwife and nurse, compared to 90% in women with standard care⁴².

The presence of a companion has been shown to provide emotional support and decrease the prevalence of anxiety, fear and stress⁴³. In this study, a high percentage (>88%) of pregnant women were accompanied by a companion. This is in contrast to a national hospital-based study conducted in Brazil with countrywide representation of 4102 low-risk pregnant women, where only 23.45% had a registered companion⁴⁴. Additionally, a study of 2,070 women in labor from the Southern region of Brazil, found that the presence of a companion was associated with a higher use of NPA techniques for pain relief. However, in our study, we did not find any associations between the presence of a companion and the prescription of analgesia, feeling any degree of fear, or the reporting of greater pain relief⁴⁵.

According to World Health Organization (WHO), opioid analgesia is recommended for pain relief for women requesting pain relief during labor, along with relaxation and non-pharmacological techniques. Intrapartum care must always respect women preferences and consider the clinical evidence and effectiveness, complexity, diversity, equity, acceptability and feasibility of treatment options. Effective staff communication is also critical in ensuring appropriate analgesia prescription⁴⁶. In our study, while we identified high rates of adherence to good practice recommendations, such as encouraging childbirth in positions other than lithotomic or not prescribing routinely episiotomy, the pain during labor and delivery assistance continued to be significant. Our findings highlighted a significant delay in the time for analgesia prescription, which may not be centered on women needs. The period of time between the initiation of labor assistance to delivery longer than eight hours was significantly associated with the patient´s higher request for analgesia and the prescription of analgesia by the medical staff. Additionally, pain intensity greater than seven on the analogic pain scale, was significantly associated with the patient´s higher request for analgesia and the prescription of analgesia by the medical staff. Therefore, hospital routines should be evaluated, as well as the development of institutional protocols that define criteria for prompt analgesia prescription and delivery.

Some limitations of this study should be noted. First, the perceptions of patients about the adequacy of infrastructure were not collected. While it is likely that modern and comfortable facilities in the new maternity hospital had a positive impact on patient´s experience, this was not formally assessed. Second, the study did not explore the patient´s prior knowledge, beliefs, and preferences about the different therapeutic modalities for pain and suffering relief which may have influenced their decisions regarding pain management during labor. Similarly, the beliefs, knowledge, concerns and needs of the healthcare providers regarding the treatment of pain were not assessed. Third, the study did not assess the prevalence of anxiety, depression or other mental health problems, which may have affected their experience of labor pain. Fourth, recall bias may have influenced the accuracy of the data collected. To minimize recall bias interviews were conducted within 24 horas after childbirth. Finally, adverse events and safety related with PA were not systematically recorded in the questionnaire.

In conclusion, this study highlights the complex nature of treating pain during labor and delivery, and the underutilization of recommended pharmacological pain management techniques. While we observed a significant reduction in the proportion of patients with severe pain after NPA and PA treatment, there was a delay in prescribing and implementing these treatments. Additionally, clinical staff did not always prescribed PA at patient´s request, as recommended by WHO standards of care. It is crucial to provide additional training for clinical staff on the appropriate prescription (timing, type and patient oriented) of analgesia techniques for pain assistance. Furthermore, there is a lack of validated, multidimensional scale instruments available to measure the impact of pain during labor and delivery assistance. Further studies use mixed methods to develop and evaluate women-centered multicomponent interventions to improve pain and suffering management during labor and delivery assistance.

Ethics approval and consent to participate

Ethical approval and consent to participate. This study protocol was approved by the Escola Bahiana de Medicina e Saúde Pública Ethical Review Board N°5.448.999. Accordingly, after the objective of the study was explained, signed informed consent was obtained from all participants. That all methods were performed in accordance with the relevant local guidelines and regulations.

Consent for publication

The authors consent to the publication of this article.

Availability of data and materials

The authors made all necessary raw data available for sharing. However, by having personal information in the dataset, it will be made available by the authors upon reasonable request.

Competing interests

The authors have no conflicts of interest to declare.

Funding

Not applicable. There was no financial support.

Authors' contributions

Authors’ contributions: manuscript writing and revision, statistical analysis, data interpretation, and table presentation: J. Calcagno; manuscript writing and revision: S. Iribarren; manuscript writing, statistical analysis: C. Villarreal; manuscript writing and revision: P. Oliveira and manuscript writing: A. Nizarala.

Acknowledgments

We thank Elizangela de Santana Santos Dias and Laiane Santos de Santana for their support in data collection for this research.

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No competing interests reported.

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Pharmacological and Non-pharmacological Prescribed Methods for Labor and Delivery Pain Relief: a Cross-sectional Study in a Maternity Hospital in Brazil

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