Bundle for quantifying vaginal blood loss after childbirth

Objective: To construct and validate the content of a bundle to quantify vaginal blood loss after childbirth. Methods: This is a methodological study developed from February to August 2022, divided into bibliographic survey, instrument construction and content validity, by 14 experts. The instrument for validity consisted of 11 items selected from a systematic review. For each item in the bundle, a Likert scale was applied


Introduction
3)(4) On the national scene, data from the Brazilian Health System Department of Informatics (DATASUS -Departamento de Informática do Sistema Único de Saúde) indicate that, of maternal deaths occurring between 1996 and 2020, 69% of cases were due to direct obstetric causes and, of these causes, 17.3% (5,056) resulted in deaths due to PPH. (5) PPH diagnosis is defined as blood loss of more than 500 ml after vaginal childbirth, or more than 1,000 ml during cesarean section in the first 24 hours, or any blood loss after childbirth capable of causing hemodynamic instability or requiring blood transfusion for control. (1,2,6)8) Measuring postpartum blood loss is extremely important to improve quality of care as well as to prevent maternal death from PPH.In 2015, the World Health Organization (WHO) published the Before birth: WHO safe childbirth checklist, an instrument in the form of a checklist that aims to promote greater safety for the dyad.The checklist must be applied upon admission, at birth, immediately after birth and before hospital discharge.Given the magnitude of PPH, the document recommends assessing maternal bleeding in the first hour after birth, instituting measures for its treatment in cases where an increase is detected, in addition to reinforcing the need for assessment before hospital discharge. (9)he prevalent diagnostic method adopted to quantify blood loss is visual estimation.It is subjective and has a chance of underestimation in around 30 to 50% of cases. (6,10)Other commonly used strategies are gravimetry via weighing of compresses and surgical drapes used to assist with childbirth, laboratory and/or clinical parameters, shock index. (1,2,6)uantifying blood loss is recommended for diagnosing PPH in all childbirth types, enabling timely care, reducing uterotonic administration and unnecessary transfusions, with reduced costs. (11)iven the above, the establishment of protocols and bundles denotes a pertinent contribution, especially if associated with team training for implementation and use. (11,12)A bundle is defined as a set of interventions with specific care that, when grouped together, provide improvements in care practices, with a view to promoting greater safety for patients.When selecting items to make up the bundle, one must consider costs, ease of implementation and adherence to proposed actions.15) In this regard, studies have shown the effectiveness of bundles for safe care.A review on bundle implementation to reduce bloodstream infections related to central venous catheter use in critically ill patients showed a reduction between 26 and 100% after their adoption, showing a positive impact. (13)iming for the same result in the neonatal population, a care bundle was designed for peripherally inserted central venous access catheters. (15)A methodological study validated a bundle for the care of newborns born to mothers with a suspected or confirmed diagnosis of COVID-19 in the birth room and rooming-in during the pandemic. (14)Thus, the results emphasize using bundles for specific care and contexts.
In the area of obstetric nursing, bundles are still in their infancy; however, it is noted that production has been growing over time, but many still focus on describing consensus for their elaboration and not exactly their validity or implementation results.Similar to previous descriptions, bundles aimed at the obstetric population have shown effective results.A bundle aimed at preventing PPH showed a reduction in cases, greater uterotonic use and a greater patient safety climate for obstetric nurses. (16)A bundle aimed at risk stratification for PPH identified that its implementation enabled an improvement in 90% of assessments, when compared to the previous period. (17)iven the magnitude of PPH and the relevance of quantifying blood loss for care procedures in this context, constructing a bundle is justified.Its innovation consists of focusing on postpartum bleeding assessment, which can favor prompt recognition of PPH cases, greater resolution of them, consequently guaranteeing safer care, with a possible impact on reduction of maternal deaths due to PPH.Therefore, the study aimed to build and validate the content of a bundle to quantify vaginal blood loss after childbirth.

Methods
This is a methodological study, developed in three stages: survey of scientific production on the topic, bundle construction with guidelines containing care for postpartum blood quantification and content validity carried out by experts.The research report was carried out in accordance with Standards for Quality Improvement Reporting Excellence (SQUIRE) recommendations. (18)n the theoretical stage, the results of a systematic review (19) with 14 articles were used, which served as the basis for constructing the bundle.
After the review, it was decided to build a bundle to quantify vaginal blood loss, given its low cost.It is noteworthy that the American College of Obstetricians and Gynecologists and the Association of Women's Health, Obstetric and Neonatal Nurses (11,12) consensus and guidelines supported all proposed items.
The validity instrument was built using the Hyper Text Markup Language (HTML) standard in Google Forms ® .Part I involved expert characterization data.Part II was responsible for composing the bundle, assessed based on a Likert scale containing the options "totally disagree", "disagree", "agree" and "totally agree".In all items, experts had a blank field for free records.It should be noted that in guidelines for filling out the form, the need to assess each item was mentioned based on the requirements as follows: usefulness/pertinence; consistency; clarity; objectivity; simplicity; feasibility; updating; accuracy; instructional sequence of topics; and form of presentation of the protocol. (21)In addition to these precautions at the end, experts gave their opinion on the bundle usefulness in practice, with a blank field for comments.
Experts were selected in May 2022 and, in this group, researchers in obstetric nursing with scientific publications on the subject were included, and this information was checked in the Curriculum Lattes.An invitation was sent by email to 23 experts and, of these, 14 agreed to participate.
Thus, the sample was composed of 14 experts, following recommendations from the literature, which recommends six to twenty validators and a minimum of three individuals when representing a professional group. (22)Expert selection followed the adapted Fehring (23) criteria: postdoctoral title (five points); PhD degree (four points); master's degree (three points); publication in an indexed journal on the thematic areas of interest of study (two points); specialization in the thematic areas of interest of study, such as pediatrics, neonatology and obstetrics; simulation (two points); care practice of at least two years in thematic areas of interest of study (two points); and participation in a scientific event in the last two years in thematic areas of interest of study (two points).To be selected, experts must obtain a minimum of five points and have at least a master's degree.
The validity questionnaire was sent followed by a term clarifying the objectives of the study and a document describing the activities requested of them.The consent form and the validity questionnaire were sent online, using an electronic form on Google Forms ® .The consent form clarified the objectives of the study and provided instructions for filling it out and, at the end of the home page, participants could tick the options: 1 -I have read and agree to participate; 2 -I have read and do not accept to participate.Participants were redirected to the validity questionnaire only if they clicked on option 1 -I read and agree to participate.Experts who did not return the instrument within 15 days of receipt were not included.Incomplete item responses were also an exclusion criterion.No participants were excluded.
Data were imported from Google Forms ® into a database in Excel ® format.Content validity data were presented in percentage and absolute frequencies.In this study, the Concordance Index (CI) was adopted, in which the number of times there is agreement (total, partial or just agreement) is divided by the total number of assessments, varying between 0 and 100%.For assessment to be adequate or excellent, a minimum CI of 80% agreement must be obtained. (24)CI calculation was the result of applying the formula: CI = sum of number of agreement responses/number of total responses x100. (24)he study was approved by the Research Ethics Committee, under Opinion 5.539.782

Results
Experts' mean age was 49.2± 13.5 years, with a minimum age of 30 and a maximum of 76 years.Most were female (13 -92.9%) and had a PhD degree (eight -57.2%).Three (21.4%) experts had master's degree and three (21.4%)had postdoctoral degrees.The mean length of training was 26.6 ± 13.8 years, with a minimum of seven and a maximum of 54 years.All were nurses, specializing in obstetric nursing and working in the area, and the majority (12 -85.8%) worked in teaching and two (14.2%) in care/management.The mean length of experience was 20.6± 12.5 years, with a minimum of five and a maximum of 41 years.Experts worked in the states of São Paulo (five -35.8%),Rio de Janeiro (two -14.2%),Santa Catarina (two -14.2%),Federal District (two -14.2%), with one (7.1%)representative each, Minas Gerais, Bahia and Portugal.Most (12 -85.7%) worked in universities, seven (58.3%) state and five (41.7%) federal.Applying the criteria adapted from Fehring (1987), selected experts had a mean of 15.4 points, with the minimum being eleven and the maximum obtained and possible score being 20 points.Table 1 presents expert characteristics.
Of the 11 items proposed for quantifying vaginal blood loss after childbirth, nine were validated by experts with high levels of agreement, considered adequate or excellent.Items 5 and 6 were excluded from the bundle because they had a CI of 79% (less than 80%), as shown in Table 2.
Eight comments/suggestions from experts were recorded.One asked about quantification given the limitation of mixing blood with amniotic fluid, urine and/or feces.This expert also described that weighing the materials before and after birth could make their implementation in practice unfeasible/ difficult.Another comment considered the importance of surveillance, theorization and adoption of preventive measures for PPH, and registered believing in bundle use application for specific situations such as women with anemia, multiparous women, coagulation disorders, third trimester bleeding and in cases that bleeding is increased by visual estimation.A third comment suggested the inclusion of whether the stretcher sheet would also be weighed in item 5 and about the possibility of inserting a PPH management protocol in item 10.Another expert made contributions regarding the agreement for the plural of an item that had a spelling error, which was accepted in the final version.Finally, the last comment suggested weighing the materials in the Surgical Center to standardize the scale and asked about mixing blood with other fluids.However, the comment highlighted the importance of bundle and quantification as a low-cost and viable strategy for detection of cases and PPH.The final version of the bundle consisted of nine items after adjustments following suggestions from evaluators (Chart 1).Regarding its usefulness in practice, 12 (86%) experts indicated that it is useful and applicable.

Discussion
The quantification proposed by the bundle is intended to be a resource to improve the assessment of blood loss after vaginal childbirth.
Vaginal childbirth is a route with greater challenges for measuring blood loss, as it is not possible to control the variables related to other secretions present during labor and immediately post-birth, such as amniotic fluid and urine, (12) requiring further studies on the topic.
Quantifying blood loss by visual estimation is a prevalent method. (25)It is considered subjective, under the influence of several variables, including the professional who assesses it.(27) Like the experts, the literature points out limits to the effective quantification and qualification of blood loss, closely related to the mixing of blood with amniotic fluid or diuresis at birth and the immediate postpartum period, the volume of blood retained in the surgical fields and the differentiation blood loss resulting from episiotomy and/or lacerations. (6,10)espite the limitations, the comparison between visual estimation versus quantification indicates that quantitative methods are more inclined to more accurate detection of PPH, (11,12,28) with a recommendation for practice.Gravimetry reveals significant differences for PPH diagnosis, (28,29) and low cost should be considered in clinical practice.
A bundle evaluator highlighted that, due to the complexity of the technique, it should only be used in specific cases.However, the American College of Obstetricians and Gynecologists and the Association of Women's Health, Obstetric and Neonatal Nurses recommend to quantify bleeding for PPH diagnosis in all childbirth types, applied to low-and highrisk postpartum women. (11,12)Furthermore, the creation of protocols and bundles associated with team training for their adoption stands out in the literature. (11,12)n this study, the bundle items that showed the highest agreement (93%) among experts were related to periodic team training, institution of protocols, records of quantification carried out and early intervention in cases of PPH.
Studies indicate that the more the care team is trained in the methods of quantifying postpartum volume loss, the fewer divergences and the more reliable the quantifications are, bringing significant care improvements, reinforcing item 1 of the bundle developed. (27,30,31)To this end, using active methodologies is encouraged, with simulation being highly recommended as a strategy.Studies based on simulation show improvement in the recognition of PPH cases after simulated team training. (27,30,31)t should be noted that with positive results, there is an exponential increase in using realistic simulation in preparing professionals for emergencies, more specifically in obstetric emergencies, including PPH. (31) According to the literature, learning, mainly through simulated scenarios for training the multidisciplinary obstetric team, associated with care protocol and/or care bundle implementation, generates a reduction in the cost of diagnostic, therapeutic and emergency identification resources. (30,32)They are highly recommended strategies for PPH diagnosis, prompt recognition and treatment.Institutional protocol implementation was one of the items with the highest agreement score.
Another item that obtained a high level of agreement was related to recording blood quantification.Clinical records or documentation are powerful communication tools among health professionals, identifying professionals' performance in the care provided. (33)However, when assessing records, a study showed that the outpatient, diagnostic support, Surgical Center and Obstetric Center sectors are those with the highest proportions of missing records in patients' medical records. (34)Thus, it is possible to note the relevance of reinforcing the registry, being an extremely important item in the bundle.
In cases of detection of high volumes of blood loss, the bundle recommends the institution of treatment protocols for PPH, which achieved high agreement among experts.
Only training for diagnoses in a timely manner does not guarantee the best results.There is a need to strengthen health services in training professionals to deal with a picture of PPH, which requires changes in institutional philosophy in addition to guaranteeing availability of resources (pharmacological and non-pharmacological) for the clinical management of PPH. (27,35)All associated measures are capable of associating better maternal health outcomes.
The clinical response to postpartum blood loss is variable and can be influenced by several factors, such as the volume of blood lost, tolerability to blood loss, general health status, speed of loss, variation in hemoglobin levels throughout pregnancy and the adequate functioning of the coagulation system. (6,7)The impact and symptoms of the loss and evolution of the picture depend on all factors listed. (27)Therefore, clinical examination based on women's response to blood loss as the only diagnostic tool is insufficient for detecting PPH, although we cannot fail to value its practice, associated with other strategies.
27) It is also important to highlight that accurate diagnostic methods to quantify postpartum bleeding are effective not only to identify but also to avoid and/or minimize a bad prognosis in cases of already established hemorrhage. (27)ost experts indicated that the constructed bundle is useful and applicable.Two experts cited its non-clinical usefulness/applicability.The issue of long-term applicability was mentioned, since new routines require major changes, including one attitude, and that implementing bundles aiming at treating PPH should be prioritized as well as the recognition of signs of shock, but strongly suggested their use in cases of higher risk for PPH.The second expert pointed out non-agreement of weighing as an assessment measure.
It is recommended to use this bundle in its final version as printed material, easy to view, posted in Obstetric Centers.However, for its effective implementation, it may be made available on health institutions' platforms and intranets.Furthermore, the need for team training and continued education is reinforced for their adherence.
The limitation of this study is the method used, as it is specifically a validity.Other investigations are necessary to verify the applicability of the items listed.However, this bundle is considered valid in terms of content, theme and best level of evidence of care.

Conclusion
This study made it possible to build and validate a bundle that includes nursing care to quantify vaginal blood loss after childbirth, with a view to prevention, prompt recognition and treatment of PPH cases based on scientific evidence.Care includes team training, establishing protocols, quantifying/ measuring bleeding, recording quantification for clinical documentation, recognizing and managing PPH cases, in addition to laboratory quantification of hemoglobin/hematocrit levels, depending on the institutional reality.It is recommended to use this bundle in its final version as printed material, easy to view, posted in Obstetric Centers.However, for its effective implementation, it may be made available on health institutions' platforms and intranets.Furthermore, the need for team training and continued education to raise awareness and promote adherence is reinforced.Furthermore, it is suggested that new studies be carried out on the subject, highlighting results regarding bundle implementation.

Collaborations
Ruiz MT, Azevedo NF, Resende CV, Silva MPC, Contim D, Santos LM, Wernet M and Linares AM contributed to study design, data analysis and interpretation, article writing, relevant critical review of intellectual content and approval of the final version to be published.

Table 1 .
Characterization of experts who validated the bundle

Table 2 .
Description of items for quantifying vaginal blood loss after childbirth for prevention, prompt recognition and treatment of cases of postpartum hemorrhage Nursing care in the final version of the bundle to quantify vaginal blood loss after childbirth an item with shock index calculation in the bundle.The fourth comment suggested qualification of the writing of item 1: training/improvement should be carried out every semester and/or whenever there are changes in many team members, instead of the annual proposition.This same expert questioned Chart 1.