2018/2019
Joana Rita Lopes de Abreu
O Uso Da Vitamina K nas Salas de Parto Portuguesas: Estudo Transversal
The use of Vitamin K in Portuguese Delivery Rooms: A Cross-Sectional Study
março, 2019
Joana Rita Lopes de Abreu
O Uso Da Vitamina K Nas Salas De Parto Portuguesas: Estudo Transversal
The use of Vitamin K in Portuguese Delivery Rooms: A Cross-Sectional
Study
Mestrado Integrado em Medicina
Área: Neonatologia
Tipologia: Artigo Original
Trabalho efetuado sob a Orientação de:
Dr. Henrique Edgar Correia Soares
E sob a Coorientação de:
Prof. Doutora Maria Hercília Ferreira Guimarães Pereira Areias
Trabalho organizado de acordo com as normas da revista:
Portuguese Journal of Pediatrics
março, 2019
Ao meu orientador, Dr. Henrique Soares, pela sua dedicação, amizade e admirável
paciência. Pelo trato simples, correto e científico.
À Professora Doutora Hercília Guimarães, por ter aceite o convite para ser minha
coorientadora.
À Dra. Filipa Flor de Lima pela ajuda preciosa na reta final.
Ao meu pai, à minha mãe, ao Gabriel e restante família que me ajudam todos os
dias a ser quem sou.
Dedico este trabalho aos meus avós Marcial, Gracinda e José Augusto e ao meu
tio Aristides que decerto teriam ficado felizes por este momento.
A todos, o meu sincero agradecimento.
O Uso Da Vitamina K Nas Salas De Parto Portuguesas: Estudo Transversal
The use of Vitamin K in Portuguese Delivery Rooms: A Cross-Sectional
Study
Joana Rita Abreu1, Henrique Soares1,2, Mariana Adrião2, Filipa Flor de Lima1,2,
Mário Mateus2, Hercília Guimarães1,2
Interest conflicts
The authors declare the absence of conflicts of interest in the accomplishment of the present work.
Financing source
There were no external sources of funding for this article.
Data Confidentiality
The authors state that they have followed the protocols of their work center on the publication of data.
1 Faculdade de Medicina da Universidade do Porto | Porto | Portugal 2 Neonatology Service | Centro Hospitalar de São João, EPE | Porto | Portugal
Corresponding Author Joana Rita Abreu [email protected] Avenida da República, nº290, apt 201, 4430-188 Vila Nova de Gaia
ARTIGO ORIGINAL / ORIGINAL ARTICLE
Resumo
Abstract
Introduction: Vitamin K deficiency bleeding prophylaxis is one of the first medical care in the delivery room,
and the incidence of this deficiency would be significantly higher without this practice. The purpose of this
study is to investigate the knowledge of Portuguese practitioners about prophylaxis of vitamin K deficiency
bleeding, and to examine their regular practice when working in the delivery room.
Methods: A multiple-choice questionnaire (attachment 1) was sent to the members of the Portuguese
Society of Neonatology by electronic e-mail. All the properly answered and returned questionnaires were
included in the study. Statistical analysis was performed using the Statistical Package for the Social Sciences
(SPSS Statistics, version 25), and included descriptive statistics, ANOVAs, Chi-square test and Spearman
correlations. A p-value lower than 0.05 was considered statistically significant.
Results: A total of 366 questionnaires were sent. Fifty-two (14.2%) questionnaires were answered and
submitted. From the 22 questions that evaluated the level of knowledge, a mean of 12.96 ±2.46 were correct.
Most participants showed average or high level of knowledge (65.3%). From the 7 questions that evaluated
the clinical practices, the mean of correct answers was 4.3 ±1.35. Approximately half of the participants
showed moderately or highly adequate clinical practices.
Conclusion: Our study highlighted the relevance of updated clinical protocols and reinforce that is essential
that physicians renew their scientific knowledge in topics relevant for the everyday practices. To evaluate and
subsequently improve practices in the delivery rooms is crucial to a better clinical practice.
Kew-words: haemorrhagic disease of the newborn, prevention and control; vitamin K deficiency bleeding,
Newborn, Portugal
Introdução: A profilaxia com vitamina K é um dos primeiros cuidados médicos na sala de parto, e sem o qual a
incidência da hemorragia do recém nascido por défice de vitamina K seria significativamente maior. Este estudo
pretende investigar o conhecimento dos neonatologistas Portugueses sobre esta profilaxia e avaliar a rotina médica
na sala de parto.
Método: Um questionário de escolha múltipla (anexo 2) foi enviado aos membros da Sociedade Portuguesa de
Neonatologia através de correio eletrónico. Todos os questionários corretamente preenchidos foram incluídos neste
estudo. A análise estatística foi realizada através do Statistical Package for the Social Sciences (SPSS Statistics,
versão 25), e incluiu estatística descritiva, ANOVAs, testes de Qui-quadrado e correlações de Spearman. Um valor
de p inferior a 0.05 foi considerado estatisticamente significativo.
Resultados: Um total de 366 questionários foram enviados. Cinquenta e dois (14.2%) foram preenchidos e
devolvidos. Das 22 questões que avaliaram o nível de conhecimento, em média 12.96 ± 2.46 estavam corretas. Dos
participantes, a maioria demonstrou ter um médio ou alto nível de conhecimento (65.3%). Das 7 questões que
avaliaram a prática clínica a média de respostas corretas foi de 4.3 ± 1.35. Aproximadamente metade dos
participantes demonstraram práticas clínicas moderadamente ou altamente adequadas.
Conclusões: Os nossos resultados enfatizam a relevância do uso de protocolos clínicos atualizados e reforçam que
é essencial os médicos renovarem o seu conhecimento científico em tópicos relevantes para as práticas do dia-a-
dia. Avaliar e subsequentemente melhorar as práticas nas salas de parto é determinante para uma melhor prática
clínica.
Palavras-chave: Doença hemorrágica do recém-nascido, profilaxia, hemorragia por deficiência de vitamina K,
recém-nascido, Portugal
Introduction
The role of Vitamin K in normal coagulation was made clear in 1939, shortly after
its discovery [1]. Vitamin K1 (phylloquinone) comes directly from a person’s diet, while
vitamin K2 (menaquinones) is obtained from the intestinal flora and corresponds to 90%
of all the stored Vitamin K in the liver [1]. It is known that Vitamin K deficiency is associated
to reduced levels of coagulation factors directly dependent on it, such as factor II, VII, IX,
and X, as well as protein C and S, that are important anticoagulant factors[2].
Newborns have a deficiency in vitamin K and this makes them vulnerable to
Vitamin K Deficiency Bleeding (VKDB), a life-threatening situation that can be prevented
by prophylactic administration of vitamin K immediately after birth[3].
The American Academy of Paediatrics recommends VKDB prophylaxis with the
intramuscular (IM) administration of a single dose of 0,5-1mg of vitamin K immediately
after birth[4, 5]. However, little is known about the appropriate dose to be administrated to
preterm newborns. Some recent studies evaluated vitamin K in these babies and found
supraphysiologic levels [1, 6-8].
VKDB prophylaxis is one of the first medical care in the delivery room, and the
VKDB incidence would be significantly higher without this regular prophylaxis [4, 9-11].
However, vitamin K administration has some risks. In 1992, a British study linked vitamin
K administration with some cancers. In more recent studies, it has become clear that
vitamin K administration is not linked to solid tumours. However, a small risk of leukaemia
cannot be completely excluded [8]. The main adverse reaction is associated with its local
administration, such as skin infection, or skin reaction and muscular or nerve lesions when
the shot is administered too deep[8]. The pain caused by the shot is also a topic of
discussion since the onset of pain in the early life may have future adverse effects. Despite
the clear benefits of Vitamin K, parents must be consulted and agree to sign an informed
consent form prior its administration by the paediatric specialist[8].
Even though the benefits of vitamin K prophylaxis are widely acknowledged, there
is a limited agreement on the proper protocols, appropriate doses and usual adverse
reactions. The purpose of this study is to investigate the knowledge of Portuguese
practitioners about the prophylaxis of vitamin K deficiency bleeding, and to analyse their
regular practice in the context of the delivery room.
Methods
A search in PubMed was conducted using Key Words “Vitamin K AND prevention
and control AND Infant, Newborn”.
A classified multiple-choice question (MCQ) questionnaire, (attachment 1), was
applied to the neonatologists registered in the Portuguese Society of Neonatology. It
comprised three parts: (1) sociodemographic characteristics; (2) level of knowledge; and
(3) current practices of physicians in prophylaxis of VKDB.
The questionnaire was written in portuguese (attachment 2) and sent to the
neonatologists by electronic e-mail. The answers were submitted anonymously using the
platform googleforms. All the properly answered and returned questionnaires were
included in the study.
The results were graded and categorized as follows: (1) Knowledge (based on
correctly answered questions): low (P25 ;≤ 11), average (P50; 11-15) and high (P75; ≥15);
(2) Practices (based on correctly answered questions): inadequate (P25 ; ≤4), moderately
adequate (P50 ; 5) and highly adequate (P75 ; ≥6).
Statistical analysis was performed using the Statistical Package for the Social
Sciences (SPSS Statistics, version 25). We used descriptive statistics to examine the
sociodemographic variables, and ANOVA, Chi-square test and Spearman correlations to
targeted analysis. A p-value lower than 0.05 was considered statistically significant.
This study was approved by the Ethics Committee of São João´s hospital /Faculty
of Medicine University of Porto and exempted from written informed consent. The collected
data was only handled by the research team.
Results
A total of 366 questionnaires were sent, and 52 (14.2%) were answered by the
members of the Portuguese Society of Neonatology. Thirty-seven (71.2%) were female,
the mean age = 47.6 years ± 10.24; range: 30 - 63 years. These individuals were
predominantly from hospital group III (highly differentiated; n=22, 42.3%). Group I (non-
differentiated) and Group II (differentiated) represented 9 (17.3%) and 21 (40.4%) of the
questionnaires, respectively. It should also be noted that 30 (57.7%) of the physicians who
answered the questionnaire participated in 21 or more births per month (Table 1).
Twenty-two questions evaluated the knowledge of the participants. A mean of
12.96 ± 2.46 questions were answered correctly. The number of correct and incorrect
answers, and the rate are presented in Table 2.
The knowledge was graded on a range according to the number of correctly
answered questions: low (≤11), average (11-15) and high (≥15). More than one third of
the questionnaires, 18 (34.6%), get a low level of knowledge. However, 15 (28.8%) of the
Portuguese Neonatologists successfully graded in the high range (Table 3).
Seven questions evaluated the clinical practice. The mean of correct answers was
4.3 ± 1.35. The number of correct and incorrect answers, and the rate are presented in
Table 2.
In more than half of the participants, 27 (51.9%), the clinical practice was
inappropriate. Only seven (13.5%) had highly appropriate clinical practices. (Table 4).
Those with more correct answers in the questions about medical knowledge were
also who had more correct answers in the questions related to clinical practices (p
=0.0393).
Neonatologist from highly-differentiated hospitals group had more correct answers
about medical knowledge (p = 0.026) and best clinical practices (p = 0.025) than their
peers from the other hospital groups (Table 5).
There was no association between the level of knowledge and the variables sex,
age, hospital group, number of births and clinical practice. Similarly, there was also no
association between the clinical practice and the variables sex, age, hospital group,
number of births and the level of knowledge (Table 6)
In question (21) - parental informed consent -, and in question (23) - clinical
protocols – the groups from different types of hospitals significantly differed (p = 0.0033,
and p = 0.0314, respectively).
Discussion
VKDB is rare in developed countries due to vitamin K prophylactic administration.
It is divided in three types: early (occurs in the first 24 hours of life), classic (occurs in the
first week of life), and the late form (occurs between the first 2-12 weeks of life until de 6
months of age) [5]. The early form is usually the most dangerous, with intracerebral
3 Anova 4 Spearman Correlation
bleeding being a very common complication, and is related to in utero exposure to
anticonvulsants (carbamazepine, phenytoin and barbiturates), tuberculostatics (isoniazid,
rifampicin), some antibiotics (cephalosporins) and vitamin K antagonists (coumarin,
warfarin) [1, 3, 12]. In this study, we aimed to examine whether Portuguese neonatologists
are familiarized with this classification, as well as if they are able to inform the parents
about the best ways of preventing VKDB. From the 52 neonatologists, 14 did know that
the dangerous form of VKDB was the early form, and not the classic one (P11). Else, 19
identified the in uterus exposure to anticonvulsants, tuberculostatics and vitamin K
antagonists as a risk factor to VKDB (P3).
The oral and parenteral vitamin K applied at birth prevents early VKDB [4, 13],
though, according to the World Health Organization, all newborns should receive 1mg IM
injection of vitamin at birth for its prevention [14, 15]. Oral administration comprises 3
doses (2 mg immediately after birth, 2 mg between the 3rd and 7th day after birth, and 2
mg at 6 weeks of life), but it is not as efficient as the IM route [1]. Additionally, it is not
approved worldwide, and the oral vitamin K formulations are highly dependent on parent’s
compliance, and this highly influences its efficiency [1, 9, 11]. Even when the correct
administration is done, some studies support that the oral prophylactic scheme does not
prevent the late form [11, 16]. However, it can be an alternative when the parents refuse
the IM route [11]. All the participants of our study knew that vitamin K should be
prophylactically administered to all newborns (P14), and not only to those with high risk
(P13). Moreover, they also knew that the best prophylactic scheme was a single dose of
vitamin K via IM route (P16); 11 physicians considered the administration of 3 oral doses
an alternative (P15), and 9 out of 52 referred that the more efficient approach was the
intravenous (P17).
The American Academy of Paediatrics recommends that all newborns receive a
single vitamin K dose of 0.5 to 1 mg, administered intramuscularly[4]. Recent studies
evaluated the blood levels of vitamin K after this dosage administration and concluded to
be supraphysiologic in pre-term newborns. [1, 6, 7, 17, 18]. Accordingly, some studies
recommend that the doses should be adjusted to the newborn weight [1, 6-8]. Newborns
with more than 36 weeks should receive 1 mg of vitamin K. Pre-term newborns should
receive 0.5 mg if the birthweight is superior to 2.5 kg or 0.4mg/Kg when the weight at birth
is inferior to 2.5 Kg [1, 6-8]. In this study, 40.4% of the participants referred that the dose
is the same for all the newborns (1 mg; P18), 15.4% affirmed that in their workplace the
dose did not depend on the newborn being term or preterm (P29), and 25% considered
the dose is independent of the weight (P30). About 40% of the physicians referred that the
information about the correct dose is easily found in the literature (P20).
Vitamin K deficiency in newborns is mainly related to the low level of vitamin K
crossing the placenta (the levels in the umbilical cord are below 0,02ng/mL), as well as
due to the low levels of this vitamin in breastmilk [1, 7]. Mother supplementation with
vitamin K, rich food or supplements are not a solution since they do not cross the placenta.
During breastfeeding, supplementation does increase the levels of vitamin K in the
maternal milk, but this is insufficient to guaranteed the levels of vitamin K that prevent
VKDB [9, 19, 20]. In our investigation, 26.9% participants supported that VKDB risk could
be lowered by administering vitamin K to the mother during labour (P10). Breast milk has
very low levels of vitamin K, and this makes infants with exclusive breast feeding extremely
vulnerable to severe vitamin K deficiency. Milk formulas have higher levels of vitamin K,
and thus, infants fed with formula are less prone to VKDB. For the same reason, as infants
are introduced to full food diet the risk of VKDB is also reduced [7, 8]. About 25% of the
participants referred that maternal milk had higher levels of vitamin K than other milk
formulas (P7), and 40% assumed that formula fed infants had higher risk of VKDB (P8).
Approximately 70% supported that the risk of VKDB is reduced as new food is introduced
to infants (P9).
In 1992, Golding and colleagues found an association between IM injection of
vitamin K prophylaxis (brand name Konakion) and the incidence of leukaemia [21].
However, this association was not found in larger studies with data from multiple sites and
time periods [22, 23]. Kleanoff and colleagues performed a nested case-control study of
54.795 infants and found no association between vitamin K prophylaxis and childhood
leukaemia or cancer [22]. Furthermore, Ekelund and colleagues compared the rates of
childhood cancer and leukaemia among 1.085.654 infants receiving IM vitamin K with
272.080 infants who received oral vitamin K and found no significant differences between
the groups [23]. Even though the findings from the Golding’s study have not been
supported by later studies, these results may be mentioned in social and internet groups,
creating a false sense of insecurity about the injection [24]. This was the main cause of
parental discussion regarding vitamin K prophylaxis. Despite being highly recommended
by paediatric organizations, the refusal of its administration is increasing among parents
[24-26]. The increase in parental refusal of vitamin K administration was recognized by 11
participants, and those argued that this refusal was supported by literature (P22). Parents
want the labour to be as natural as possible and they believe that IM vitamin K is not only
unnecessary but also harmful [24, 25]. We tried to understand whether Portuguese
neonatologist were aware of this, considering that parents must always be informed about
the risks and benefits of vitamin K prophylaxis. More than 40% considered unnecessary
the explanation of the risks and benefits, as well as collecting informed consent with the
newborn’s parents before its administration (P21). In fact, only 19.2% of the participants
referred to collect informed consent before its administration. Vitamin K administration is
associated with local infection and putative nerve or muscular lesion in the site of
inoculation [8, 25]. Most of the participants recognized infection as a risk associated with
its administration (P2), while 48.1% referred that Vitamin K is completely safe for the
newborn. Leukaemia was considered as a possible adverse effect by 15.4% of the
participants, and solid tumours or jaundice by 3.8% and 5.8%, even if the actual
recommended dose is completely safe for haemolysis [8]. About 69% of the neonatologist
considered that it lacks discussion and information about the dose and administration of
vitamin K prophylaxis for prevent VKDB.
In this study we showed that a better knowledge was correlated with the number
of correct clinical practices. However, when the participants were divided according to their
clinical practice and medical knowledge, this difference was not statistically significant.
This result may be associated to the reduced number of participants in each group, that
is, a lower statistical power.
There was no association between clinical practice and medical knowledge and
the variables age, sex, number or births or hospital group. The most relevant factor should
be the level of knowledge of each participant, though it was not possible to clearly highlight
this relation.
We found a relation between hospital group and the use of a defined protocol;
highly differentiated hospitals had more protocols for vitamin K administration than the
others. The same was true for the information transmitted to parents about the risks and
benefits of its administration.
The limitations of this study are: (1) the lack of questionnaire´s validation, (2) the
bias introduced by the distribution of the questionnaires through the internet, and (3) the
small number of participants, which may lead to misleading conclusions.
In sum, this is the first Portuguese study evaluating knowledge and clinical practice
of Portuguese neonatologists concerning to the vitamin K prophylaxis. This study
highlights the relevance of updating the clinical protocols, as well as of the scientific
knowledge of the physicians that is relevant for the everyday practices. Finally, we should
also note the relevant role of the Portuguese scientific committees on the evaluation and
subsequent improvement of the practices in the delivery rooms.
References
1. Van Winckel, M., et al., Vitamin K, an update for the paediatrician. Eur J Pediatr, 2009. 168(2): p. 127-34.
2. Sutor, M.D.A.H., Vitamin K Deficiency Bleeding in nfants and Children SEMINARS IN THROMBOSIS AND HEMOSTASIS, 1995. 21(3): p. 317-329.
3. Clarke, P. and S. Mitchell, Vitamin K prophylaxis in preterm infants: current practices. Journal of Thrombosis and Haemostasis, 2003. 1(2): p. 384-386.
4. American Academy of Pediatrics, C.o.F.a.N., Controversies Concerning Vitamin K and the Newborn. Pediatrics, 2003. 112(1): p. 191-192.
5. Majid, A., et al., Newborn Vitamin K Prophylaxis: A Historical Perspective to Understand Modern Barriers to Uptake. Hospital Pediatrics, 2019. 9(1): p. 55-60.
6. Kumar, D., et al., Vitamin K Status of Premature Infants: Implications for Current Recommendations. Pediatrics, 2001. 108(5): p. 1117-1122.
7. Ardell, S., et al., Prophylactic vitamin K for the prevention of vitamin K deficiency bleeding in preterm neonates. Cochrane Database of Systematic Reviews, 2018(2).
8. Guideline, N.S.C., Vitamin K prophylaxis and Vitamin K Deficiency Bleeding. Health Board, August 2013.
9. Phillippi, J.C., et al., Prevention of Vitamin K Deficiency Bleeding. J Midwifery Womens Health, 2016. 61(5): p. 632-636.
10. Miller, H., B. Wheeler, and N. Kerruish, Newborn vitamin K prophylaxis: an analysis of information resources for parents and professionals. N Z Med J, 2016. 129(1446): p. 44-52.
11. Darlow, B.A., A.A. Phillips, and N.P. Dickson, New Zealand surveillance of neonatal vitamin K deficiency bleeding (VKDB): 1998-2008. J Paediatr Child Health, 2011. 47(7): p. 460-4.
12. Ng, E. and A.D. Loewy, Position Statement: Guidelines for vitamin K prophylaxis in newborns. A joint statement of the Canadian Paediatric Society and the College of Family Physicians of Canada, 2018. 64(10): p. 736-739.
13. Sutor, A.H., et al., Vitamin K deficiency bleeding (VKDB) in infancy. ISTH Pediatric/Perinatal Subcommittee. International Society on Thrombosis and Haemostasis. Thromb Haemost, 1999. 81(3): p. 456-61.
14. Hutton, A.R.J., et al., Transdermal delivery of vitamin K using dissolving microneedles for the prevention of vitamin K deficiency bleeding. Int J Pharm, 2018. 541(1-2): p. 56-63.
15. Organization, W.H., WHO recommendations on newborn health: guidelines approved by the WHO Guidelines Review Committee. No. WHO/MCA/17.07, 2017.
16. von Kries, R., A. Hachmeister, and U. Gobel, Repeated oral vitamin K prophylaxis in West Germany: acceptance and efficacy. Bmj, 1995. 310(6987): p. 1097-8.
17. Clarke, P., et al., Vitamin K prophylaxis for preterm infants: a randomized, controlled trial of 3 regimens. Pediatrics, 2006. 118(6): p. e1657-66.
18. Costakos, D.T., et al., Vitamin K prophylaxis for premature infants: 1 mg versus 0.5 mg. Am J Perinatol, 2003. 20(8): p. 485-90.
19. Greer, F.R., et al., Improving the vitamin K status of breastfeeding infants with maternal vitamin K supplements. Pediatrics, 1997. 99(1): p. 88-92.
20. von Kries, R., et al., Vitamin K1 content of maternal milk: influence of the stage of lactation, lipid composition, and vitamin K1 supplements given to the mother. Pediatr Res, 1987. 22(5): p. 513-7.
21. Golding, J., et al., Childhood cancer, intramuscular vitamin K, and pethidine given during labour. Bmj, 1992. 305(6849): p. 341-6.
22. Klebanoff, M.A., et al., The Risk of Childhood Cancer after Neonatal Exposure to Vitamin K. New England Journal of Medicine, 1993. 329(13): p. 905-908.
23. Ekelund, H., et al., Administration of vitamin K to newborn infants and childhood cancer. BMJ (Clinical research ed.), 1993. 307(6896): p. 89-91.
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25. Block, S.L., Playing newborn intracranial roulette: parental refusal of vitamin K injection. Pediatr Ann, 2014. 43(2): p. 53-9.
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Tables
Table 1- Sociodemographic characteristics of the participants (n=52)
Sex, n (%)
Female 37 (71.2)
Male 15 (28.8)
Age group, n (%)
≤40 years old 17 (32.7)
41-49 years old 20 (19.2)
≥50years old 25 (48.1)
Hospital group, n (%)
Non-differentiated 9 (17.3)
Differentiated 21 (40.4)
Highly-differentiated 22 (42.3)
Number of births per month, n (%)
≤10 3 (5.8)
11-20 19 (36.5)
21-30 12 (23.1)
≥30 18 (34.6)
Table 2- Incidence of correct and incorrect answers
QUESTION INCORRECT CORRECT RATE(%) QUESTION INCORRECT CORRECT RATE(%)
P1 50 2 3.8 P16 0 52 100
P2 52 0 0.0 P17 9 43 82.7
P3 33 19 36.5 P18 21 31 59.6
P4 27 25 48.1 P19 29 23 44.2
P5 5 47 90.4 P20 23 29 55.8
P6 49 3 5.8 P21 22 30 57.7
P7 12 40 76.9 P22 11 41 78.8
P8 21 31 59.6 P23 10 42 80.8
P9 16 36 69.2 P24 0 52 100
P10 14 38 73.1 P25 42 10 19.2
P11 38 14 26.9 P26 26 26 50.0
P12 24 28 53.8 P27 38 14 26.9
P13 0 52 100 P28 16 36 69.2
P14 0 52 100 P29 8 44 84.6
P15 11 41 78.8 P30 13 39 75.0
Table 3- Knowledge of the participants.
KNOWLEDGE
n (%)
Low level 18 (34.6)
Average level 19 (36.5)
High level 15 (28.8)
Table 4 – Practices of the participants.
PRATICES
n (%)
Inappropriate pratices 27 (51.9)
Moderately adequate pratices 18 (34.6)
Highly adequate pratices 7 (13.5)
Table 5- Number of correct answers by hospital group, and comparison of the three hospital groups.
NUMBER OF CORRECT ANSWERS ABOUT KNOWLEDGE
Mean ± SD p
Non-differentiated (n=9) 11 ± 2.4
0.0261 Differentiated (n=21) 11.57 ± 2.27
Highly-differentiated (n=22) 12.91 ± 1.95
NUMBER OF CORRECT ANSWERS CLINICAL PRATICES
Non-differentiated (n=9) 3.56 ± 1.51
0.0251 Differentiated (n=21) 4.19 ± 1.23
Highly-differentiated (n=22) 4.82 ± 1.3 1ANOVA
Table 6- Association between knowledge and clinical practices and sex, age, hospital group and number of
births per month
KNOWLEDGE
Low Average High p
n (%) n (%) n (%) Sex
Male 4 (28.6) 6 (23.1) 5 (41.7) 0.3712
Female 10 (71.4) 20 (76.9) 7 (58.3)
Age
≤40 years old 5 (35.7) 8 (30.8) 4 (33.3)
0.2812 41-49 years old 2 (14.3) 5 (19.2) 3 (25.0)
≥50years old 7 (50.0) 13 (50.0) 5 (41.7)
Hospital group
Non-differentiated 4 (28.6) 4 (15.4) 1 (8.3)
0.3322 Differentiated 7 (50.0) 12 (46.2) 2 (16.7)
Highly-differentiated 3 (21.4) 10 (38.5) 9 (75.0)
Number of births per month
≤10 2 (14.3) 1 (3.8) 0 (0.0)
0.8622 11-20 6 (42.9) 8 (30.8) 5 (41.7)
21-30 1 (7.1) 8 (30.8) 3 (25.0)
≥30 5 (35.7) 9 (34.6) 4 (33.3)
Clinical pratices
Inadequate 10 (71.4) 11 (42.3) 6 (50.0)
0.1252 Moderately adequate 4 (28.6) 12 (46.2) 2 (16.7)
Highly adequate 0 (0.0) 3 (11.5) 4 (33.3)
CLINICAL PRATICES
Inadequate Moderately Highly adequate p
n (%) n (%) n (%) Sex
Male 7 (25.9) 5 (27.8) 3 (42.9) 0.7662
Female 20 (74.1) 13 (72.2) 4 (57.1)
Age
≤40 years old 8 (29.6) 4 (22.2) 5 (71.4)
0.1422 41-49 years old 4 (14.8) 5 (27.8) 1 (14.3)
≥50years old 15 (55.6) 9 (50.0) 1 (14.3)
Hospital group
Non-differentiated 7 (25.9) 1 (5.6) 1 (14.3)
0.1912 Differentiated 11 (40.7) 9 (50.0) 1 (14.3)
Highly-differentiated 9 (33.3) 8 (44.4) 5 (71.4)
Number of births per month
≤10 2 (7.4) 1 (5.6) 0 (0.0)
0.9062 11-20 12 (44.4) 5 (27.8) 2 (28.6)
21-30 5 (18.5) 5 (27.8) 2 (28.6)
≥30 8 (29.6) 7 (38.9) 3 (42.9)
knowledge
Low level 10 (37.0) 4 (22.2) 0 (0.0)
0.1252 Average level 11 (40.7) 12 (66.7) 3 (42.9)
High level 6 (22.2) 2 (11.1) 4 (57.1) 2Chi-square test
I-CARACTERIZATION OF THE POPULATION
Gender:
Male_ Female__
Age: ___ Years
What Hospital Group does your hospital belong to:
Grupo I – Hospitals with Gynaecologists, obstetricians with labour rooms and paediatrics emergency. Direct Influence area between 75000 and 50000 inhabitants. No indirect influence area.
Grupo II- Hospitals with Gynaecologists, obstetricians with labour rooms and paediatrics emergency. Direct and indirect influence area for their medical specialties.
Grupo III- Hospitals with Gynaecologists, obstetricians with labour rooms, paediatrics emergency, Paediatric Cardiology, Paediatric surgery and genetics as well as all its subspecialties and differentiated units. Direct and indirect influence areas for this medical specialties.
Number of labours you assist per month:
<10
11-20
21-30
>30
II-MEDICAL KNOWLEDGE (choose the correct answer. You can choose more than one option)
P1- Which of the next are risk factors for newborn vitamin K deficiency bleeding
Mothers using corticosteroids
Mothers using anticonvulsants
Mothers with previous surgery
Mothers without vitamin K supplementation during pregnancy
Mothers who cannot breastfeed
P2- Which of the following are adverse effects associated with intramuscular vitamin K
administration.
Increased risk of solid tumours
Increased risk of leukaemia
Risk of infection
Increased risk of haemolysis or jaundice
Its administration has no risk.
P3- Which of this, when taken during pregnancy, is associated with increased risk of vitamin K
deficiency bleeding.
Anticonvulsants (phenobarbital or phenytoin)
Vitamin K antagonists
Tuberculostatica (Rifampicin and isoniazid)
Benzodiazepines
Neuroleptics
P4- According to recent studies, the risk, per 100000 newborns, of vitamin K deficiency bleeding,
without prophylaxis, is approximately:
55
35
20
10
<1
P5- According to recent studies, the risk, per 100000 newborns, of vitamin K deficiency bleeding,
with prophylaxis, is approximately:
55
35
20
10
<1
P6- According to recent studies, the risk of death, per 100000 newborns, of vitamin k deficiency
bleeding is:
55
35
20
10
<1
Y- Yes, N- No, DK, don’t know
Y N DK
P7- Breastmilk has lower levels of vitamin K when compared with other milk formulas.
P8- Vitamin K deficiency is less likely in formula-fed infants
P9- Vitamin K deficiency risk gets lower as other food, other than milk, is introduced to infants.
P10- Vitamin K deficiency bleeding can be prevented by administration of vitamin K to mothers in labour.
P11- Classic vitamin k deficiency bleeding, which happens in the first week of life, is the more dangerous one, with intracranial bleeding as a common complication.
P12- Healthy newborns, with vitamin K prophylaxis at birth, are no longer in danger of bleeding after the first week of life.
P13-Vitamin K should only be administered to high risk newborns (traumatic labour, low weight or biliary atresia).
P14- Vitamin K prophylaxis should be administered to all newborns.
P15- The recommended prophylaxis for prevention of vitamin K deficiency bleeding is three oral doses of vitamin K.
P16- The recommended prophylaxis for prevention of vitamin K deficiency bleeding is one single dose of intramuscular vitamin K.
P17- Intravenous administration of vitamin K is the most efficient form for prophylaxis of vitamin K deficiency bleeding.
P18-The recommended dose of vitamin K to be administered to all newborns, for vitamin K deficiency bleeding prophylaxis, is 1 mg.
P19- The dosage of vitamin K, recommended by the WHO, for prophylaxis of vitamin K deficiency bleeding is supraphysiologic.
P20- The correct dosage to be administered do pre-term neonates is easily found in the literature.
P21- Vitamin K administration, for prophylaxis of vitamin K deficiency bleeding, is the first health related decision parents should take. For this reason, risks and benefits should be explained, and informed consent should be provided.
P22- Parental refuse of vitamin K administration to newborns is increasing and the reasons are supported by the literature.
II- Clinical Practice
Y N DK
P23- In my workplace we have an updated protocol for prophylaxis of vitamin K deficiency bleeding of the newborn.
P24- In my workplace all the newborns receive vitamin K prophylaxis
P25- In my workplace vitamin K prophylaxis is discussed with the parents and informed consent is provided.
P26- In my workplace the physician responsible for the labour decides the vitamin K dosage to be administered.
P27- In my workplace the labour nurse decides the vitamin K dosage to be administered.
P28- In my workplace there is little discussion and information about the correct dosage and administration way for prophylaxis of vitamin K deficiency bleeding of the newborn.
P29- In my workplace vitamin K dosage varies whether a it is a full term or preterm infant.
(Choose whether the statement is true or false)
P30- In my workplace vitamin k dosage varies with newborn weight.
True ___; False ___
(Answer the next two questions only if you choose “True” in the previous question)
The vitamin K dosage administered to term newborns is :
0,1 mg/kg
0,2 mg/kg
0,4 mg/kg
0,6 mg/kg Other, which?
Q The vitamin K dosage administered to pre-term newborns is:
0,1 mg/kg
0,2 mg/kg
0,4 mg/kg
0,6 mg/kg Other, which?
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I-CARACTERIZAÇÃO
Sexo:
F__ M__
Idade: ___ anos
Grupo hospitalar a que pertence o hospital onde exerce a profissão:
Grupo I - Hospitais de Apoio Perinatal (especialidade de ginecologia/obstetrícia com bloco de partos e pediatria com urgência Pediátrica. Área de influência direta para as valências existentes entre 75.000 e 500.000 habitantes, sem área de influência indireta)
Grupo II- Hospitais de Apoio Perinatal- (especialidade de ginecologia/obstetrícia com bloco de partos e pediatria com Urgência Pediátrica. Área de influência direta e indireta para as suas valências).
Grupo III- Hospital de Apoio Perinatal Altamente Diferenciado (especialidade de ginecologia/obstetrícia com bloco de partos, pediatria, Cardiologia Pediátrica, Cirurgia Pediátrica e Genética Médica e todas as subespecialidades ou unidades diferenciadas. Área de influência direta e indireta para as suas valências)
Número de partos que assiste por mês:
<10
11-20
21-30
>30
II-CONHECIMENTO GERAL (escolher a/as respostas corretas)
P1- Dos seguintes qual/quais são fatores de risco comprovado(s) de hemorragia no recém
nascido (RN) por défice de vitamina K:
Mãe sob terapêutica com corticosteroides
Mãe sob terapêutica com anti-convulsionantes
Mãe sujeita a cirurgia
Mãe que não fez suplementação com vitamina K durante a gravidez
Mãe que não pode amamentar
P2- De entre as seguintes selecione a(s) que representa(m) riscos comprovadamente associados
à administração de vitamina K via Intra-Muscular(IM) no RN:
Risco de tumores sólidos
Risco de leucemia
Risco de infeção
Risco de aumento de icterícia ou hemólise
A vitamina K é completamente inócua para o RN
P3- Indique o(s) grupo(s) de fármacos que, quando se verifique a exposição in útero, pode(m)
aumentar o risco de hemorragia do RN por défice de vitamina K:
Anti-convulsionantes (fenobarbital ou fenitoína)
Anticoagulantes
Tuberculoestáticos (rifampicina e isoniazida)
Benzodiezepinas
Antipsicóticos
P4- De acordo com os estudos mais recentes, o risco, por 100,000 lactentes, de hemorragia por
défice de vitamina K, no RN que NÃO fez esquema de profilaxia, é de aproximadamente:
55
35
20
10
<1
P5- De acordo com os estudos mais recentes, o risco, por 100,000 lactentes, de hemorragia por
défice de vitamina K, no RN que fez esquema de profilaxia, é de aproximadamente:
55
35
20
10
<1
P6- De acordo com os estudos mais recentes o risco de morte, na hemorragia por défice de
vitamina K, no RN é:
55
35
20
10
<1
(escolher a respostas corretas)
S-sim, N-não, NS- não sei
S N NS
P7- O leite materno tem níveis mais baixos de vitamina K quando comparado com fórmulas de leite adaptado
P8- O défice de vitamina K é menos provável no RN sob aleitamento com leite adaptado
P9- O risco de hemorragia por défice de vitamina K diminui quando o lactente introduz outros alimentos para além do leite materno
P10- O risco de hemorragia por défice de vitamina K pode ser evitada administrando vitamina K a mães em trabalho de parto
P11- A hemorragia por défice de vitamina K na forma clássica, que ocorre na primeira semana de vida, é a forma mais grave, sendo a hemorragia intracraniana uma complicação comum
P12- RN saudáveis, que fizeram profilaxia com vitamina K ao nascimento, deixam de estar em risco de hemorragia por défice de vitamina K ao completarem uma semana de vida
P13- A vitamina K só deve ser administrada a RN considerados de alto risco (parto traumático, baixo peso ou com patologia associada como atresia das vias biliares)
P14- A vitamina K deve ser administrada profilaticamente a todos os RN
P15- A profilaxia recomendada para prevenção da hemorragia por défice de vitamina k consiste na administração de três tomas vitamina K por via oral
P16- A profilaxia recomendada para prevenção da hemorragia por défice de vitamina K consiste na administração de uma toma única de vitamina K por via IM.
P17- A forma mais eficaz de administração de vitamina K para profilaxia da hemorragia é a via IV.
P18- A dose recomendada, em todos os recém nascidos, para profilaxia da hemorragia por défice de vitamina K, é de 1 mg
P19- A dose de vitamina K recomendada pela OMS, no recém nascido, para a profilaxia de hemorragia por défice de vitamina K, corresponde a uma dose plasmática suprafisiológica
P20- A dose de Vitamina K a administrar no recém nascido pré-termo é facilmente encontrada na literatura.
P21- A administração de vitamina K, para profilaxia da hemorragia por défice de vitamina K, é a primeira decisão em saúde que os pais do recém nascido têm que tomar. Devem, por isso, ser meticulosamente explicados os riscos e benefícios da sua administração, clarificar as dúvidas e pedir o consentimento
P22- A recusa pelos pais da administração de vitamina K está a aumentar e os motivos são fundamentados pela literatura
II- PRÁTICAS CLÍNICAS
S N NS
P23- No meu serviço existe protocolo atualizado do esquema profilático de vitamina K para prevenção de hemorragia por défice de vitamina K no recém nascido
P24- No meu serviço todos os recém nascidos recebem profilaxia com vitamina K
P25- No meu serviço a administração profilática de vitamina K é discutida com os pais, aos é pedido o consentimento
P26- No meu serviço o médico responsável pelo parto controla a dose que é administrada de vitamina K
P27- No meu serviço a enfermeira parteira controla a dose que é administrada de vitamina K.
P28- No meu serviço há falta de discussão/informação sobre a dose e via de administração de vitamina K capaz de prevenir a hemorragia do recém nascido por défice de vitamina K
P29- No meu serviço a dose de vitamina K a administrar é diferente caso se trata de um recém nascido de termo ou de um recém nascido pré-termo
(escolher a resposta verdadeira)
P30- No meu serviço a dose a administrar é diferente e depende do peso do recém nascido.
VERDADEIRO ___
FALSO ___
(Responder às duas últimas questões caso tenha escolhido verdadeiro na questão anterior)
Quando se trata de um recém nascido de termo a dose que administro é:
0,1 mg/kg
0,2 mg/kg
0,4 mg/kg
0,6 mg/kg
Outra, qual?
Quando se trata de um recém nascido pré termo a dose que administro é:
0,1 mg/kg
0,2 mg/kg
0,4 mg/kg
0,6 mg/kg
Outra, qual?
O questionário chegou ao fim. Salientar mais uma vez que todos os dados são confidenciais.
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