Reasons for Refusal of Newborn Vitamin K Prophylaxis: Implications for Management and Education
OBJECTIVE: The American Academy of Pediatrics recommends intramuscular (IM) vitamin K prophylaxis for all newborns to prevent vitamin K deficiency bleeding. Given the serious implications of late-onset vitamin K deficiency bleeding, our objective was to examine factors influencing parents’ decisions to refuse IM vitamin K prophylaxis.
METHODS: Parents intending to refuse IM vitamin K prophylaxis at delivery were recruited from 5 community hospitals, 1 academic medical center, and 2 birthing centers in a single Southeastern state. Participants completed a written survey including demographics, birth and parenting decisions (eg, breastfeeding), and open-ended questions about their vitamin K information sources, concerns, and knowledge of risks.
RESULTS: The incidence of refusal was highest at the birthing centers. Fifty-four parents intending to refuse IM vitamin K completed the survey. Most were white (78%), over age 30 (57%), and college graduates (65%). All reported intention to exclusively breastfeed. Most refused hepatitis B vaccine (90%) and erythromycin eye ointment (77%). The most common source of information was the Internet (70%). Concerns included synthetic or toxic ingredients (37%), excessive dose (28%), and side effects (24%). Eighty-three percent of parents reported awareness of risks associated with vitamin K refusal. However, only 6 parents (11%) decided to accept IM prophylaxis.
CONCLUSIONS: This study provides an understanding of the concerns, mindset, and information sources used by parents refusing IM vitamin K. Educating parents about the importance of IM prophylaxis should begin in the prenatal period and must address concerns parents identify on the Internet.
In 1961, the American Academy of Pediatrics (AAP) first recommended intramuscular (IM) vitamin K prophylaxis immediately after the birth of all newborns to prevent vitamin K deficiency bleeding (VKDB).1 This recommendation has been highly effective2,3 and was reaffirmed with AAP policy statements in 1993 and 2003.4,5 VKDB is uncommon in the United States, with the few reported cases from the 1980s to 2013 restricted to deliveries in which vitamin K prophylaxis was either not offered or was refused.6–12 In this context, it is concerning that an increasing number of mothers delivering at traditional hospitals and birthing centers are now refusing IM vitamin K.13–16
Of the 3 types of VKDB (early, classic, and late onset), the late-onset type has a higher association with intracranial bleeding, making prevention especially important.17 In 2013, the diagnosis of 4 cases of late-onset VKDB in Tennessee brought national focus back to this disease.18 These exclusively breastfed infants did not receive vitamin K prophylaxis and suffered significant bleeds, including 3 with intracranial bleeds.
Excluding infants with liver and malabsorption diseases, virtually all cases of late-onset VKDB are in exclusively breastfed infants who do not receive vitamin K prophylaxis or supplementation (eg, infant formula).5,17,19,20 Studies from Europe using data from the 1980s give a VKDB incidence of 4.4 cases per 100 000 in the British Isles17 and a relative risk ratio of 81.721 for infants who do not receive prophylaxis. However, the actual incidence and risk figures may be higher because the number of breastfed infants who do not receive prophylaxis and are not subsequently protected by infant formula supplementation is unknown.
Several authors have identified the need to study parental refusal of vitamin K prophylaxis,14,18,22,23 and speculation has arisen that this refusal may be related to online social networks and websites.13,20 Given the serious implications of late-onset VKDB, our objective was to examine factors associated with the decision to refuse IM vitamin K.
This is an 8-site, prospective, descriptive study of parents who intended to refuse vitamin K prophylaxis at delivery. All 8 sites were located in a single southeastern state.
Parents who expressed an intention to refuse IM vitamin K at delivery for their full-term newborn infants were recruited from 6 hospitals, including 5 large community hospitals and one academic center, as well as 2 midwife birthing centers between January 2014 and January 2015. Birthing centers are staffed by certified nurse midwives (CNMs), along with nurse practitioners, because the state does not provide licensure for lay midwives.
All parents refusing vitamin K were eligible for the study; no other exclusion criteria were applied. The participating hospital sites differed in the dates of involvement depending on the date of approval by their respective Institutional Review Boards (range 8–12 months). One of the 2 birthing centers was involved for 12 months. The other birthing center joined the study late and was involved for only 1.5 months.
A 2-page survey (see Supplemental Information) was designed by the authors to elicit information from refusing parents on the following topics: the sources they used to obtain information about vitamin K prophylaxis; their understanding of the medical consequences of vitamin K refusal; their concerns about the IM injection; related decisions about their newborn infant, including plans for breastfeeding, hepatitis B vaccine, circumcision, and eye prophylaxis; and basic demographic data. The questions on sources of information, medical consequences, and concerns about the IM injection were open ended.
Incidence of refusal of IM vitamin K was based on pharmacy records (ie, a newborn without delivery of vitamin K).
Each site had designated medical providers (physicians, advanced practice providers [nurse practitioners and physician assistants], certified nurse midwives, or registered nurses) who approached mothers in the first 24 hours postdelivery seeking their cooperation in completing an anonymous survey. Although the goal was to approach all parents refusing vitamin K, the procedures for notifying study workers of an eligible mother were determined by each site, resulting in variation in recruitment attempts. The number of missed recruitments was 0% for the 2 birthing centers, and 13% to 68% for the hospitals. Overall, >65% of eligible mothers were approached. The survey was completed by parents by hand, without assistance from study workers. Mothers were targeted in the recruitment. However, because fathers or other family members may have been involved in completion of the survey, we refer to the respondents as “parents.”
After completion of the survey, parents were offered a 1-page information sheet that stressed the importance of prophylaxis to prevent serious bleeding and the safety of the IM injection. Medical providers were available to discuss VKDB and prophylaxis but were not given guidelines for subsequent interaction. Also, there was no study-related protocol concerning requests for oral vitamin K prophylaxis; each site acted independently in this regard. Before hospital discharge, the final decision regarding prophylaxis was recorded. The details of individual encounters were not recorded (total time spent discussing their decision, number of separate encounters, participation of other family members in the discussions, etc.).
Institutional Review Board Approval
The study was reviewed and deemed exempt by the institutional review boards of all participating institutions. As an exempt study, no written consent was obtained before study participation.
Open-ended responses were coded into categories developed based on survey responses; codes were not developed a priori. Two authors (LAM and ACS) established likely codes based on a scan of the survey responses. Each then independently coded approximately half of the surveys and discussed any disagreements. Some responses were general, and others were specific. For example, parents could respond that a source was “online” or cite a specific Web site; these would both be categorized as “Internet.” Once codes were established, the remainder were coded by a single author (ACS). We used descriptive statistics to describe the sample and examine the reported reasons for refusal of vitamin K on the basis of coded responses.
Incidence of refusal was highest at the birthing centers, compared with the hospitals (Table 1.) A total of 85 parents were approached, and 54 provided complete answers, for an overall response rate of 64%. The majority of responders were white (78%), over age 30 (57%), and college graduates (65%). All of the parents reported an intention to exclusively breastfeed, and most refused other prophylactic interventions (Table 2). Parents reported a variety of vitamin K information sources and concerns regarding the use of vitamin K prophylaxis (Table 3). By far the most common source of information was the Internet. Concerns included synthetic or toxic ingredients, excessive dose, the belief that it was “unnatural,” and potential side effects (24%).
Although 83% of parents reported an awareness of the risks of not receiving vitamin K, only 67% reported an awareness of bleeding (Table 4). Additionally, only 17% reported an awareness of intracranial bleeding specifically, and 9% the risk of death. Despite awareness of risks, only 6 of fifty-three parents (11%) who completed the survey and initially refused IM prophylaxis decided to accept it after discussions with study workers.
The findings in this study suggest that most parents in this older, well-educated cohort had been proactive in making decisions on vitamin K prophylaxis, hepatitis B vaccine, and eye prophylaxis before presenting in labor. They wanted as “natural” a birth process as possible and believed, on the basis of their own research, that IM vitamin K was probably not necessary and may even cause harm. The findings also suggest that it is difficult to change firmly held beliefs about birth decisions in the brief postdelivery period. The vitamin K information sheet and bedside discussions with medical providers had little influence on the refusal decision to accept IM prophylaxis.
Incidence of Refusal
Similar to other reports,18,24 the incidence of refusal was highest among the parents at birthing centers. This is likely related to parents’ choosing midwife delivery based on the desire to seek a more natural birth experience compared with those who select delivery in a traditional hospital setting.22,24,25 The higher incidence of IM refusal at the 1 community hospital is not explained by our data but is possibly related to the presence there of an established system of oral prophylaxis at that hospital and to regional cultural differences where complementary and alternative medicine have a strong presence.
It is not possible in this study to assess the relative influence of the various information sources on the decision-making process. However, similar to mothers who refuse vaccines,26,27 a large proportion of these mothers consulted the Internet for information, with some parents indicating specific Web sites in their responses. Eight participants (24% of those who obtained online information) specifically mentioned the Web site of Dr. Joseph M. Mercola, who is described on Wikipedia as “an alternative medicine proponent, osteopathic physician, and web entrepreneur.”28 Other websites that are not scientifically based are sponsored by individuals with little or no formal medical experience or training. All espouse an alternative and holistic philosophy of pregnancy and natural childbirth that generally views oral and IM vitamin K prophylaxis as unnecessary. Additional sources of information without a scientific base included printed materials from authors with philosophies similar to the Web sites. Specific authors mentioned include Ina May Gaskin, Penny Simon, Henci Goer, and Robert Sears; however, no single printed source was reported more than once.
Health care providers were another source of information cited by study participants. However, provider types were not typically identified (ie, no distinction was made among licensed physicians, nurses, or midwives; specially trained laypersons such as doulas; or alternative medicine practitioners). Therefore, the information gathered regarding medical providers is too broad to draw meaningful conclusions.
Reasons for Refusal
The top 3 reasons for refusal were (1) concerns that the ingredients in the injection were synthetic or toxic, (2) the impression that the dose of vitamin K was excessive and therefore may be harmful, and (3) fear of adverse side effects. These concerns clearly correlate with the information provided on various Internet websites. The potential for leukemia was listed by only 4 respondents, which likely reflects the acknowledgment by some negative Web sites that this concern is unfounded. Additionally, some respondents listed that unspecified religious and/or personal factors impacted their decision-making process.
Awareness of Risks
Sixty-seven percent (67%) of the parents were aware that infants who do not receive vitamin K prophylaxis are at risk for bleeding. However, most did not understand the potential severity of bleeding, particularly the possibility for intracranial hemorrhage or death. This is consistent with a recent study performed on a convenience sample of educated expectant parents from Israel, which found that the majority were unaware of the potential consequences of refusing infant vitamin K prophylaxis.14
Alternatives to Vitamin K Prophylaxis
In contrast to the Canadian Paedatric Society,29 the AAP does not have a policy statement on the use of oral prophylaxis as an alternative when parents refuse IM prophylaxis.5 Also, there is no licensed liquid preparation for infant prophylaxis in the United States. Therefore, medical providers, hospitals, and birthing centers act independently in this regard. As mentioned earlier, the hospital with the oral prophylaxis system in place had a much higher incidence rate (4.58%) for refusal of IM prophylaxis. It appears that the availability of an established oral option system provided an attractive choice for a number of mothers.
Human milk does not have enough vitamin K to be protective against excessive bleeding.30 However, 2 mothers commented that they planned to increase the concentration of vitamin K in their breast milk by eating more vitamin K–rich foods and/or by taking a proprietary product. Although maternal supplementation can increase the levels of vitamin K in breast milk, there are no studies to demonstrate that the achieved levels are consistently sufficient to prevent VKDB.30,31
Parents Refusing Vitamin K Prophylaxis
Because parents who decline vitamin K prophylaxis are also more likely to oppose childhood immunizations,24 the vaccine refusal literature provides some insight into their characteristics and belief systems. Our sample was similar to others who refused vaccinations, in that they are fairly well educated and have a need to investigate all aspects of a medical decision and to feel that they are in charge of the process.32,33 Published material and Internet Web sites are key sources of information and are more influential than social networks and societal standards.34 Their personal beliefs, which include mistrust of traditional medicine, government, and the pharmaceutical industry, are reinforced by biased interpretation of information obtained in their research and may be refractory to change.26,32 The majority of parents in this study demonstrated this mindset in that they were unwilling to consider scientifically accurate information and remained steadfast in their refusal.
Implications for Prenatal Education
Parents who refuse vitamin K prophylaxis appear to have made their decision well before delivery. Therefore, attempts to change their minds in the immediate postpartum period are unlikely to succeed. To counter the trend of vitamin K prophylaxis refusals, primary medical providers, prenatal class instructors, and others concerned with newborn health must establish credibility with parents in prenatal settings through discussion and presentation of accurate information. These materials should address the role of IM vitamin K in preventing late-onset VKDB and, importantly, should provide rebuttals and logical explanations for the common online arguments against vitamin K (Table 5).
In response to the 2013 report of 4 cases of late-onset VKDB,18 several excellent information sources have been developed. An Internet Web site by Dekker effectively addresses common concerns and arguments about vitamin K prophylaxis.35 In addition, the Centers for Disease Control has produced an online video presentation, several dramatic case histories, and Web frequently asked questions that target the common negative online arguments.36,37 The AAP has also published information to assist providers in addressing concerns about vitamin K.16,38
The results of this study depict important factors associated with maternal vitamin K refusal in North Carolina but may not reflect patterns in other parts of the United States. In addition, as a convenience sample, the study did not capture all eligible mothers. It is possible that parents refusing to participate differed, although response rates were quite high at most sites. Additionally, it is unlikely that parents who were inadvertently missed because study workers were not notified were systematically different from those surveyed. As was mentioned earlier, the survey questions regarding parents’ information sources, concerns about the vitamin K injection, and awareness of risks were open ended. Therefore, some specific information, including the types of medical providers used for information, the names of printed information sources, and participation in prenatal group discussions, was not always elicited. We chose the survey method to capture as many parents as possible, but future research using qualitative methods could provide richer detail about the vitamin K refusal.
Our principal finding is that parents who refused IM vitamin K often sought information about vitamin K prophylaxis from numerous sources, but the Internet was most frequently consulted. The Internet information used often lacks the support of peer-reviewed scientific evidence and is generally presented to encourage a completely natural birth experience without medical intervention. As a result, the infants of these parents are at increased risk for late-onset VKDB. This study also notes the similarities between parents who refuse IM vitamin K and those who refuse childhood vaccinations. This association may help inform future efforts to educate parents who are reluctant to consent to IM vitamin K prophylaxis. Perhaps most important, the study identifies specific concerns from Internet sites that are not regularly addressed by providers in discussions with mothers.
We thank Dr Thomas Young and Ms Ginger Rhodes-Ryan, Wake County Medical Center, Raleigh, NC; Dr Susan Mims, Mission Hospital System, Asheville, NC; Ms Maureen Darcey, Women’s Birth and Wellness Center, Chapel Hill, NC; Ms Marcia Ensminger, Natural Beginnings Birth and Wellness Center, Statesville, NC; Dr Carl Seashore, Ms Jamie Haushalter, and Ms Erin Burnette, University of North Carolina Hospitals, Chapel Hill, NC.
Drs Hamrick and Gable, Ms Freeman, Drs Dunn, Zimmerman, Rusin, and Linthavong, and Ms Wright were involved in the conception and design, acquisition of data, and interpretation of data and drafting the article and revising it critically for important intellectual content; Ms Moss was involved in the acquisition and interpretation of data and drafting the article and revising it critically for important intellectual content; Dr Skinner was involved in the study design, acquisition of data, and analysis and interpretation of data and drafting the article and revising it critically for important intellectual content; and all authors approved the final manuscript as submitted.
FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.
FUNDING: No external funding.
POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose.
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- ↵American Academy of Pediatrics. American Academy of Pediatrics Vitamin K Ad Hoc Task Force: Controversies concerning vitamin K and the newborn. Pediatrics. 1993;91(5):1001–1003
- ↵American Academy of Pediatrics Committee on Fetus and Newborn. Controversies concerning vitamin K and the newborn. Pediatrics. 2003;112(1 Pt 1):191–192
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- ↵Abrams SaSS. Be prepared to address parents’ concerns about vitamin K injection. AAP News. 2014:35:1
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- ↵Wikipedia. Joseph Mercola. http://en.wikipedia.org/wiki/Joseph_Mercola. Accessed November 13, 2014
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- ↵Centers for Disease Control and Prevention. Frequently asked questions (FAQ’s): vitamin K and the vitamin K shot given at birth. 2014. Available at: http://www.cdc.gov/ncbddd/vitamink/faqs.html. Accessed February 5, 2015
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- ↵American Academy of Pediatrics. Where we stand: administration of vitamin K. 2014. Available at: http://www.healthychildren.org/English/ages-stages/prenatal/delivery-beyond/Pages/Where-We-Stand-Administration-of-Vitamin-K.aspx. Accessed February 9, 2015
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- Copyright © 2016 by the American Academy of Pediatrics