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Midwife Informed Consent for Vitamin K

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by Ronnie Falcao, LM MS

This is from the informed consent I give my clients:

Vitamin K Injection or Oral Administration

It is currently the medical standard of care to inject newborn babies with very high doses of vitamin K within an hour or two of birth; this is done to prevent a rare condition involving excessive bleeding.

The practice of injecting vitamin K into newborns shortly after birth started during the days when most mothers were so heavily medicated during labor and birth that they couldn't push their babies out, so most babies were pulled out by forceps.  These forceps deliveries often caused trauma to the baby's head or face and often left significant bruising.  Normally, there would be adequate clotting factors in the baby's blood to control a modest amount of internal bleeding.

However, the common medical practice then, as now, was to cut the umbilical cord almost immediately after birth; this practice deprives a baby of a significant amount of blood - up to 40% of the baby's normal blood volume, and thus up to 40% of the platelets and other clotting factors that nature intended to help control bleeding.

A newborn's ability to manufacture clotting factors was also restricted because breastfeeding opportunities were limited.  Thus newborns didn't get their full amount of early breastmilk, also called colostrum, which is high in vitamin K.  Since the liver requires vitamin K in order to synthesize key clotting factors, a vitamin K deficiency caused by reduced breastfeeding can result in an inability of the blood to clot appropriately.  The baby’s body is able to manufacture additional vitamin K once the gut is colonized with Vitamin-K-producing bacteria, but this isn’t well established until the baby is about 8 days old.

In addition, many newborn boys were circumcised soon after birth, before their clotting factors had naturally risen; note that Jewish culture understands the natural rise in clotting factors and so postpones their ritual circumcision until eight days after the birth.

So the birth practices of those days created a situation in which a baby had a reduced supply of clotting factors along with a greater need for clotting factors.  Some of these babies "used up" their clotting factors and didn't have the vitamin K necessary to make more clotting factors and thus had no ability to control the bleeding within the brain from the forceps trauma.  This bleeding in the brain could cause permanent brain damage; the condition is called hemorrhagic disease of the newborn (HDN).

Some doctors concluded that "the problem" was that a baby’s vitamin K levels are lower at birth than they will be a few days later.  (Vitamin K is a naturally occurring fat-soluble vitamin which is necessary for the production of prothrombin, a clotting factor).  For reasons that are not clearly understood, nature takes great pains to keep a newborn baby's vitamin K levels low; even if a pregnant woman takes high levels of vitamin K during her pregnancy, this will not increase the baby's vitamin K levels or clotting factors at birth.  Without understanding exactly what they were doing, doctors decided to try injecting very high doses of vitamin K into babies, which did increase the babies’ clotting factors and which did reduce the incidence of HDN.  (An astute observer might conclude that they might just as easily have reduced the incidence of HDN by reducing the use of forceps and by leaving the umbilical cord intact for at least five minutes so the baby got the level of clotting factors that nature intended.)

So, without any research to determine the optimal dosage of vitamin K, and without any research to investigate whether increased clotting factors might actually cause a different problem for a newborn, doctors made it a routine practice to inject all newborns with a dose of vitamin K that is 20,000 times the normal newborn levels.  This practice has remained largely unchanged since 1944, without adequate followup research. However, some indirectly related studies done on "delayed" cord clamping in premature babies have confirmed that babies who get more of the blood that nature intended are less likely to have bleeding in the brain.

In modern births, the use of forceps has been replaced by vacuum extraction, which can also cause physical trauma and bruising and bleeding in the bran.  In addition, the drugs which are commonly injected in epidurals and spinal anesthesia have the possible side effect of causing bleeding in the newborn's brain.  Circumcision is still a risk factor for excessive newborn bleeding.

One of the most disturbing aspects of the vitamin K controversy is that there is little research to determine whether such high levels of vitamin K might be harmful to a newborn in some way.  Research regarding vitamin K has only looked at the effect on HDN, the bleeding issue.

Almost everyone (myself included) agrees that if a baby has a traumatic birth that causes a lot of bruising or if a newborn shows signs of clotting difficulties, then it makes sense to administer vitamin K in a timely fashion to prevent HDN.

However, advocates of physiological birth assume that nature got it right when it comes to optimal levels of clotting factors for most babies.  These will be the levels of clotting factors that a baby gets when the umbilical cord is left intact for at least five minutes after the birth.  And, obviously, a physiological birth is much less likely to cause bruising than a forceps or vacuum birth.

Arguments against the routine use of vitamin K include three main observations:

1) Nature seems to go to a lot of trouble in regulating the baby's vitamin K levels: the level at birth gradually rises over the eight days following birth to a higher level.  It is almost as if nature very specifically wants the baby to have a specific level of clotting factors at birth, followed by a higher level of clotting factors a week after the birth.  This may be related to the fact that in a physiological birth, where the baby gets all the blood from the placenta that the baby wants, the baby's blood is a little thicker; this is especially true in the 72 hours following birth, since the babies naturally become a little dehydrated until the mother's milk changes to a higher volume flow, so the blood is thicker.

2) There has been some association between vitamin K injection and childhood leukemia.  Followup research indicated that the leukemia might have been related to mercury used to preserve the vitamin K solution.  Theoretical observations are that precise levels of vitamin K are required to regulate the rate of cell division in newborns and that excessive levels of vitamin K disrupt this regulatory process, thus increasing the possibility of leukemia and other childhood cancers.

3) Research shows that babies who contract meningitis are more likely to die if they have higher clotting factors.  It's not clear whether this is due to genetic factors or whether it applies to all babies who receive vitamin K.

We know that a baby born in a physiological birth with no unusual birth trauma, an intact umbilical cord, and normal breastfeeding gets exactly the correct amount of vitamin K intended by Nature. The concern is that if a baby is born with exactly the right amount of vitamin K, then additional vitamin K might be an overdose that increases clotting factors above healthy levels.  These excessive clotting factors might cause other problems, such as susceptibility to meningitis or SIDS (Sudden Infant Death Syndrome).

Most of the above discussion pertains to the issue of "early HDN", which occurs within the first week after birth and seems strongly related to traumatic births and early cord clamping.

There is another form of HDN: Late-onset HDN is a completely different condition, which is thought to be more related to a vitamin K deficiency in the breastfeeding mother, or to the breastfeeding mother's use of drugs or alcohol, which might compromise liver function.

The medical approach to the problem of late-onset HDN is to give such a high of vitamin K to the baby in the injection at birth that the baby continues to be affected for the next six months.  Research is clear that repeated oral doses given to the baby once a week for the first three months of life provide better protection against late-onset bleeding than the single injection at birth.  Some research shows that the mother's daily vitamin K supplementation is also adequate protection.

There may be a very few babies with undiagnosed liver disease who would not be protected by a physiological birth and weekly oral vitamin K supplementation, so parents need to be vigilant for unusual signs of bruising or bleeding, regardless of whether the baby receives vitamin K supplementation.  It is generally believed that a prompt response to these signs will prevent long-term problems for the baby.

The Cochrane Collaboration (an international committee of medical doctors of the highest caliber) reports: “Very similar rates of protection against classical and late hemorrhagic disease can be achieved by giving repeated oral doses, either 1 milligram weekly or 25 micrograms daily.  Undertaking this form of oral prophylaxis requires that parents accept responsibility for ensuring the course is completed.”

I offer vitamin K by injection or by mouth, and it is your option to decline this treatment.

My perspective - From a philosophical point of view, I am reminded of how important all aspects of labor and birth are to the survival of the species. There is a complex interrelationship between delayed cord clamping, blood viscosity, colostrum, jaundice and vitamin K, and this delicate interplay is not well understood by the medical community that recommends vitamin K injection. If your baby experiences a gentle birth without premature cord clamping and nurses readily, your baby will probably receive exactly the dose intended by nature.  Nature generally gets these things right, and it seems a mistake to interfere with this process unless there are signs of a problem

Since I draw blood from the placental blood vessels after the birth to check the baby’s blood type, I have a direct observation of the clotting factors that your baby has at birth.  Every once in a while, I will notice a situation where the needle entry point seems to bleed more than usual, and in those cases, I might recommend vitamin K to increase clotting factors.

In my practice, I will let you know if I think there are good reasons for using vitamin K: a traumatic birth, unusual bleeding from the placental blood draw, or any other signs.

Whether or not your baby receives vitamin K supplementation orally or by injection, it is best to contact me or your baby’s care provider immediately if you notice that your baby seems to have a lot of bruises or free bleeding from the umbilical cord stump, or the eyes or nose, or if the baby’s stool turns black after the meconium has cleared.  These are common precursors to more serious bleeding problems, and prompt injection with vitamin K can then prevent permanent damage.

Summary of vitamin K Issues - There is no research on the subject of vitamin K in physiological birth.  This seems like an extreme intervention without adequate justification.  Concerned parents can remain alert for signs of early-onset HDN: unusual bleeding during the first week. Breastfeeding mothers can prevent late-onset HDN by eating large amounts of green, leafy vegetables rich in vitamin K or by taking vitamin K supplements.  I will let you know if I see any signs that the baby might benefit from vitamin K supplementation.  If you do choose vitamin K supplementation, I recommend oral administration at weekly intervals.

[More information about these routine newborn procedures can be found in A Guide to Effective Care in Pregnancy & Childbirth by Enkin, Keirse, et al., and at http: ****************************************************************************************

NOTE to other healthcare providers:

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Copyright ©2005 Ronnie Falcao, LM MS CPM – All Rights Reserved
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