Acknowledgement of the pioneering contribution made by the Newman Goldfarb Protocols for Induction of Lactation - and why the NDC Clinical Guideline for Induction of Lactation has differences
The Newman Goldfarb Protocol for induction of lactation has made a pioneering contribution to the wellbeing of families who want to breastfeed their babies
Induction of lactation has become increasingly important as our society becomes more aware of the needs of, and possibilities within, the diversity of families.
I gratefully acknowledge the pioneering Newman Goldfarb Protocol (NGP, found here), first published in 2000 by Dr Jack Newman, the Canadian breastfeeding medicine doctor who then published the protocol online in collaboration with his colleague Dr Lenore Goldfarb PhD IBCLC. Their work was developed out of their extensive clinical experience, given the lack of research available to inform it, and has constituted the original pioneering guideline for those who wished to support induction of lactation.
In the articles on induction of lactation which comprise the NDC Clinical Guidelines, I'll both highlight the recommendations which have been made prominent by the NGP, and which I in part integrate into the NDC Guidelines for the Induction of Lactation. I'll also critique elements of the NGP which I propose are no longer useful, or which may even undermine lactation success.
I engage in this analysis in the spirit of ongoing intellectual discussion and debate, for the sake of improving our capacity as clinicians to support breastfeeding or lactating families and their little ones.
The Newman Goldfarb Protocol concerning hormonal and medication preparation of the breasts has significant limitations
Here I quote statements in the NGP protocol which are inaccurate.
On hormonal preparation
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"Once pregnancy is completed, progesterone and estrogen drop and prolactin levels increase, resulting in lactation." In fact, prolactin levels rapidly decrease in the couple of days after the birth. You can read about this here.
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"Should the medical practitioner be concerned about the quality or composition of the mother's breastmilk, the MICAM [Maturation Index of Colostrum and Milk] test may be performed to test the various stages of the mother's milk." The Maturation Index of Colostrum and Milk (MICAM) test utilises biological markers to assess the rate of breast milk maturation, but there is no reliable evidence that this test improves management or outcomes, and I don't recommend its use.
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"As a rule, the longer the mother can be on her particular protocol, the more milk she will end up with." This is not demonstrated to be the case in research so far, and may not be true.
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"Because the birth control pill is started at any point in the woman's cycle, and is taken non-stop for the duration of the protocol, it does not provide the usual contraceptive protection." This information is inaccurate.
On domperidone use
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The NGP recommends 20 mg of domperidone four times daily, which is higher than internationally accepted standard effective dose, is not evidence-based, and increases the risk of side-effects.
- You can find out about domoperidone's side-effects here.
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"Most mothers find that when they forget a dose [of domperidone] their milk supply decreases." This statement misunderstands
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The dominance of autocrine and paracrine mechanisms after secretory activation.
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The role of domperidone, unnecessarily driving up anxiety and psychological dependence on domperidone use.
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The NGP recommends commencing domperidone at the same time as the parent commences hormonal treatment, preferably six months prior to the arrival of the baby. But McBride et al 2021 showed that 45% of patients self-report side-effects from domperidone use. There is no evidence to support such a long duration of domperidone use for the induction of lactation. If the patient experiences side-effects from domperidone use, the domperidone may be ceased and re-introduced closer to the cessation of hormonal preparation.
The Newman Goldfarb Protocol for mechanical stimulation of the nipples and breasts during induction of lactation has significant limitations
The Newman Goldfarb Protocol (found here) recommends
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Low to medium setting
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Pump day and night for at least four weeks
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Pump every three hours or more often during the day
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Start each session with 5-7 minutes of pumping, then
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Massage, stroke, and shake the breast, followed by
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Another three or four minutes of pumping.
However, there is no reason to think that massage, stroking, shaking of the breast, or breast compression will improve milk production outcomes.
There is no reason to think that pumping in any one session for longer than ten minutes will improve milk production outcomes.
The NGP recommends pumping for ten minutes after each breastfeed in the first days and weeks. This may not be necessary, and may even undermine milk production, as baby is the best pump (once underlying clinical problems, including of fit and hold and feed spacing, are addressed).
NGP also suggests supplementer use in some circumstances. The NGP suggests that the supplementer is taped onto the patient's breast and then only allowed to flow with milk after the baby has finished suckling without it. However, supplementer use could undermine the milk supply of a patient who has induced lactation.
You can find out about use of the supplementer here.
The NGP states that since COCP (containing oestrogen) inhibits milk production, no pumping is to occur until the hormones are stopped. However, women regularly engage in antenatal expression of colostrum when pregnant, from 36 weeks a few times a day without adverse effects. Although both the progesterone and oestrogen of the COCP may inhibit milk secretion, the doses are much lower than in pregnancy.
There's no scientific reason to believe that herbal galactogogues improve outcomes from induction of lactation
The NGP recommends commencing galactogogue herbs when pumping commences. The NGP states: "The following herbs have been found to be helpful in increasing milk supply for women on the protocols.
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Fenugreek seed: 3 capsules (580-610 mg each) 3 times a day with food.
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Blessed Thistle herb: 3 capsules (325-390 mg each) 3 times a day with food
... Many women on the protocols have found that fenugreek taken alone may cause stomach upset, but when taken in combination with the blessed thistel the stomach upset is reduced or nullified."
The NGP also recommends oatmeal for breakfast three times a week.
There is no evidence-based reason to believe that herbal preparations act as effective galactogogues and result in improved breastmilk volumes in patients who undertake non-puerperal induction of lactation.
These statements are not derived from reliable evidence, once the available research is critically analysed. Adding in herbs and oatmeals as prescriptions in an induction of lactation protocol, so that their use by patients is seen to be a necessary and scientific part of induction of lactation, is unhelpful at best and misleading at worst.
I acknowledge the many ancient folk traditions of herbal use for the support of breastfeeding women and their milk. There are many reasons why some families use traditional or cultural galactagogues. The way we relate to our bodies and imagine our lives, bodies, and relationship with our babies and children is much bigger and more powerful than the narratives told by the biomedical model and our science-based research. Families may choose to use herbal galactogogues and derive enjoyment and meaning from their preparation or from receiving these preparations from loving others.
However, we work as clinicians in a complex 21st century context which is dominated by market forces, including the multibillion-dollar natural supplement industry. It's our responsibility to be clear about what has a genuine evidence-base, or in the absence of evidence, biologic plausibility or physiological rationale. We can then allow families to make choices and to make meaning in their own way - without falsely claiming that herbal galactogogues are an effective way to promote milk production.
Recommended resources
Research about induction of lactation in transgender patients
Induction of lactation: taking a history and why each question matters
Case report of preparation for induction of lactation in a cisgender woman (NDC Clinical Guidelines)
NDC Co-lactation Feeding Plan (to be adapted adapted)
Selected references
McBride GM, Stevenson R, Zizzo G, Rumbold AR, Amir LH, Keir AK, et al. Use and experience of galactogogues while breastfeeding among Australian women. Plos One. 2021;16(7):e0254049
Other references available here.