Conclusions ~ “Statistical” significance, fully-informed consent & a fully-integrated maternity care system that includes the obstetrical profession

by faithgibson on July 15, 2016

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Before reading this post, please acquaint yourself with the previous  article & information on “statistical significance”,
This previous post examines and comments on the study Patricia A. Janssen et al entitled
Outcomes of planned home births versus planned hospital births after regulation of midwifery in British Columbia  {CMAJ. 2002 Feb 5; 166(3): 315–323  

Comments on the article concerning “statistical significance”, and my conclusions and recommendation relative to “informed consent” for OOH childbirth services

The absolute numbers in this study were relatively low: only 862 PHB, of which only 86% by delivered by midwives, with 13% by MDs and 6 unattended births, and only 404 midwife-managed hospital birth and 762 physician-managed deliveries, for a total of 2,177.

However, the resulting statistics give us a wonderful opportunity to contrast like-with-like among the three categories of birth attendants – OOH midwifery, hospital midwives and hospital physicians — and the two planned places-of-birth.

In addition, this particular comparison is uniquely valuable to us — in fact, a gold mine of relevant information — because all the childbearing women in all three arms of the study were matched for demographic factors and for their medical and pregnancy status based on criteria comparable for a planned OOH birth with a midwife.


Ina May Gaskin with her baby daughter, midwife, author and spiritual midwife of planned home birth in the U

Hosptial-physicians and hospital-midwives both provided care to the same cohort of women — healthy, had normal pregnancies and if they’d wanted to, could have planned to labor at home or other OOH setting.

Nobody can claim that differences between hospital and OOH reflect different population groups — either more high-risk women (hospital) or more “healthy” women that were so super low-risk as to be “bullet-proof”.

So we can contrast outcomes based on the caregiver categories AND on the planned place-of-birth. In that regard, place of birth was more important than the category of caregiver when it came to negative outcomes.



LDRP with standard obstetrical equipment and devices, that keep the mother hooked up to the EFM and IVs. Computer monitor and keyboard used by nurse for charting; mother immobilized in bed, looking pretty discouraged and despondent

1. Planned hospital births were strongly associated a dramatically increased use of labor interventions (Pitocin, epidural, etc) and CS-AVD, whether the birth was attended by a midwife or an MD.

Planned hospital births were associated with a significant increase in Cesarean surgery.

Photo_OB_Scrubs_CS_06 Photo_Gross_Csec_table
caesarian section

Copy of CS_del13_small

Breech baby being extracted by obstetrician from incision in mother’s uterus

While the Canadian C-sections rates in this study are lower than those in the US, we must remember that Cesarean surgery is the gift that keeps on giving. The most frequent potentially fatal post-Cesarean complication is an abnormal implantation of the placenta in a post-Cesarean pregnancy.

One medical commentator notes that the most serious complication of Cesarean surgery in the NEXT C-section.

This truly frightening complication of Cesarean surgery has given rise to a whole new obstetrical specialty — Accrete specialists. There are new regional hospital centers (ex. Houston, Tx) that now specialize in delivering previous Cesarean mothers with placenta accretes and percretas.

The rate of accreta-percreta has grown along with the rate of cesarean surgery: it has increased 8-fold — from 1 in 4,027 pregnancies — in the 1970s, rising to 1 in 2,510 pregnancies in the 1980s, to very sharply to 1 in 533 from 1982-2002 [ACOG, 2012]. The risks rise at a statistically significant rate with each additional cesarean section [Silver, Landon, Rouse, & Leveno, 2006]. Up to 7% of women with accreta will die from it (ACOG, 2012).

In addition to possible death, the intra-operative and post-operative complications in the first 2 weeks after a repeat Cesarean. These surgeries are major factors in life-threatening maternal hemorrhage that frequently requires an emergency hysterectomy to stop the bleeding.

These and other delayed and downstream complications go along with tripling the obstetrical intervention, especially the high Cesarean rate when healthy women with normal pregnancies at term are exposed to current forms of highly-medicalized hospital care.

That said, planned place-of-birth rather than category of caregiver — in this case, the planned OOH group of 862 births — had a greater number of serious maternal-infant complications than the two hospital comparison groups with 1,333 birth.  

  • There were 3 perinatal deaths in the planned OOH cohort, compared to 1 for hospital-MD, and zero for the hosp-midwives.
  • Five babies developed MAS or other types of respiratory embarrassment requiring more than 24 hour of ventilation (this included one of the perinatal deaths), while the rate of prolonged ventilation for both hospital groups was zero.
  • The planned OOH group (12% physician-attended births) included 3 of the 4 women who required blood transfusions and the only cases of obstetrics shock (2) in the entire study.

The relatively large number of these events in this study did NOT rise to the level of “statistical” significance, which is why the study’s conclusions are accurate when they report no statistically-significant difference in any of the major outcome measures.

While that is theoretically reassuring, the study nonetheless provides us with indisputable facts — there were 3 intrapartum mortalities; 3 mothers and 4 babies suffered significant morbidity. Even though one of the perinatal deaths was pre-labor, and another was apparently the rest of prenatal events, these extenuating circumstances do not change either the facts themselves or their implications relative to informed consent for OOH childbirth services.

IMG_4692Difference between abstract population-based medicine and personal, real-time, real-life experience of individuals who have to make critical health-related decisions 

There is a critical distinction between population-based medicine and our personal lives as individually experienced by each of us.

The thinking in population-based medicine goes like this: a 100,000 patients are enrolled in study on the efficacy of a certain drug or treatment regime for a particular disease. If a statistically ‘significant’ number of these patients — for example, 40,000 are still alive at the pre-determined 2, 3, or 5 years mark, the efficacy of the drug or treatment will have been established. This same winnowing process applies to medical treatments, devices and technologies, (for example EFMs) surgical procedures, medical treatments, regimes, protocols and policies.

Whatever side the ‘statistically-significant’ number lands on, that particular drug, procedure or protocol will be designated as the evidence-based treatment. This inheriently assumes that that patients and the public already knew everything worth knowing, but often that is not really the full story. When these studies are carefully read, one often finds that the absolute number of successfully treated patients in the original group that tipped the scales toward “statistical significance” was surprisingly quite small.

Particularly in drug trials, where the placebo effect is typically between 20 and 30%, a pharmaceutical formula that improves the study’s identified measure — reports of less pain, still alive at the 2-year mark, etc — at only 5% or 10% more than the placebo (which does not produce side-effects). For example, 10% of the study’s test subjects drop out or became ineligible (moved, died, etc), 25% noticed no change, 30% of those receiving a placebo reported improvement of symptoms and 35% of those taking the test drugs experienced improvement. In this case, the drug or procedure that ranked highest wins the lottery.

For example, 10% of the study’s test subjects drop out or became ineligible (moved, died, etc), 25% noticed no change, 30% of those receiving a placebo reported improvement of symptoms and 35% of those taking the test drugs could be documented as having less symptions or longer survival. In this case, the drug or procedure that ranked highest (35% improvement) wins the lottery.

Often the absolute death rate within 2 to 5 years for the disease in question (malignant brain tumor, pancreatic cancer, etc) is 99%. The drug did not ‘cure’ the patient but instead delayed an inevitable demise. That makes it virtually important that equal consideration is given to quality-of-life issues, economic cost and long-term consequences that include deaths directly traceable to the drug, or iatrogenic death several years or decades later (often the case for radiation treatments) that will never show up in any of the published research for that particular drug or other treatment regime.

While a considerable number of disturbing and debilitating side-effects were reported, including inter-drug reactions that result in extreme reactions and death, these issues are downplayed or totally ignored while singing the praises of the treatment. Also there can be an economic issue, when newer drugs or treatments are 5 times more expensive but only 10% better.

However, these rarely acknowledged but statistically “unimportant” issues have such a high impact on the individual person. It’s 100% “statistically” important to the person who suffers permanent harm or death. This information must also be part of the decision-making and informed consent process when individuals and families are trying to figure out what is the right thing for them to do.

MonkeyLookCameraLens_09Acknowledging full information to balance both population-based studies and high-impact, low-frequency personal consequences of maternity care

Each time a family has a baby, the parents have only one opportunity to get it right. As noted earlier, the inherent risk associated with childbearing when combined with the artificially-produced risks associated with various types of highly medicalized childbirth practices make this decision-making process difficult for everyone involved.

For this very reason, families deserve to know all these facts, or at least have access to such facts, for every aspect of the maternity care system, public policy recommendation (campaigns that promote “early and often prenatal”, etc) and any care offered by professional practitioners.

Care vs. “No Care” ~ No contest — the secret ingredient in relative safety for contemporary women is access to high-quality maternity care

This should begin by providing all families with information on morbidity and mortality that contrasting the difference in outcome for women who have access to and take advantage of modern maternity care versus women with no access to care or who decline to use maternity services.

This is the single most important piece of information there is on the actual dangers of childbirth and effectively eliminating them in the modern world of the 21st century.

The secret ingredient in relative safety for contemporary women is access to high-quality maternity care. Much to the surprise of many, it does NOT matter whether this care is provided by midwives or physicians, as long as it includes access to a modern and functional health care system with comprehensive perinatal services as needed.

Fully Informed Consent ~ standard obstetrical care

Families who are considering an obstetrical provider need quantified information provided by disinterested 3rd parties on the risks and benefits of all the popular medical and surgical interventions used routinely on healthy women with normal pregnancies receiving care within the obstetrical model:

  • Elective hospitalization of labor patients
  • Routine immobilized in bed
  • Intravenous fluids (IVs)
  • Continuous electronic fetal monitoring (EFM)
  • Epidural analgesia
  • Use of automatic blood pressure cuff
  • Foley catheter
  • Laboring women pushing while laying on their back (wrong use of gravity)
  • Inducing or speeding up labor with the artificial hormones including Cytotec, prostaglandin gels & Pitocin
  • Operative procedures including episiotomy, forceps, vacuum extraction and Cesarean section

These families also need accurate information  on CS rates of the local hospital and each of the obstetricians on staff. VBSC issues, delayed and downstream complications and increased rates of maternal morbidity and mortality must be revealed. This full disclosure process needs to include any increased likelihood that their baby will have to be admitted to the NICU such as induction before the term of their pregnancy.

KittenBack_Sleep_MAr2010Fully Informed Consent for OOH Care by midwives and family practice physicians

For families considering community-based childbirth services, I believe all OOH birth attendants have an ethical obligation to include both the population-based statistics — the mile-high big picture from 5,000 feet that is consistent with textbooks and other public resources, as well as how the practice of midwifery differs from obstetrics. Ethically this must also include information on the rate of iatrogenic complications associated with interventive obstetrics as currently (and inappropriately) applied to healthy women with normal pregnancies, as this is a part of the information that families need to consider when choosing a place of birth and category of caregiver.

But the informed consent process for OOH midwifery care must also provide the close up and personal view from 25 feet for couples considering an OOH labor, which is the numerically relevant outcomes — even when they are not “statistically significant”. For community-based midwifery care (even if provided by an MD), there is

For community-based, OOH maternity care (even if provided by an MD), there is small but real increase in morbidity and even smaller but still personally significant increase in site-specific mortality relative to severe breathing problems for babies and excessive bleeding problems for immediate postpartum mothers .

Realistically speaking, neonatal breathing and maternal bleeding are relatively more frequent and therefore more important than the rare (but still real) complications that worry us such as umbilical cord prolapse and amniotic fluid embolism(AFE). Unfortunately focusing on the long-shots can mean missing what is right in front of us. The concerns of parents making a place-of-birth decision needed to be addressed by providing data from population-based and the actual numbers that those statistical determination are based on.

Thankfully most other studies do not show the same higher rate of perinatal mortality reported by the 2002 British Columbia study, but even when those numbers are the same for both settings (in and out of hospital), it is a fact that timely access to emergency medical services does matter when it comes to breathing problems for babies and bleeding problems for mothers. The requisite ‘timely access’ is always reduced for OOH birth when compared to a tertiary care Level III obstetrical unit. It is further reduced by the family’s geographical location relative to hospitals with in-house laborist services, blood-banking, surgical scrub techs, anesthesiologists and level II or higher NICU.

As OOH practitioners, we have a duty to consider driving distance, traffic conditions, difficult mountainous or desert terrains, possibility of inclement weather, impassable roads and ever hospital staffing patterns into account when making clinical decisions relative to hospital transfer. Likewise, families considering an OOH labor and birth should know these facts, think about the feasibility of urgent hospital transfer and factor in their geographical location when deciding on a planned place-of-birth.

Currently, this is an artificially hard choice to make, since the high rate of obstetrical intervention and Cesarean delivery makes prophylactic hospitalization unpredictably risky because the default position for this system is excessive medicalization, with a statistically significant increase in iatrogenic/nosocomial complications .

Literature from the American “Every Mother Counts” program notes the many problems with our current obstetric-centric maternity care system:

  • The U.S. spends more on healthcare than any other country yet when it comes to maternal health outcomes, we rank 60th in the world.
  • Every day approximately two women die from preventable pregnancy and childbirth complications in the U.S. – approximately 650 women per year.
  • For every woman who dies, another 75 women experience a near-fatal complication – 50,000 women each year.
  • The U.S. is one of 13 countries with a rising maternal mortality rate, and the only industrialized country where maternal mortality is consistently on the rise.

0-47Looking beyond statistical issues to a more fully functional maternity care system for healthy women

Last but not least, childbirth activists and childbearing families must continue to “push” (pardon the pun!) for two things that actually are two sides of the same coin — a best outcome for everyone — mothers, babies, careproviders AND society who ultimately pays the bills for lack of appropriate care, excessive use of unwanted medicalization and the expensive complications they engender.

We need, want and deserve an evidence-based, 21st century maternity care system that does not segregate its midwives to the ‘back of the bus’, or claim that any woman who does not want to be unnecessarily medicalized is a hedonist who values her own birth experience more than the life of her baby. Gender-oriented or MD vs midwife-related trash-talk of that sort must stop.

What healthy childbearing women and their families want and need is an evidence-based model in which the individual management of pregnancy and childbirth would be determined by the health status of the childbearing woman and her unborn baby, in conjunction with the mother’s stated preferences, rather than the occupational status of the care provider (obstetrician, other physician, or midwife).

In practical and political terms, the cultural controversy over childbirth practices should not pit physicians and midwives against each other or pit obstetricians against family practice physicians. No healthy childbearing woman should ever be forced to choose between a midwife and a physician-obstetrician, or have to choose between a home and hospital birth in order to have a physiologically managed normal birth

Our ultimate goal for the 21st century is to integrate the principles of physiological management with best advances in obstetrical medicine to create a single, evidence-based standard for all healthy women with normal pregnancies, with obstetric interventions reserved for those with complications or if requested by the mother.

The most basic purpose of maternity care is to protect and preserve the health of already healthy women. Its basic goal is a cost-effective model of care that is able to preserve health and effectively prevent and/or successfully treat complications during pregnancy and childbirth.

Such a goal must factor in the full spectrum of reproductive mortality and morbidity over the course of a woman’s entire reproductive life, including delayed and downstream problems, complications in subsequent pregnancies, future fetal or neonatal loss and over-all cost of care to individuals and society.

Mastery in normal childbirth services for healthy women with normal pregnancies means bringing about a good outcome without introducing any unnecessary harm or unproductive expense.

The ideal maternity care system seeks out the point of balance where the skillful use of physiological management and adroit use of necessary medical interventions provides the best outcome with the fewest number of medical/surgical procedures and least expense to the health care system.

Ultimately, all maternity care is judged by its results — the number of mothers and babies who graduate from its ministration as healthy, or healthier, than when they started.

This would require:

  1. Medical schools and clinical training programs in the US to teach principles, protocols and skills required to support physiologic childbirth and all American hospitals to adopt this physiologic model as the standard for healthy women.

A new, non-surgical billing code for physiologically-based care is required so physicians can be fairly reimbursed for the added time required when providing physiological support for normal childbirth.

Labor and delivery units should be staffed by midwives as hospital employees and should have in-house hospitalist-laborist coverage that is 27-7-365. In geographical regions that would provide adequate utilization, hospitals should have ‘step-down’ units for midwife-led intrapartum care. These units must NOT be controlled by the obstetrical department but instead by a committee of midwives, family practice physicians, childbirth educators, and birth activists appointed by grass-roots community organizations.

Together these changes will lower the rate of obstetrical interventions, the number of Cesarean deliveries, and help resolve the issues that surround VBAC and post-Cesarean maternal morbidity and mortality from placenta accrete and percreta.

  1. Over the next decade or so, national maternity care policies must be changed so the vast majority of healthy women having normal pregnancies are receiving routine maternity services from professional midwives (of all backgrounds) and family practice physicians.

Over the next decade midwives and family practice physicians should work in collaboration with one another to become the primary birth attendants for healthy women, by providing ’normal care for normal birth’ in a variety of OOH setting. This should include step-down “maternity care” units in hospitals that are separate from the obstetrical department.

In addition, healthy families must also have the choice of a free-standing birth center or planned home birth. The mere fact that an ‘alternative’ to local hospitals exists will provide an economic incentive for these hospitals to create and maintain a genuinely “mother-baby-father friendly” maternity program that applies to all levels of midwifery, obstetrics, and neonatal services as provided all by  all hospitals in each community.

The small number of families that choose OOH care must receive appropriate informed consent as described above. This is to include realistic plans for dealing with the more common intrapartum-postpartum problems for mother or baby in which travel time to emergency services is an important factor.

Via la difference!