Identifying the ethical and essential foundation for research on the relative safety of PHB & other non-medical birth settings

In the “Story of Philosophy” by Will Durant (1926) describes Aristotelian logic and quotes the French philosopher Voltaire as saying:

“If you wish to converse with me, define your terms”.

Mr. Durant observes that a great percentage of the world’s debates would have been quickly deflated into a paragraph had the disputants dared to define their terms!

So prior to addressing the issue of science-based research on childbirth practices — in particular, relative safety associated with planned place-of-birth, I also will pay homage to the the logic of Aristotle, Voltaire and Durant by defining our terms.

The Purpose of Maternity Care:

Maternity care is one of the few forms of healthcare (the other being cosmetic surgery) that is primarily provided to an already healthy population. fact, that is the point. When it come to pregnancy and childbirth in an healthy population, the main goal of such professional care is protect, preserve and promote health in an already healthy population of childbearing women and to reduce potential or actual hard (risk-reduction) via monitoring health status and taking or recommending appropriate action or interventions to prevent or reduce the harm of medical complications in mother or unborn.newborn baby.

LIFT TEXT HERE – from MaternityCare2.0, Dr, Carreon, Essential qualities of Maternity care, etc. 

Developing “Standard Characteristics” for OOH Studies

When it come to research on planned place-of-birth, RCTs are never going to be part of the picture, but that doesn’t mean that researchers are not interested in collecting informative data.

Unfortunately, a number of high-profile studies on place-of-birth have been designed by those with no direct experience or interest in OOH birth and in some cases, with an obvious preference for high medical intervention settings (hospitals). Some researchers apparently started out with a strong prejudice against OOH settings or equally strong desire to definitively prove the greater safety of highly medicalized care. Most media reports of OOH research do not distinguish between well-done studies with useful information and those that were poorly done and arrived at mistaken or misleading conclusions.

For example, a large retrospective study of planned home birth published in 2002 chose to use state birth certificate data from a state that did not collect or record the “intended”  or planned place of birth. As a result, the study’s conclusion — that planning an OOH birth doubled the risk of neonatal death (a statement widely circulated by the media) was based on this unreliable data.  A number of other studies that claim to prove hospital birth is safer or OOH more dangerous) have missing data, used poor methodology or other technical errors. This meant the study’s conclusions were not be supported by their own data.

Another example of this same problem is a recently published but much disputed OOH study — the Wax et al  meta-analysis available on-line on July 2, 2010. Out of 16,500 birth that (may or may not) have been planned to occur OOH, the Wax analysis recorded a total of 32 neonatal death.”  Twenty of these 32 deaths — nearly two-thirds — were taken from the 2002 study mention above that could not reliably determine whether an OOH birth was intended or not, or if the mother had been treated in the hospital for a considerable time during labor or if the baby was actually born in the hospital.

Even when planning status for OOH birth can be confirmed, the researcher still has the dilemma of what to do with appropriate transfers of women late in pregnancy for medical problems (breech baby, pre-term labor, PROM) or immediate transfer at the time of the initial labor evaluation to  due to discovery of a high risk condition such as bleeding, fever, thick meconium, etc. Since some percentage of women (or their babies) who planned an OOH birth will eventually need, want or receive hospital-based medical care, so the question is how to fairly determine place-of-birth outcomes relative to the mother’s choice of OOH.

If midwives transfer all the complications that occur in their OOH practices to the hospital, the stats for OOH (with all problems automatically eliminated) might unrealistically portray OOH birth as 100% safe, while hospital birth — recipient of all those complicated OOH transfers — would look (but not really be) more dangerous. In an attempt to circumvent this problem, outcomes have been assigned to the “intended” (planned) place of birth, no matter who actually provided care, or what type of care was actually provided or where the mother actually labored (in or out-of-hospital) or where the baby was actually born.

Studies that focus solely on the pregnant woman’s  plan to give birth OOH assign all subsequent data to the OOH-PHB cohort, even when a pregnancy risk factor or complication  was identified by the birth attendant and a necessary transfer of care was initiated long before labor. Another aspect of this confounding factor is assigning neonatal outcomes to OOH care even when the mother was transferred to the hospital early in labor and 80% (or more) of the intrapartum care was standard obstetrical management — IV, Pitocin, EFM, immediate access to Cesarean surgery, perinatology services at delivery, etc — for many hours before the baby was born in the hospital.

Unfortunate, this attempt to make the statistical comparison more fair means the outcome of the care as it was actually received is not correctly identified. The initial “intention” or preference of the family for a situation that never materialized becomes more relevant than the actual situation and type of medical care received. Without knowing if the adverse events in question occurred at home with a professional (or experienced) attendant present (i.e., not a precipitous delivery before the midwife arrived) or happen in the hospital, or if the medical problem was avoidable vs. unavoidable, or if the parents declined prenatal testing or medically recommended treatments, there is no rational way to assess the impact of place-of-birth.

How the data for ‘intended’ place of birth is defined, collected and used makes a big difference. Done poorly, it merely trades one type of statistical dilemma for another, which means these particular OOH studies fail to answer the fundamental question of relative safety or  provide us with “actionable” information in designing public policies, educational curriculums and identifying ‘best practices’.

Newspaper reporters and media spokespersons naturally assume that each of these must touted studies was based on rock-solid data and impeccable methodology. This would includes a full forensically investigation of each of these deaths so that all facts were verified and a complete set of specific information was available for each bad outcome and that conclusions of the studies was internally consistent with the data. But that is not the case for the this small subset of studies aggressively promoted by ACOG. In fact, the opposite is true. Because these studies tells us so little about the proximal cause and circumstances surrounding each of these individual incidence of neonatal death, it keeps their authors and the rest of us from coming to meaningful conclusions. With such rare events and small numbers, each adverse event could and should be specifically confirmed and forensically evaluated.

OOH maternity care is an articulated model that purposefully includes policies and protocols for transfer of care as needed. This is no different than the  triage process used by small and medium-sized community hospitals. Hospitals routinely assess labor patients on admission for complications that require a higher level of medical service and arrange for those with such complications to be transported to tertiary care facility.

Nowhere in the scientific literature does one see maternal-infant outcome statistics used to evaluate a form of maternity care based on the hospital where the mother initially planned or preferred to give birth, but in fact did not actually give birth, either because she delivered elsewhere or developed a complication that required her to be transported to another facility. The current convoluted methodology of OOH birth would not be tolerated in any other aspect of modern healthcare and it is also not appropriate for place-of-birth research.

While the consensus of the scientific literature supports planned and attended OOH labor and birth as a responsible choice for healthy women with normal pregnancies, the lack of “standard characteristics” for OOH studies does a great deal of mischief and causes no end of grief for the midwifery profession. Studies on place-of-birth need to use standard scientific criteria that reduce personal bias and hidden political agendas, and instead  helps inform public health officials and others who make policy decisions.

The only statistics on safety that are relevant to planned OOH birth are those that reflect outcomes for a normal term pregnancy that confirms the OOH status after onset of spontaneous labor and initial evaluation by the birth attendant. Only after the mother-to-be and her fetus are both confirmed to be essentially healthy and labor is at that point is normal can this mother’s labor and birth be documented as a planned OOH event. In addition, the actual place of birth, the timing of any transfer (how many hours before or after the birth) and the actual reasons for any labor or birth-related ‘bad outcome’ is crucial.