281BIRTH 27:4 December 2000

A CONSUMER VIEWPOINT

Challenges for Birth-Related Research

Susan Hodges, MS

To improve the quality and relevance of its work, the The Scientific Method: How Useful Is It forUnderstanding Childbirth?Cochrane Collaboration has made a commitment to

include consumer participation in all dimensions. Asa member of the Consumer Panel for the Cochrane The scientific method involves articulating a hypothe-Collaboration’s Pregnancy and Childbirth Group, I sis and testing it to see if it is true or not. In planninghave had the opportunity to referee, from a consumer those tests (trials), the investigator must try to eliminateperspective, protocols (formal plans) for systematic or control any factors not being studied that mightreviews on several pregnancy and childbirth topics. inadvertently influence the data. The goal is to obtainThe authors of the protocols receive evaluations from clear, unambiguous, reproducible results. Thus the sci-Consumer Panel members together with feedback from entific method requires clear definitions, rigid bound-peer referees. The experience of evaluating a protocol aries, limited variables, precise measurements, andcomparing midwifery and medical care for low-risk overall objectivity. However, these requirements arewomen led me to reflect on the challenges of studying in conflict with the complex and variable nature ofbirth in general and midwifery care in particular. This childbirth, for which subjective and imprecise ele-article describes some of my thoughts and questions. ments such as attitudes, beliefs, and feelings (of safety,

The scientific study of outcomes in childbirth is empowerment, comfort, freedom) are important; rigid-challenging from the start because childbirth is a com- ity, control, limitations, and precision are the antithesisplex, variable biological process. Since it is a hormon- of normal, natural childbirth.ally mediated and mind-body experience, the emotions, Although generally considered to minimize bias,attitudes, preferences, and expectations of the child- and to be a big improvement over conclusions drawnbearing woman and the people around her can affect from anecdotes or beliefs, the scientific method ofthe processes of pregnancy, labor, and birth. Medically investigation itself can easily incorporate biases inbased researchers approach the study of childbirth terms of the hypotheses chosen to test, the questionspractices with the framework of the scientific method asked, and the choice of outcome measures. For exam-combined with the attitudes and beliefs inherent in ple, investigating the effects of a discrete intervention,the medical/technological model of maternity care in such as artificially rupturing the membranes, is muchwhich they were trained. This model and the require- more straightforward than determining the effects ofments of the scientific method both conflict in funda- something less defined and subjective, such as emo-mental ways with the nature of childbirth—conflicts tional support. Similarly, it is simpler to determine thatthat can cause research biases and distorted a birth was or was not by cesarean section than toconclusions. determine the outcome in terms of the mother’s emo-

tional well-being. The scientific method by its verynature tends to focus attention and place value on thoseaspects that can be most readily studied; those aspectsthat are not studied tend to be ignored, forgotten, or

Susan Hodges is President of the Citizens for Midwifery, Inc., in dismissed as ‘‘unscientific.’’Athens, Georgia, and has been an activist for midwifery since 1985.

In addition, funding for research is highly competi-Her two children were born at home with midwives.tive. Factors influencing the allocation of research

Address correspondence to Susan Hodges, Citizens for Midwifery, funds, including economic interests, the success ofInc., PO Box 82227, Athens, GA 30608-2227.

previous related investigations, and the philosophy andattitudes of grant review committee members, tend toq 2000 Blackwell Science, Inc.

282 BIRTH 27:4 December 2000

support funding for research that fits the status quo. women who have no preference about the type ofcaregiver, and the results may not apply to womenPerhaps it is not surprising that relatively little research

has been done on the ‘‘touchy-feely’’ aspects of birth who do not fit that description.Could a woman’s preference for one type of care-and midwifery care or on longer-term outcomes, such

as the emotional impact of medical procedures and giver (or type of care) or another, or experiencing alack of choice regarding type of caregiver, influenceinterventions.

The scientific method even influences how we think the outcome? Since a woman’s emotional state canaffect her labor, an effect might well occur, but oneabout a process like childbirth. Consider that scientific

thinking and values focus attention on average values, that could be difficult to isolate from many relatedfactors (e.g., her beliefs and experiences, prior knowl-rather than on the range of what could be ‘‘normal’’

for any given individual. The medical model values edge of the possible caregivers, their personalities). Ifthe woman has her preferred caregiver (or type ofthe ‘‘average’’ as being the most ‘‘normal’’, even

though what is actually normal and healthy for an care), is the care element being studied more effectivefor her than the same care element provided by aindividual may not be ‘‘average.’’ For example, the

focus on the ‘‘average’’ length of gestation means that caregiver she would not choose? Would it even beethical to study this? If factors like the mother’s prefer-the ‘‘due date’’ is emphasized, and the pregnant woman

is ‘‘late’’ if birth has not happened by the due date (or ence and expectations affect the progress of labor, theoutcome measures, or both, what is the point of trying‘‘early’’ if the baby arrives before the magic date).

As a result, many childbearing women now suffer to eliminate those factors by randomization? Maybeit would be more meaningful to look at outcomes whenunwarranted anxiety, and unnecessary interventions—

inductions and even cesarean sections—are being per- each mother has the caregiver or the ‘‘type of care’’she prefers. However, this would appear incompatibleformed well before 42 weeks’ gestation with increasing

frequency. The scientific method can be extremely with the very concept of randomized controlled trialmethodology. Can meaningful questions about child-useful, but it tends to discourage practitioners and

researchers from valuing the great variety of ‘‘normal’’ birth and about midwifery versus conventional care beanswered solely (or at all) with randomized trials?that is typical of a biological process like childbirth.

My point here is that such trials have limitationsand are not always appropriate. Other research method-Randomized Controlled Trials:

Are They Appropriate for Studying Birth? ologies are also valuable and can provide useful infor-mation. I would suggest that the limitations of anyDo They Avoid Biased Results?type of experimental design should be pointed out andconsidered when setting criteria for trials or analyses,Human subjects and researchers can influence the re-

sults of some experiments if they know what is being when deciding on hypotheses and outcome measures,and when discussing the results. I would like to seestudied and which participants are ‘‘experimental’’ or

‘‘controls.’’ Whereas double-blind studies are consid- studies acknowledge what has not been studied andmention conclusions that cannot be drawn to helpered optimal because the design avoids those influ-

ences, using this method with human birth is feasible practitioners, researchers, and others avoid generaliz-ing conclusions to situations that simply have not beenand ethical only for certain limited types of investiga-

tions, such as studying the effects of a specific thera- studied.peutic drug. Although less ‘‘blind,’’ randomizedcontrolled trial methodology avoids or prevents bias Do Medically Trained Researchers Using the

Scientific Method Avoid Medical Model Bias?in the selection of individuals for each experimentalgroup in the study, so this is considered an acceptable

Care provided to pregnant and birthing women gener-type of investigation. In fact, some literature reviewsinclude only this design, excluding all studies using ally falls within one or the other of two main models

of care: the medical/technological model and the mid-other methods.I believe that several important considerations must wifery/holistic model. These two models are character-

ized by fundamentally different beliefs and attitudesbe addressed in attempting a randomized controlledtrial of childbirth care. For example, if the mothers in toward the birth process itself and toward women dur-

ing pregnancy, labor, and birth. Midwifery model carea study voluntarily agreed to participate knowing thatthey would be randomly assigned to either a midwife is woman-centered, respectful, supportive, and holis-

tic; unnecessary medical interventions are avoidedor a doctor, the investigators are not studying ‘‘low-risk pregnant women’’ in general. Rather, they are since birth itself is considered inherently normal,

healthy and safe except for relatively rare occurrenceslooking at the self-selected subgroup of low-risk

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of serious complications or medical conditions. In con- doing more interventions or treatments to ‘‘fix’’ a prob-lem rather than investigating the possibility that nottrast, the medical model is control centered, authorita-

tive, and focused on the ‘‘mechanics’’ of childbearing. doing something might be the solution.Investigators may dehumanize and objectify theSince labor and birth are considered to be dangerous,

this model calls for aggressive management of both study participants by using medical terminology (nul-lipara, c-section, subject, case) to refer to the womenthe mother and the birth process with monitoring,

drugs, and medical interventions, to meet fairly inflexi- and by avoiding any reference the fact that these arereal, live, individual women each experiencing herble medical expectations and institutional needs, even

when mother and baby are healthy and without regard own miraculous, unique and challenging process ofgiving birth.for the mother’s emotions, self-perceived needs, and

preferences. Also, the woman’s role is different in the The medical model rarely stimulates researchers toask participants what benefits (if any) they themselvestwo models. With the midwifery model, the mother is

the central active person, laboring and birthing her see in the procedure being studied, or to inquire aboutwomen’s concerns or feelings or level of satisfactionbaby herself, in contrast to the passive role she is

assigned in the medical model, under which many with the treatment or intervention. Few researchers areinterested in studying the effects of the pervasivenessthings are done to her before the medical team finally

‘‘delivers’’ the baby. of labeling that inspires doubt and fear (‘‘high risk,’’‘‘trial of labor,’’ ‘‘incompetent cervix’’), electronic sur-Because the medical model is so dominant in the

culture of North America and other industrialized veillance, and similar practices. The impacts of proce-dures, practices, and protocols on women’s feelingscountries, its characteristic beliefs, values, attitudes,

and philosophy of care have become that culture’s and lives are simply outside of the medical model ofcare, yet may be highly significant.unconscious assumptions about birth and maternity

care. However, from the standpoint of the midwifery The control group in a study is likely to be womenwho are similar with respect to a few key factorsmodel, those assumptions become more apparent, and

they affect perceptions and interpretations of what hap- and who receive ill-defined ‘‘routine care.’’ Unless theeffects of doula care, for example, is the main focus,pens throughout the childbearing process, with signifi-

cant consequences for the mother and baby. For a study is unlikely to provide a specific or detaileddescription of ‘‘routine care.’’ Did any individual haveexample, a pause in labor that is accepted as simply

a variation of normal labor in the midwifery model is social support? Were the women up and walking orin bed? What about intravenous drips? Access to food?likely to be perceived as a complication in the medical

model—labor is not proceeding according to the ‘‘nor- Even though these factors could influence outcomes,this type of information usually is not collected ormal’’ timetable and ‘‘requires’’ interventions.

Asking some questions can help point out places even discussed. How valid are the results and conclu-sions when these aspects are omitted?where the beliefs and values of the medical model may

have introduced bias into birth studies. What research A condition such as gestational diabetes typicallyis studied as an all-or-nothing situation, rather than asquestions are asked and not asked? What words are

used? What are the controls? What underlying assump- a continuum with a range of severity and a variety oftreatments. If the effectiveness of a medication is beingtions are being made? What kinds of results are valued?

I believe these biases are unconscious and uninten- studied, a medical model researcher is unlikely to seekeating disorder history, body image problems, or di-tional but very pervasive, because the medical model

dominates the cultural perception of birth. Since peer etary information for the study participants, eventhough these factors could reasonably affect the results.reviewers of research articles generally have the same

beliefs and values, the bias can go unnoticed. In some papers I have reviewed, I noted an eager-ness to overstate conclusions showing that a medicalBecoming aware of the bias seems a bit like becom-

ing aware of one’s own ethnocentrism; once one’s or pharmacological intervention was effective, andfailure to discuss the limitations of the results, nega-consciousness is raised, examples are easily recog-

nized. The medical model leads to research questions tive results, confounding influences, or alternativeapproaches.focusing on the effects of using an intervention rather

than on noninterventive approaches. For example, the Although not every study can include every vari-able, medical model researchers tend to not accountconcept of active management of labor as a way to

lower the rate of cesarean deliveries is based on as- for or control for emotional and environmental factorsthat could affect the outcomes being measured. In addi-sumptions that interventions are good and that low-

ering the rate requires yet more interventions. The tion, when medically trained investigators try to studyaspects of midwifery model care, the ‘‘culture gap’’medical model viewpoint encourages research on

284 BIRTH 27:4 December 2000

between the two models also comes into play. A re- of safety and autonomy, and determines whether ornot many aspects of care and procedures are readilysearcher steeped in the medical model and unaware

of the inherent bias is likely to have trouble asking available. For example, epidural pain relief, internalfetal monitoring, and cesarean deliveries are not avail-meaningful questions, let alone designing a study that

will produce valid results. able at home, but the mother can have a great deal ofpersonal autonomy and privacy; many women reportthat these are positive and helpful conditions for labor‘‘Midwifery Care’’ vs. ‘‘Medical Care’’: Type of

Caregiver or Type of Care Given? and birth. In contrast, hospitals impose many rules andprocedures on the mother and often repeatedly offer

How are midwifery care and medical care to be differ- drugs and interventions rather than emotional supportduring labor. The effect is to curtail the mother’s free-entiated? Is it enough simply to categorize or differenti-

ate caregivers only by their credentials? To describe dom and privacy and to undermine her confidence andconcentration, all of which can negatively affect thea cohort of caregivers as simply ‘‘midwives’’ or ‘‘ob-

stetricians’’ invites each individual to make his or her birth process.A few researchers have attempted to compare homeown assumptions about just what constitutes the care

they are giving, and to assume that each category is and hospital birth by trying to simulate the home settingin the hospital. ‘‘Home,’’ however, is not just furnish-fairly homogeneous, which is not necessarily true.

Both ‘‘midwives’’ and ‘‘doctors’’ include wide and ings; for most women home is her private, familiar,safe space where she has freedom and ultimate control.overlapping ranges of practitioners who vary in the

way they provide care. It is the lack of these very qualities—privacy, familiar-ity, safety, freedom, and control of the environ-If researchers are looking at effectiveness of the

care, then the care itself, not merely the credential of ment—in the hospital that for many women clearlycontribute to feelings of fear and anxiety that can pro-the caregiver, must be defined or described, and should

be as consistent as possible in a given study. If a study long labor and increase pain and complications. It isdifficult to see how a mother’s home could ever beincludes midwives or doctors with no documentation

on how these individuals were actually practicing, is meaningfully simulated for research on the site of birth,and randomized controlled trials examining this sub-it valid to generalize any conclusions about the effec-

tiveness of one type of practitioner vs. the other? Dif- ject would appear to be either unethical or impossible.Can the midwifery model of care be provided fullyferences in how the caregivers behave and what they

do are critical factors that should be studied. in the hospital setting? Perhaps. However, because themedical model is so dominant, and because the wayThese issues are also really important for consum-

ers. For pregnant women who are selecting a profes- medical institutions generally operate is at such oddswith the midwifery model, the full-blown midwiferysional for their perinatal care, and for people providing

perinatal services, it would seem vitally important to model of care is rarely achieved in the hospital settingat this time, and then only with difficulty and luck.determine what specific practices, behaviors, and ac-

tions affect outcomes. Future studies might include Hospital policies and rules, the nature of the facilityitself (layout, uniforms, equipment, sounds, staffmuch more information about what the caregiver(s)

are and are not doing; subgroup analyses might be shifts), rigid medical protocols, legal considerations,and insurance company requirements can and do limituseful to investigate possible differences and discour-

age overgeneralizing the conclusions. and distort hospital-based midwifery. The medicalmodel has developed within hospitals. That mothers,midwives and births are supposed to accept and adaptThe Setting: Can It Be Ignored?to the institutional needs and expectations is perfectlycompatible with the medical model. In contrast, theIn most studies all the births take place in the hospital,

although often this is not pointed out and the implica- midwifery model evolved as support and assistanceoffered to each individual mother giving birth on hertions are not addressed, the assumption apparently

being that the site of birth is insignificant. In fact, own terms in an atmosphere of freedom and empow-erment, also in conflict with the controlling structureenormous differences exist between hospital and home

for the site of birth. Routine hospital births, at least in and demands of hospitals as institutions.the United States, include many practices and proce-dures that are done to the mother solely because she Outcome Measures: What Is Valued?is in the hospital and that could affect outcomes. Onecan even ask if birth in the hospital can be considered The list of outcome measures for a given study can

also reflect a medical model bias. What are the vari-‘‘normal.’’The site of birth also affects the mother’s feelings ables being studied and how are they described? What

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is an ‘‘intervention,’’ and which ones are chosen? Out- of the effects of the ‘‘treatment’’ being studied. Aninvestigator who has never sat through an entire laborcome measures tend to include only discrete interven-

tions, events, and measurements (cesarean section, with a woman or observed a labor and birth withnone of the common interventions (e.g., induction,death, Apgar scores), often stated in negative terms,

for example, incidence of perineal tears, rather than augmentation, electronic fetal monitoring, drugs forpain, intravenous drip, episiotomy) is likely to be se-the incidence of intact perinea, or Apgar scores lower

than, rather than above a certain value. verely limited in his or her understanding of labor andbirth. Whereas the degree of mother-infant bonding,In one review of midwifery versus medical care

studies, only three maternal outcome measures were or feelings of satisfaction and empowerment (or feel-ings of anger, failure or helplessness), for example,listed (rates of epidural use, cesarean section, perineal

tears). I wondered why rates of induction, augmen- are more difficult to measure, they may be at leastas important as other outcomes when evaluating thetation, electronic fetal monitoring, forceps or vacuum

extraction, episiotomy, and infection were not in- overall safety and effectiveness of a given treatmentor type of care.cluded, and what about birth position, emotional status

(elation to depression, birth through postpartum), andbreastfeeding? The seven outcome measures for the Conclusion and Suggestionsbaby included three measures for death; the remaindercovered preterm birth, low birthweight, and low Apgar

With childbirth, investigators are attempting to studyscores. These choices of outcome measures are notneutral; they embody the medical model focus on birth a process for which they have not even defined the

original control group. What exactly are labor and birthas disease, full of crises needing interventions. Thisemphasis represents the standard, and is consistent in the absence of interventions? The medical model

considers providing ‘‘emotional support’’ an ‘‘inter-with the value placed on interventions by the medicalmodel rather than on measures of health and normalcy vention’’ in one study, but the unnatural constraints

and interventions of the typical hospital birth comprise(and avoidance of interventions) that are valued by themidwifery model. the ‘‘routine care’’ received by the controls in another

study. All those involved in maternity care, but espe-What outcome measures are not determined in aresearch study? A study may report rates of certain cially medical researchers, need to become aware of

the limitations posed by the context in which researchoutcomes but not determine or discuss the broaderimplications or meanings of them for the mother and is undertaken, and to guard against the limitations and

bias posed by their own ‘‘cultural’’ assumptions abouther family. Emotional and behavioral outcome mea-sures are rarely included when assessing the effects of birth.

How can these biases be minimized? How aboutan intervention, and almost no studies look at outcomemeasures beyond the first few weeks after birth, or collaborative research teams that include midwifery

model midwives, doulas, women experienced inlook at effects on broader relationship issues. In addi-tion, few studies of perinatal care attempt to find out childbearing, and consumer advocates? Research pro-

grams could include policies and resource allocationsthe mother’s feelings of satisfaction or dissatisfactionwith the care or intervention being studied, again re- to design and carry out research agendas that address

imbalances in questions asked, and include the use offlecting the medical model’s disinterest in the mother’sfeelings, opinions, or preferences. qualitative research and routine inclusion of broad-

range outcomes and long-term effects. Aware research-The bias of the medical model in the thinking ofthe investigator is subtle. I would suggest that any ers and reviewers could develop new standards for

disclosure about ‘‘routine care’’ conditions, and findinvestigators undertaking a birth-related research proj-ect should work diligently to become aware of their ways to reduce the high background rates of taken-

for-granted interventions.almost unavoidable, unconscious bias favoring medi-cal model thinking, and for any trial should carefully The scientific method can be a wonderful tool for

gaining knowledge, but it is no guarantee of unbiasedconsider what outcome measures to study. Althoughsome of the commonly chosen outcomes (rates of cer- research. Only by working hard to become aware of

and avoid their subtle and unconscious biases willtain interventions or events) are relatively easy to study(the mother either had a cesarean delivery or she did investigators have a chance of gaining a meaningful

understanding of birth through research.not), they can result in an extremely limited picture