Virginia Regulatory Town Hall
Agency
Department of Health Professions
 
Board
Board of Medicine
 
chapter
Regulations Governing the Practice of Licensed Midwives [18 VAC 85 ‑ 130]
Action Disclosure requirements for high-risk pregnancies
Stage NOIRA
Comment Period Ended on 11/25/2009
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42 comments

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11/4/09  7:57 am
Commenter: Brynne Potter CPM, Commonwealth Midwives Alliance

please utilize quality research in informed choice
 

On behalf of the Commonwealth Midwives Alliance, I am writing to commend the Board of Medicine for its efforts to bring together the medical and midwifery communities in the development of comprehensive informed choice documents for Certified Professional Midwives.  

The hallmark of the Midwives Model of Care is to support a woman as she moves through her pregnancy, labor, and birth. CPMs work with women to both promote a healthy pregnancy and provide education to help her make informed decisions about her own care.  This is a constant process that begins with the first visit and hopefully shapes and empowers the woman as she transitions into motherhood.

By striving to provide relevant, comprehensive, and evidenced based information to midwives and their clients regarding issues of risk related to maternity care decisions, the Board of Medicine can help to ensure that the great body of evidence about home birth and maternity practices in the US and the rest of the world makes its way into the hands of the women who are making critical decisions about their health and the health of their babies.

CMA encourages the Board of Medicine to utilize objective, quality research in determining the content of the regulatory documents.  Resources such as the Cochrane Database and the Agency for Healthcare Research and Quality (AHRQ) are good examples.  We also ask that you consider ways to provide for updates to these documents as new research and understanding develops regarding best practices for optimal outcomes for mothers and babies.

Sincerely, 

Brynne Potter, CPM

www.mountainviewmidwives.com

 

 


CommentID: 10065
 

11/4/09  1:02 pm
Commenter: Maddy Oden, The Tatia Oden French Memorial Foundation

MIdwives/Homebirth/ Informed Choice
 

Type over this text and enter your comments here. You are limited to approximately 3000 words

The Tatia Oden French Memorial Foundation ( www.tatia.org) fully supports CPM's and the choice of home birth. Informed choice in birth should include ALL the risks and benefits of birth. This includes risks at home, as well as the risks of  medical interventions used in the hospitals. The choice of a mother to birth her child with a CPM at home goes to the very root of freedom of choice in this country. 

The evidence points to the safety and health benefits of both the mother and child when birthing at home,

Informed choice is a vital part of this process.

 

Maddy Oden, Executive Chair

The Tatia Oden French Memorial Foundation

CommentID: 10066
 

11/4/09  3:01 pm
Commenter: Maryann Combs

I commend all of you for insuring women have evidence based informed consent
 

I commend the Board for ensuring that women have continued access to evidence based informed consent through the MMOC. Evidence based is a term that allows for change and growth as our understanding of the well being of mothers and babies change and grow. Outlining a system that supports this is for sighted of all involved. 

CommentID: 10067
 

11/5/09  11:27 am
Commenter: Dr. Lori Flanagan

Equality of regulations
 

I hope that you will consider expanding the requirement of giving factual information to all members of the maternity care system including obstetricians and general practioners.  Women and their families have a right to know choosing a ceserean carries with it an increased risk of death for the mother and an increased risk of permanent lung damage for their child. 

I would love to see this expanded to include that doctors and midwives keep mandatory records or their ceserean rates and other measures of infant and maternal mortality and morbididty that they make available to potential clients.  Similarly, hospitals should be required to keep similar records.  In the interest of public health expectant parents should be given information such as the percentage of infants delivered at a facility that are admitted to the NICU.

Full disclosure, evidenced based care and equality are a wonderful idea.  Thanks.

CommentID: 10070
 

11/5/09  12:31 pm
Commenter: Jennifer Cassell

Informed Consent for Maternity Care
 

I would like to voice my support in the involving establishment of regulatory precedent for evidenced-based informed consent for women seeking maternity care.

Last year, the General Assembly passed a bill requiring Certified Professional Midwives to prove evidenced-based informed disclosure to all women seeking home birth.  I think that it is only right and fair to require women seeking hospital births to be provided with information regarding the potential risks of hospital births, including increased chances of infections, potential risks of any medications used, and the increased risks of Caesarean sections.  Women seeking hospital births should be given scientific research-based evidence, not just opinions, of the risks and benefits of hospital birth, as well as the risks and benefits of home birth.

CommentID: 10071
 

11/5/09  9:57 pm
Commenter: maddy cassell

Knowledge for women.
 

Women should be given access to ALL information available as to the risks and benefits of all types of deliveries and locations.  It should be up to the individual woman to decide which risks she wants to take.  Home delivery reduces the possibility of infection and provides a superior environment.  Hospitals increase the possibility of infection but have superior facilities in case of total disaster.  Midwives work to prevent C-sections; doctors over use them to prevent malpractice suits.  Informed women can make the best choice for themselves and their families.

CommentID: 10073
 

11/12/09  2:39 am
Commenter: Jenne Alderks, Solace for Mothers, Inc.

Upholding Women's Right to Consent
 

I commend the State for Virginia for working to ensure that women are supplied with accurate, unbiased information upon which to make their decisions regarding their child's birth setting. Providing the hallmarks of informed consent will protect women from the psychological trauma that results when women are stripped of their right to self-determination. Midwives are known for their adherence to the principles of informed consent, and those attending births in hospital settings would do well to heed their example and hold themselves to the same standard that the State of Virginia is seeking for homebirth midwives.

CommentID: 10082
 

11/12/09  5:17 pm
Commenter: grainne ostrowski

Home Birth Informed Consent
 

I gave birth at home last year, and I want to ensure that women in Virginia retain the right to birth at home.  My experience at home was relaxing, peaceful, and private, and I feel that I would have felt stressed out and imposed upon by doctors and nurses had I been in a hospital environment.

In mandating "informed choice," I ask that you ensure that Midwives include the benefits and risks of home birth to their clients.  I would like to see scientific research-based "evidence"  -- not anecdotal evidence or opinions. Pregnant mothers should ask for information on the risks of hospital and caesarean delivery (and yes-- there is a risk to the mother to give birth in the hospital, and the medicine and surgery involved in C-sections has been shown to be harmful to both the mother and the baby).  Pregnant mothers should also review current midwifery regulations and make a well-researched, informed decision on whether to birth at home or in the hospital.  

 

CommentID: 10085
 

11/13/09  9:07 am
Commenter: Tami Conklin

true informed consent should be the standard for ALL birth care providers in ALL settings
 

I wholeheartedly support the idea that ALL birth care providers should present their clients or patients with research-based facts concerning the possible outcomes and effects of every procedure and health condition they encounter during pregnancy.  This should include actual data about the risks and possible outcomes of c-sections, repeat c-sections, inductions, artificial rupture of membranes, pitocin and other drugs, continuous electronic fetal monitoring, VBAC, breech, diabetes, gestational diabetes, "big" babies, high blood pressure, multiples, etc., and outcomes of those conditions in hospital and home settings.  Then allow women to make their own choices after being presented with all the information.  Please make sure this applies to obstetricians as well as midwives, because ALL women have the right to true informed consent when making choices about their own bodies and the lives of their babies.  Too many women have told me that their doctors have told them outright lies about the risks of certain procedures (or of not performing those procedures).  I as a consumer have opted for home births with midwives precisely BECAUSE I trust midwives to offer me true informed consent--to give me the facts (pros and cons) and then let me make my own decisions.  I have had births in 2 different Virginia hospitals and have received prenatal care from several obstetricians, and only when I rejected them and started seeing Certified Professional Midwives did I receive this kind of information.  Making it a legal requirement wouldn't change what the midwives do, but it would have a huge impact on maternity care if this were required for ALL birth care providers. 

CommentID: 10086
 

11/13/09  9:36 am
Commenter: Virginia Ferguson

Midwives should be required to disclose....
 

Having been the client of a midwife, the information I'd want her to disclose to me would be advice based on my condition, and what she had learned from dealing with situations like mine.  My midwife instructed me to read the midwife textbook on dealing with complications, including unexpected unassisted birth, and had my husband, coach, read it as well.  I think that would be a great thing for all women using midwives to read.  She should be required to inform me of all the options I have, the rights I have, and let me know if there could be side effects from any treatment she suggested.  She shouldn't be required to tell me any more than a doctor would tell his patient.  She should be required to tell me whether she was certified or not, or had nurses' training or not.  I shouldn't need to hear confidential information of another patient's experience, but in my experience, a midwife will answer any question posed to her honestly, as long as it doesn't violate another person's privacy.  I am in favor of less rather than more regulation in this area.

 

CommentID: 10087
 

11/13/09  6:57 pm
Commenter: Tammi McKinley, CPM, Northern Virginia Midwifery

Current, Quality, Evidence-based information is critical
 

As a CPM, it is very easy for me to provide Disclosure of Risks to Clients - this is an established part of my practice.  I am very comfortable with providing not only the Midwifery Model of Care and the latest quality research to my clients, but I also include information from the medical model when informing my client of risks and benefits.  Although this is not a new task for meit is an on-going challenge due to the lack of clear, evidence-based medical model materials.

This NOIRA states:

"If the factors or criteria have been identified that may indicate health risks associated with birth of a child outside a hospital, a requirement for the midwife to provide evidence based information on such risks. Such information would be specified by the Board for certain conditions and would include statements and evidence from both the medical and midwifery models of care."

I urge the Board of Medicine to use data from well-designed, well-executed studies in formulating the information and disclosures that will be required of CPMs.  Furthermore, any statements used in generating the information/disclosures for CPM clients must themselves also be backed by such.  One source that I turn to is the Agency for Healthcare Research and Quality (AHRQ) which continually looks at the data available by topic and the quality of the data available in making its recommendations for evidence-based practice.  The AHRQ helps clinicians in "obtaining objective, detailed information on clinical practice guidelines," looking for "consistent results from well-designed, well-conducted studies."  This is the quality of information that I use in my practice, while continually reviewing the latest data available.   I want to make sure that my clients continue to receive the latest, well-founded research to assist them in making their decisions and that the information/disclosures that I am subject by the Board of Medicine to providing to my clients arcontinually updated.

Respectfully,

Tammi L. McKinley, CPM
Northern Virginia Midwifery, PLLC
Arlington, VA
http://www.novamidwife.org

CommentID: 10090
 

11/13/09  10:39 pm
Commenter: Kristen Marsh

Certified Professional Midwives
 

I am a consumer of services from a Certified Professional Midwife in Virginia.  I have a Masters Degree in Public Health from the University of California at Berkeley and am a trained nutritionist with clinical and community-based work experience.  I have also worked internationally supporting the Midwifery Model of Care in a variety of settings. After receiving care from an Obstetrician whith my pregnancy, I sought the care of a CPM instead.  I carefully researched my alternatives and was very proactive and involved in my own health care and wanted to work with a health care provider that was a colleague and a partner in my care.  I was impressed by my CPM's standard of care, her competency and her practice of evidence-based midwifery care.  I was always offered informed consent of any and all procedures and was treated with compassion and respect.  I felt this was lacking in my experience with my OB care and in general with other health care related experiences in this area. 

I would encourage this action be taken of ALL health care providers and not single out CPMs, who, in my experience and professional opinion, tend to practice evidence-based care more consistently than other health care providers such as Obstetricians.  In my experience, CPMs insist that their clients be informed consumers of their services and that they give their full consent to interventions offered during their care. 

Respectfully,

Kristen Marsh, MPH

Vienna, VA

CommentID: 10097
 

11/14/09  10:49 am
Commenter: Pamela H. Pilch, JD, LCCE

CPMs and Evidence-Based Informed Consent
 
I am the mother of three young children, two of whom were born at home with Certified Professional Midwives.  I understand the state's interest in consumer protection, and I support in principle the provision of evidence-based maternity care across the board.  My own experience is that CPMs already obtain the fully informed consent of their clients without the need for additional oversight in this area by the state.  Before choosing a home birth, I fully researched my options and I interviewed and questioned the midwives in much more detail and at greater length than I would ever have questioned a physician about his training, competence to handle complications, and philosophy of care.  I was completely satisfied with the training and competence of the CPMs and I had safe and successful births at home.  I know many other women who have had successful home births and all have been fully informed without the need for state-mandated documents, including some women who have given birth at home following previous Cesarean sections. 
 
I would only urge the Board of Medicine, in drafting these documents, to be educated by the Certified Professional Midwives involved in the process about their practices and protocols, and the evidence that underpins it.  Please rely on good quality evidence, including that coming from the Cochrane database and the Agency for Healthcare Research and Quality (AHRQ).  And please consider, once the document is drafted, extending the requirement to provide evidence of both the risks AND benefits of both home- and hospital birth to all maternity care providers.
 
Thank you.
 
CommentID: 10098
 

11/14/09  11:02 am
Commenter: Pamela H. Pilch, JD, LCCE

High Risk Conditions
 

I would like to add to my comment above that I hope in drafting the state-mandated informed consent document for Certified Professional Midwives, the Board of Medicine will consider the fact that many conditions that are considered 'high risk' by some obstetricians are really only variations of normal human birthing.  Certified Professional Midwives are, or can be trained, perfectly well to handle all variations of normal birth.  For this reason, I hope that the Board will carefully restrict the conditions deemed "high risk" for home birthing to those few that have clear and objective evidence of the need for immediate access to hospital care at the time of birth.

CommentID: 10099
 

11/14/09  2:05 pm
Commenter: Aimee L. Crane, Esq., IBCLC, Birth Blessings

Regulations Governing the Practice of Licensed Midwives
 

To whom it may concern:

  I am writing in response to the proposed regulatory change to the Regulations Governing the Practice of Licensed Midwives in Virginia.  First, I believe that this proposed change is clearly redundant to the obligations to which all of Virginia's Licensed Midwives are already bound under the pre-existing Midwifery Model of Care.  As such, this is a waste of extremely limited state funds for the purpose of improving healthcare in the Commonwealth.  Additionally, the redundance such an adopted change would create could also have unintended negative consequences in chilling the environment in which health care consumers are able to not only consider, but act upon, all of the evidence-based research available to them regarding every aspect of maternity care, most especially those areas which may be defined as high-risk by certain obstetric care-providers.

  Virginia's Licensed Midwives are already providing REAL, EFFECTIVE informed consent to their clients regarding the risks associated with home birth, home birth after cesarean surgery, home birth of twins, home birth of breech babies, home birth for diabetic mothers, and home birth for women of so-called advanced maternal age.  This informed consent ALREADY includes the provision, by Virginia's Licensed Midwives, of current, evidence-based research on the relative risks and benefits of homebirth in each of these scenarios, as well as the always-present option of consultation or referral to obstetric care if the client so chooses.  I CANNOT say the same is currently being providing to Virginia's birthing families who elect obstetric care in a hospital setting.  As an erstwhile attendant of hospital births in Northern Virginia, I can attest that I have often seen an utter and complete lack of informed consent given to birthing women on any and all manner of non-emergent issues which arise in the course of labor and childbirth by their obstetricians and the other hospital personnel attending them.  When will the Board of Medicine take action to require fulsome, timely informed consent by obstetricians and other hospital-based maternity care providers?

  Certainly, all maternity  care consumers in the Commonwealth are entitled to full disclosure of the known risks and benefits attached to their health care choices.  Happily, the client's of Virginia's Licensed Midwives ARE ALREADY RECEIVING THIS.  Consumers are choosing homebirth after deliberate and careful consideration of the risks and benefits, including in those situations where obstetricians may not feel comfortable delivering other than surgically.  THIS IS THEIR LEGAL RIGHT.  Do not impinge on consumer's rights or waste the taxpayer's money by adopting these unnecessary regulations.

CommentID: 10100
 

11/14/09  9:38 pm
Commenter: Denton Romans

Less regulation, more evidence
 

Although I prefer less regulation in principle, I believe it is important for expectant parents to be fully informed of both the risks and benefits, regardless of where the baby is born.  The critical element is that the risks/benefits be evidence based - published studies in reputable journals.

I would also add that as a father of four, none of whom were born at home, I do not feel that we received adequate disclosure of risks, especially as related to induction of birth and the increased risk of c-section.  Any regulation should include disclosure requirements for both hospital and home births.

CommentID: 10101
 

11/18/09  12:34 pm
Commenter: Sara Fariss Krivanec, VABirthPAC

Evidence-based care for all women
 

The VABirthPAC mission is to impact evidence based Maternal/Child Health policies for the citizens of the Commonwealth of Virginia. When developing the NOIRA for professional midwives, it is imperative that informed choice includes the risks and benefits of home birth and that any "evidence" be based on research, not the obstetrical standard of care.

 

We applaud the Board of Medicine for looking at evidence based maternity care, but feel strongly that this needs to also filter into the current obstetrical system of care. Many women in the care of a physician are given one recommendation for their care without full disclosure about risks, benefits and alternatives. Given the fact that studies show that low risk women who give birth at home with midwives have better outcomes with fewer interventions than low risk women in hospitals, wouldn't if be reasonable to expect home birth to be included in the list of alternatives ALL low risk women should be offered when making maternity care decisions?  

 

With midwifery care, there is a partnership between the client and the midwife. Informed consent/Informed refusal is the hallmark of midwifery care, which makes this NOIRA somewhat redundant. But it is our hope that the medical model and the midwifery model will come together with more understanding through this process. If we can create a precedent for evidence based care being the standard, whether a woman is in the care of a midwife or a physician, we will be doing a great service for childbearing families in the

Commonwealth.

 

Sincerely,

 

Sara Fariss Krivanec

Chair, VABirthPAC

CommentID: 10113
 

11/18/09  3:07 pm
Commenter: Calli Curtis

Strongly desire access to midwifery care, home birth
 

As a mother of four children (three born at home in three different states), I feel very strongly that it is crucial to have access to midwifery care, home birth, and evidence-based information as I (and other women) make decisions regarding pregnancies, births, postpartum, and newborn care. I want to be unhindered should my husband and I choose (with my healthcare provider) that home birth is the best choice for our family, that we feel safe delivering VBAC or a breech baby at home, or other decisions that are dificult to make and yet really are OUR decision. Having evidence-based information is the best possible antidote for misinformation and it protects our freedom of choice.

 

CommentID: 10116
 

11/18/09  10:19 pm
Commenter: Rebecca Aquino

Evidence-based information
 

Our caring midwives and the Midwifery Model of Care already ensure that we mothers and fathers receive evidence-based information regarding each decision we face in the course of a pregnancy.  If our pregnancies involve a special situation, we receive well-researched information regarding risks at home and risks associated with hospital birth and medical intervention and we must be free to choose the setting and methods we believe will be best and safest for our birth.  Special situations should not exclude any from gaining access to midwifery care and home birth.

The evidence supports the safety of home-birth, even in many "high-risk" cases.  I do not believe any more regulation is necessary.  Additional regulations must not prevent our Midwives from being able to provide us with the care we most desire and need.  If any oversight is needed, it is in the OB office and hospital ward.  Mothers must have freedom of choice regarding their birth - it is a basic American right.  Let our state's midwives and physicians lead the nation with our model of care.

 

   

 

CommentID: 10120
 

11/18/09  11:39 pm
Commenter: Dawn Kubik

Informed Consent
 

Informed consent is critical for all women to be able to chose the safest place for them to birth.  The decision for where to birth and who to have as attendants must remain with the woman.  She is the one who will benefit or suffer the consequences of a mismatch...which is why quality/evidence based info is critical.  Thank you for looking at this issue.

Unfortunately for me I was not given true informed consent from the OBs that attended my first two births.  Both ended with cesarean section.  I learned later there were things that I could've done to avoid them and that in fact they were both probably unnecessary.  After doing my own research into birth, I decided to hire CPMs.  For the first time I was given informed consent.  My midwives were very thorough with me on not only the risks of VBA2C/risks of homebirth, but they also covered nutrition, explained what tests they felt might be necessary and why. They gave me information and references for me to review over time and gave me ample time to discuss my concerns. 

It is my hope that requirements/enforcement for informed consent will be made for OBs as well.  It's my understanding that it is a requirement, but they are not actually providing it.

Sincerely,

Dawn Kubik

CommentID: 10122
 

11/20/09  3:53 pm
Commenter: Michele Sullivan, consumer, mother

Certified Professional Midwives
 

Hello. As a mother of two children, who were delivered at home with a Certified Professional Midwife, I want to see full information for informed choice documents.

This includes the risks and benefits of home birth, AND of hospital births. I want the evidence to be based on research, not opinion.

As part of the complete decision making process, consumers should also see the risks associated with hospital births and caesarean deliveries in particular.

Thank you.

Michele Sullivan 

CommentID: 10133
 

11/24/09  7:05 am
Commenter: John Smith

Evidence Based Regulation
 

I think it is vital for parents- to-be to have the full facts detailing the risks and benefits as related to induction of birth and the increased risk of c-section. Parents should always be given the full facts as far as they are known and any regulation should include disclosure requirements for both hospital and home births. Without the appropriate regulatory framework for this, there will not be the adequate disclosure of risks necessary for parents to make informed decisions – and it is the parents who will have to live with the consequences going forward.

John Smith

CommentID: 10147
 

11/24/09  12:08 pm
Commenter: Maria Hishikawa

Informed consent and evidence-based information
 

As a mother of two, one born in a hospital and one born at home, I feel I had better opportunities for informed consent and access to evidence-based information through my midwife than through my OB.  The Midwifery Model of Care already incorporates full disclosure of risks and benefits of all alternative options and treatments, then allows the patient to make decisions without pressure. The OB model of care I've experienced made decisions for the patient without full disclosure prior to treatment being given.  Parents seeking midwifery care frequently have to go out of their way to find a suitable provider. They do this because they have done their homework and have made an informed decision on maternity care that they want. What is needed is more OBs who properly administer informed consent and evidence based information.

All maternity (and medical for that matter) care providers should be held to the same threshold of ethical, moral and professional standards, regardless of the letters following their names.

 

CommentID: 10149
 

11/24/09  1:27 pm
Commenter: Michelle Byrom

Educated Choice
 

I fully support true informed consent for all healthcare providers. All care providers should offer evidence-based, accurate, unbiased information for birthing families to use to make their own educated choices.

I made an educated choice for a homebirth for our third baby. My only regret was that I didn't make the same choice for our first two births!

 

CommentID: 10150
 

11/24/09  3:10 pm
Commenter: Vickie Liguori, CPM

New Regs are Redundant but provide Opportunity
 

As a midwife in the Commonwealth, I am grateful for the privilage of licensure, and to be able to serve women in my community in this important way.  Having read thru the comments, I agree that these additions to the regulations are redundant, our regulations already demand Informed Consent.  The proposed additions do provide an opportunity for evidence-based informed consent to be required of all health care providers in the State, especially in regards to maternity care providers.  It is also an opportunity to clarify, that even in unusual or difficult circumstances, clients need to be provided with the information that they need in order to make the best decision for them and their family.  Women should be free to pursue their options regarding their health care and to make the best choice for themselves.  Care providers should continue to provide solid evidence based information from reliable sources thru out the decision making process.   I encourage the Board to refrain from issuing cookie-cutter standardized statements that become rote and therefore lose their impetus.  Formulating our own keeps them current.  Again, it can't be emphasized enough, that true choice for women in the Commonwealth will only occur when all maternity care providers are required to provide evidence based informed consent to those seeking care.

Vickie Liguori, CPM

  

CommentID: 10151
 

11/24/09  7:09 pm
Commenter: Sabrina McIntyre

Informed Concent and Certified Professional Midwives
 

Thank you for looking into this for all women and their children.

As a mother of 2 children, one born in the hospital with an OB and one born at home attended by 2 Certified Professional Midwives, I can state the differences in my experience of care in reference to  informed consent by both of these providers (Certified Professional Midwives and OBs).

The CPMs informed me of any and all risks, procedures and general expectations during my initial prenatal visits and any there after.  However, my experience in the hospital was quite different. I received no informed consent or risk assessment of the procedures and medications that I received while in the care of my OB before, during and after my labor and subsequent birth.

Thank you,

Sabrina McIntyre

 

 

CommentID: 10153
 

11/24/09  8:40 pm
Commenter: Janelle Seymour

Informed Consent by ALL birth care providers
 

I took this from Tami Conklin because it sums up everything I wanted to say:

I wholeheartedly support the idea that ALL birth care providers should present their clients or patients with research-based facts concerning the possible outcomes and effects of every procedure and health condition they encounter during pregnancy.  This should include actual data about the risks and possible outcomes of c-sections, repeat c-sections, inductions, artificial rupture of membranes, pitocin and other drugs, continuous electronic fetal monitoring, VBAC, breech, diabetes, gestational diabetes, "big" babies, high blood pressure, multiples, etc., and outcomes of those conditions in hospital and home settings.  Then allow women to make their own choices after being presented with all the information.  Please make sure this applies to obstetricians as well as midwives, because ALL women have the right to true informed consent when making choices about their own bodies and the lives of their babies.  Too many women have told me that their doctors have told them outright lies about the risks of certain procedures (or of not performing those procedures).  I as a consumer have opted for home births with midwives precisely BECAUSE I trust midwives to offer me true informed consent--to give me the facts (pros and cons) and then let me make my own decisions.  I have had births in 2 different Virginia hospitals and have received prenatal care from several obstetricians, and only when I rejected them and started seeing Certified Professional Midwives did I receive this kind of information.  Making it a legal requirement wouldn't change what the midwives do, but it would have a huge impact on maternity care if this were required for ALL birth care providers. 

CommentID: 10154
 

11/24/09  9:03 pm
Commenter: Kim Pekin, CPM, Birth by Design, LLC

Informed Choice/Refusal for all maternity care providers
 

I am a Certified Professional Midwife (CPM) serving women making an informed choice to give birth at home.  I am also a woman who has received care from obstetricians, as well as midwives, for the births of my own children.  From first-hand experience both as a professional and as a consumer, I can tell you that the informed consent process with midwives is thorough, evidence-based, and extensive throughout the maternity care cycle.  This, unfortunately, has not been my experience with the care I received from obstetricians.

As a CPM, I engage in numerous discussions throughout my client’s care regarding the risks and benefits of various prenatal testing options, as well as any relevant variations in normal birth (twins, breech, VBAC, etc.) that may involve special consideration.  My clients are given ample evidence-based information, provided opportunities to discuss the information I have given them, and are encouraged to explore available research themselves in order to make a truly informed choice to accept or refuse interventions and testing I might propose.

The proposed regulatory action is redundant and its implementation is costly to taxpayers.  However, this is an opportunity for ALL maternity care professionals (CPM, CNM, OBGYN, etc.) serving women who choose to give birth both in and out of hospitals, to provide Virginia women with truly evidence-based information upon which they can base their maternity care decisions. 

It is my hope that this evidence-based information will be objective, and that it will come from sources such as the Cochrane Database and the Agency for Healthcare Research and Quality (AHRQ).  Women singled out by the NOIRA should be given balanced, evidence-based information regarding the risks and benefits relative to their intended place of birth and their birth attendant.  This information should include the increased risks of surgical birth arising from the use of common hospital interventions such as continuous electronic fetal monitoring, oxytocin augmentation and induction, and obstetrical anesthesia (amongst others), as well as the increased risk of infection.  In fact, all Virginia women, whether they are considered to be “high risk” or “low risk”, and regardless of their provider’s credential, should be given evidence-based information about the risks and benefits of their intended place of birth, as well as their choice of birth attendant.

Thank you for your consideration of my comments.  I hope that this NOIRA will lead to a greater dissemination of evidence-based information regarding maternity care options available to Virginia women.

Kim Pekin, CPM
www.birthbydesign.org
CommentID: 10155
 

11/24/09  10:28 pm
Commenter: Gina Bass

disclosure embedded in midwifery model of care
 

My sentiments have already been communicated by others, but I write as another mother and midwifery consumer who believes disclosure to be a hallmark of midwifery care.  If collaboration is the heart of this issue, the fight is not with the midwives.  Please do not put up roadblocks to women receiving quality prenatal care. 

CommentID: 10157
 

11/24/09  10:42 pm
Commenter: Jennifer Downey

Evidence-Based Informed Disclosure/Homebirth
 

Hello.  I am a mother of three and a journalist.  Evidence is important to me when I make decisions affecting my family, as well as in my professional life.  I am encouraged that this regulatory action is intended to make sure that consumers have access to any available evidence related to health risks associated with  out-of-hospital births.

I look forward to a future regulatory action that will do the same for consumers in terms of health risks of in-hospital obstetrical procedures, as well.

I read with interest the text of the proposed change, and have some concerns about the wording of Item #3 under "Substance".    Here is the text:

"If the factors or criteria have been identified that may indicate health risks associated with birth of a child outside a hospital, a requirement for the midwife to provide evidence based information on such risks. Such information would be specified by the Board for certain conditions and would include statements and evidence from both the medical and midwifery models of care."  

"Evidence",  if genuine,  is an improvement as a basis for decision-making,  over tentative conclusions  reached through  the interpretation of competing opinions.   The current wording makes it appear that opinions or perspectives  from competing  "models of care", rather than objective research results, will be the basis for information the midwife will be required to share.

If by "statements" the drafters of this text intend to mean "opinions", then I would have to argue that there should be no place for them in the Informed Disclosure documents that midwives will give to home birth clients..  

I would encourage drafters to be exceedingly careful to base the substance of the required information on objective evidence, rather than subjective opinion.

Thank you for your diligence and service in this effort,.

Respectfully,

Jennifer Downey

101 Bollingbrook Dr.

Charlottesville, VA  22911

434-971-4679

jsdowney@earthlink.net

 


CommentID: 10158
 

11/24/09  10:50 pm
Commenter: Peggy Franklin RN,ND,CPM

Preserve Individual Choices
 

A core belief in the midwifery model of care is that pregnancy and childbirth are a natural life process that with proper nutrition and health will culminate in a healthy mom and baby most of the time. This natural life event has abundantly supplied earth with human beings for hundreds of years.. Some mothers did die, some babies did die. They still do. Unfortunately birth does not come with any guarantees no matter what we do or don't do. No matter what evidence based information we share.  As a CPM with nearly 40 years experience working with childbearing women in the hospital, birth center and home setting, I have always given my clients information about the risks and benefits of every part of their care including their options, helping them understand what, why and when certain tests are done and the effects of various conditions on their health and safety. I also discuss their options for prevention and treatment. I spend about 30-60 minutes at each prenatal, offer classes, handouts, online resources and references from many sources. In short, my midwifery practice is an educational and a relational experience rather than a series of tests, brief review of symptoms and a prescription for treatment. We discuss issues from a holistic perspective that includes evidence from statistics but evaluates a woman's own situation individually rather than from a simple list of rules with protocols that are "one size fits all". I take each piece of the puzzle to see the big picture. Many signs or symptoms by themselves seem to indicate a plan of action, but taken in conjunction with the "big picture" they may indicate a different plan of action, including doing nothing. My request to the board in formulating these evidence-based informed consents is to recognize each individual situation may be personalized according to the midwifery model of care. Many statistics are written from a biased perspective. This is especially true in regard to medical vs. midwifery perspectives.  I believe the intent of this new amendment is to assure that clients are aware of what the studies show not to impose an impersonal protocol that limits their choices. I hope they will complement our care rather than burden it with increased costs of both time and money with little benefit. It is essential that we preserve the midwifery model of care and the client's freedom of choice in their care.

Thank you for your consideration.

Sincerely,

Peggy Franklin RN, ND, CPM

 

 

CommentID: 10159
 

11/25/09  7:21 am
Commenter: Jill Carrillo

evidenced based care/informed consent should be standard for ALL maternity care providers
 

I support *true* informed consent for ALL healthcare providers.  ALL care providers should offer evidence-based, accurate, unbiased information for birthing families to use to make their own educated choices.  Currently, this is inherent in the Midwifery Model of Care, but the same CANNOT be said for obstetrics.  To make this a part of the current regulation for CPMs would be redundant, but if it opens up the door to getting OBGYNs practicing evidenced based care and not just the status quo, it can be a great thing for Virginia's women!


CommentID: 10160
 

11/25/09  8:51 am
Commenter: Melissa Fawley

Informed consent for maternity care
 

Informed consent is critical for all women to be able to make the best choice concerning their births.  The decision has to remain with the individual woman.  I had 5 hospital births and 1 homebirth with a CPM.  The care that I received with my CPM far surpassed what I received with OBs.  My CPM gave greater overall care concerning the entire pregnancy and birth.  She always gave me all the information (both sides) and then left it to me to make an informed choice for me and my family.  That is what maternity care should be.  Thank you so much for your time and attention.

CommentID: 10161
 

11/25/09  9:05 am
Commenter: Amy Ferguson

Preserving my individual choice to know
 
 

I fully support true informed consent for all healthcare providers. ALL care providers should offer evidence-based, accurate, UNBIASED information for birthing families to use to make their own educated choices.

I made a well informed decision for  homebirths for 3 of my last 6 children. My only regret was that I was not given the same unbiased information that I recieved for my homebirths as I had in the ob/gyn office.  Had I been given  information from an unbiased prospective during my first 3 pregnancies, I would have had all 6 of my children at home.  I only wish that someone would have taken the time to inform me with truthful and unbiased information about the natural life process that birth truly is.

My request to the board, is to formulate a list of evidence-based informed consents in an unbiased manner and to recognize we will all be better off if we look at the big birth picture....Birth is more often than not a natural and healthy life event that has abundantly supplied earth with human beings for hundreds of years.

Thank you for your time.


CommentID: 10162
 

11/25/09  10:36 am
Commenter: Freeda Cathcart, Mothers United for Midwifery

Protect individual's choice based on informed consent
 

In order to have true informed consent the evidence based research must be compiled from quality studies.  Often politics plays into the summary of studies.  The summaries are influenced by the people who commissioned the studies or the researchers who were hoping the research would prove a certain aspect but the evidence proved another aspect.  Mothers will only have the ability to make true informed consent when they are able to access the evidence revealed in studies themselves.  Then the health care providers need to be respectful of the mother's conclusion and the law needs to honor her choice.  The mother is the one with the highest motive to protect the health of her baby and her own body.

Thank you for the work of providing mothers with a data base of quality evidence based research.

CommentID: 10163
 

11/25/09  10:51 am
Commenter: Beth Ashton

Informed consent--CPM's
 

I am a Virginia mother of three children, the third of whom was born at home under the care of a Certified Professional Midwife.  I opted for homebirth midwifery care with a CPM because I desired to give birth vaginally after a previous Cesarean section.  I carefully researched my birthing options, and I studied all of the current research available on VBAC, both in the hospital and at home.  I diligently interviewed several physicians and midwives, seeking out the best evidence-based care I could find.  In the end, my judgment led me to CPM care.  In working with my CPM, I was given ample opportunity to parse the research, and ask questions.  She was well versed in the evidence and my consent to her care was more fully informed than it would have been had I simply accepted the standard advice I received from the physicians' practices I interviewed.  I delivered a healthy baby safely and comfortably at home, and I hope to have the opportunity to do again, many times.  One wonderful thing about my homebirth VBAC is that my fertility is preserved in a way that another Cesarean section might have burdened.  I don't believe my physician disclosed evidence to me of the effect of repeat C-section on my future fertility, but that is an important value to me and my family.
 
Based on my experiences, I believe that CPMs already obtain more fully informed consent than physicians practicing obstetrics, and I personally believe that the regulation that has been passed here is redundant and is an improper government intrusion into the practice of midwifery and the right of families to determine the course of their own health care. 
 
Thank you.

CommentID: 10164
 

11/25/09  9:45 pm
Commenter: Kelly Elder

Research based informed-consent
 

II am so pleased that all of this dialogue is taking place between the medical community and advocates for CPM's and home birth.

This society places a high regard on women's choice when choosing the end life. It is now past time we have the same high regard for choice in how we want to bring life into the world, whether that be a hospital or home setting. Informed choice based on sound research is important in both settings.

My first two children were hospital births that while they were okay birth experiences, I knew I wanted something different for my next child. My homebirth was more than I could have ever hoped or anticipated. There was absolutely no comparison in my previous birth experiences to the care my  CPM gave me and my baby. It was so wonderful and yet I could not even tell anyone who she was at that time. Virginia has come a long way through some really great Midwifery legislation, but we have a ways to go. Not only was a I constantly admonished by my (now former) OB/GYN, but I would go so far as to say she used opinion based information to try to shame me about using homebirth options and discourage me from doing it again.

I believe that women must be given research based information to make an informed choice when it comes to their birth experience - whether that be in a hospital or at home..

Thank you for giving us a forum to make our voices heard.

 

Kelly Elder

Brookneal, VA

 

 

 

 

 

 

CommentID: 10178
 

11/25/09  10:25 pm
Commenter: Becky Banks

evidence-based risk for all health care providers/reasonable regulation
 

I am a woman who has experienced five births.  The first was with an OB/GYN, the second two were with CNMs in a hospital-based birth center, and the last 2 were at home with a CPM.  I have a lot of interest in the field of childbirth, as well as a background in an unrelated medical field.

I can honestly say that of the health care providers I had, I received the fullest disclosure from the CPMs who attended my last two births. After them, the CNM's who attended the second and third births, and finally, I do not believe that I had full disclosure from the OB/GYN who was present when I birthed my first child. Some things just never appeared to come up in discussion, such as losing the opportunity to eat while in labor, or what the definition of high blood pressure actually is.

The wording of the NOIRA tacitly assumes that giving birth outside the hospital is the only thing that needs risk disclosure. There are no guidelines for equivalent evidence-based risk guidelines for giving birth in a hospital setting, although there are documented risks for doing so, such as infection.. This is an obvious disparity that should be taken into consideration and addressed.

I am also concerned about the whole idea of more regulation. There are so many examples in which the guidelines that label a woman as “high-risk” are relative at best and completely arbitrary at worst. Evidence-based guidelines for risk for birth in all settings will put birthing women on an even footing and empowered as they make their own choices, but it does seem that more regulations will put more limitation and less choice for women. Certified professional midwives assess continually throughout the pregnancy and birth for risk. Each birth is considered in and of itself. Excessive external guidelines will remove their ability to assess each woman for safety as a “full picture.”

I felt the greatest amount of control in the births with CPMs. I felt that I had full disclosure about every health issue, and I was in control of each birth. Childbirth is a natural process of women's bodies, and nothing so much as autonomy in birth can enable their choices in their lives and regarding their children and families.

CommentID: 10179
 

11/25/09  10:42 pm
Commenter: Trinlie Wood, CPM

Creation of Proposed Regulations
 

Please ensure that the responsibility for the development of the language that will implement this legislative mandate rests primarily with those who practice this profession, midwives, along with input from the public who will be affected by the outcome.  Thank you.

CommentID: 10180
 

11/25/09  11:19 pm
Commenter: Carol Sakala, Director of Programs, Childbirth Connection

Regulations Governing the Practice of Licensed Midwives
 

I am contacting the Commonwealth of Virginia as the lead author of the 2008 Milbank Report, Evidence-Based Maternity Care: What It Is and What It Can Achieve. This report was issued jointly by Childbirth Connection (a national not-for-profit organization that has worked for 91 years to improve the quality of maternity care), the Reforming States Group of state-level health policy makers, and the Milbank Memorial Fund (a 104-year-old national foundation that provides decision makers with best available evidence to inform health policy). In a separate communication I have submitted a PDF file of this report to Ms. Elaine Yeatts, Agency Regulatory Coordinator. We are sending paper copies of this report for members of the Board of Medicine to its Executive Director, Dr. William Harp. It can also be accessed online at http://www.milbank.org/reports/0809MaternityCare/0809MaternityCare.html

We believe that our report might be of use in developing regulations governing the practice of midwifery. In the report, we identify considerable opportunities for improving the quality of maternity care in the United States, and present a framework for understanding evidence-based maternity care. Such care must recognize the physiologic basis for childbearing and ensure that the vulnerable population of childbearing women and newborns receives effective care with least harm. The first broad body of systematic reviews was developed to understand the safety and effectiveness of pregnancy and childbirth care, and many scholars have continued to expand and update this work. Exceptional, abundant and often underused evidence-based resources are thus available to guide maternity practice.

We devote much attention in Evidence-Based Maternity Care to highlighting lessons from recent well-conducted systematic reviews that apply to the care of the majority of childbearing women who are healthy, at low risk, and have good reason to anticipate uncomplicated childbirth. As such, this report is highly relevant to the work of primary maternity caregivers such as Certified Professional Midwives.

We would like to express our concern about the primary focus of the regulations on risk. We strongly encourage the board to address effectiveness as well, and to consider adopting the standard of effective care with least harm, as outlined in the Milbank Report.

We commend the Board of Medicine for its support of midwifery and maternity choices for Virginia's childbearing families. Our report identifies several systematic reviews that are consistent in their support of midwifery care.

Please feel free to contact me if I can provide additional support: sakala@childbirthconnection.org or 212 777-5000 x5.

Best wishes,
 
Carol Sakala, PhD, MSPH
Director of Programs
Childbirth Connection
281 Park Avenue South, Fifth Floor
New York, New York 10010

 

 


 

CommentID: 10181
 

11/25/09  11:26 pm
Commenter: Aimee Fairman, CPM

Informed Consent is a Cornerstone of the Midwifery Model of Care
 
CommentID: 10182
 

11/26/09  12:10 am
Commenter: Lisa Pratt, JD Candidate, University of D.C., David A. Clarke School of Law

Reconsider this regulation
 

Please, reconsider passing this regulation that is harmful to the women you are trying to protect.  Women seeking vaginal birth after cesarean (VBAC), vaginal breech and vaginal twin births are increasingly finding their options limited to a surgical delivery regardless of her individual needs.  Thousands of hospitals across the nation have banned these types of birth vaginally, requiring women to undergo a surgical delivery regardless of individual risk and out of fear of legal liability, not medical necessity, effectively denying women any informed consent of meaningful choice.  The risks associated with these types of deliveries are minimal and risks associated with having a cesarean cannot be ignored when considering the balance of harms.  When women are forced to choose between unassisted births and hospital births that they don't desire, it is reasonable to expect an increase in black market births, emergency transports where no prenatal care was established beforehand, and unassisted births for which families may not be fully prepared.  This ultimately creates additional burdens for the system. It makes greater sense, both from a consumer rights standpoint, and an economic one, not to require additional risk assessments beyond what is already required by the current law.

CommentID: 10184