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Working to Improve Perinatal Depression Rates – An Interview with Researcher Nancy Byatt, DO

September 1st, 2015 by avatar

By Walker Karraa, PhD.

sad mother and baby dropboxPerinatal and/or postpartum depression affects more than 15% off all women during pregnancy or after birth.  Many women are not diagnosed and therefore are not referred on to specialists who can help them with appropriate treatment. Last month, the Centers for Disease Control (CDC) announced an inaugural grant of 2.5 million dollars to University of Massachusetts Medical School researchers for the purpose of exploring the feasibility and effectiveness of obstetricians diagnosing and treating women suffering from perinatal or postpartum depression within their current obstetrical practice.  The ability of obstetricians to identify and treat affected women may help to close the gap that exists in women receiving treatment, and ensure adequate care is available and provide the ability to monitor how the women respond to treatment.  Creating a network of resources and providing OB access to psychiatric specialists for consultations can result in more women receiving more effective treatment faster from the provider they are already seeing.  Dr. Walker Karraa, perinatal mental health expert interviewed on of the co-investigators, Dr. Nancy Byatt about this research grant and what it might mean for women suffering from perinatal depression. – Sharon Muza, Community Manager, Science & Sensibility.

Walker Karraa, PhD: How is this grant first of its kind?

Nancy Byatt, DO: This is the first time the Centers for Disease Control put forth a request for applications for the Evaluation of a Stepped Care Approach for Perinatal Depression Treatment in Obstetrics and Gynecology Clinics.

WK: How long have you and your colleagues been working on this grant?

NB: Our team began working on understanding how depression could be addressed in obstetric settings in 2010. Driven by our commitment to helping women get treatment by leveraging the obstetrical care setting, we were awarded two institutionally funded grants to conduct three formative research studies with obstetric providers and staff, postpartum patients and pregnant women.

Jeroan Allison, MD, Nancy Byatt, DO, and Tiffany Moore Simas, MD.

Investigators Jeroan Allison, MD, Nancy Byatt, DO, and Tiffany Moore Simas, MD.

Our preliminary studies evaluated the perspectives of obstetric providers and postpartum women, about ways to improve depression treatment in the obstetric setting. We found that barriers occurring at the patient, provider, and systems-level prevent perinatal women and obstetric providers from addressing depression. Our preliminary data led us to hypothesize that transforming obstetrical practice to include depression treatment would enhance women’s access to and engagement in treatment and thereby improve depression outcomes.

WK: Tell us about the pilot study and how it revealed the gaps in treatment. What are the gaps identified? Why do you feel these gaps exist?

In our formative studies, and literature reviews, we identified a number of patient, provider, and systems-level barriers and facilitators to the treatment of perinatal depression and reviewed clinical, programmatic, and systems-level interventions. Provider and systems-level barriers include: (1) lack of obstetric provider training in technical aspects of depression care and communication skills; (2) absence of standardized processes and procedures for stepped depression care; (3) lack of mental health providers willing to treat pregnant women; (4) lack of referral networks; and, (5) inadequate capacity for follow-up and care coordination. These are exacerbated by patient-level barriers. Perinatal women report they fear stigma, losing parental rights, and being judged as an unfit mother. Many women perceive obstetric providers and staff as unsupportive, unavailable, and inadequately trained in depression.  We have built the RAPPID program to address these critical barriers at the provider, patient, and system level.

WK: If readers wanted to learn more about your work and/or the gaps in treatment, what literature would you recommend?

NB: We have several peer-reviewed articles that summarize our work. (see the reference section below.)

WK: What was your original vision for MCPAP?

NB: We aimed to translate the successful Massachusetts Child Psychiatry Access Project (MCPAP) to address perinatal depression. MCPAP has transformed the delivery of child mental health services in Massachusetts by making immediate psychiatric consultation available to pediatricians, to address depression in obstetric settings.   Our vision was that expanding MCPAP to create MCPAP for Moms, a new program that could provide obstetric, psychiatric, primary care and pediatric providers with access to care coordination and psychiatric telephone consultation to help them address perinatal depression. We aimed to create a population-based program that would help the entire state of Massachusetts address depression by building capacity of the frontline providers who are serving pregnant and postpartum women in their medical setting.

WK: Can you explain how the RAPPID program will be compared to the MCPAP program?

NB: To build on and address the limitations of MCPAP for Moms, we developed and pilot tested the Rapid Access to Perinatal Psychiatric Care in Depression (RAPPID) Program to create a more comprehensive intervention that is proactive, multifaceted, and practical. RAPPID aims to improve perinatal depression treatment and treatment response rates through: (1) access to the immediate resource provision/referrals and psychiatric telephone consultation for Ob/Gyn providers via MCPAP for Moms; (2) clinic-specific implementation of stepped care, including training support and toolkits; and, (3) proactive treatment engagement, patient monitoring, and stepped treatment response to depression screening/assessment. RAPPID was developed using formative data and feedback from key stakeholders.

We will compare two active interventions, enhanced usual care (access to MCPAP for Moms) vs. RAPPID in a cluster randomized controlled trial (RCT) in which we will randomize 12 Ob/Gyn clinics with diverse patient populations to either RAPPID or enhanced usual care.

WK: How is stepped care different than collaborative care?

NB: Stepped care models involve initial determination of treatment based on illness severity and intensification of care (such as stepwise increases in dose of antidepressant medication) for those with persistent illness.

WK: What has inspired your work in this field?

NB: I have been moved by women’s stories and how hard it was for them to access the care that they needed and deserved. In the beginning of my career I was seeing this time and time again.

I am inspired by the women I serve. I have worked with countless pregnant and postpartum women. Perinatal women initially or in a prior pregnancy were not able to access the care they needed and deserved. This led me to want to make an impact beyond patient care and I envisioned a program would help pregnant and postpartum women access treatment for their depression.

WK: What are the most critical issues in perinatal mental health today?

NB: Despite having evidence based treatments available, depression is not detected among many pregnant and postpartum women and even if it is detected, many women will not be able to access treatment. Depression during pregnancy is twice as common as diabetes and it needs to be a routine part of obstetric care just as diabetes is a routine part of obstetric care.

References

  1. Byatt N, Levin L, Ziedonis D, Moore Simas T, Allison J. To What Extent Does Screening and Referral Improve Depression Outcomes and Mental Health Care Utilization Among Perinatal Women? Obstetrics and Gynecology. In Press.
  1. Byatt N, Rui X, Dinh K, Waring EM. Trends in Mental Health Care Use in Relation to Depressive Symptoms Among Pregnant Women. Archives of Women’s Mental Health. 2015 Apr 7. Epub ahead of print.
  1. Weinreb L, Byatt N, Moore Simas TA, Tenner K and Savageau JA. What happens to mental health treatment during pregnancy? Women’s experience with prescribing providers. Psychiatr Q. 2014;85:349-355.
  1. Byatt N, Biebel K, Friedman L, Debordes-Jackson G, Pbert L, Ziedonis D. Patient’s Views on Depression Care in Obstetric Settings: How Do They Compare to the Views of Perinatal Health Care Professionals? General Hospital Psychiatry. 2013;35(6):598.
  1. Byatt N, Biebel K, Debordes-Jackson G, Lundquist R, Moore Simas T, Weinreb L, Ziedonis D. Community Mental Health Provider Reluctance to Provide Pharmacotherapy May Be a Barrier to Addressing Perinatal Depression: A Preliminary Study. Psychiatric Quarterly. 2013;84(2):169-174.
  1. Byatt N, Moore Simas T, Lundquist R, Johnson J, Ziedonis D. Strategies for Improving Perinatal Depression Treatment in North American Outpatient Obstetric Settings. Journal of Psychosomatic Obstetrics & Gynecology. 2012;33(4):143-61.
  2. Byatt N, Biebel K, Lundquist R, Moore Simas T, Debordes-Jackson G, Ziedonis D. Patient, Provider and System-level Barriers and Facilitators to Addressing Perinatal Depression. Journal of Reproductive and Infant Psychology. 2012;30(5):436-439.
  3. Byatt N, Moore Simas T, Lundquist R, Johnson J, Ziedonis D. Strategies for Improving Perinatal Depression Treatment in North American Outpatient Obstetric Settings. Journal of Psychosomatic Obstetrics & Gynecology. 2012;33(4):143-61.

About Nancy Byatt, D.O., M.S., M.B.A., F.A.P.M.

© Nancy Byatt

© Nancy Byatt

Nancy Byatt, D.O., M.S., M.B.A., F.A.P.M is a psychiatrist focused on improving health care systems to promote maternal mental health. Dr. Byatt is an Assistant Professor at UMass Medical School in the Departments of Psychiatry and Obstetrics and Gynecology. Byatt is a psychosomatic medicine psychiatrist with subspecialty expertise in perinatal mental health. She provides expert psychiatric consultation to obstetric, psychiatric, primary care and pediatric providers serving pregnant and postpartum women. She is the Founding and Statewide Medical Director of the Massachusetts Child Psychiatry Access Project for Moms (MCPAP for Moms). MCPAP for Moms addresses perinatal depression across Massachusetts by providing mental health consultation and care coordination for medical providers serving pregnant and postpartum women.

Byatt’s research focuses on developing innovative ways to improve the implementation and adoption of evidence-based depression treatment for pregnant and postpartum women. She has a Career Development Award that funds her research to help women access and engage in perinatal depression treatment in obstetric settings. She has also received federal funding from the Center for Disease Control to test an intensive, low-cost program that aims to ensure that pregnant and postpartum women with depression receive optimal treatment. Her academic achievements have led to numerous peer-reviewed publications and national awards.

 

Babies, Depression, Guest Posts, Infant Attachment, Maternity Care, New Research, Newborns, Perinatal Mood Disorders, Postpartum Depression, Research , , , , , , ,

Black Breastfeeding Week – “Lift Every Baby” Supports Breastfeeding Black Families

August 27th, 2015 by avatar

BBW-Logo-AugustDates-300x162August 1-7th was World Breastfeeding Week, and the entire month of August was National Breastfeeding Awareness Month.  Science & Sensibility shared information and resources in two posts; Breastfeeding and Work – Let’s Make It Work! Join Science & Sensibility in Celebrating World Breastfeeding Week and Happy World Breastfeeding Week! The Celebration Continues with More Free Resources, along with a “Brilliant Activities for Birth Educators: Nine Ideas for Using Knit Breasts in Breastfeeding Classes” post for those who teach expectant families.

This week we want to recognize and honor Black Breastfeeding Week (August 25-31, 2015) and share information about the “Lift Every Baby” awareness campaign that is the theme of this year’s program.  Black Breastfeeding Week is designed to raise awareness and provide support in black communities.  Both the initiation rate and the duration rate of breastfeeding in black families has been lower than the rates in white families for more than four decades. Low birth weight, preterm deliveries and maternal complications such as preeclampsia are all higher in black women and the black infant mortality rate is more than twice that of white babies.  Breastfeeding and the important benefits it provides can help all babies, but for the most vulnerable and the sickest, breastmilk is a critical component that can mean the difference between life and death.

black breastfeeding mother babyBlack Breastfeeding Week was established three years ago by three women, Kimberly Seals Allers, Kiddada Green and Anaya Sangodele-Ayoka, all leaders in the field of maternal child health, with a focus on families of color.  In the past three years, attention, discussion and events focused on supporting Black Breastfeeding Week have only grown as people of all colors recognize the health disparities that exist right here in the United States, between white families and black families that have lifelong impacts, simply due to the color of one’s skin.

Kimberly Seals Allers wrote an excellent commentary on why there is a need for Black Breastfeeding Week.

There are many activities around the country to support Black Breastfeeding Week.  A full event list can be found here.  On August 29 at 3 PM EST the first nationally coordinated “Lift Up” will be held in various cities across the United States.  Black families will join together at different meeting points across the country to “Lift Up” their babies, regardless of their size or age, to recognize the importance of community support for children.

There will also be the first ever Twitter chat (#LifeEveryBaby) in honor of Black Breastfeeding Week, scheduled for tonight, August 27th at 9 PM EST that you are invited to participate in.

Cara Terreri, from Lamaze International’s blog for parents, Giving Birth With Confidence, has compiled a list of  black breastfeeding resources that you should be aware of:

Black Breastfeeding Week website & Facebook page

It’s Only Natural,” – CDC & Office of Women’s Health breastfeeding guide for African American families

Normalize Breastfeeding

Black Women Do Breastfeed website & Facebook page

Mocha Manual

Your Guide to Breastfeeding for African American Women

You can also find more information and resources on the Black Breastfeeding Week Resources and Toolkit page.

Additionally, I would like to refer you to two previous posts in our “Welcoming All Families” series, written by Lamaze educator and lactation consultant Tamara Hawkins, discussing welcoming families of color to your classes.  Working with Women of Color and Working with Women of Color – Educator Information can help educators create and provide applicable classes and information to the families of color joining their classes.

Black Breastfeeding Week is an important event that can help create awareness for the importance of culturally relevant and accessible breastfeeding support and information for black families.  Childbirth educators and other birth professionals should be ready to provide resources that can help close the gap to the families they work with.  Are you participating in any Black Breastfeeding Week events?  Let us know in the comments section and please, let us all join together to “Lift Every Baby.”

 

Babies, Breastfeeding, Childbirth Education, Infant Attachment, Newborns, Push for Your Baby , , , , ,

Meet William Camann, MD – Lamaze/ICEA Conference Plenary Speaker

August 25th, 2015 by avatar
William Camann, MD

William Camann, MD

With the Lamaze/ICEA Joint Conference a little more than three weeks away, final details are well underway to make sure this joint conference offers something for everyone who attends.  And if for some reason, you are unable to join the conference in person, there is a Virtual Conference option for some of the sessions.  Today on Science & Sensibility, we meet Dr. William Camann, Director of Obstetric Anesthesia, Brigham and Women’s Hospital, author and researcher.  Learn more about Dr. Camann and hear some of his thoughts today on the blog.  Then plan on attending Dr. Camann’s plenary session – “What Does the Informed Childbirth Educator Need to Know About Labor Pain Relief in 2015?” at the Lamaze/ICEA 2015 Joint Conference in Las Vegas, NV next month.

Sharon Muza: What is the role of the childbirth educator in helping families to understand their childbirth pain relief options as they prepare for labor?

William Camann, MD: One of the things I often say is that “the most predictable thing about labor is that it is unpredictable”. The childbirth educator plays a critical role in properly preparing women and their partners for labor and birth. But the educator is also up against the reality of our electronic age. Much information is available online, and many women utilize these electronic resources as an adjunct to, or even in place of, traditional classes. Openness to all options, realization that things may change as labor begins and progresses, and an understanding of why some common medical procedures and interventions are done, is critical.

The educator needs to be realistic and unbiased and not try to place their own thoughts/feelings/agendas onto the woman and her partner. Just as the woman and her partner need to go into labor with an open mind, likewise those who teach childbirth education must approach the task with all options open. It can indeed be a very tricky interaction. Some do it better than others. Another important thing is for the educator to be aware of particular practices at local hospitals. Not all hospitals do things exactly the same way. Being aware of local practice patterns and preferences can assist with proper preparation of the women for what they can expect. Hopefully conferences like this one will assist with sharing of valuable ideas for all of us to make ourselves better educators.

SM: What are some of the common misconceptions that parents and/or childbirth educators have about epidurals?

WC: Many parents have heard that epidurals:

  1. don’t work
  2. are dangerous, to both mother and baby
  3.  cause back pain
  4. cause headaches
  5. contribute to unnecessary cesarean deliveries
  6. make it impossible to push the baby out
  7. you have to be a certain number of centimeters dilated to get an epidural and if labor has progressed very far, it may be “too late” to get an epidural
  8. are not needed in most labors
  9. can result in paralysis

All of these concepts need to be discussed in proper context. There is very comprehensive research behind each of these concepts, but it is complex, and sometimes conflicting and confusing. This is where a good, insightful, informed and realistic childbirth educator can be so helpful.

A related misconception is that some, perhaps many, women feel that they do not need to attend childbirth classes if they are planning to have an epidural. Not true!

easy labor book cover camannSM: How have labor pain relief options changed in the past 10 years? What is new and exciting?

WC: The most significant changes have been with regard to the technology and medications used in epidurals. “Low-dose” epidurals with ability to maintain movement, and “patient-controlled” epidurals which give a large degree of control back to the patient, are now very commonly used in most labor units. Small changes in needle and catheter design, and drug delivery systems, have made these techniques more effective, with even lower doses of medications, resulting in fewer side effects. Likewise, technological advances allow for increased flexibility and comfort in how the actual epidural is inserted. Overall, these changes have made the use of epidural anesthesia a much more user-friendly technique, and a technique that can really facilitate a good, safe, satisfying birthing experience.

SM: As an obstetrical anesthesiologist, how has your role as a valuable member of the birth team changed over the years?

WC: There has been increasing awareness, among both anesthesiologists and others also (nurses, obstetricians, midwives, doulas, childbirth educators) that anesthesiologists are a critical part of the entire birth team. We can provide much more than just administering anesthesia. We are often sought after for advice on appropriate pain management choices, particularly in mothers with various comorbidities and other complex medical conditions. We are more often being asked to participate in prenatal education classes. We are very welcoming to learning about alternative methods of pain relief, and how this may fit into the overall paradigm of care during labor. As more and more mothers with complex medical conditions become pregnant, our role as anesthesiologists has expanded to include significant consultations with obstetricians and other medical colleagues to assist with ensuring a safe pregnancy and birth.

SM: You do a lot of work and research around offering a family centered cesarean? Do you consider it important for the mother to have a second support person (doula or other support) along with her partner, in the OR for the birth? How can families advocate for their desire to have two support people during a cesarean?

WC: For those who do want a second support person, if properly chosen and truly desired by the woman, then I believe there is value in this. In my personal practice, I am totally fine with a second support person in the operating room, if this is what the family wants. In the overall picture of women having cesareans, it just is not a common request.

SM: Do you see any challenges to presenting informed consent information to a woman in the throes of labor? How do you do this effectively?

Photo by Patti Ramos Photography

Photo by Patti Ramos Photography

WC: YES! This is an extraordinarily difficult and complex time to properly obtain informed consent. In these situations, we try our best. It is not easy. The involvement of a good obstetrician, labor nurse, midwife and doula can be very helpful. Pre-labor education is crucial, to avoid these difficult circumstances. However, pre-labor it is impossible to really know what the pain is like. We have all seen “best laid plans” rapidly change once the reality of labor pains commence. This is why having an open mind and flexibility is so important for women about to embark on labor and birth.

SM: What are you looking forward to most about being a plenary speaker and presenting to the Lamaze/ICEA 2015 conference attendees?

WC: I always enjoy these types of conferences. I feel I become a better anesthesiologist when I interact with and learn from interested colleagues who may share some different perspectives. I also hope that the attendees at the conference will become better educators, doulas, and midwives as a result of what I will share in my lecture and by attending the meeting.

SM: Is there anything else you would like to share with the readers of Science & Sensibility and attendees at the upcoming conference?

WC: We are all working together to ensure a safe, satisfying birth for mom, partner and baby. Thank you for the opportunity to participate in this conference.

 

 

2015 Conference, 2015 Lamaze & ICEA Joint Conference, Childbirth Education, Conference Schedule, Epidural Analgesia , , , , ,

Brilliant Activities for Birth Educators: Nine Ideas for Using Knit Breasts in Breastfeeding Classes

August 20th, 2015 by avatar

babe breastfeedingAugust is National Breastfeeding Awareness Month (and August 1-7 was World Breastfeeding Week) and Science & Sensibility covered the WBW theme “Breastfeeding and Work: Let’s Make It Work!” in a post earlier this month.  August’s Brilliant Activities for Birth Educators will continue to increase the awareness about breastfeeding and breastfeeding education.  I would like to talk about how I and the families in my class use a set of  wonderful knitted breasts when I cover breastfeeding topics in my childbirth class.  You can find all the Brilliant Activities for Birth Educator posts here.

I currently teach a seven week series and cover the majority of  the breastfeeding topics on the last week.  The entire series is rich in information about breastfeeding, skin to skin, safe and healthy birth options, and other choices that support getting breastfeeding off on the best path possible.  Week seven is the nuts and bolts of breastfeeding, covering topics like latch, how the breasts make milk, positions for breastfeeding, is your newborn getting enough milk and common problems that new families experience as well as other information.

For the breastfeeding class, I use these wonderful handknitted breasts that I purchased from a talented colleague here in Seattle.  You can find similar patterns to make your own in the links below.  Each breast is unique in skin tone, nipple and areola size, overall size and weight.  Every family receives one breast and one baby. (I use these Ikea dolls, for their affordability, size and softness.)  Using these knitted breasts and dolls allows the families to experience common breastfeeding situations in a comfortable and humorous way, while gaining experience positioning themselves and their babies for comfortable and supportive breastfeeding.

Nine Breastfeeding Teaching Ideas Using a Knitted Breast

1. Having different size breasts with different size nipples and areolas gives me an opportunity to share that breastfeeding can be successful no matter the size of a person’s breast tissue or breast anatomy.  Large and small breasts can both feed a baby quite satisfactorily.  My collection is quite varied.

2. When a person uses their finger to press in on the tissue around the baby’s nose in order to “make space for air”during breastfeeding, it can change the angle of the nipple in the baby’s mouth and create unnecessary discomfort.

3. Supporting the breast with the “c-hold” and placing the fingers well back from the areola will help the baby to have a deeper latch and pull more breast tissue into their mouth.

4. Shaping and supporting the breast “like a hamburger” so the baby can get a good latch can reduce nipple pain and help the baby to transfer milk.

5. The five most common positions to breastfeed – laidback breastfeeding, cross cradle, cradle, football and side lying can feel awkward, but with practice will become second nature.  Everyone gets to try them using their “breast” and “baby”.  They can practice holding and positioning the knitted breast in the best way for each position.

6. Placing lots of pillows for proper support for the dyad can help keep breastfeeding comfortable.

7. A baby can nurse “around the clock” on the breast, with sometimes subtle position changes that allows the baby to stimulate and remove milk from all parts of the breast.

8. There is a small bead sewn into each of these weighted knitted breasts.  I can ask the families to find the little pea sized lump and can discuss how this might be a sign of a clogged duct, and how to resolve it.

9. Hand expressing milk if parents are separated from their baby after birth, can help with overall supply and volume while supplying valuable colostrum for their baby.  They can also use this skill to increase supply, or if they are experiencing engorgement.  Learning this skill on the knitted breast in class is great.

Open Mouthed Ikea Doll

If you are extra creative, there is a great “hack” that can be done to the Ikea doll to make the mouth open and include a tongue, (which can even be “tongue-tied”) to make the knitted breast/doll demo even more realistic.  Find this clever idea created by Tova Ovits, CLC here on Galactablog.

Bonus Diaper

© Sharon Muza

© Sharon Muza

I also use a knitted diaper that shows how a newborn baby’s stool changes over time from dark meconium to mustardy breastfed baby stool. A great visual aid and always gets lots of comments from families.  Thanks Betsy Hoffmeister, IBCLC,  for making me such a great tool to use in my Lamaze classes.

Family Reactions

At first, families may feel a little awkward handling the knitted breast, and may laugh if it is particularly large or small, or as an unusually large nipple.  But over the course of the night, they become comfortable in handing the breast, confident in finger placement and are eager to try different positions and experiment with their own additional suggestions for comfortable and useful techniques.  We all have fun, they leave class excited and ready to get breastfeeding off to a good start and knowledgeable in some of the basics to help them do so.

Knitted Breast Patterns

LCGB Knitted Breast Pattern

Breastfeeding Network Pattern

What interesting techniques and tools do you use to help your families during your breastfeeding instruction?  Share your ideas and resources in our comments section below.

Babies, Breastfeeding, Childbirth Education, Series: Brilliant Activities for Birth Educators , , , , ,

The PregSense Monitor: A useful new tool or fear-based marketing

August 18th, 2015 by avatar

By Deena Blumenfeld, ERYT, RPYT, LCCE 

pregsensePart of a parent’s job description is to worry about their children. In doing so, parents can help the child maintain their physical health and their emotional wellbeing. However, when the line is crossed into fear based parenting; they may become overprotective to the point of stifling a child’s natural curiosity and the need to learn by making mistakes. They are then at risk of becoming “helicopter parents”.

This is an issue of control. When parents take full control, of their child’s overall well being, they feel that they are protecting them from all the negative aspects of the world. This is a fallacy.

Advertisers and marketers play into this fear and the need for control, that feeds into the parents’ feelings of limited or lack of control. Companies create and market products that provide the impression of safety and security. These products provide a false sense of control for parents, which furthers the illusion that they are doing something “good” or “right” as they “protect” their baby.

Making the rounds of Facebook, and other social media feeds, was this nifty little video about an at-home, wearable baby monitor. It’s called the PregSense Monitor by Nuvo Group. The general consensus from the online community, both mothers and professionals alike, was “Wow! This is amazing! We’ll save so many babies this way!”

My own reaction was a bit different. I’m a skeptic at heart and like all Lamaze educators; I’m a big fan of evidence based products, treatments, procedures and medications. So, I knew I needed to learn more about the PregSense monitor. What’s the evidence behind it? Would it really meet expectations, and save babies and reduce moms’ anxiety?

I attempted to contact Nuvo Group for an interview, but I have not received a response from them at the time of this writing.

Nuvo Group claims

The Israeli tech firm hopes the device will reassure anxious mothers like Michal, in week 32 of her pregnancy, who require monitoring without having to see her doctor.

Claim:  “(The monitor will) allay mothers’ fears by transmitting data about the health of the mother and fetus.”

  • It appears to monitor all of the mother’s vital signs, not unlike a Fitbit or other activity tracker. But how does having the knowledge about your own vital signs and getting additional information about baby’s activities reduce fear?
  • What if the monitor malfunctions? What does that do to a mother’s level of fear?
    • Can one make the assumption that if the monitor isn’t picking up the baby, the mother will become more worried, rather than less. This might lead to increased health care provider visits and further unnecessary medical testing.
  • Could wearing this monitor increase anxiety and potentially cause mothers to be so focused on the monitor it becomes a bit of an obsession?
    • Mothers may become hypervigilant and reliant on the constant stream of “data” available to be reviewed.
  • How would a mother feel if she was unable to wear the monitor one day? Would that increase her fears, even if those fears were unfounded?
    • Removing access, even for a short time could increase worry and interefere with a mother’s ability to continue her daily activities.
  • When there is a constant stream of data it becomes easy to tune out the information. Wouldn’t that defeat the purpose of this device?
    • The information may become white noise and fade into the background, because it’s a nonstop stream.

Claim: Mothers can connect, see and hear the fetus whenever they want, without needing to consult a doctor.

  • Do mothers need a device to help them connect with their babies?
    • This product is trying to create a consumer need that does not exist.
    • Mothers connect with their babies all the time by feeling their movements; talking to them; touching their growing bellies, etc. Would the device reduce this natural mother/fetus interaction? Would a mother be more likely to turn to her smartphone for results from the monitor instead of paying attention to what her baby is actually doing throughout the rhythm of the day.?
  • Using this device would require a health care provider to be monitoring all of these women, all the time. This doesn’t take into account staffing levels or time to complete the task. 24/7 monitoring would be a massive time commitment and responsibility.
  • What about additional liability for the health care provider for not monitoring a woman properly or correctly identifying a problem?
    • We live in a very litigious society. A care provider might be facing a lawsuit if the data from the monitor is not evaluated regularly and an anomaly was missed.
  • Since there are two monitor types – the clinical monitor and the consumer monitor, this raises additional questions. What if the mother is low-risk and healthy, but chooses to wear the consumer model, without a prescription to “reassure” herself that all is well?
    • Would the physician then be required to monitor this mother, if there is no medical need and was not advised by the physician?
    • What is the physician’s liability in this case?

Claim: “We will be able to analyze this data to predict about events of pregnancy, like preterm labor, like preeclampsia and more and we will be able to intervene in the right time…”

  • Preterm labor may be able to be detected with continuous monitoring. However, the monitor is only identifying contractions. It’s not looking at vaginal discharge, cervical change, flu-like symptoms or downward pressure from the baby.
  • Would the monitor be able to tell the difference between Braxton-Hicks contractions and early labor?
    • The limited information on Nuvo Group’s website and in their press release does not provide enough information to say for sure.
  • What about those women who experience Braxton-Hicks regularly throughout pregnancy but are not in labor? Would the monitor be helpful or harmful for them in identifying mothers in preterm labor? Would they be in and out of their care provider’s offices more frequently, causing disruption to their daily lives?
  • Preeclampsia cannot be prevented at this time. So, at best, the monitor would let the mother and her care provider know that her blood pressure is high. It would not test for protein in her urine, swelling in her face, headaches, vision changes or any of the other symptoms of preeclampsia, so it’s an incomplete test. Would preeclampsia be missed because mother’s blood pressure is borderline and no other tests were administered.

Claim: Regarding monitoring high risk mothers with continuous monitoring in hospital; the monitor will benefit the health care provider by replacing a bulky machine with one that is lightweight and not connected to the wall.

  • We already have telemetry units for Electronic Fetal Monitoring (EFM), in many hospitals. This device is now redundant and may not integrate with the current software used to monitor the EFM units.
  • How much will this cost a hospital to replace all of their current EFM units by purchasing these PregSense clinical monitors? Is the financial outlay for a new convenience worth the expense?
  • Does the new monitor increase safety for mother and baby in comparison to traditional EFM. Is this alternative truly better for mothers and for doctors in an in-patient setting? Where are the studies that compare the two options? Is the data we get any better? Or are we still subject to human interpretation of the data in identifying the appropriate course of action?

Claim: The PregSense monitor is safer than ultrasounds that can cause tissue damage

nuvo-ritmo-beats-pregsenseAt this point in time there is no evidence and no research, to support monitoring mothers at home during pregnancy. All of the literature refers to full time electronic fetal monitoring (EFM) during labor. Therefore my assumptions are based off of that literature.

Consensus among professional and governmental groups is that, based on the evidence, intermittent auscultation is safer to use in healthy women with uncomplicated pregnancies than electronic fetal monitoring (EFM).  (Heelan 2013) These professional groups include ACOG and AWHONN.

The issue with the beneficial claims made by Nuvo Group is they are in opposition to what the research finds for routine continuous EFM. Continuous EFM in low risk mothers provides no benefit for babies and increases the risk of cesarean for mothers. Therefore the whole concept of the PregSense Monitor is based on an erroneous assumption. It is not possible to prevent a problem by monitoring the baby. A problem can only be detected as it is occurring. So, even if a problem is observed while doing at home monitoring, by the time the mother makes it to the hospital it is may be too late to intervene effectively.

There is also the risk of false positive results. The monitor may detect an anomaly that then increases the mother’s fear about her baby’s well being only to be examined to find out that her baby is doing just fine, causing undue stress and panic.

The claims of the manufacturer of this product don’t hold up under current EFM guidelines and are not FDA approved.

Simplifying fetal monitoring for the care provider may not actually be the case when we look at 24/7 monitoring which still needs to be interpreted by a human being and a potentially large financial investment for a hospital that already has an EFM system that is adequate.

The claim that this product is safer than what currently exists with today’s EFM technology and ultrasonography is unsubstantiated. Without proper research, we do not know if it is safer, more harmful or neutral in relation to EFM and ultrasound as they are done today.

Resolving mother’s fears and helping her connect with the baby are at best an assumption regarding the “softer side” of the product’s results. It may be that some women do have greater piece of mind and feel a greater connection with their baby when using the device. Selling a feeling does not provide medical benefit to mother or baby. It is, however, good marketing.

The takeaway for your students is to have them look at all products with a discerning eye. Fear based marketing is insidious and plays to their emotions. They need to be making informed decisions based on accurate and evidence based information, rather than an emotional response to something that hits them in the heart.

References:

 Nuvo Group’s website

Reuters, “Wearable device provides continuous fetal monitoring”

Dekker, Rebecca, Evidence Based Fetal Monitoring, 2012

Dekker, Rebecca, What is the Evidence for Fetal Monitoring on Admission, 2012

FDA, Avoid Fetal “Keepsake” Images, Heartbeat Monitors, 2014

FDA, Ultrasound Imaging

ACOG Practice Bulletin #106, “Intrapartum Fetal Heart Rate Monitoring: Nomenclature, Interpretation, and General Management Principles,”, July 2009

ACOG press release, ACOG Refines Fetal Heart Rate Monitoring Guidelines, 2009

Lisa Heelan, MSN, FNP-BC, Fetal Monitoring: Creating a Culture of Safety With Informed Choice, J Perinat Educ. 2013 Summer; 22(3): 156–165.

 

 

 

ACOG, Babies, Fetal Monitoring, Guest Posts, Medical Interventions, News about Pregnancy , , , ,

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