Delaying newborn's first bath increases exclusive breastfeeding rate

A new Cleveland Clinic study has shown that delaying the first baby bath after delivery increases the breastfeeding rate by 8%, with 49% increased odds of exclusive breastfeeding while in the hospital. These mothers also continued breastfeeding their babies after discharge from the hospital. The odds further increased to 60% if the mother had a vaginal birth versus cesarean birth. 

The researchers at Cleveland clinic looked at data from about 1000 mother-newborn couplets in this retrospective, two-group, pre- and postintervention design study. In the intervention group, the first bath was delayed for at least 12 hours vs. following the routine hospital practice of bathing the baby in a couple of hours after birth in the control group.

The demographics were comparable in both the groups. After multivariate regression analysis, it was observed that there was a significant increase in exclusively breastfeeding rates in the study group in whom the bath was delayed for 12 hours.

Why delaying the bath increases the breastfeeding rate is unclear, but researchers behind the study speculate that similarity between the smell of breast and amniotic fluid may better help the baby to latch.

The study adds support to the initiative of establishing immediate skin-to-skin (STS) contact between mother and baby. STS contact has been promoted internationally through the Baby-Friendly Hospital Initiative (BFHI) as a means to improve breastfeeding initiation, exclusivity, and duration after hospital discharge.

“Human touch is vital to the parent and the baby. You need to have that human touch. I think that by not washing the baby (so soon), encouraging skin-to-skin contact and breastfeeding, you’re improving that human touch. So, you’re now looking at a long-term health benefit,” explains Heather DiCioccio, DNP, RNC-MNN, who led the study. The study was published ahead of print in Journal for Obstetrics, Gynecologic, and Neonatal Nursing.

Those babies who received bath after 12 hours were also able to maintain their temperature better as compared to early bathers.

Research has also shown that increased rates of breastfeeding have a wealth of benefits for mother and child in years to come. Risk of childhood and maternal illnesses decrease considerably potentially decreasing the lifetime healthcare costs.

Here is a beautiful video by Cleveland Clinic explaining the findings

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NAMS video series 2019: Understanding the etiology and mechanism of vasomotor symptoms

The North American Menopause Society (NAMS) regularly posts comprehensive videos for clinicians about important midlife health topics. All interviews in the series are hosted by NAMS Board of Trustees Member and Past-President Dr. Marla Shapiro, a Canadian physician who led this exciting initiative. Dr. Shapiro is also a medical consultant for CTV News.

In this first video of 2019, Dr. Rebecca Thurston, Director of the Women’s Biobehavioral Health Laboratory and Professor of Psychiatry, Psychology, Epidemiology, and Clinical and Translational Science at the University of Pittsburgh throws some light on the why and how about vasomotor symptoms (VMS).

The natural history of vasomotor symptoms is still evolving. It is estimated that about 75% of women experiencing menopause will have hot flashes. A substantial number of women seen in everyday gynecological practice or specialty menopause clinic report VMS well past the age of 60 and some well into the 80s.

Hot flashes considerably reduce the quality of life and hamper the day to day activities. Prevalence of VMS is generally associated with increased risk of CVD due to endothelial dysfunction. Hence, women with VMS could be screened for CVD risk factor and offered lifestyle modifications and frequent screening for early diagnosis and prevention.

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Osteoporosis drug Romosozumab receives marketing approval in Japan

Monoclonal antibody romosozumab gains first-ever marketing approval in Japan for the treatment of osteoporosis in patients at high risk of fracture announced Amgen and UCB in a joint press release. The drug will be known as Evenity in Japan and would be developed by Amgen Astellas BioPharma K.K.–a joint venture between Amgen and Astellas Pharma Inc., headquartered in Tokyo.

Romosozumab has a dual effect on the bone– it works by binding and inhibiting the activity of the protein sclerostin which increases bone formation and decreases bone breakdown.

Japanese people have the longest life expectancy in the world and with that comes the burden of osteoporotic fractures. In Japan, the osteoporotic fracture is the leading cause of disability that requires long term nursing home care.

"The approval of EVENITY in Japan is a significant milestone that reinforces our commitment to bringing effective treatments to the millions of patients who suffer from osteoporosis," said David M. Reese, M.D., executive vice president of Research and Development at Amgen in a news release.

"A patient with a prior osteoporotic fracture is twice as likely to suffer another fracture if left undiagnosed and without appropriate treatment. With this approval, physicians in Japan now have a new medicine to help patients reduce their risk of fracture."

The approval is based on results of two phase 3 clinical trials– FRAME and BRIDGE. The FRActure study in postmenopausal woMen with ostEoporosis (FRAME), included 7,180 postmenopausal women with osteoporosis. The women received romosozumab 210 mg s.c. or placebo once monthly for 12 months, followed by denosumab 60 mg s.c. once every 6 months in both groups for 12 months. The drug significantly increased spine and hip BMD and reduced vertebral and clinical fracture risk.

The BRIDGE study (placeBo-contRolled study evaluating the efficacy anD safety of romosozumab in treatinG mEn with osteoporosis) involved 245 men with osteoporosis (163 romosozumab, 82 placebo) randomized 2:1 to receive either 210 mg romosozumab or placebo subcutaneously once monthly for 12 months. Men on Romosozumab showed a significant bone mineral density (BMD) gains at the lumbar spine, total hip and femoral neck compared to placebo at six and 12 months.

The approval is also significant because FDA rejected Amgen’s initial marketing application for Romosozumab in the US because of cardiovascular side effects of the drug in ARCH trial. The drug is also under regulatory review in Europe.

The Japanese Pharmaceuticals and Medical Devices Agency undertook a thorough review of the safety profile of EVENITY, including the cardiovascular safety findings in the ARCH trial.

Toshio Matsumoto, M.D., Ph.D., emeritus professor of Tokushima University and the advisor of the university's Fujii Memorial Institute of Medical Sciences said in the press release, "Physicians have been waiting for a new therapeutic option. I have great hope that the approval of EVENITY will help reduce the fracture risk for patients in Japan."

"Patients with a prior fracture face the risk of having another fracture and particularly stand to benefit from the option of a new bone-forming agent," he further added.

Meanwhile, During the second review cycle, the US Food and Drug Administration (FDA) Bone, Reproductive, and Urologic Drugs Advisory Committee (BRUDAC) recently voted in favor of approving Amgen and UCB’s romosozumab (EVENITY) In the US for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The committee indicated that the drug benefits for treatment of postmenopausal osteoporosis outweigh its risk.

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Ultrasound revisited–Personalized imaging anywhere, anytime and by anyone

Will personal ultrasound scanners be readily available and accessible as home glucose or blood pressure monitors? It is possible right now with the Butterfly iQ handheld ultrasound wand and an iPhone– recently showcased at the CES 2019 at Las Vegas.

The new FDA cleared, pocket-sized ultrasound ushers in a new era of medical imaging at a fraction of the cost of large in-office machines. Currently, the FDA clearance covers 13 clinical applications, the broadest ever for a single ultrasound transducer.

The technology is currently only available for trained medical professionals, but shortly it may be possible to get an ultrasound examination without leaving the comforts of the home. The Butterfly team is beta testing software that can guide patients to capture the scans correctly and share it with respective healthcare providers in real time.

iQ is equipped with the latest Ultrasound-on-Chip technology™, where a single silicon chip replaces the piezo-electric crystals of the traditional ultrasound machines. The 2D array of 9000 programmable micro-machined sensors eliminate the need of linear, curved or phased probes for different parts of body. A single probe can be used to image different systems of the body including Ob/gyn, cardiology, musculoskeletal, and many others.  Just slather the probe with gel, and it is possible to switch between different examinations easily.

The probe is compatible with many iPhone models including Apple iOS 11.0 or newer. The built-in battery is optimized for 2 hours continuous scanning or 10-hour shift and can be easily recharged by placing it on the wireless charging base. The iQ device is sleek and housed in an anodized aluminum body to withstand fall or temperature variations,

All the data and images are stored on Butterfly cloud and can be accessed from anywhere at any time. HTTPS, TLS 1.2 and AES 256-bit encryption and monitoring ensure that patient’s scan and personal is protected while at rest and at the time of sharing with the colleagues, peer or health providers. Images can be shared as easily as texting. Just open the image, tag the person and send it as a message.

The Ultrasound comes with deep learning-based artificial intelligence applications tightly coupled to the hardware and helps clinicians with both image acquisition and interpretation. As more and more clinicians use the system, the data acquired to improve the neural network models. This, in turn, will enable the less skilled personnel to capture images correctly.

Priced under $2,000, the Butterfly iQ is currently available for purchase in the US, but it can be reserved for purchase in other countries.

Here is a video about working of Butterfly iQ

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Novel implantable shock absorbing device to relieve pain and delay progression of knee osteoarthritis

Patients with osteoarthritis (OA) could now delay or avoid knee replacement surgery with the help of a new shock absorbing device that can be implanted alongside the knee joint.  The Wexner Medical Center at the Ohio State University becomes the first center in US to implant the CalypsoKnee System to address the pain of the osteoarthritic knee.

Developed by Moximed, a company based in Fremont, California, a prospective, multicentric clinical trial is underway to look at the ability of the device to extend the life of knee joint and enable the patients to lead a pain-free, comfortable life.

The system is put in place under the skin, alongside the medial side of the affected knee through a small incision. The ligaments and bones forming the knee joints are preserved, keeping options open for any future surgical interventions.

With more than 700,000 knee replacement surgeries performed in the U.S. every year, the Calypso Knee System could reverse the trend and delay or avoid the replacement surgery.  

Dr. David Flanigan, an orthopedic surgeon at The Ohio State University Wexner Medical Center who performed the surgery said in a news release, “ It works like a shock absorber to take pressure off the inside of the knee while creating a cushion similar to what cartilage provides in a healthy joint. The hope is that it increases joint functionality, reduces pain and delays a total knee arthroplasty for years or even decades.”

If found successful, it will soon be available as an option to knee replacement for osteoarthritic patients across the country.

The video shows how the system works in our body

Here is a video with more information on the first patient fitted with the system

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Ohio state university press release

Minimally invasive transcervical radiofrequency ablation shows promising results for uterine fibroids

Ultrasound-guided transcervical radiofrequency ablation provides an effective, safe and minimally invasive alternative for the treatment of symptomatic uterine fibroids suggests the results of pivotal IDE trial published in the January issue of Obstetrics & Gynecology.

The prospective, longitudinal, multicenter Sonography-Guided Transcervical Fibroid Ablation (SONATA) trial evaluated Gynesonics's investigational Sonata system in the treatment of heavy menstrual bleeding (HMB) because of uterine leiomyomata.

The Sonata System combines real-time intrauterine ultrasound guidance with targeted radiofrequency ablation in an incisionless procedure to treat symptomatic uterine fibroids.

The trial enrolled 147 premenopausal women between age 25-50 years with HMB for at least three months, across 22 centers in the United States and Mexico. The size and number of fibroids varied between 1 to 5 cm diameters and 1-10 fibroids per woman respectively.

All women were followed for 12 months and results assessed in terms of relief from heavy menstrual blood loss, device-related complications, and surgical intervention rate.

Scott Chudnoff, Chief of OB/GYN at Stamford Hospital, Stamford CT a principal investigator in the SONATA trial, said in a press release, “The actual results achieved in the SONATA trial far exceed the required thresholds established by the FDA for the co-primary endpoints of reduction in menstrual bleeding and freedom from surgical reintervention for bleeding. These results, along with the impressive levels of patient satisfaction and rapid return to normal activity achieved, clearly demonstrate the potential for Sonata as a first line treatment for symptomatic fibroids.”

At the end of follow-up period of 12 months, 99% of patients did not require any additional surgical intervention for controlling HMB, 94% of patients reported relief from substantial blood loss with 60% reporting a 50% reduction in the amount of blood loss.

There was minimal surgical downtime with half of them returning to regular activity the next day of surgery, and 97% were satisfied with the procedure. No device-related complications were reported.

Procedure-related adverse events reported include fibroid sloughing (30.6%), cramping or pain (7.5%), leukorrhea (6.1%), and uncomplicated genitourinary infections (4.8%).

The results of the study earned FDA clearance for the SONATA system in August 2018. The results were also consistent with the previously published FAST-EU trial. Chris Owens, President and CEO stated.

 “Considering these two prospective, multicenter trials were comprised of several disparate patient populations across two continents and performed by a broad range of physician operators across various healthcare delivery systems, and clinical settings, the consistency of these results is remarkable. The reproducible results highlight the robustness of the Sonata platform design and its potential to become a new standard of care for fibroid treatment.”

Gynesonics funded the study, and lead author have received travel and lodging expenses and honoraria for speaking for Gynesonics. 

Here is a video showing SONATA system overview

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Media courtesy: Gynesonics

New café in Tokyo houses all robot staff operated remotely by people with disabilities

A new café recently opened in Tokyo is entirely staffed by robots controlled by disabled people remotely. Contrary to the negative side of automation, the café creates jobs for people with severe debilitating conditions like amyotrophic lateral sclerosis (ALS) and spinal cord injuries.

Named Diverse Avatar Working Network) ver.β (DAWN), the café was launched as a joint project between Ory Lab, which develops the robots, Nippon Foundation, and ANA Holdings. The robots serving in the café is OriHime-D–a 4-foot-tall, altogether robot that moves, look around, handles objects, and speak with patrons at Tokyo’s Café. It has a built-in camera, a microphone and a speaker and can remotely control from a smartphone or a PC using the Internet.

Joysticks, blow tubes, or just the movements of the eye easily control the robots to serve coffee and intermingle with the customers. The disabled person or other people who cannot get out of home can earn money comfortably working from home or nursing home.

Currently, there is a staff of 10 people all working remotely from home and get paid 1,000 yen (US$8.80) an hour (a standard wage for part-time work in Japan).

The café was a pilot project for a temporary period and was funded by crowdfunding drive which doubled its funding goal. If the funds are made available on a regular basis, it is hoped that a full-fledged Dawn will open in 2020.

Here is a promo video to give a glimpse of how the concept works

A more realistic demonstration of how a operator controls the robot

A video of the opening ceremony

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What is the most effective uterotonic agent to prevent PPH?

Postpartum hemorrhage (PPH) is responsible for more than 25% of all maternal death around the world and is the leading cause of maternal mortality in low resource settings. It affects 5% of all women during labor and leads to substantial morbidity because of compromised maternal blood volume. 

Use of uterotonics during the third stage of labor could avoid a majority of complications due to PPH. WHO recently published updated guidance on uterotonics for the prevention of PPH, after which the Cochrane Review published the results of a network meta‐analysis to identify the most effective uterotonic agent.

The network meta‐analysis included 196 trials involving 135,559 women, with the majority of women having vaginal births (71.5%, 140/196) in a hospital setting (95.4%, 187/196). 

The WHO recommendations and results of the Cochrane analysis suggest:

To effectively prevent PPH, only one of the following uterotonics should be used: Oxytocin, Carbetocin, Misoprostol, Ergometrine/methylergometrine, Oxytocin, and ergometrine fixed-dose combination.

Oxytocin (10 IU, IM/IV) is the standard recommended drug of choice for prevention of PPH in all cases. The drug has minimum side effects and is cost effective too. The main problem with Oxytocin is it requires refrigeration and rapidly loses its potency if stored at room temperature.

The use of carbetocin (100 µg, IM/IV) is also recommended for the prevention of PPH for all births if cost is not the limiting factor. It is also not readily available everywhere.

Misoprostol, injectable prostaglandins, and ergometrine have no additional benefits compared with oxytocin. Misoprostol causes more undesirable effects than oxytocin (including nausea, vomiting, shivering, fever, and diarrhea).

Combination therapy involving ergometrine plus oxytocin combination (Syntometrine ®), misoprostol plus oxytocin combination and carbetocin have the additional desirable effects compared with oxytocin and can be used if oxytocin is unavailable. However, there is always a risk of undesirable side effects as compared to oxytocin. Injectable prostaglandins (carboprost or sulprostone) are not recommended for the prevention of PPH.

Misoprostol and oxytocin are not available in fixed-dose combination and require different routes of administration so its use in routine clinical settings may not be very feasible as compared to using them alone.

If using ergometrine (alone or in combination), it is important to rule out hypertensive disorders and cardiovascular diseases.

In low resource settings and non-availability of skilled healthcare personnel, misoprostol (400 µg or 600 µg) can be administered orally by the community or lay health workers.

WHO recommendations Uterotonics for the prevention of postpartum haemorrhage

Uterotonic agents for preventing postpartum haemorrhage: a network meta‐analysis

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