FDA approves first ever bioidentical hormone combo for treatment of menopausal symptoms

The U.S. Food and Drug Administration (FDA) approved TherapeuticsMD’s oral hormone combo, BIJUVA™ (estradiol and progesterone) for relief from menopause symptoms such as mild to moderate hot flashes, sleep disturbances, and night sweats.

Bijuva is the first and only FDA-approved bio-identical* hormone therapy combination of estradiol and progesterone in a single, oral capsule available for treatment of distressing hot flashes or flushes in menopausal women with a uterus.

Brian Bernick, Co-Founder and Director of TherapeuticsMD said in a press release, “The approval of BIJUVA represents an important and new opportunity for menopausal women suffering from moderate to severe vasomotor symptoms. Menopausal women and their health care providers have been seeking bio-identical combination therapies for many years without an FDA-approved option.”

This is also an important milestone for TherapeuticsMD raking its third approval from FDA this year following Imvexxy, a bioidentical estradiol vaginal insert, and Annovera, a hormonal birth control ring.

The approval is based on results of a large 12 months, well-controlled, multicenter, randomized phase III Replenish clinical trial that has demonstrated both safety and efficacy of the drug in the treatment of moderate to severe hot flashes due to menopause. The study results were published July 2018 in the journal Obstetrics & Gynecology.

The primary efficacy end-point studied was a change in frequency and severity of hot flashes from baseline at weeks 4 and 12 weeks as compared to placebo in the vasomotor symptoms substudy group. Secondary endpoints were responder analyses and menopause-specific quality of life (MENQOL) questionnaire.

The primary safety endpoint of endometrial hyperplasia was evaluated in the entire study population at the end of the study period of 12 months.

One thousand eight hundred forty-five women (1,255 were eligible for the endometrial safety population; 726 comprised the vasomotor symptoms substudy) were randomized over a period of nearly two years to receive either daily estradiol (mg)-progesterone (mg) (1/100, 0.5/100, 0.5/50, or 0.25/50), or placebo. The average age was 55 years and BMI 27.

No endometrial hyperplasia was observed at the end of 12 months, while single dose estradiol-progesterone capsule (1 mg/100 or 0.5 mg/100 estradiol and progesterone) provided significant relief from vasomotor symptoms and improvement in the MENQOL domain was observed. Women reported a reduction in hot flashes as early as four weeks of treatment.

The researchers concluded, “This estradiol-progesterone formulation may represent a new option, using naturally occurring hormones, for the estimated 3 million women using nonregulatory-approved, compounded hormone therapy.” Although, currently there is no evidence that bio-identical hormones are superior to synthetic hormones.

Dr. James Liu, M.D., President of the North American Menopause Society and Chairman of the Department of Obstetrics and Gynecology, UH Cleveland Medical Center said, “The approval of BIJUVA represents an important, novel and effective treatment option for women and their healthcare providers to manage the vasomotor symptoms of menopause.”

Bijuva is expected to hit the US markets in the second quarter of 2019. According to the U.S. Census Bureau, about 43 million American women are of the menopausal age of between 45 and 64, and some 80 percent of all menopausal women experience symptoms like hot flashes and night sweats.

The most common side effects are breast tenderness, vaginal discharge and spotting, headache, and pelvic pain.

Bijuva comes with a boxed warning for cardiovascular disorders, breast cancer, endometrial cancer, and probable dementia.

FDA press release

TherapeuticsMD press release

REPLENISH Trial

Abstract

CDC: Meeting the Challenges of Measuring and Preventing Maternal Mortality in the United States

Women in the United States are more likely to die from childbirth or pregnancy-related causes than other women in high-income countries. More evidence is needed to understand the actual causes of death better, but research suggests that half of these deaths may be preventable. Racial disparities persist. The risk of pregnancy-related deaths for black women is three to four times higher than those of white women.

Watch this session of Grand Rounds to learn about efforts to analyze and prevent future deaths. Hear our speakers discuss the effects maternal deaths have on the family and on the community. You will also learn about how CDC has collaborated and intervened through public-private partnership efforts to prevent deaths associated with childbirth and pregnancy.

About CDC Public Health Grand Rounds

CDC Public Health Grand Rounds is a monthly scientific presentation featuring the important work that CDC is doing in the United States and around the world to protect people and save lives.  Experts discuss major public health issues, key challenges, cutting-edge scientific evidence, potential solutions, and recent developments. Each session is the result of a rigorous process which takes months to prepare. This attention to detail ensures that our audiences receive up-to-date, scientifically accurate, and usable information. Grand Rounds welcomes clinicians, researchers, students of public health, medicine and nursing, and the public that we serve to attend in person or watch the live webcast.

At least one year is the ideal pregnancy spacing time for the health of mother and baby

  

One to one and a half year is the ideal spacing time between pregnancies according to researchers from the University of British Columbia (B.C.) and the Harvard T.H. Chan School of Public Health.

The study found an increased risk of premature births, maternal morbidity and mortality, and adverse neonatal outcome following an interpregnancy interval of fewer than 12 months in women of all ages. However, women who were 35 or more were at increased risks of maternal mortality or severe morbidity, while women aged 20 to 34 years were at increased risk of preterm labor and adverse fetal and infant outcomes.

In this large cohort study published online October 29 in JAMA Internal Medicine, the researchers looked at data from 148,544 pregnancies in B.C. to examine the relationship between interpregnancy interval and adverse pregnancy. The data was gathered from billing codes, hospitalization data, birth records, prescription data for infertility information, and census records for a period of 10 years (2004 to 2014).

The study is the most extensive and in-depth evaluation of the relationship between pregnancy spacing and maternal age. Currently, it is unknown whether older women face the same risk as younger women because of a shorter interpregnancy interval.

Women aged 35 and more who conceived within six months of a previous birth, faced 1.2 percent risk (12 cases per 1,000 pregnancies) of maternal mortality or severe morbidity (mechanical ventilation, blood transfusion >3 U, intensive care unit admission, and organ failure). Keeping an interpregnancy interval of 18 months, however, reduced the risk to 0.5 percent (five cases per 1,000 pregnancies).

For younger women, who conceived within six months of last childbirth, the researchers found an 8.5 percent risk (85 cases per 1,000 pregnancies) of spontaneous preterm birth, but the risk dropped to 3.7 percent (37 cases per 1,000 pregnancies) if the women waited 18 months before the next conception. 

Among older women, the risk of spontaneous preterm labor was about six percent (60 cases per 1,000 pregnancies) at the six-month interval, compared to 3.4 percent (34 cases per 1,000 pregnancies) at the 18-month interval.

“Our study found increased risks to both mother and infant when pregnancies are closely spaced, including for women older than 35,” said the study’s lead author Laura Schummers in a University of British Columbia news release. Dr. Schummers is a postdoctoral fellow in the UBC department of family practice who carried out the study as part of her dissertation at the Harvard T.H. Chan School of Public Health. “The findings for older women are particularly important, as older women tend to more closely space their pregnancies and often do so intentionally,” she further added. 

Senior author Dr. Wendy Norman, associate professor in the UBC department of family practice, said these findings of a shorter optimal interval are encouraging for women over 35 who are planning their families.

“Older mothers for the first time have excellent evidence to guide the spacing of their children,” said Norman. “Achieving that optimal one-year interval should be doable for many women and is clearly worthwhile to reduce complication risks.”

JAMA Internal Medicine Full Text

UBC News

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ESHRE appeals to national societies to spread awareness about oocyte donation

The European Society of Human Reproduction and Embryology (ESHRE) has created an oocyte donation brochure DONATION OF OOCYTES in collaboration with the Council of Europe European Committee on Organ Transplantation (CD-P-TO).

ESHRE is encouraging national societies across Europe to translate the publication into their national languages. Composed by internationally recognized experts, the patient brochure on oocyte donation is a guide for women to support informed decisions about donating oocytes.

Many women are unsure whether it is safe or not to donate oocytes and are interested in knowing the future implications of such donations. This guide will provide clear, accurate and balances information about the cause.

To translate the guide into regional language first seek permission with the Council of Europe who holds the copyright of the publication. This can be done by sending an e-mail to publications.info@edqm.eu where you will have to specify your intention and the language of translation.

DONATION OF OOCYTES Brochure

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ISUOG Practice Guidelines: Intrapartum Ultrasound

Ultrasound in labor is not a proposed standard of care; however, several studies have reported it to be more accurate and reproducible than clinical examination. It is especially helpful in knowing the fetal position and station and prediction of the arrest of labor.

The International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) recently issued practice guidelines for Intrapartum Ultrasound. These Guidelines address exclusively the use of ultrasound in labor to determine fetal head station, position and attitude.

Intrapartum ultrasound can predict mode of delivery (vaginal or operative) and outcome of instrumental vaginal delivery. It is used in the labor ward as an adjunct to clinical digital examination to assess the position of the fetal head, fetal head station, progression, and attitude. 

Ultrasound in labor is performed using a transabdominal or transperineal approach depending upon the clinical situation. A wide-sector, low-frequency (< 4 MHz) exposure is best suited to ultrasound in labor.

Indication for Ultrasound in labor room

Slow progress or arrest of labor in the first or second stage

To determine the fetal head station and position before attempting instrumental vaginal delivery

Assessment of fetal head malpresentation.

While performing ultrasound in labor, data documentation includes fetal viability and FHR, fetal presentation, the position of the spine and occiput, the position of the placenta in relation to the cervix and presenting part.

While performing a transperineal ultrasound, the sonographer should also look for following parameters, especially before operative vaginal delivery (OVD):

Angle of progression (AoP)

Head–perineum distance (HPD)

Head direction with respect to the

pubic symphysis

Midline angle (MLA)

Here is an informative and detailed video by ISUOG about practice guidelines on intrapartum ultrasound

ISUOG practice guideline on intrapartum ultrasound

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The Pink Ribbon should have a Blue Streak: Male Breast Cancer

October is breast cancer awareness month, which is an annual campaign to increase the awareness about the deadly disease. I am sharing a series of articles on breast cancer this month. There is a common belief that breast cancer only occurs in women, but contrary to the popular belief breast cancer does occur in men. 

Male Breast Cancer is a very informative article authored by Dr. Avinash Deo, M.D., from his Health and Wellness website All About Cancer. Dr. Deo is a Medical Oncologist and Haematologist, Medical Blogger and Medical Writer based at Mumbai, Mumbai, Maharashtra, India.

Male Breast Cancer

The pink ribbon is for breast cancer because pink is for women. Some of the breast cancers are not pink. They are blue. About 0.5-1% of the breast cancer patients are men. In Africa as many as 6% of the breast cancer patients are men. This is about a ribbon pink to the world, blue from inside.

What Causes Breast Cancer in Men?

The risk of breast cancer increase with age. Men develop breast cancer at an older age than women. On an average, a patient with a male breast cancer is 5 years older than a female patient with breast cancer. Male breast cancer is more common in blacks.

Male relatives of female breast cancer have a higher risk of breast cancer. The risk is doubled if a first degree (immediate) relative has suffered from breast cancer. One of the reasons for this is BRCA gene mutations. BRCA genes are involved in repair of DNA. There are two BRCA genes. The lifetime risk of breast cancer in men with BRCA2 gene mutations is about 5-15% and for BRCA1 gene mutations is up to 4%. This is opposite that seen in women. Women with BRCA1 mutations have a higher risk of breast cancer than those with BRCA2 mutations.

Conditions associated with an increase in the female hormone, estrogen, increased the risk of breast cancer. The conditions include

Klinefelter’s syndrome: Klinefelter’s syndrome, a disease where the patient has one extra X chromosome, increases the risk of breast cancer 50 times.

Liver Disease: Patients with a chronic liver disease have increased levels of estrogens and an increased risk of breast cancer.

Other Diseases: Obesity and testicular dysfunction may increase the risk of male breast cancer.

Exposure to radiation increases the risk of male breast cancer.

What Are The Symptoms of Male Breast Cancer?

The symptoms of male breast cancer include:

Lump in the breast

Ullcer or deformity of the nipple

Lump in the armpit

Rarely there may be swelling of the arm

Diagnosis of Breast Cancer In Men?

The diagnosis of breast cancer is made by a biopsy of the lump. Almost all males with breast cancer have cancers that have oestrogen receptors. This means that these cancers depend on the female hormone oestrogen for growth. This is a paradox as more breast cancers in men than in women depend on female hormones. Only 80% of the breast cancers occurring in women depend on female hormones for growth. Breast cancer in women can be diagnosed early by mammography. Mammography is not useful in men.

How is Male Breast Cancer Treated?

Male breast cancer is treated like female breast cancer with surgery followed by chemotherapy and/or radiation. There are however a few differences.

Male breast cancer patients have a more advanced cancer. Many need radiation and chemotherapy.

Almost all breast cancers in men depend on oestrogens for growth. They need to be treated with hormonal drugs that deprive the cancer of oestrogens. Tamoxifen is such a drug. Another category of drugs that deprive a cancer of oestrogen is aromatase inhibitors. It is not certain is they are as active in men as in women. Tamoxifen can cause nausea, headaches, fatigue, hot flashes, skin rash, sexual dysfunction, mood changes an and weight gain.

Men with breast cancer may carry a BRCA mutation, that is also likely to affect other members of the family. Women with BRCA mutations are at a very high risk of breast and ovarian cancer. Men with breast cancer should be tested for BRCA mutations. If a mutation is detected blood relatives should also be tested.

Is Male Breast Cancer More Dangerous?

Male breast cancer is perceived to be more dangerous than female breast cancer. In reality, males and females have comparable cure rates if they are diagnosed at the same stage. Lack of awareness about male breast cancer results in a delay in both men consulting a physician and the physician ordering the appropriate investigations. The delay results in a diagnosis at a more advanced stage and makes the disease more difficult to control.

Men with breast cancer are older than women with breast cancer. Age-related diseases like cardiac diseases that are more common in men come in the way of giving the complete treatment. This reduces the cure rate.

The Pink Ribbon Should Have A Blue Streak!

Should the pink ribbon have a blue streak? Probably yes. To remind us that about one percent of patients with breast cancer are men. To remind men not to ignore a lump under the nipple. Men who are diagnosed late because of lack of awareness about the male breast cancer. Men who have to deal with the psychological consequences of suffering a “woman’s disease”.

All About Cancer 

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Global cesarean section rates almost double since the turn of the century

Globally, the cesarean section rate has almost doubled since 2000, with wide geographical variations based on economic prosperity. The rate is unprecedently high, reaching almost 60% in some parts of Latin America and as low as 5% in southern Africa. The intervention is often overused unnecessarily in some parts of the world and denied to mothers in the area where it is needed the most. The linear increases in rates make it highly unlikely that it will be reversed soon.

The considerable variation in C-section rates indicates that the increase is not backed by scientific evidence, as evident by a whopping 6·2 million unnecessary caesareans performed each year, half of which are done in Brazil and China.

Lancet launched a three-part series on optimizing the cesarean section rates at the World Congress of Gynecology and Obstetrics (FIGO) on Oct 18. Simultaneously, the World Health Organization (WHO) also published guidelines on October 11 to reduce the incidence of unnecessary cesarean sections. 

The WHO guidance is unique because it includes the first ever non-clinical interventions to decrease the rising cesarean rates. The guidance consists of 3 sets of separate recommendations targeted at women, healthcare professionals, and health organization and systems.

Those addressed at women, stress the importance of health education to allay fear of childbirth and misconceptions. The WHO guidance states, comprehensive health education, including tailored information and support about childbirth fear, pain relief, and the advantages and disadvantages of cesarean sections, should be provided to all women.

Providers guidance is crucial in a sense it includes a mandatory second opinion for cesarean section indication, audit and timely feedback in good resource settings to bring down the cesarean rates. Another significant recommendation is the equal remuneration for the vaginal birth and cesarean deliveries.

The guidance also acknowledges other barriers towards practicing evidence-based medicines such as cultural beliefs, litigations, increased surgical skills of younger providers with decreasing confidence in conducting difficult vaginal births.

As the part of the Lancet series, the editorial by Wiklund and colleagues highlights the importance of investing in midwives and midwives-led care in bringing down the global cesarean section rate. Trained midwives can provide continuous and watchful support during labor, creating an atmosphere of trust that may calm the patients resulting in more natural births.

The series further analyzed the significant trends of cesarean section in Brazil and China. Both are emerging economies with the highest cesarean section rates seen in wealthier, educated women in private clinics as compared to less well-educated women (54.4% of births versus 19.4%). Wealthier women are 6 times more likely to have surgical delivery as compared to women from a low socioeconomic background.

FIGO also issued a position paper on how to curb the recent cesarean section epidemic. Gerard Visser, MD, from the University Medical Centre, Utrecht, the Netherlands, and chair of FIGO's Committee on Safe Motherhood and Newborn Health, and colleagues note, “Worldwide there is an alarming increase in C-section rates. The medical profession on its own cannot reverse this trend.

Drivers for the increasing C-section rates can vary between countries and include a loss of medical skills to confidently and competently attend a (potentially tricky) vaginal delivery, as well as medico-legal issues."

In the position paper, FIGO calls upon governmental bodies, UN partners, professional organizations, women's groups, and other stakeholders to join hands to bring down the global cesarean section rates.

The six recommendations by FIGO includes:

• Educating the women about benefits and harm of operative delivery
• Matching the rates of surgical and vaginal deliveries, especially in private practice
• Making mandatory for hospitals to publish their Cesarean section rates
• Ensuring that all hospitals adopt a uniform classification system for CS
• Reinvesting the money saved from lower cesarean section to improve the infrastructure
• Increasing access to skilled care, fetal monitoring and assisted births in low-income, rural areas

The authors further note that the only aspect that has consistently resulted in a significant reduction in CS rates has been an altered reimbursement model for doctors and hospitals that favor vaginal delivery. This has been shown in Portugal following wide dissemination of information on the increased risks of CS, as well as in governmental hospitals in Iran and in a large hospital setting in Shanghai.

WHO recommendations non-clinical interventions to reduce unnecessary caesarean sections

Lancet series: Optimising caesarean section use

Global epidemiology of use of and disparities in caesarean sections

Short-term and long-term effects of caesarean section on the health of women and children

Interventions to reduce unnecessary caesarean sections in healthy women and babies

Comments

FIGO position paper: how to stop the caesarean section epidemic

Appropriate use of caesarean section globally requires a different approach

Strategic measures to reduce the caesarean section rate in Brazil

Editorial

Stemming the global caesarean section epidemic

Profile

Ana Pilar Betrán: seeking the optimum use of caesarean section

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FDA approves the first new drug for the treatment of Influenza in nearly 2 decades

The U.S. Food and Drug Administration (FDA) today approved Roche Xofluza ™ (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours.

 “This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option,” said FDA Commissioner Scott Gottlieb, M.D. “While there are several FDA-approved antiviral drugs to treat flu, they are not a substitute for yearly vaccination. Flu season is already well underway, and the U.S. Centers for Disease Control and Prevention recommends getting vaccinated by the end of October, as seasonal flu vaccine is one of the most effective and safest ways to protect yourself, your family and your community from the flu and serious flu-related complications, which can result in hospitalizations. Yearly vaccination is the primary means of preventing and controlling flu outbreaks.”

Influenza is a severe infectious disease worldwide with annual epidemics of 3 to 5 million cases of severe disease, millions of hospitalizations and up to 650,000 deaths worldwide.

Xofluza is a first-in-class, single-dose oral medicine and acts by inhibiting the polymerase acidic endonuclease, an enzyme essential for viral replication. It has shown efficacy against a wide range of influenza viruses, including oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies.

The safety and efficacy of this single dose, antiviral drug Xofluza, was proved by the results of two randomized controlled clinical trials of 1,832 patients recently published in the 6 September 2018 issue of the New England Journal of Medicine. In phase III CAPSTONE-1 trial, participants were randomized to receive either Xofluza, a placebo, or another antiviral flu treatment within 48 hours of experiencing flu symptoms.

Xofluza significantly reduced the duration of flu symptoms by more than one day (median time 54 hours versus 80 hours; p<0.001) as compared to placebo. The efficacy was comparable to oseltamivir when it comes to duration of symptoms, but Xofluza significantly reduced the viral load 1 day after the start of therapy.

In the other phase 2 trial, the median time to alleviation of influenza symptoms was 23.4 to 28.2 hours shorter in the baloxavir groups than in the placebo group (P<0.05).

Thus, single-dose baloxavir was superior to placebo in alleviating influenza symptoms and was superior to both oseltamivir and placebo in reducing the viral load one day after initiation of the trial regimen in patients with uncomplicated influenza.

The most common adverse reactions in patients taking Xofluza included diarrhea and bronchitis, nausea, common cold symptoms (nasopharyngitis) and headache.

 FDA approved Xofluza under priority review, and the drug will be available across the U.S. in the coming weeks. Xofluza was discovered by Japanese drug maker Shionogi & Co., Ltd and was its 10mg/20mg tablets were approved by the Ministry of Health, Labour and Welfare in Japan in February 2018 for the treatment of Influenza Types A and B. 

The drug is being further developed and commercialized globally in collaboration with the Roche Group (which includes Genentech in the US). Under the terms of this agreement, Roche holds worldwide rights to Xofluza excluding Japan and Taiwan, which will be retained exclusively by Shionogi & Co., Ltd.

FDA press release

Roche press release

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Study: Dad's exercise before conception impacts child's lifelong health

Researchers at Joslin Diabetes Center have shown that paternal exercise has a significant impact on the metabolic health of their offspring well into adulthood.

Study: Dad's exercise before conception impacts child's lifelong health

Flu shot reduces the risk of hospitalization by 40% in pregnant women

Pregnant women who receive influenza vaccine during pregnancy are at 40% reduced risk of flu hospitalization as compared to women who are not vaccinated during pregnancy reports the results of a Center for Disease Control (CDC) co-authored study published online October 11, 2018, in the journal Clinical Infectious Diseases.

“Expecting mothers face a number of threats to their health and the health of their baby during pregnancy, and getting the flu is one of them,” explains Allison Naleway, Ph.D., a study co-author from the Kaiser Permanente Center for Health Research. “This study’s findings underscore the fact that there is a simple, yet impactful way to reduce the possibility of complications from flu during pregnancy: get a flu shot.

In this retrospective cohort study, the researchers gathered data from more than 2 million pregnancies for 6 years (2010-2016), across cross 5 regions in 4 countries through the Pregnancy Influenza Vaccine Effectiveness Network (PREVENT), which consists of healthcare systems with integrated laboratory, medical, and vaccination records. Nearly 85% of pregnancies were ongoing during the flu season making it highly likely that pregnant women were exposed to flu at some point during their pregnancy.

Key study findings include:

With nearly 84% pregnancies overlapping the influenza season, the risk of influenza virus infection is a real threat during pregnancy.

Influenza vaccine reduced the risk of moderate to severe laboratory-confirmed influenza (LCI) infection during pregnancy.

Flu vaccine was equally protective in women with other medical co-morbidities like asthma and diabetes, which puts them at higher risk of other medical complications.

Flu vaccine offers equal protection during all the three trimesters.

“Our study found that flu vaccination worked equally well for women in any trimester and even reduced the risk of being sick with influenza during delivery,” adds Mark Thompson, Ph.D., a study co-author and epidemiologist with CDC’s Influenza Division.

In addition to protecting the mothers from flu while being pregnant, influenza vaccine offers protection to the newborn for several months after birth, till they are old enough to get vaccinated.

CDC press release

Full Text

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News for ASRM 2018: Procuring enough uteri for transplant will be a challenge in coming years

Researchers predict that it will be a great challenge to procure enough organs to meet the increasing need and willingness to undergo uterine transplant (UTx) in near future report the results of a feasibility study presented at the American Society for Reproductive Medicine’s Scientific Congress in Denver, Colorado.

 Uterine transplant is the emerging treatment for thousands of women of childbearing age who suffer from absolute uterine factor infertility. The world recently saw the birth of the world’s 12th and India’s first baby born after a uterine transplant. There is a growing interest among the community about transplant procedure, as evident by the long waiting list of patients at the high-volume transplant centers around the world.

Researchers from Division of Reproductive Endocrinology and Infertility, University of Pennsylvania, Philadelphia, Pennsylvania carried out this study to quantify and characterize candidacy and interest in UTx.

They examined the medical and social histories of all deceased donors from the database of large organ procurement organization (OPO), the Gift of Life Donation Program (GLDP) to see how many women would have been eligible to donate uterus after death. Of the 585 total donors, 186 were females, of whom 94 were of reproductive age.

After applying ‘liberal’ screening criteria, which included no evidence of active Hepatitis B/C, diabetes, and no active intravenous drug use only 31 were found eligible to be a potential donor. If in addition to above criteria more stringent criteria that includes parity, related gynecological conditions that could impact the future pregnancy, age < 45 years, and no smoking were set, only 6 women were left in the list as being eligible for the uterine donor.

The researchers report that only 1-5% of all organ donors from a large OPO could potentially be eligible to qualify as a deceased donor.

Abstract O-86 presented Monday, October 8, 2018. 
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India’s first baby born after uterine transplant delivered in Pune

Pune becomes the first city in India to have a baby girl delivered after successful uterine transplant 17 months back. The team at Galaxy Hospital Pune delivered the 1,4-kg baby girl at 12.12 am, after a 12-minute Cesarean section operation. Tears rolled down the cheeks of Meenakshi, 27 when she heard the robust cry of her baby girl.

Meenakshi received the uterus from her mother, thus giving birth to her daughter out of the same womb from which she was born. Meenakshi had Asherman’s syndrome after one term stillbirth and 5 miscarriages, one of which ended in uterine and bowel perforation.

She received a laparoscopic uterine transplant on May 18-19, 2017. The transplants in the US and Sweden were performed by open surgeries, but Meenakshi’s case both the organ retrieval and transplant were performed laparoscopically.

Meenakshi conceived after the first embryo transfer in March this year. She was kept under close observation for the last 5 months in the Galaxy Hospital. She developed borderline gestational diabetes because of immunosuppressant drugs.

She also developed Pregnancy Induced Hypertension and was scheduled for an elective cesarean at 34 weeks. However, her Amniotic fluid index fell sharply, and the team has to perform an emergency cesarean section at 12.12 A.M. on Thursday, October 18, 2018.

The man behind the first uterine transplant in India is Dr. Shailesh Puntambekar, a cancer surgeon, specialized in laparoscopic cancer surgery. He is considered as an expert in laparoscopic pelvic surgery and gynecological cancer surgery in the world and has developed laparoscopic radical hysterectomy for cancer cervix known world over as the 'Pune technique.'

Speaking about the first baby girl delivered he said, “History has been created. This is, in fact, a very proud moment for India, as figures show that this is the twelfth baby in the world to be born through a uterus transplant. Nine such babies were born in Sweden, two in the United States, and now this is the first one in all of Asia.”

More on Uterine Transplant:

Uterine Transplant-------Is this the final frontier!

India's first donor uterine transplant successfully performed in Pune.

Cleveland Clinics performs first Uterine Transplant from deceased donor in U.S.

First US baby born after uterine transplant delivered inTexas

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Dates fruit consumption during the last few weeks of pregnancy facilitates cervical dilatation and spontaneous labor

It is said that Mary gave birth to Jesus under a palm tree and ate date fruits to ease her labor pains. Almost 2000 years later scientist and researchers are turning towards dates to find safer alternatives for induction and augmentation of labor.

A prospective study carried out at the Jordan University of Science and Technology from 2007 to 2008 and published in 2011 in the Journal of Obstetrics and Gynaecology documented that consumption of 6 dates fruits (Phoenix dactylifera) per day for 4 weeks before the estimated due date resulted in significantly higher mean cervical dilatation at admission, intact membranes, and spontaneous labor. Spontaneous labor occurred in 96% of those who consumed dates, compared with 79% of women in the non-date fruit consumers (p = 0.024)

Results of a randomized controlled trial published in Iranian Journal of Nursing and Midwifery Research reports that consuming dates in late pregnancy shortens the labor significantly and eliminates the need of labor augmentation by oxytocin.

Another randomized trial published July 2017 in Journal of Obstetrics and Gynecology supports the findings of earlier studies and states that “dates consumption in late pregnancy is a safe supplement to be considered as it reduced the need for labor intervention without any adverse effect on the mother and child.”

Here is a very informative YouTube video about dates as the best food during late pregnancy by Dr. Michael Greger, M.D., FACLM. He is a physician, author, and internationally recognized speaker on many important public health issues and believes that food is medicine. Dr. Greger is the founder of the non-profit, science-based website NutritionFacts.org.

Abstract: Iranian Journal of Nursing and Midwifery Research
Abstract: Journal of Obstetrics and Gynaecology
Abstract: Journal of Obstetrics and Gynecology

FDA approves PARP inhibitor talazoparib for BCRA-positive, HER2‑negative advanced breast cancer

The US Food and Drug Administration (FDA) approved talazoparib (Talzenna, Pfizer Inc.) for patients with advanced BCRA-positive, HER2‑negative locally advanced or metastatic breast cancer. Talazoparib is administered orally and belongs to the class of drugs called poly (ADP-ribose) polymerase (PARP) inhibitors, which block the enzymes involved in repairing of damaged DNA.

BRCA mutation is responsible for 25-30% of all hereditary breast cancers and 5-10% of all breast cancers. The FDA has also approved the BRACAnalysis CDx test (Myriad Genetic Laboratories, Inc.) to identify patients with breast cancer with deleterious or suspected deleterious germline BRCA mutation who are eligible for talazoparib.

BRACAnalysis CDx is defined as an in vitro diagnostic device created for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA.

The approval is based on results of international EMBRACA (NCT01945775) trial, an open-labeled, RCT involving 431 patients with gBRCAm HER2‑negative locally advanced or metastatic breast cancer. The other inclusion criteria were having received prior treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant, and/or metastatic treatment setting. Patients were excluded if they have received more than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease.

The patients were randomized to receive 1 mg oral talazoparib or physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). The primary endpoint was progression-free survival (PFS), as assessed by a blinded independent central review.

At the median follow-up of 11.2 months, talazoparib reduced the risk of disease progression or death by 46% versus chemotherapy. Patients in talazoparib arm demonstrating median survival of 8.6 months as opposed to 5.6 months in the chemotherapy arm.

Patients on talazoparib also showed higher objective response rate (ORR) as compared to patients on other chemotherapy drugs (62.6% vs. 27.2%; odds ratio, 4.99; 95% CI, 2.9-8.8; 2-sided P value <.0001). The FDA defines ORR as the “proportion of patients with a tumor size reduction of a predefined amount and for a minimum period of time,” and ORR is one of the many oncology endpoints for the approval of cancer drugs and biologics.

Most commonly reported side effects of the drug include nausea, headache, fatigue, anemia, neutropenia, thrombocytopenia, vomiting, alopecia, diarrhea, and decreased appetite. The drug also comes with a warning and precautions for myelodysplastic syndrome/acute myeloid leukemia, myelosuppression, and embryo-fetal toxicity.

BRACAnalysis CDx also has a diagnostic indication for the detection of deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes for patients with ovarian cancer to select therapy for olaparib (Lynparza) and/or rucaparib (Rubraca).

FDA approval

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GE Healthcare introduces it's new automated breast ultrasound for dense breast

There could not have been more appropriate time for the launch of GE Healthcare new Invenia Automated Breast Ultrasound (ABUS) 2.0 than October, which is celebrated as breast cancer awareness month. The Invenia ABUS is the only FDA approved 3D ultrasound system for supplemental screening for breast cancer along with mammography.

In conjunction with mammography, it increases the chances of cancer detection in the dense breast by 55%. All breasts are not the same, the density of breast is determined by a proportion of fat and breast tissue—when the percentage of breast tissue exceeds that of fat, breasts are labeled as being dense.

Dense breast tissue and cancer both appear white on mammograms, thereby creating a diagnostic dilemma for the radiologists. It is estimated that about 71% of all breast cancers occur in dense breast and 1 in 3 cancers are missed by mammography. 

In the USA, about 40% of women have dense breast; thereby putting them at increased risk of having breast cancer and detection at a late stage. Early detection of breast cancer increases the chance of cure and patients may void chemotherapy.

The Invenia ABUS uses particular software-based graphics processor to capture operator independent, high-quality images making it possible to reproduce consistent images every time the machine is used. Unlike manual device, the focal zone and grain are automatically adjusted eliminating the inter-operator variability.  All these features enable the Invenia to pick-up small cancers that are predominantly invasive but node negative,  culminating into substantial patient benefits.

Invenia ABUS also provides 2-mm thick coronal slices which allow the operator an efficient visualization of the entire breast for architectural distortions and multifocal disease. With the reconstruction of 2-mm thick coronal slices, it is easy to obtain a persistent orientation and location of the lesions relative to the nipple and to scan the entire breast from the skin to chest wall.

The machine is also designed keeping patients comfort at the forefront. The gentle Reverse Curve™ transducer is designed according to the natural contour of breast allowing full contact and effective compression. The operator can customize the examination by programmable scan protocols to personalize it to patient needs.

The windows 10 provides a user-friendly interface to review, interpret patients' results quickly. Compression time can be shortened once tissue acquisition is complete. The three-view layout and Auto Prior Compare enable the physician to compare the results and focus on a region of interest.

“We believe ABUS can help clinicians find significantly more cancers than mammography alone, especially in women with dense breasts,” said Luke Delaney, general manager of Automated Breast Ultrasound at GE Healthcare, in a published statement. “As breast ultrasound technology continues to advance, we are investing to continually improve image quality, workflow, and patient comfort – all of which contribute to early detection and improved outcomes.”

Here is a video about the Invenia ABUS 2.0 acquisition process

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GE press release

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