First live birth after deceased donor uterine transplant takes place at the Cleveland clinic

This June 18, 2019 photo provided by the Cleveland Clinic 

Cleveland Clinic in Ohio becomes the first hospital in North America to deliver a baby born out of uterus that was transplanted after the donor was deceased.

The mother, who is in her mid-30s, is part of a groundbreaking research trial involving 10 women with uterine factor infertility, who are all destined to receive uterus from deceased donors.  Since the start of the trial, the team has performed 5 uterine transplants, of which 3 were successful, including the one which resulted in a live birth. Two other women are waiting for embryo transfer.

The baby was delivered “en caul,” meaning the amniotic sac remained intact until after the delivery. This is an extremely rare but safe occurrence and happened spontaneously with this delivery, adding to the special occasion. The woman whose identity was not disclosed chose to remove the uterus after delivering the baby.

This is the second birth from a uterus from a deceased donor, the first occurred in 2017 in a Brazilian trial involving a 32-year-old woman born without a womb who received a uterine transplant from a 45-year-old woman who'd died of a stroke.

Here is the video from Cleveland Clinic

FDA approves first ever diagnostic test for Mycoplasma genitalium

The US Food and Drug Administration (FDA) approved the first-ever diagnostic test to aid in the diagnosis of sexually transmitted Mycoplasma genitalium infection. The Aptima Assay from Hologic Inc, is the only FDA-approved test to detect this under-recognized but increasingly common sexually transmitted infection (STI).

First discovered in the early 1980s, M. genitalium was listed as an emerging public health threat by the U.S. Centers for Disease Control and Prevention (CDC) in 2015. Currently, it is responsible for causing approximately 15 to 30 percent of persistent or recurrent urethritis cases in men in the United States and 10 to 30 percent of cervicitis cases in women.

This slow-growing pathogen is difficult to detect by traditional laboratory testing methods. In the absence of FDA approved diagnostic test, the STI is often misdiagnosed and treated with wrong antibiotics resulting in persisting infection and widespread transmission.

“Although Mycoplasma genitalium is typically more common than gonorrhea, there is very little public awareness of this rising sexually transmitted infection, which can cause serious and potentially devastating health problems,” said Damon Getman, Ph.D., senior principal research scientist and director of research at Hologic in a press release.

The Aptima Assay is a nucleic acid amplification test, which detects M. genitalium in urine samples and urethral, penile meatal, endocervical or vaginal swab collected in a clinical setting, such as a doctor’s office or clinic.

In the clinical study involving 11,774 samples, the Aptima test correctly identified M. gen. in approximately 90 percent of vaginal, male urethral, male urine and penile samples. It also correctly identified the presence of the pathogen in female urine and endocervical samples 77.8 percent and 81.5 percent of the time.

The test also has a high negative predictive value and correctly identified the negative samples 97.8 to 99.6 percent of the time. Vaginal swabs are the preferred samples to perform the test, but urine samples can be used as alternative sample types.

The assay is immediately available at clinical laboratories, physicians and healthcare providers can immediately order the tests by reaching out to the labs. Hologic further anticipates that most insurance plans will cover the testing for M. genitalium.

The Aptima Mycoplasma genitalium Assay was reviewed through the de novo premarket pathway, a regulatory pathway for some low- to moderate-risk devices of a new type.  The FDA exercises special controls over the individual tests approved by the de novo premarket route to ensure the safety and effectiveness of the tests.

The newest M. genitalium assay joins the comprehensive list of men and women’s health assays by Hologic that include sexual and cervical health, and virology testing.

FDA press release

Hologic press release

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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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RCOG updates its guidance on Pregnancy pain relief

It is important to prescribe the correct analgesic during pregnancy to optimize the maternal and neonatal outcome. Inadequate pain-relief in pregnancy leads to anxiety and psychological strain for mother and affects her ability to provide care for her newborn–note the recent Scientific Impact Paper published December 12, 2018, in the BJOG.

The paper was developed for the Royal College of Obstetricians and Gynaecologists (RCOG) by a group of eminent doctors and researchers following the advisory issued by the Medicines and Healthcare products Regulatory Authority (MHRA) and European Medicines Agency (EMA) on the use of codeine in pregnancy because of neonatal mishap and three other fatalities in children.

The findings reflect current NHS guidance on the use of medical pain relief options in pregnancy and during breastfeeding. However, the guidance does not address the concerns for Intrapartum analgesia.

Women often need analgesic during the antenatal period for a headache, backache, and pelvic pain. 

Non-pharmacological interventions like relaxation, adequate rest, heat, massage, acupuncture, posture training, physiotherapy, and exercise should be considered before starting any drugs. Notably, all drugs should be avoided during early pregnancy to prevent the teratogenic effects of drugs during the organogenesis period (4-10 weeks).

Paracetamol

Paracetamol remains the drug of choice for pain relief throughout pregnancy, although few studies have demonstrated an increased incidence of childhood asthma, behavioral problems, and a delay in gross motor and communication development in children with long‐term antenatal exposure.

NSAIDs 

Studies have failed to demonstrate any clear association between congenital malformations and the use of nonsteroidal anti-inflammatory drugs (NSAIDS) in early pregnancy.

However, there is conflicting evidence regarding the use of NSAIDs and risk of miscarriage in the first trimester.  Therefore, NSAIDs be avoided during pregnancy, especially during the first trimester. They should only be used when absolutely necessary in conditions such as a migraine or ankylosing spondylitis, that too in lowest possible dose and for the shortest duration of time.

Use of NSAIDs should be avoided after 30 weeks of gestation because it can cause neonatal pulmonary hypertension and premature closure of the ductus arteriosus. NSAIDs also reduce fetal renal blood flow leading to decreased urine production and causing oligohydramnios. 

Opioids (including codeine, dihydrocodeine, tramadol, and morphine)

The review says that opioid analgesic should only be used under the care of health professional in the lowest possible dose and shortest amount of time. It should be used when paracetamol has been ineffective. Limited data available does not point towards increased risk of fetal toxicity.

However, if used around the time of labor, it may lead to neonatal respiratory depression and if used for prolonged time cause neonatal withdrawal symptoms and maternal dependence.

The guidelines also highlighted the critical difference between the use of codeine and DHC during breastfeeding. If stronger analgesia is required, Dihydrocodeine (DHC) is much safer to use as compared to codeine which causes fetal toxicity.

Low doses of dihydrocodeine in combination with paracetamol can be bought over the counter but regular use of any opioid beyond 3 days should be under close medical supervision.

Gabapentin

Gabapentin is mostly used in chronic pain syndrome, and only a few studies have been done on the use of gabapentin in pregnancy. Evidence does not link the use of the drug to a particular birth defect; however, women are advised to take high doses of folic acid before conception and during the first trimester.

Gabapentin use in pregnancy after 30 weeks is very limited, and if used around the time of delivery it may lead to neonatal withdrawal syndrome.

Analgesics at the time of discharge

Majority of women who require analgesics at discharge should be prescribed paracetamol or ibuprofen. If stronger analgesics are required (cesarean delivery), women should be sent home with a limited supply of DHC. Tramadol is only given if a woman is intolerant to DHC.

Dr Dina Bisson, consultant obstetrician and gynecologist at the North Bristol NHS Trust and the lead authors of the guidance said: "It is absolutely essential that pain is managed appropriately during pregnancy and breastfeeding. Many women may develop headaches, lower back pain, and pelvic pain during pregnancy and breastfeeding, while others may have chronic conditions, where pain management is necessary.

"If pain is not adequately managed, this can have a negative impact on a woman's physical and mental wellbeing.

RCOG Scientific Impact Paper Full Text

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Hologic launches multipurpose Omni-Hysteroscope

Hologic announced the launch of its FDA cleared, innovative 3-in-1 Omni™ Hysteroscope equipped with advanced visualization capabilities to streamline the diagnostic and therapeutic procedures.

The scope comes with 3 interchangeable sheaths which eliminate the physician need to change the scope between diagnostic and treatment procedures. Additionally, the scope is armed with Premium MyoSure optics to ensure clarity and quality visualization throughout the procedure.

The patients experience less pain and discomfort because the scope can be easily inserted because of thin sheaths (3.7 mm diagnostic sheath; 5 mm operative sheath; 6 mm operative sheath). It also provides long 200 mm working length to efficiently work with obese patients.

The sheaths are compatible to use with Hologic’s Fluent™ hysteroscopic fluid management system and all MyoSure® tissue removal offerings including MyoSure REACH, MyoSure XL, MyoSure LITE, and MyoSure MANUAL devices.

“Experts agree that direct visualization of the uterine cavity in women with abnormal uterine bleeding is the gold standard that allows physicians to accurately identify and collect quality samples and remove pathology – in a safer and more effective manner than blind biopsy and curettage,” said Edward Evantash, M.D., Medical Director and Vice President of Global Medical Affairs, Hologic. 

“Featuring three easily interchangeable sheaths in one scope, our new Omni scope gives physicians excellent visualization capabilities with the convenience of seeing and treating pathology in a more streamlined procedure,” he added.  

Product page

Press release

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EZbra breast dressing facilitates easy and safer recovery after various breast procedures

EZbra Advanced Wound Care Ltd is about to launch its EZbra– a sterile, disposable, all-in-one breast dressing in US markets. The unique dressing aims to address the various needs and challenges that patients face while recovering from breast surgery. Founded by Efrat Roman– EZbra is a women-led start-up based in Israel and aims to design innovative wound care products for breast and chest surgery.

Every year, about 13 million breast procedures are performed globally, yet there is no uniform standard for breast dressing. EZbra is designed to meet the needs of surgeons and patient both.

The design enables the operating surgeons to customize it according to each patient and procedure need. EZbra allows for stabilization of breast implants and holds drain in addition to offering tailored compression level and adaptation to individual breast anatomy.

It is free from latex and does not adhere to the skin wound providing protection from Medical Adhesive-Related Skin Injuries (MARSI) and other adhesive related complications.

At the same time, it helps patients to ease the healing process and improve the body image. It can be worn under any top and hugs the body snuggly providing feminine shape and defined anatomy. It is easy to apply with detailed instruction so that patients can change at any time in the privacy of their own home. It comes in 3 different sizes – to cover a range of breast and body shapes and varying bra sizes.

“We are proud to bring our product to the US market and to introduce our solution to surgeons and their HCP staff to provide patients with a tailored, sterile and disposable breast dressing option,” said Efrat Roman, a breast cancer survivor, and EZbra CEO. “Our goal is to offer a quality post-operative option while providing patients with the independence, dignity, and self-esteem they deserve during recovery.”

Here is a video showing how to apply the EZbra dressing

Product page

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Adaptive Vapor Ablation offers a safe, effective, and minimally invasive option for performing in-office endometrial ablation

AEGEA Medical, Inc., a privately held Silicon Valley company has developed a unique Adaptive Vapor Ablation technology for the in-office treatment of heavy menstrual bleeding. AEGEA Vapor System is unique because it does not require cervical dilatation, nor does the probe needs to reach the fundus like other conventional ablation systems.

Heavy menstrual bleeding (HMB) is a common entity nearly affecting 25% of the premenopausal female population and negatively impacts on the physical, emotional and social quality of life. 

Endometrial ablation became a popular non-surgical alternative for treatment of HMB with the advent of hysteroscopically guided techniques. Several devices that involve the delivery of heat, cold, radiofrequency, and microwave energy are in use for endometrial ablation, each with its limitation and downside.

AEGEA Vapor System harnesses the ability of water vapor to effectively reach every part of the endometrial cavity and ablate the endometrial lining. It is the only FDA approved device with the patented Smart Seal and IntegrityPro technology.

The slender, soft tip disposable vapor probe is gently inserted in the uterine cavity without the need for cervical dilatation. The cervical color of the probe holds it securely in place. The SmartSeal technology allows for real-time monitoring of the uterine and cervical seal while the IntegrityPro technology performs patented secondary safety check to ensure correct placement of the device. It is only after the secondary safety check that vapor is initiated. 

The total procedure time is 4 minutes with 2 minutes of vapor treatment, eliminating the need of any balloon, ice or other arrays. The vapor ablation can safely be performed in patients with a prior lower transverse cesarean scar, a particular type of fibroids and in the presence of Essure. It can also treat uterine cavities that are wider and up to 12 cm in length as opposed to conventional devices that can only treat cavities up to 10 cm length.

Recently, results of the 12-month prospective, multicenter, pivotal study of its AEGEA Vapor System™ were published in the peer-reviewed Journal of Minimally Invasive Gynecology. Conducted across 15 sites in the United States, Canada, Mexico, and the Netherlands, the prospective trial involved 155 perimenopausal women aged 30 to 50 years with heavy menstrual bleeding who received 120-sec vapor ablation to treat HMB.

At the end of 12 months study period, 90% of women had bleeding reduced by ≥50 percent and 99% reported an improvement in the quality of life. Additionally, 85% reported an improvement in physical intimacy after the treatment. No serious device or procedure related side effects reported.

AEGEA Vapor System also allows post-ablation uterine cavity access as shown by 11 patient data from the Pilot study. “This issue has never been addressed before and gives the vapor system a distinct advantage of the possibility of future uterine-related interventions,” said Maria Sainz, president, and CEO of AEGEA Medical in a press release.

AEGEA Medical, Inc. has announced the commencement of the Post-Ablation Cavity Access (PACE II) clinical study in women who previously underwent endometrial ablation as part of AEGEA’s pivotal trial of the company’s patented Adaptive Vapor Ablation technology. The multi-center observational study, which is being conducted at seven sites across the U.S. in up to 50 women, is designed to assess uterine cavity access as well as the feasibility of diagnostic and therapeutic interventions three to four years following treatment.

Here is an animation video about AEGEA Vapor Ablation procedure:

Product page
Abstract 

News release about results of the pivotal study

News release about the launch of Post-Ablation Cavity Access (PACE II) clinical study

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Elagolix shows promising results in the treatment of heavy menstrual bleeding associated with uterine fibroids

Oral elagolix either alone or with add-back therapy significantly reduces menstrual blood loss in 90% of pre-menopausal women with uterine fibroids reports the results of a new clinical trial published in November issue of Journal Obstetrics & Gynecology.

Elagolix is an oral gonadotropin-releasing hormone receptor antagonist and recently won FDA approval as the first and only oral drug for the management of severe pain associated with endometriosis.

This interventional, double-blind, randomized Phase 2b Study was conducted across five countries to evaluate the safety and efficacy of elagolix. Over a period of nearly 2.5 years, researchers enrolled 571 premenopausal women suffering from heavy menstrual blood loss and an ultrasound documented uterine fibroids.

These women were randomized to cohorts 1 (259) and 2 (308) and received 300 mg twice daily and 600 mg daily elgolix respectively. Each cohort has four arms: placebo, elagolix alone, elagolix with 0.5 mg estradiol/0.1 norethindrone acetate, and elagolix with 1.0 mg estradiol/0.5 mg norethindrone acetate.

The primary outcome measure was the percentage of women with a Menstrual Blood Loss (MBL) volume of < 80 mL at the last 28 days of the treatment cycle and a ≥ 50% Reduction in MBL volume from baseline to the final month.  The primary safety concern was the change in bone mineral density.

The average age of the participant was 43±5 years, and 70% were black.  Women in both cohorts demonstrated a significant reduction in menstrual blood loss and reached the primary endpoint in all three arms (all P<.001 vs. placebo). 

Elagolix arm showed a significant decrease in lumbar spine bone mineral density as compared to placebo, but add-on therapy with 1.0 mg estradiol/0.5 mg norethindrone acetate stopped the bone loss.

Dr. Bruce Carr, Professor of Obstetrics and Gynecology at UT Southwestern Medical Center and lead author on the study said the oral therapy offers new hope for patients suffering from menorrhagia with uterine fibroids for whom hysterectomy or myomectomy was the gold standard treatment. 

 “There are no orally approved drugs to decrease bleeding and prevent anemia in women with these tumors. Now, there is a medical option for this devastating disease that affects up to 75 percent of women,” he further added in a new release by UT Southwestern Medical Center.

A phase 3 ELARIS UF-EXTEND study of elagolix has also shown parallel results as the phase 2b trial and ELARIS UF-I and ELARIS UF-II phase 3 studies. AbbVie plans to include the ELARIS UF-EXTEND data as part of a submission for regulatory approval of elagolix for the treatment of uterine fibroids in 2019.

Abstract

UTSouthwestern Medical Center news release

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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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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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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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Weight loss decreases breast cancer risk in postmenopausal women

October is breast cancer awareness month, which an annual campaign to increase the awareness about the deadly disease. With over 2 million new cases every year, it is the most prevalent cancer in women. Although breast cancer runs in families, there are other lifestyle and environmental factors which increase the risk of breast cancer.

Obesity increases the risk of postmenopausal breast cancer; the risk is 1.5 times higher in overweight women and about 2 times in obese women than healthy weight women. The association between weight loss and incidence of breast cancer is inconsistent, and few studies have evaluated the association between the two.

 A recent observational study by Chlebowski RT et al. published in Cancer, the peer-reviewed journal of the American Cancer Society reported that women decreased the risk of breast cancer by 12% if they lost weight in 3 years as compared to the ones whose weight remained stable.

“Obesity is associated with increased risk of incident postmenopausal breast cancer,” Rowan T. Chlebowski, MD, Ph.D., research professor in the department of medical oncology and therapeutics research at City of Hope National Medical Center, and colleagues wrote. “Because approximately one-third of postmenopausal women in the United States are obese, obesity represents a common and potentially modifiable factor related to breast cancer outcome. However, it has not been established that weight loss in postmenopausal women decreases breast cancer incidence or breast cancer mortality.”

The researchers from the Department of Medical Oncology and Therapeutics Research, City of Hope National Medical Center, Duarte, California used data from the Women’s Health Initiative (WHI) Observational Study to study the association.

The study included 61,335 postmenopausal women with no prior history of breast cancer and normal mammogram with body weight and height measured and body mass index (BMI) calculated at baseline and after 3 years.

At the end of 3 years, the analysis was based on 3 weight categories: stable, 5% increase or 5% decrease.

The study participants were between 50 to 79 years, and the mean follow-up duration was 11.4 years, during which the researchers observed 3,061 cases of breast cancer.

Women (n = 8175) who lost weight faced a 12% decreased risk of breast cancer as compared to women whose weight remained stable (n = 41,139) (hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.78‐0.98; P = .02). The association remained the same even after adjustment for mammography.

The mean time to develop breast cancer was 6.5 years after the 3-year weight determination.

Women who gained (≥5%) weight (n = 12,021) were not associated with increased risk of breast cancer (HR, 1.02; 95% CI, 0.93‐1.11) but did show a slightly higher incidence of triple‐negative breast cancer (HR, 1.54; 95% CI, 1.16‐2.05).

“Our study indicates that moderate, relatively short-term weight reduction was associated with a statistically significant reduction in breast cancer risk for postmenopausal women,” said Dr. Chlebowski in Wiley press release. “These are observational results, but they are also supported by randomized clinical trial evidence from the Women's Health Initiative Dietary Modification trial where, in a randomized clinical trial setting, adopting a low-fat dietary pattern that was associated with a similar magnitude of weight loss resulted in a significant improvement in breast cancer overall survival. These findings, taken together, provide strong correlative evidence that a modest weight loss program can impact breast cancer.”

Here is the visual abstract of the study.

Abstract

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