ACOG update: Letrozole is the first line therapy for ovulation induction in PCOS

The American College of Obstetricians and Gynecologists (ACOG) now recommends Letrozole (aromatase inhibitor) as the first-line treatment for ovulation induction in women with Polycystic Ovarian Syndrome (PCOS) due to data demonstrating increased ovulation rates, clinical pregnancy rates and live-birth rate vs clomiphene citrate. The guidelines are published as Practice Bulletin No. 194 in the June issue of Journal Obstetrics and Gynecology.

This replaces the Practice Bulletin Number 108, published October 2009, which recommends letrozole as first-line therapy for ovulation induction only in women with PCOS and a BMI greater than 30.

It is estimated that polycystic ovary syndrome (PCOS) affects 1 in 10 women of childbearing age and it is the most common cause of ovulatory infertility. If lifestyle modifications and weight loss are unable to achieve conception, currently clomiphene citrate (CC) is usually prescribed as the first-line treatment for ovulation induction.

  

The gonadotropin-stimulating action of letrozole has been used off-label in the treatment of patients with ovulatory dysfunction, such as polycystic ovary syndrome.

The results of recent double-blind, multicenter trial show that letrozole was associated with higher live-birth (27.5% vs 10.1%) and ovulation rates (61.7% vs 48.3%) among infertile women with the polycystic ovary syndrome as compared to CC.

Women on letrozole also had a 40% higher clinical pregnancy rate (OR 1.40 95% CI, 1.18-1.65) and 64% increased live birth rate (OR 1.64 (95% CI, 1.32-2.04) as compared to CC.

If prescribing letrozole, the starting dose is 2.5 mg/day for 5 days typically starting on day 3, 4, or 5 after a spontaneous menses or progestin-induced bleed. If ovulation does not occur, the dose can be increased to 5 mg/day for 5 days with a maximum dose of 7.5 mg/day. Doses higher than 7.5 mg/day have been associated with thinning of the endometrium as seen with clomiphene citrate.

Lifestyle modification and weight loss are strongly encouraged along with letrozole therapy.

Several studies have also shown that letrozole is also the drug of choice in clomiphene non-responders with 50–80% women ovulating on letrozole.

Letrozole and clomiphene citrate are pregnancy category X drugs, and studies have demonstrated similar rates of congenital malformation in mothers who achieved pregnancy because of ovulation induction using these drugs.

When prescribing letrozole for ovulation induction, patients should be counseled that unlike clomiphene citrate, letrozole is not approved by the U.S. Food and Drug Administration for ovulation induction.

More recent papers on PCOS:

Fresh or frozen-embryo transfer results in similar pregnancy rates in women without PCOS

The therapeutic dilemma in PCOS patients not desiring pregnancy: A systematic review and meta-analysis

Clomiphene compared with other drugs in terms of ovulation, EMT, pregnancy and live births: systematic review and meta-analysis

Stair-step clomiphene protocols shorten time to ovulation in women with PCOS

Preconception IGT in PCOS results in adverse pregnancy outcome, independent of BMI

New study quantifies the risk of developing type 2 Diabetes in women with PCOS

Polycystic ovarian syndrome increases the risk of subsequent early ovarian aging later in life

PCOS is often underdiagnosed as the common cause of Abnormal Uterine Bleeding in Adolescents

Letrozole does not increase the risk of adverse pregnancy or neonatal outcomes and major congenital anomalies in patients conceived by ARTs

ACOG calls upon all obstetrician-gynecologists to screen PCOS patients for metabolic abnormalities.

Current options for ovulation induction in Polycystic Ovarian Syndrome (PCOS)

PCOS and Infertility: Pretreatment Weight loss hikes the live birth and ovulation rate in overweight and obese patients. 

PracticeBulletin No. 194

Ob/Gyn Updated Facebook page

Human eggs grown to maturity in the lab first time could unlock future fertility options

image credit: Prof David Albertini

In an extraordinary scientific feat, researchers were successful in growing human oocytes from the earliest follicular stage in the laboratory in just 20 days instead of 5 months in the body. The eggs fertility potential is unknown yet, and it remains to be seen whether they can produce healthy babies. 

The study was carried out in collaboration with the Royal Infirmary Edinburgh, The Center for Human Reproduction in New York and the Royal Hospital for Sick Children in Edinburgh, and published January 2018 in Journal of molecular human reproduction.

This process of oocytes maturation in lab could find potential applications in fertility preservation of cancer patients during the chemotherapy treatments. Immature eggs recovered from patients’ ovarian tissue could be matured in the lab and stored for later fertilization without the fear of reintroducing cancer.

Professor Evelyn Telfer from School of Biological Sciences said, “Being able to fully develop human eggs in the lab could widen the scope of available fertility treatments. We are now working on optimizing the conditions that support egg development in this way and studying how healthy they are. We also hope to find out, subject to regulatory approval, whether they can be fertilized.”

Till now researchers have successfully produced live offspring in mouse from in vitro grown (IVG) oocytes from primordial follicles. They have also grown human oocytes from secondary/multi-laminar stage to obtain fully grown oocytes capable of meiotic maturation.

However, this is the first report of in vitro complete human oocyte growth from immature primordial/unilaminar follicles using two-step culture system.

A series of magnified images show human eggs in development stages. Prof. Evelyn Telfer and Dr. Marie McLaughlin/University of Edinburgh/Handout via REUTERS

The scientist obtained fresh ovarian cortical pieces of approximate size 5 mm × 4 mm from women undergoing elective cesarean section. Fragments were cultured for 8 days according to the institute predetermined protocols.

Follicles ranging in diameter from 100–150 μm were dissected for further isolated culture. After about 8 days cumulus-oocyte complexes (COCs) were retrieved by gentle pressure on the cultured follicles. These COCs were further cultured for 4 more days when complexes containing oocytes >100 μm diameter were selected for in vitro maturation (IVM) in SAGE medium and subsequently fixed for analysis.

Confocal immuno-histochemical analysis of oocytes more than 100 μm diameter showed the presence of a Metaphase II spindle confirming that these IVG oocytes had resumed meiosis but their developmental potential is unknown.

Other scientists are looking at this process with great concern because of the shortened maturation process and lack of genetic analysis of the matured egg.

Telfer agrees that much work needed to be done and said, “We had no great expectations. To see at least one [egg reaching maturity], we thought, ‘Wow, that’s actually quite incredible.’”

The eggs fertility potential is unknown yet because of lack of regulatory approval, and even if they have can be fertilized much research is needed to see whether they can produce healthy babies.

But, the study has given new insights on human egg development that could be very useful in fertility treatment and regenerative therapies.

Her team is working on improving the process and getting an approval from the United Kingdom’s Human Fertilization and Embryology Authority—to try fertilizing the lab-matured eggs to create human embryos.

Full Text

University of Edinburgh press release

Ob/Gyn Updated Facebook page

News from ACOG 2018: Aspirin cuts down the risk of superimposed preeclampsia in women with chronic hypertension

Keeping up with the American College of Obstetricians and Gynecologists (ACOG) 2016 practice guideline of supplementing low-dose aspirin to pregnant women with chronic hypertension was associated with a 57% decrease in superimposed preeclampsia.

Investigators at Thomas Jefferson University presented the results of this retrospective study in a poster presentation at the ACOG 2018 annual meeting (April 27–30, 2018, Austin, Texas).

The study participants included 715 women with chronic hypertension carrying singleton pregnancy, who delivered at Thomas Jefferson University Hospital between January 2008 to July 2017.

The women were divided into 2 groups based on whether they delivered before and after ACOG recommendations. The pre-ACOG group included 635 women while the post-ACOG group had 80 women.

The cohort was further stratified based on additional risk factor for the development of superimposed preeclampsia (SIP) like a previous history of preeclampsia or pregestational diabetes. The primary outcome of interest was the development of preeclampsia, while the secondary outcomes studied were the incidence of SIP with severe features (SIPSF), small for gestational age, and preterm birth was also studied.

The incidence of SIP was dramatically reduced by 57% in women with chronic HT who received low dose aspirin (OR 0.43 (95% CI 0.26-0.73).

Women who had no other risk factor for the development of SIP, the incidence of SIP and SIP with severe features decreased by 75% and 77% respectively.

The incidence of secondary outcomes did not show any significant changes. Aspirin showed the highest benefits in women with chronic hypertension who did not have any additional risk factor for preeclampsia.

Hence the authors concluded that this study showed that ACOG guidelines have a significant positive impact on bringing down the incidence of superimposed preeclampsia in patients with chronic hypertension.

Abstract

ACOG Practice Advisory on Low-Dose Aspirin and Prevention of Preeclampsia

Ob/Gyn Updated Facebook page

3-D Printed Models of cervix developed to train doctors in cervical cancer screening and treatment

The researchers from Rice University

Many resource-poor settings are not able to provide cervical cancer screening, diagnosis, and treatment of women population because of lack of training. A team of students from Rice University has designed a 3-D Printed Models of the cervix that can help the healthcare providers to train them to carry out screening and provide treatment for cervical cancer.

This will be specifically used for training doctors and nurses in developing countries and low-resource areas in the U.S.

Cervical cancer kills nearly 300,000 women every year and more than 80% deaths are reported in developing countries. In about 90% of patients, the cervical cancer is preventable.

Rice students Christine Luk, Elizabeth Stone and Rachel Lambert are senior design students enrolled in the course Global Health Design. Together with graduate student Sonia Parra, they developed a low-cost, interactive training model that mimics a woman’s pelvic region and can be used to practice different cervical cancer screening and treatment procedures.

The simple device includes different models of cervix showing evolving stages of cervical cancer from entirely normal to pre-cancerous to definitive cancer.  The models fit into holder placed at the back of the device.

The training doctor or nurse can have real-life experience of what it looks like at the doctor’s office after the speculum is inserted and the cervix is visualized. The models can easily be switched around to simulate different conditions of the cervix and they also respond to the application of hot water just as a gynecologist applies acetic acid in clinical settings.

In addition to the training aspect, the device also is handy in teaching the doctors and nurses about how to proceed with abnormal results of the screening tests or a lesion is seen during the examination.

Some cervical models are made of a ballistic gel, that allows the doctors to practice colposcopy, cervical biopsy; cryotherapy, and loop electrosurgical excision procedure at low costs.

“Here in the states we have the ability to perform Pap smears and other practices, but in other countries where this model is used, such as Mozambique and El Salvador, they may not have the necessary infrastructure to do so,” Christine Luk said. “That’s why it’s important that this model can train as many procedures as possible.”

The students have already tested the device in training clinics in El Salvador and the Rio Grande Valley in Texas. Each training session is modified to fit the specific needs of an area.

The team from Rice is trying to collaborate with manufacturers to mass produce the device for areas in need so newly trained medical providers can train others.

Rice News Release

Ob/Gyn Updated Facebook page

Here is a video about how the device works

Landmark cancer prevention report puts forth a blueprint to reduce the risk of cancers

The American Institute for Cancer Research (AICR) and the World Cancer Research Fund (WCRF) recently issued an evidence-based blueprint for healthy living that could prevent nearly half of all cancer cases.

This is the 3^rd report in the series of expert reports Diet, Nutrition, Physical Activity, and Cancer: A Global Perspective, and updates the two previous comprehensive reports, which were published in 1997 and 2007.

The report has distilled evidence of 30 years of research into 10 recommendations that could help prevent cancer by lifestyle modification. The report is based on a review of data from 51 million people, including 3.5 million cancer cases in 17 cancers.

The evidence shows that a modification in your diet, staying physically active, having a healthy body weight and other health-related choices can prevent 12 cancer diagnoses. These include breast, colorectal, pancreatic, endometrial, ovarian, prostate, liver, gallbladder, kidney, bladder, stomach and esophageal cancers.

In 2012, an estimated 14.1 million new cases of cancer occurred worldwide, with nearly 1 in 6 deaths due to cancer.

Biology Computes

“The evidence is clear that making changes to diet and exercise and maintaining a healthy weight cuts cancer risks, regardless of age. The message may not be glamorous, but these changes can save your life,” said Kelly Browning, Chief Executive Officer of AICR.

The ten recommendations are:

1) Maintaining a healthy weight is the most important thing you can do to reduce your risk of cancer. Aim to be in the lower end healthy Body Mass Index (BMI) range.

2) Be physically active-incorporate physical activity as a part of your daily life. Walk more and sit less, for maximum health benefits, aim for 150 minutes of moderate, or 75 minutes of vigorous, physical activity a week.

3) Eat a diet rich in vegetables, fruits, whole grains, and beans. AICR recommends a plant-based diet that forms at least two-thirds of your plate.

4) Limit the intake of fast food. There is strong evidence that consuming "fast-foods" and a "Western-type" diet are causes of weight gain, overweight and obesity, which are linked to 12 cancers. Glycemic load also increases the risk for endometrial cancer.

5) Limit red meat and avoiding processed meat - red meat includes beef, pork and lamb and processed meat includes ham, bacon, salami, hot dogs, sausages.

6) Limit consumption of sugar-sweetened beverages- Whenever you feel thirsty drink water or unsweetened beverages.

7) Limit alcohol consumption- alcohol in any form is a potent carcinogen. It's linked to 6 different cancers. The best advice for those concerned about cancer is not to drink.

8) Do not take the supplement for cancer prevention-Aim to obtain nutrition from diet instead of popping the supplements. The panel doesn’t discourage the use of multivitamins or specific supplements for those sub-sections of the population who stand to benefit from them, such as women of childbearing age and the elderly. But, dietary supplements will not avoid cancer.

9) Mothers, please breastfeed your baby- There is a strong evidence that breastfeeding your baby protects against breast cancer later in life.

10) If you are already diagnosed with cancer, you should follow the nutritional advice from an appropriately trained professional. For breast cancer survivors, there is persuasive evidence that nutritional factors and physical activity reliably predict important outcomes from breast cancer.

The report emphasizes the need for knowledge about the link between lifestyle and cancer. In a 2017 AICR Cancer Risk Awareness Survey more than 50% of the population who responded was not aware of the link between obesity and cancer.

The report provides robust evidence for healthcare professionals and government officials to advise the patients about healthy eating and making policies that make healthy eating more affordable.  

AICR today launched Cancer Health Check – an easy-to-use tool, which shows how your lifestyle stacks up against known cancer risks and outlines the changes you can make to follow AICR’s evidence-based Cancer Prevention Recommendations.

ACIR News Release

Cancer Health Check – an easy-to-use tool

Diet, Nutrition, Physical Activity, and Cancer: A Global Perspective, the Second Expert Report

Ob/Gyn Updated Facebook page

Here is a video about AICR 10 recommendations for cancer prevention.

Purdue develops at home wearable preeclampsia testing device

supine pressor test

Researchers at Purdue University are working on an app-based preeclampsia testing that enables pregnant women to use a smartphone to detect her risk of developing preeclampsia.

The team, led by Craig Goergen, an assistant professor in Purdue’s Weldon School of Biomedical Engineering is modifying the way the underused tool called the supine pressor test records the Blood Pressure for a pregnant woman.

“We hope this will allow us to predict and prevent preeclampsia and reduce the number of children born prematurely each year. This could also reduce the long-term health complications for mothers,” Goergen said.

Other team members include George Wodicka, the Dane A. Miller Head of Biomedical Engineering at Purdue, and Kirk Forster, a senior research engineer at the Weldon School.

The supine pressor test measures a woman’s blood pressure in two different positions and the difference predicts her risk of developing the disease. But, to carry out the test, a woman must go visit the hospital or other healthcare providers, not an easy task in some parts of the world.

The researchers are working to combine available existing technologies such as smartphones, a conventional inflatable blood pressure cuff, and a wireless accelerometer (which measures body position) to build an innovative prototype that will detect preeclampsia before it develops.

  

A supine pressor test is an old, valuable tool that assesses blood flow through the kidney, and 90 percent of women with a positive test eventually develop preeclampsia. The women can send the test results to a doctor's office, a health-care system or a centralized network for the results to be read.

Based on the results the women can receive advice about prevention and early management to avoid the development of terminal consequences.

The World Health Organization estimates that nearly 10 percent of all maternal deaths in Africa and Asia are associated with hypertensive disorders during pregnancy and 25 percent of all maternal deaths in Latin America. Most of those deaths are avoidable, according to the WHO.

The American Journal of Obstetrics & Gynecology issued a report last year estimating the costs to the U.S. health-care system for preeclampsia at $2.18 billion for the first 12 months after birth  — $1.03 billion for mothers, and $1.15 billion for babies.

The researchers received a $100,000 Grand Challenges Explorations grant from the Bill & Melinda Gates Foundation in November.

While the Gates Foundation’s goal is to help women in developing countries, Goergen said the device the Purdue researchers are working on also could help women in inner cities and rural areas of the United States and other developed countries.

Here is video by the lead scientist Craig Goergen about the app and wearable device

Purdue News Release

Ob/Gyn Updated Facebook page

News from ACOG 2018: Elagolix promises long-term safety and efficacy in the treatment of Endometriosis

Elagolix, The first oral drug Elagolix showed promising results in the treatment of three types of pain in endometriosis reports the results of a study presented at the annual clinical and scientific meeting of the annual American College of Obstetricians and Gynecologists at Austin, Texas.

Elagolix, is a gonadotropin-releasing hormone (GnRH) receptor antagonist manufactured by AbbVie, a global research and development-based biopharmaceutical company in cooperation with Neurocrine Biosciences, Inc.

“There have been no new medications approved for a long time for systematic endometriosis and there is a huge gap because the current options are expensive, and they are often injectable drugs,” said presenter Dr. Surrey.

In this extension of an earlier phase3 trial, women with moderate to severe endometriosis-related pain who participated in the initial randomized, placebo-controlled trial were given either a 150- or 200-mg dose of Elagolix (NCT01620528).

About 569 women from 149 locations continued the treatment during the extension phase of 12 months to study the safety and efficacy of Elagolix over prolong period.

The average age of each patient group was between 31 and 34 years, and all groups were majority white, with a mean length of time from surgical diagnosis ranging from 45.5 to 56.6 months.

Patients reported a decrease in daily analgesic use by 46%-77% and improvement in dysmenorrhea and chronic pelvic pain by 49%-53% with 150 mg dose and by 82% for those at 200 mg.

Common side effect reported during the extension period was hot flashes, but they were not as severe as GnRH analogs and did not require any additional treatment. GnRH analogs are current gold standard for endometriosis and cause severe hot flashes requiring additional treatment.

The drug is also being evaluated in the treatment of uterine fibroids.

FDA is already on Elagolix and has announced April 2018 that it requires extended time to review additional information regarding the results of liver function tests provided by AbbVie in connection with its New Drug Application (NDA) for Elagolix in endometriosis-associated pain.

" We are pleased with the outcomes of the pivotal trials thus far. AbbVie will continue to pursue Elagolix as a potential new treatment for the disease's most common symptoms, including pain related to menstruation and chronic pelvic pain throughout the menstrual cycle," said Michael Severino, the chief scientific officer at AbbVie, at the time.

Abstract

FDA release 

Ob/Gyn Updated Facebook page

ACOG/AHA calls for including a ‘Heart-talk’ during the annual well-woman visit

A joint advisory issued by American College of Obstetrician and Gynecologists (ACOG) and American Heart Association(AHA) calls for all gynecologist to screen women for signs of cardiovascular disease and risk factors during their annual ‘well-woman’ visit.

The presidential advisory published 10 May in Journal Circulation calls for a collaboration between cardiologists and Ob/Gyn physicians to use these visits as an opportunity to screen, counsel and educate women about lifestyle factors that influence the risk of heart diseases.

This is important because, for more than 50% of women, their Ob/Gyn physician is the only primary care doctor they visit every year.

“OB/GYNs are primary care providers for many women, and the annual ‘well woman’ visit provides a powerful opportunity to counsel patients about achieving and maintaining a heart-healthy lifestyle, which is a cornerstone of maintaining heart health” said John Warner, M.D. president of the American Heart Association, executive vice president for Health System Affairs at University of Texas Southwestern Medical Center in Dallas, Texas.

Dr. Stacey Rosen, MD, a cardiologist, co-author of the advisory and vice president of The Katz Institute for Women's Health at Northwell Health said, "We know that 90 percent of women have at least one risk factor for heart disease and that 80 percent of heart disease is preventable through a heart-healthy lifestyle.”

A post-partum visit is an ideal opportunity to identify women with pregnancy complications like pre-eclampsia, eclampsia, chronic hypertension, gestational diabetes, gestational hypertension, pre-term delivery, and low-for-estimated-gestational-age birth weight which all indicate a subsequent increase in the mother’s cardiovascular risk.

Preeclampsia and gestational hypertension impart a three- to six-fold excess risk of subsequent hypertension and a two-fold risk for subsequent heart disease.

In 2001, the Institute of Medicine now the National Academy of Sciences, issued a monograph" Exploring the Biological Contributions to Human Health: Does Sex Matter?" This initiated research on gender-specific risk factors for chronic diseases and development of guidelines that are distinct for men and women based on their unique health risks.

This has considerably helped in bringing down the morbidity and mortality associated with cardiac disease in women in last two decades.

Despite this progress, gender-specific inequalities continue when it comes to managing risk factors for cardiac disease. For example, women who have diabetes are at increased risk of CVD as compared to men (19% vs 10%) but they are far less likely to receive preventive treatment as compared to men.

Similarly, only 29% of older women have a well-controlled blood pressure as compared to 41% of older men.

In women, the CVD risk factors are often related to hormonal or pregnancy influences, such as pregnancy complications and polycystic ovary syndrome, menopausal status and hormone use, but these are seldom considered when calculating the risk of CVD.

Some of the common recommendations in the advisory include:

• All women should be weighed at every visit and diet assessment should be performed through a predetermined questionnaire.
• Women are advised to perform 150 minutes per week of moderate-intensity physical activity, 75 minutes per week of vigorous-intensity aerobic physical activity or a combination of both levels. Women should also walk 10,000 steps per day.
• Presence of behavioral risk factors like smoking and alcohol should be assessed.
• Screening for Glucose intolerance should be done in women 40 to 70 years with obesity or overweight, a history of gestational diabetes, a family history of diabetes or established CVD.
• All women above 20 years of age with a family history of CVD, should undergo lipid screening. Lifestyle modification followed by statins is advised in those with elevated lipids.
• Women with family history of CVD should also be screened for blood pressure every 2 years and annually after 40 years of age.
• Medical therapy would be considered for women without CVD or elevated risk for the disease and with BP measurements greater than 140 mm Hg/90 mm Hg.
• Ob/Gyn and cardiologist should make sure that patients Electronic Health Record (EHR) is complete during each visit and is something does not look good, patients should be referred to a specialist.

The clinicians and patients can visit the following websites to get patient education material.

AHA Life's Simple 7 

AHA's Go Red for Women

ACOG's patient page

Full Text

Ob/Gyn Updated Facebook page

Here is one video from  AHA series ' Life's Simple 7'

Cuff closure by Laparoscopic vs transvaginal route significantly cuts down vaginal dehiscence after Total Laparoscopic Hysterectomy

Laparoscopic cuff closure after laparoscopic hysterectomy is associated with a nearly 3-fold reduction in vaginal dehiscence as compared to vaginal cuff closure reports the result of first randomized control trial published in May issue of American Journal of Obstetrics and Gynecology.

Total Laparoscopic Hysterectomy (TLH) is rapidly gaining popularity among surgeons and patients as the desired route for performing hysterectomies. It results in better cosmetic outcomes and quick return to normal activities as compared to open surgery.

However, it is also associated with higher incidence of vaginal cuff dehiscence (5–10 times higher) compared with the abdominal and/or vaginal hysterectomy. It may be because of thermal damage, difficult laparoscopic suturing techniques, reduced suture width because of magnification, or early resumption of intimacy and daily activities.

An earlier meta-analysis of case series and case-control studies suggested that a transvaginal approach of vault closure after TLH reduces the incidence of vaginal cuff dehiscence. But, these studies have drawbacks of retrospective data collection and lack of standardized protocol for post-operative data collection.

This is the first multicenter RCT carried out at 8 Italian institutions over a period of 2.25 years (NCT02453165). All women above 18 years of age, with benign condition scheduled for elective TLH up to colotomy stage, were included in the study.

A total of  1395 women were randomized in 1:1 to receive either transvaginal(TV) cuff closure (695 women) or laparoscopic (LPS) closure (700 women). The vaginal cuff closure in both the arms was done by the single-layer technique with braided and coated 0-polyglactin suture on a half-circle HR26 needle. In LPS arm intracorporeal knot-tying technique was used.

All women were advised to avoid intercourse for 2 months and they were followed up 3 months postoperatively because almost all vaginal cuff dehiscences after TLH occur within 2 months after surgery.

The researchers looked at the rate of vaginal cuff dehiscence as the primary outcome while vaginal bleeding, vaginal cuff hematoma, postoperative infection, vaginal resuturing, and any reoperation were secondary outcome studied.

Patients in the TV arm had a significantly higher incidence of vaginal dehiscence and any vaginal complications, cuff hematoma, vaginal bleeding, post-operative infection and vaginal resuturing (P<.05).

Women who were premenopausal or smoked were at higher risk of vaginal dehiscence independent of the route of closure.

The findings were so striking that the data monitoring committee ordered the trial to be terminated early.

The study was endorsed by Italian Society of Gynecologic Endoscopy which ensured that the surgical procedures were efficiently performed. Randomized design, large sample size and good follow-up program ensured the reliability and robustness of the study data.

The study has some limitations in terms of using only one type of suture, and not taking into account the role of barbed sutures. Finally, in accordance with other surgical trials, unavoidable human surgical skill variations may play a role in the results. 

The authors concluded, “LPS closure of the vaginal cuff at the end of TLH has been proven to be associated with less vaginal dehiscence, vaginal cuff hematomas, vaginal bleeding, vaginal resuture, and postoperative infections, compared to the TV suturing route. This study may change practice due to its impact and represents an important step toward an evidence-based approach to TLH, and more so in general, toward a standardization of gynecological surgical procedures.”

Full Text

Ob/Gyn Updated Facebook page

News from ACOG: Skills Demonstration Video for the Localization and Removal of Non-Palpable Contraceptive Implants

This year’s film festival at the at American College of Obstetricians and Gynecologists (ACOG) 2018 annual meeting at Austin, Texas offered more audience-friendly format with three 1-hour sessions with 30 minutes break in between the first 2 sessions.

The organizers reviewed 96 videos this year, and while videos about minimally invasive surgical techniques are very popular, they were outnumbered by patient education and anatomic videos.

This popular video about how to localize and remove a non-palpable contraceptive implant earned a spot among the top 3 videos.

This video was developed by Jhpiego, an international, non-profit health organization affiliated with The Johns Hopkins University for clinicians who provide implant services to be able to locate and perform a difficult removal of a deeply placed implant as well as sonographers and other healthcare providers who participate in localizing deep implants.  

 Ob/Gyn Updated Facebook page

North American Menopause Society (NAMS) video series about important midlife health topics: Hormones and Breast Health

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

In this video of 2018 series, Dr. Shapiro discusses the very controversial topic of hormones replacement therapy (HRT) and breast cancer with Dr. Stephanie Faubion, Director, Office of Women’s Health at the Mayo Clinic, Rochester, Minnesota.

HRT remains the most effective solution for the relief of menopausal symptoms and is also effective for the prevention of osteoporosis. It is thought to be associated with increased risk of stroke and breast cancer, but the risk has not been yet quantified. Dr. Faubion talks about HRT in various clinical settings, including women who have a family history of breast cancer and those with BRCA mutations.

Ob/Gyn Updated Facebook page

News from ACOG 2018: First trimester bleeding linked to increased risk of retained placenta

Women who have a history of first-trimester hemorrhage face 8 times the increased risk of undergoing D&C for removal of the retained placenta as compared to women with a history of bleeding reports the result of a study presented at American College of Obstetricians and Gynecologists (ACOG) 2018 annual meeting at Austin, Texas.

This abstract also won the first prize among the oral award winners at the conference.

These women also have a higher incidence of postpartum hemorrhage and require blood transfusions more frequently says Marissa Le Gallee, of Jewish General Hospital in Montreal, and colleagues who conducted the research.

This case-control study was conducted over a period of four years (2012-2016) at a tertiary care center in Montréal, Canada. Subchorionic hemorrhage was identified by the patient's obstetric history on as an anechoic structure visualized on ultrasound.

The authors recruited 68 cases who had post vaginal delivery D&C for retained placenta and matched them to 330 controls who delivered on the same day but did not have D&C after going through the medical records.

The demographics of cases and controls were similar, except women requiring a D&C for placental removal were slightly older than controls. The incidence of retained placenta requiring D&C was 3/1000 deliveries.

There were 11 women with a history of the first trimester bleeding who underwent post-partum D&C as compared with only two controls without a D&C (adjusted OR 35.00, 95% CI 6.96-175.69, P=0.0002).

This association strongly existed even after adjusting for confounders (OR 7.70, CI 1.-37.5).

A significant number of women who had undergone D&C lost blood greater than 500ml and needed manual removal as well as blood transfusions compared with patients with no D&C.

Dr. Le Gallee hypothesized that Subchorionic bleed leads to adhesion of portions of the placenta that necessitates D&C at birth. It is also associated with placental abruptions and preterm births.

The authors concluded that women with a history of the first-trimester bleed should be watched carefully watched for other potential pregnancy and peripartum complications.

Abstract

Ob/Gyn Updated Facebook page

A 132-pound ovarian tumor removed after 5 hours of surgery

A team of 20 doctors with Dr. Vaagn Andikyan, as the lead surgeon successfully operated on a 132-pound ovarian tumor from a woman's abdomen at Connecticut's Danbury Hospital, USA.

The woman's identity was not disclosed but she reported that the tumor began growing at a rate of about 10 pounds per week since November. A CT scan showed that she had a large mass on her ovary.

The woman was 38 years old, extremely malnourished and was confined to a wheelchair because of the weight of the tumor.

Dr. Andikyan, who is a gynecologic oncologist for Western Connecticut Health Network said, "During the surgery, we removed this gigantic tumor that originated from her left ovary. We removed her left ovary, her left (fallopian) tube, and we removed the affected peritoneal tissue that was adhering to the ovary."

The tumor was confirmed to be benign mucinous cystadenoma during a histopathological examination.  Mucinous tumors comprise 15% of all ovarian tumors and are known to grow to very large size.

“She had gotten to the point where she slept in a chair because she couldn’t lie flat, and the first thing we were going to need to do after we got her to sleep was to lie her flat for the operation,” said Dr. Karl Kulikowski, vice chairman, of the anesthesia department at Danbury Hospital. “Would her body tolerate that?”

“The huge weight of the tumor made anesthesia really dangerous,” said Dr. David Goldenberg, section chief of plastic surgery. “All of a sudden you are going to reduce that weight in a flash, and the cardiac system has to adjust very quickly, so there was a tremendous amount of preparation done beforehand to anticipate that kind of a problem.”

Dr David Goldenberg, left, Dr Karl Kulikowski and Dr Vaagn Andikyan, right, in a Danbury Hospital operating room. 

The team was prepared to perform open heart surgery in case of an emergency, but the pre-op planning and preparation were successful, and the tumor removal was uneventful.

The surgeons also removed 6 pounds of the excess abdominal wall and performed a reconstructive surgery afterward during the same surgery. The woman was discharged after 2 weeks and has recovered well.

The world’s largest ovarian tumor to be removed was 300 pounds from an unnamed 34-year-old woman’s abdomen in Stanford Hospital, Palo Alto, California on October 1991.

Danbury hospital news release 

Ob/Gyn Updated Facebook page