TRUCLEAR 5C System Expands Office Hysteroscopy Treatment Options

Over the last several decades, significant progress in both technique and instrumentation has turned hysteroscopy into a common outpatient procedure for treatment, as well as diagnosis.¹ Penn State Health Milton S. Hershey Medical Center has offered outpatient hysteroscopy for seven years, and recently acquired a more advanced type of instrumentation, the TRUCLEAR 5C System. The new system allows specialists to perform procedures in the office that would have previously required surgery, along with its associated risks. “This is a ‘see and treat’ model,” says Stephanie Estes, MD, director of robotic surgical services and associate professor, reproductive endocrinology and infertility. “With it, I can do full operative procedures in the office, not just small polypectomies and the removal of malpositioned IUDs, but also larger polypectomies and adhesion resections, as well as myomectomies.”

New Evidence Supports Value of Preconception Weight-Loss for PCOS Patients

Until recently, specialists treating obese women with polycystic ovary syndrome (PCOS) have lacked research-based evidence to support the theory that weight-loss prior to fertility treatments may improve ovulation and, ultimately, live births. The topic had not been extensively studied, and most advice was from clinicians’ “common knowledge” that weight-loss prior to conception is beneficial. However, a recent study published in The Journal of Clinical Endocrinology & Metabolism¹ now provides the clinical evidence to support that guidance. Richard S. Legro, MD, reproductive endocrinologist, Penn State Health Milton S. Hershey Medical Center, led the team that conducted a secondary analysis of two randomized trials to evaluate various approaches.¹ They compared outcomes from the Pregnancy in Polycystic Ovary Syndrome II (PPCOS II) trial (n=187 women) of immediate treatment with clomiphene to outcomes from the treatment of Hyperandrogenism versus Insulin Resistance in Infertile PCOS Women (OWL PCOS) trial (n=142 women) of delayed treatment with clomiphene after preconception treatment with oral contraceptives, lifestyle modification or the combination of both.¹

OWL-PCOS Study Weight Loss Protocol

The OWL-PCOS study provided physicians with a detailed weight-loss strategy to share with their patients.¹ Patients are instructed to take the following action:

• Orlistat: (available OTC under the brand name Alli) to be taken as recommended + meal replacements contributing to a hypocaloric diet (~1200kcal/d) + lifestyle modification. To ensure adequate vitamin effects, take a vitamin supplement once a day, at least two hours before or after Orlistat. Institute Orlistat at a dose of 60 mg to be taken three times a day with meals. The dose may be skipped if the patient anticipates eating a high-fat meal to avoid the occurrence of unwelcome gastrointestinal side-effects.

Groundbreaking Research Advances Women’s Health

Research programs in maternal-fetal medicine, reproductive endocrinology, gynecologic oncology, female reproductive endocrinology and minimally-invasive gynecologic surgery at Penn State Health Milton S. Hershey Medical Center continue to advance the understanding of women’s health and garner placement in peer-reviewed clinical journals. This new knowledge translates from bench-to-bedside into improved diagnosis, treatment and prevention.

Reduction in the rate of Cesarean delivery following Consensus guidelines¹

This before-after retrospective cohort study examined 200 consecutive nulliparous women managed prior to the Consensus for the Prevention of the Primary Cesarean Delivery guidelines were adopted, and then 200 similar patients after the guidelines were implemented. In one year, the Cesarean delivery rate among women delivering after induction or augmentation decreased from 35.5 percent to 24.5 percent; the overall rate decreased from 26.9 percent to 18.8 percent.

Novel Research Rotation Prepares Future Researchers and Clinicians

While many institutions have a general research requirement for residents, few have formally defined it. Beginning in 2016, however, all Penn State Health Milton S. Hershey Medical Center OBGYN residents are required to complete an officially sanctioned rotation on a self-developed research question. This rotation is overseen by Timothy Deimling, MD, director of resident research and assistant program director, fellowship in minimally invasive gynecology surgery, and Rebecca Phaëton, MD, assistant director of resident research. The research rotation helps each resident develop projects and identify mentors who are experts in their respective fields, and comprises two five-week blocks beginning in the resident’s second year. The ultimate goal is that each resident presents a publication-ready manuscript.

Timothy Deimling, MD, far left and, Rebecca Phaeton, MD, far right, meet with second-year residents to develop research questions.

This was prompted by Dr. Deimling’s own experience as a resident; a research requirement frequently lacked dedicated time to develop that research. This reflects a common dilemma in medical education; clinical needs are prioritized at the expense of the more long-term research projects. As a Center of Excellence in the advancement of women’s health, Penn State Obstetrics and Gynecology has created this dedicated rotation to emphasize the importance of research, as well as the more widely recognized requirements of hands-on, clinical practice. The program is expected to expand, with measurement of future publication rates to mark its success.

Endometriosis Tissue Bank to Identify Key Biomarkers for the Disease

Timothy Deimling, M.D., Obstetrics and Gynecology, is in the final stages of obtaining institutional review board approval to launch a prospective database and tissue bank for endometriosis research. The primary purpose is to identify biomarkers for less invasive diagnosis, in addition to identifying targets for treatment of endometriosis. “Most women with pelvic pain and infertility obtain definitive diagnosis of endometriosis after a long history of problems; the delay in diagnosis is in large part due to the fact that it requires surgery,” notes Dr. Deimling. The tissue bank is being established according to guidelines set by the supporting World Endometriosis Research Foundation (WERF), and is planned to include multiple centers in the U.S. and internationally.

Pathology slide of endometriosis, as well as an intra-operative picture of an endometriosis legion.

Routine Identification of Placental Umbilical Cord Insertion Location during Detailed Fetal Anatomic Ultrasound

Velamentous cord insertion (VCI) occurs more commonly in pregnancies involving twins, and in women who are older who have undergone in vitro fertilization (IVF) and who may be associated with a higher risk for fetal growth restriction. “With VCI, there is a higher risk for a poor birth outcome, such as pre-term delivery, low birth weight, vasa previa, thrombosis, fetal hypoxia and stillbirth [or perinatal death],” explains William Curtin, M.D., Obstetrics and Gynecology. “In addition, after a vaginal delivery, placentas with VCI are more likely to be retained, requiring manual removal of the placenta or even curettage resulting in postpartum hemorrhage. It is important for the delivering physician to have this information prior to the delivery as excessive traction on the umbilical cord to deliver the placenta may result in avulsion of the cord causing retention of the placenta in the uterus.”

Lynch Syndrome Screening is Routine in Women with New Endometrial Cancer Diagnosis, Regardless of Age

A representative picture of endometrial adenocarcinoma typically associated with HNPCC.

Lynch syndrome, often called hereditary nonpolyposis colorectal cancer (HNPCC), is an autosomal dominant mutation affecting the mismatch repair system that leads to nearly 80 percent of affected individuals developing one or more types of cancer during their lifetime. In women, the most frequently observed cancers are colorectal, endometrial and ovarian. Two to 3 percent of all endometrial cancer cases are related to Lynch syndrome; Lynch syndrome-related cases of endometrial cancer emerge 10 to 15 years earlier than in sporadic cases.

According to Joshua Kesterson, M.D., Obstetrics and Gynecology, “Previously, we screened for Lynch syndrome by assessing personal and family history.” Penn State Health Milton S. Hershey Medical Center’s screening program is in line with the 2014 American College of Obstetricians and Gynecologists (ACOG) and Society of Gynecologic Oncologists (SGO) recommendations for Lynch syndrome screening.¹ Dr. Kesterson explains, “We are now transitioning to universal screening, where all women with newly diagnosed endometrial cancer are screened for Lynch syndrome.” As noted in the ACOG/SGO recommendations, this is the most sensitive approach for accurate detection of Lynch syndrome cases, with the least risk of false negatives.¹

Improving Quality of Care Using a Small Systems Approach

At tertiary hospitals around the world, a team-centered systems approach has evolved to help physicians provide more evidence-based care to improve patient outcomes. A major challenge toward implementing systems change is the sheer size and scope of any such organization.

Using a unique alternative approach, Penn State Hershey Obstetrics and Gynecology has begun two quality initiatives. The first places the power to define and enact systematic changes to care within each of its six smaller subdivisions (see Text Box for initiatives overview), led by Matthew F. Davies, M.D., FACOG, chief of female pelvic medicine and reconstructive surgery, and vice chair of quality and patient safety. A key feature of the program focuses on small teams as drivers of change. Dr. Davies states, “I’ve been impressed by how many great ideas for change have come out of the small group approach; with a few people acting as drivers, there is very little bureaucratic inertia and teams can make changes to patient care in a relatively short period of time.” Dr. Davies and each quality team member gathers patient outcomes data to evaluate the impact of each quality initiative. The teams also define precise timelines for examining the impact of process.

New Study Explores Pre-Treatment Lifestyle Modification for Obese Women with Unexplained Infertility

Obesity in women is associated with a negative impact on ovulation, delayed time to conception, increased pregnancy loss, and an increased risk of serious adverse maternal pregnancy and neonatal outcomes.¹ A new randomized controlled trial recently began enrolling patients, aimed at evaluating the impact of two varying 16-week lifestyle modification interventions (see chart) on the frequency of healthy births (e.g., live birth at 37 or more weeks gestation with no major congenital anomaly, birth weight between 2500g to 4000g). To achieve a weight loss of approximately 7 percent of total body weight, the intensive intervention promotes increased physical activity combined with calorie restriction and a weight loss medication. The other standard intervention group promotes activity alone. Richard Legro, M.D., Penn State Hershey Obstetrics and Gynecology (lead study site), the lead investigator of this nationwide study explains, “Although the epidemiology of obesity and adverse fertility outcomes is well established, there is no evidence that losing weight or achieving fitness prior to pregnancy improves fertility. In fact, there are studies that show excessive weight loss or activity can harm the chances for pregnancy. We are doing this study to answer the question of what is safe and best for women seeking pregnancy.”