includes principal investigator, collaborator or consultant and pending grants as test to 78%-96% in the post-test, with one question
th one question in older postmen-
well as grants already received. The other authors did not report any potential
conflicts of interest.
Sonohysterogram and Uterine Neoplasia: The
Significance of the Changes in Endometrial Findings
[3M]
Ohad Rotenberg, MD
Albert Einstein College of Medicine, New York, NY
Pamela Escobar, MD, Dmitry Fridman, MD, George Doulaveris, MD,
Malte Renz, MD, and Pe’er Dar, MD
INTRODUCTION: We assessed the significance of variations in
endometrial echo (EE) findings between transvaginal sonogram (TVS)
and saline infusion sonohysterogram (SIS).
METHODS: A prospective study of 440 women 50 years and older,
who underwent TVS, SIS and pathological sampling for endometrial
assessment. Endometrial findings and measurements on TVS and SIS
were evaluated and assessed in benign and Cancer/hyperplasia cases.
RESULTS: Patients median age was 60.1+/-8.1 (range 50-91) and
mean BMI was 33.3+/-7.2. The main indication for evaluation was
bleeding (87.3%) and 34/440 (7.7%) had either cancer or hyperplasia.
In 4/34 (11.8%) cases with cancer or hyperplasia the EE was poorly
visualized on TVS and 3/34 (8.8%) had intracavitary fluid. Only 3
(8.8%) had EE between 4-5mm and the rest had “thick EE.” On SIS
23/34 (67.6%) had polyps, 10/34 (29.4%) had focal thickening and only
1/34(2.9%) had diffuse thickening. As for EE thickness on SIS, 13/27
(48.1%) had EE ,5mm and in 11/27 (40.7%) cases it was ,4mm. The
mean EE on TVS was 14.768.6mm as compared to 5.963.7mm, on
SIS (p , 0.0001). In 319/440 (92.3%) of cases with benign pathology,
the TVS EE was significantly thicker than sis, even after excluding
cases with polyps (n5159), focal thickening (n562) and submucosal
fibroids (n535): 6.564.3mm on TVS vs 3.962.4mm on SIS, (n563,
p50.001). EE conversion formula was created using scatterplot of the
measurements with regression line: TVSEE 51.413SISEE.
CONCLUSION: SIS EE was significantly thinner than TVS EE both
in the cancer/hyperplasia and the benign groups. The EE conversion
formula is: TVS EE51.41xSIS EE. This finding suggests that the cur-
rent interpretation of thin endometrium on TVS may not be applied in
SIS.
Financial Disclosure: The authors did not report any potential conflicts of
interest.
Then and Now: Experts Insights on Understanding
the Women’s Health Initiative Hormone Therapy
Trials [4M]
JoAnn V. Pinkerton, MD, NCMP
University of Virginia, Charlottesville, VA
Andrew Kaunitz, MD, and Andre Lalonde, MD
INTRODUCTION: More than a decade following publication of the
Women’s Health Initiative (WHI) clinical trials for hormone therapy
(HT), perception in the medical community remains that HT is unsafe
for postmenopausal women. The evidence suggests otherwise for the
majority of symptomatic menopausal women under 60 years and
within 10 years of menopause.
METHODS: A 30-minute expert interview CME program discussed
the accurate interpretation of data from the WHI trials. Correct
answers were compared between immediate pre- and post-tests,
including case-based scenarios.
RESULTS: 15,236 participants have engaged with the program to
date (July 1–August 31, 2016) with 355 completions. Participants
included physicians, 50%, and nurses, 21%, with 31% in women’s
health, 30% in primary care and the rest distributed among other
specialties. Correct responses improved from pre- to post-test for all
questions, including outcomes from the WHI trials (22%-52% to 49%-
88%), attributes of new menopausal medications (43% to 67%) and
appropriate application of clinical guidelines (64% to 90%). For most
case-based questions, responses improved from 58%-83% in the pre-
VOL. 129, NO. 5 (SUPPLEMENT), MAY 2017 Copyright ª by The American College of Obstetricians
and Gynecologists. Published by Wolters Kluwer Health, Inc.
Unauthorized reproduction of this article is prohibited.
opausal women (aged 62) only improving from 42% to 48%.
CONCLUSION: Results demonstrate the negative impact of inappro-
priate data interpretation, its effect on clinical care and guideline
application. Continued uncertainty remains regarding HT risks, interpre-
tation of follow-up studies, and the benefits/risks of newer medications.
Future educational efforts must reinforce the need to treat symptomatic
menopausal women according to the best available evidence, and how
benefits exceed risks for many women with existing/new HT medications.
Financial Disclosure: JoAnn Pinkerton disclosed the following—Pfizer:
Consultant/Advisory Board; Therapeutics MD: Research Grant includes prin-
cipal investigator, collaborator or consultant and pending grants as well as
grants already received. Andrew Kaunitz disclosed the following—Allergan:
Consultant/Advisory Board; Bayer: Consultant/Advisory Board, Research
Grant includes principal investigator, collaborator or consultant and pending
grants as well as grants already received; Merck: Consultant/Advisory Board;
Therapeutics MD: Research. The other authors did not report any potential
conflicts of interest.
REPLENISH Trial: Combination Capsule of Estradiol/
Progesterone (TX-001HR) for Treating Hot Flushes
[5M]
David F. Archer, MD
Eastern Virginia Medical School, Norfolk, VA
Shelli Graham, PhD, Gina Gasper, Ginger Constantine, MD,
Brian Bernick, MD, and Sebastian Mirkin, MD
INTRODUCTION: Many FDA-approved hormone therapies (HTs)
combining estrogens and progestins are currently available in the US
for treating menopausal symptoms. The use of FDA-approved HT has
recently declined, while that of custom-compounded hormone therapy
(CHT) with estradiol and progesterone has increased. Current reports
suggest that up to 3 million women 40 years and older are using CHT
(30 million prescriptions/year). Compounded BHT may be associated
with endometrial cancer. No single product combining natural 17b-
estradiol and progesterone has been approved yet by the FDA.
METHODS: REPLENISH (NCT01942668) was a phase 3, random-
ized, double-blind, placebo-controlled, multicenter trial (;100 US
sites) that evaluated the safety and efficacy of TX-001HR (a 17b-estra-
diol‒natural progesterone combination capsule) for treating moderate
to severe hot flushes in postmenopausal women with an intact uterus.
Of the total 1,847 women enrolled, 767 were randomly assigned to one
of four TX-001HR daily doses (estradiol 1.0 mg/progesterone 100 mg,
0.5 mg/100 mg, 0.5 mg/50 mg, or 0.25 mg/50 mg) or placebo for 12
months (vasomotor symptom substudy); the remaining 1,080 women
were randomly assigned between the active treatments. The four co-
primary efficacy endpoints were the mean change from baseline to
weeks 4 and 12 in frequency and severity of moderate to severe vaso-
motor symptoms for active treatments vs placebo. The primary safety
endpoint was the incidence of endometrial hyperplasia at 12 months.
RESULTS: TX-001HR 1.0 mg/100 mg or 0.5 mg/100 mg met all 4 co-
primary endpoints, with significant improvements from baseline in
frequency and severity of moderate to severe hot flushes at weeks 4 (all,
P, 0.05) and 12 (all, P, 0.001) compared with placebo. Women treated
with TX-001HR 0.5 mg/50 mg had significant improvements in hot flush
frequency and severity at week 12 (both, P, 0.05) vs placebo, while those
taking 0.25 mg/50 mg had significant improvements in frequency, but not
in severity, at weeks 4 and 12 (both, P# 0.001). The incidence of endo-
metrial hyperplasia or malignancy was 0% (by consensus read) with all
four TX-001HR doses and placebo after 12 months of therapy. A high
incidence of amenorrhea was achieved with all TX-001HR doses.
CONCLUSION: TX-001HR 1.0 mg/100 mg or 0.5 mg/100 mg
effectively treated menopause-related moderate to severe hot flushes
and had a safe endometrial safety profile. If approved, TX-001HR –
the first combination HT product containing naturally occurring 17b-
estradiol and progesterone – may provide an alternative option for the
estimated 3 million of women currently using unregulated, unap-
proved, compounded bio-identical in the US.
Financial Disclosure: David F Archer disclosed the following—AbbVie (Con-
sultant/Advisory Board); Actavis PLC (Consultant/Advisory Board, Other
Research Support includes receipt of drugs, supplies, equipment or other
MONDAY POSTERS 133S
in-kind support); Agile Therapeutics (Consultant/Advisory Board); Ascend
Therapeutics (Speaker/Honoraria includes speakers bureau, symposia, and
expert witness); Bayer Healthcare (Consultant/Advisory Board, Other Research
Support includes receipt of drugs, supplies, equipment or other in-kind support);
Endoceutics (Consultant/Advisory Board, Other Research Support includes
receipt of drugs, supplies, equipment or other in-kind support); Exeltis
(Consultant/Advisory Board); Ferring Pharmaceuticals (Consultant/Advisory
Board); Glenmark (Other Research Support includes receipt of drugs, supplies,
equipment or other in-kind support); InnovaGyn (Consultant/Advisory Board);
Merck (Consultant/Advisory Board, Other Research Support includes receipt
of drugs, supplies, equipment or other in-kind support, Speaker/Honoraria
includes speakers bureau, symposia, and expert witness); Noven
(Speaker/Honoraria includes speakers bureau, symposia, and expert witness);
Pfizer (Consultant/Advisory Board, Speaker/Honoraria includes speakers
bureau, symposia, and expert witness); Radius Health (Consultant/Advisory
Board, Other Research Support includes receipt of drugs, supplies, equipment or
other in-kind support); Sermonix Pharmaceuticals (Consultant/Advisory
Board); Shionogi Inc (Consultant/Advisory Board, Other Research Support
includes receipt of drugs, supplies, equipment or other in-kind support);
Teva Women’s Healthcare (Consultant/Advisory Board); TherapeuticsMD
(Consultant/Advisory Board, Other Research Support includes receipt of drugs,
supplies, equipment or other in-kind support). Shelli Graham disclosed the
following—TherapeuticsMD (Employment, Ownership Interest includes stock,
stock options, patent or other intellectual property. Ginger Constantine disclosed
the following—TherapeuticsMD (Consultant/Advisory Board, Ownership Inter-
est includes stock, stock options, patent or other intellectual property). Brian
Bernick disclosed the following—TherapeuticsMD (Board Member, Employment,
Ownership Interest includes stock, stock options, patent or other intellectual prop-
erty). Sebastian Mirkin disclosed the following—TherapeuticsMD (Employment,
Ownership Interest includes stock, stock options, patent or other intellectual prop-
erty). The other authors did not report any potential conflicts of interest.
Editor’s Note: Poster no. 6M was withdrawn during production.
HIV/AIDS PROGRAM
Breastfeeding for U.S. Women Living With HIV: A
Medical and Ethical Policy Analysis [7M]
Marielle Gross, MD
Johns Hopkins University School of Medicine, Baltimore, MD
Cecelia Tomori, PhD, Jean Anderson, MD, and Jenell Coleman, MD, MPH
INTRODUCTION: US HIV guidelines recommend against breast-
feeding (BF) by women living with HIV (WLHIV), regardless of viral
load (VL) and combination antiretroviral therapy (cART), to eliminate
risk of breast milk mother-to-child-transmission (MTCT). Cultural stigma
may prompt intermittent, non-exclusive BF, further increasing risk.
However, BF decreases morbidity and mortality for children and women,
and is an important reproductive right. We sought to evaluate the medical
and ethical bases of categorically prohibiting BF for WLHIV.
METHODS: Our empirically informed ethical analysis: (1) reviews
MTCT risk; (2) explores unique health risks of HIV-exposed infants
and WLHIV; and (3) explores potential harms of universally prohibit-
ing US WLHIV from BF.
RESULTS: (1) MTCT from short-term exclusive BF is less than 1%
with cART, even in low-resource settings. (2) Formula-fed HIV-
exposed infants have increased risk of prematurity, low birth weight,
sudden infant death syndrome, and necrotizing enterocolitis (all causes
of US child mortality); and diabetes, asthma, and obesity. Without BF,
WLHIV have increased risk of breast/ovarian cancer, hypertension,
diabetes, heart disease, depression and unintended pregnancy. (3)
Given low MTCT with cART and BF health outcome data, both
groups may be disproportionately harmed by withholding BF. Further,
non-exclusive BF without provider knowledge/support increases
MTCT risk, and avoiding BF may impair bonding.
CONCLUSION: There is extremely low MTCT from exclusive BF
with cART and undetectable VL. Given potential benefits of BF for
WLHIV and their infants, eliminating choice is ethically problematic.
We propose a nationwide discussion to critically reevaluate the
medical and ethical bases of prohibiting BF for select cART-
adherent, virally suppressed WLHIV.
134S MONDAY POSTERS Copyright ª by The American College of Obstetricians
and Gynecologists. Published by Wolters Kluwer Health, Inc.
Unauthorized reproduction of this article is prohibited.
Financial Disclosure: The authors did not report any potential conflicts of
interest.
INFECTIOUS DISEASES
Providers Perspectives on Tdap Vaccination in
Pregnancy Patients [8M]
Samantha Vidrine, MD
Sacred Heart Hospital, UF Health at Pensacola Residency Program,
Pensacola, FL
Julie DeCesare, MD, Dikea Roussos-Ross, MD, Mary Ashby, MD,
Elizabeth Floyd, and Hanna Peterson
INTRODUCTION: The CDC recommends Tdap vaccination during
pregnancy to increase infants’ protection against pertussis. The best
time to vaccinate is between 27 and 36 weeks gestation in order to
maximize the maternal antibody response and transfer to the infant.
This project looks at the providers prospective as to why women are
not receiving the vaccine.
METHODS: An 8 question survey was sent out to all members of the
American College of Obstetricians and Gynecologists District XII. The
questions were concerning Tdap vaccination in pregnancy. Responses
were received from 139 providers.
RESULTS: According to the survey, 83.4% of obstetricians univer-
sally offer Tdap vaccinations in the third trimester in their office. Of the
patients who are offered the vaccine, 51-75% of patients accept the
vaccine. Concern for vaccination safety was the most common
response for why patients decline, followed by lack of understanding
of importance. 55.9% of providers answered that they encounter
barriers in trying to offer Tdap in their practice, and identified was
lack of point of care availability (70.3%) as the most common barrier.
Difference in vaccination rates between insure types were noted and
59% answered that Medicaid patients are less likely to receive Tdap in
the third trimester due to lack of reimbursement.
CONCLUSION: The most common reasons cited for patients to not
receive Tdap vaccination in the third trimester is concern for safety and
lack of understanding of importance. More than half of the providers
answered that Medicaid patients are less likely to receive the vaccine
due to reimbursement and point of care issues.
Financial Disclosure: The authors did not report any potential conflicts of
interest.
A Single Institution Review of Appropriateness of
Prophylactic Antibiotics in Hysteroscopy [9M]
Erika R. Wallace
University of Illinois College of Medicine at Peoria, Peoria, IL
Brad Nitzsche, MD, Abbie Massengill, MD, Nicole Clevenger,
and Thusitha Cotter, MD
INTRODUCTION: To examine our institution’s adherence to Amer-
ican College of Obstetricians and Gynecologists guidelines for antibi-
otic prophylaxis in gynecologic surgeries for which antibiotics are not
recommended.
METHODS: A cross-sectional study of hysteroscopy cases performed
at a single tertiary care center from August 2011 to September 2015
was completed. Descriptive statistics summarized patient character-
istics. Chi-square tests examined antibiotic use associated with cate-
gorical variables; t- test was used for continuous variables. Multiple
logistic regressions analyzed the effects of variables on the odds of
receiving antibiotics of unproven benefit.
RESULTS: Among 1,075 women who underwent hysteroscopic
procedures for which antibiotics are not recommended, 196 (18.23%)
received antibiotics. 770 (71.62%) women had a hysteroscopy alone,
and 305 (28.37%) women had additional procedure(s) that also did not
warrant antibiotics. The mean age was 45 (SD 13, Range 18-88) years.
The odds of having unproven antibiotics increased by 2 percent (OR
1.02) with every one year age increase, adjusted for primary procedure,
diagnosis and length of stay [95% CI, 1.76-4.58]. Age (P , .0045),
primary procedure (P , .0022), primary diagnosis (P , .0019), admit-
ted year (P , .0302) and length of stay (P , .0005) had statistically
significant effects on the impact of having unproven antibiotics. Pa-
OBSTETRICS & GYNECOLOGY