bluuebunny/crossref_metadata_2025 huggingface dataset:
Efficacy of LF111, an Investigational, Drospirenone-Based Progestogen Oral Contraceptive [10J]
Authors: Kimble Thomas Dudley , Burke Anne E. , Barnhart Kurt T. , Colli Enrico , Archer David F.
Published: May 2019

INTRODUCTION:

Progestogen only oral contraceptives are associated with a decreased risk of venous thromboembolism making them indicated in women who are breast feeding or present contraindications to estrogens, including obesity, age > 35 years and smokers. Drospirenone (DRSP), a progestogen derived from spironolactone with a pharmacological profile similar to natural progesterone possesses anti-mineralocorticoid and anti-androgenic activity.

METHODS:

Multicenter, open-label trial in sexually active females ≥15 years seeking contraception were administered LF111 (4.0 mg DRSP: x 24 days with x 4 placebo tablets) in 13 sequential cycles of 28 days each. The Pearl Index (PI) was calculated in evaluable cycles in the overall population (Full Analysis Set [FAS]) and in non-breastfeeding women (modified FAS; [mFAS]) aged ≤35 at the time of enrollment, who received at least one dose of LF111, excluding discontinued sites.

RESULTS:

The FAS and mFAS comprised 1004 and 993 subjects, respectively. The PI in 5337 evaluable cycles in 903 non-breastfeeding subjects with 12 confirmed on-drug pregnancies was 2.9 (95% CI 1.5-5.1). The overall PI in 5835 exposure cycles in 903 subjects with 12 confirmed pregnancies was 2.7 (95% 1.4-4.7). The PI for method failures in 2664 perfect cycles in 908 subjects with 7 pregnancies was 3.4 (95% CI 1.4-7.0). There were no pregnancies in women >35 years.

CONCLUSION:

The primary endpoint, PI from evaluable cycles in non-breastfeeding women age ≤35 years at the time of enrollment, showed that LF111 provided effective contraception protection with a PI of 2.9., historically comparable to recently approved combined oral contraceptives.
The Effect of Linzagolix on Bone Mineral Density (BMD): Safety Results From a Dose-Ranging Trial [21J]
Authors: Bestel Elke , Humberstone Andrew , Lecomte Veronique , Loumaye Ernest , Gotteland Jean-Pierre , Simon James A.
Published: May 2019

INTRODUCTION:

Linzagolix is a new, non-peptide, GnRH receptor antagonist being developed to treat endometriosis-associated pain (EAP). The EDELWEISS trial is a Phase 2b, double-blind, randomized, placebo-controlled, multicenter, dose-ranging trial in and Europe evaluating oral once daily doses of 50, 75, 100 and 200 mg taken for 24 weeks. Subjects randomized to placebo were crossed-over to 100 mg after 12 weeks.

METHODS:

IRB approval was obtained. Participants were women with surgically confirmed endometriosis and moderate to severe EAP. Women with a history of osteoporosis or other metabolic bone disease were excluded. BMD of the femoral neck, total hip and lumbar spine was assessed by DXA at baseline and after 12 and 24 weeks of treatment. Reading of DXA scans and monitoring of scan quality, including cross-calibration between sites, was centralized.

RESULTS:

327 patients were randomized and treated. Mean percent (95% CI P value) BMD changes for lumbar spine from baseline to week 24 in the 50, 75, 100 and 200 mg dose groups were 0.137% (-0.83, -1.11 P=.777), -0.798% (-1.57, -0.03 P=.042), -1.365% (-2.14, -0.59, P<.001), -2.602% (-3.56, -1.65, P<.001), respectively. BMD of femoral neck and total hip showed a similar pattern but with generally smaller changes from baseline.

CONCLUSION:

Mean BMD losses at 24 weeks were <1% at doses of 50 and 75 mg and increased with increasing dose up to 2.6% for 200 mg. Long term use of 75 mg daily is not expected to require concomitant estrogen/progestin add-back therapy, while higher doses may require it.
Cervix Elasticity and Length Measurements With Tactile-Ultrasound Probe: First Clinical Experience [32J]
Authors: Rosen Todd , van Raalte Heather , Egorov Vladimir
Published: May 2019

INTRODUCTION:

Premature cervix softening and shortening may be considered an early mechanical failure that predisposes to preterm birth. Clinical studies demonstrate that cervical elastography may be able to predict spontaneous preterm delivery. The purpose of the study was to access a new approach to cervix elasticity and length measurements based on the acquisition of stress-strain data by tactile and ultrasound transducers.

METHODS:

A Cervix Monitor (CM) was designed to provide a single-use, inexpensive cervix probe with a tactile array and an ultrasound transducer. 10 non-pregnant and 10 pregnant women at 22-29 weeks of pregnancy were examined with the CM in IRB approved studies. Cervix stress-to-strain ratio was used to calculate cervix elasticity (Young's modulus) for four cervix sectors at 3, 6, 9, and 12 o'clock.

RESULTS:

The study with non-pregnant women demonstrated the device safety. The study with pregnant women with gestational age 25.4±2.3 weeks demonstrated cervix elasticity 19.7±15.4 kPa and length 30.7±6.6 mm. Intraclass correlation coefficients between two measurements at the same cervix sector were found to be 0.97 for cervix elasticity and 0.93 for cervix length. The bias and the 95% limits of agreement (Bland-Altman plot) of cervix elasticity measurement are 3.8% and -22.4% to +14.9%, the precision was 9.5%. The bias and the 95% limits of agreement of cervix length measurement are -1.6% and -13.3% to +16.5%, the precision was 7.6%.

CONCLUSION:

The CM stress-strain data allowed computation of cervix elasticity and length. This approach has a potential to provide cervix markers to predict spontaneous preterm delivery in a cost-effective manner.
Current Practices in Hepatitis C Screening in Pregnant Women in a Regional Health System [36J]
Authors: Amgalan Ariunzaya , Scott Rachel , Tefera Eshetu , Sawney Shari , Deeb Hala , Fishbein Dawn
Published: May 2019

INTRODUCTION:

In May 2018, AASLD and IDSA recommended that all pregnant women be screened for hepatitis C viral (HCV) infection, shifting away from risk-based testing. Our study examines prenatal HCV screening practices and results in a regional health system serving greater Washington DC.

METHODS:

We reviewed HCV results of pregnant women tested from January 2017-April 2018 across our health system and conducted a retrospective chart review of women who tested positive. We used Chi-square, Fisher Exact and Student t-tests for the bi-variate analyses, and multivariate logistic regression to determine predictors of HCV screening and antibody positivity. IRB approval was obtained.

RESULTS:

Of 10,362 pregnant women seen for outpatient prenatal visits, 3,067 (29.6%) were HCV screened; 44 (1.4%) were HCV antibody positive. Pregnant women were more likely to be HCV screened if they were older (ORadj 1.02, CI95 [1.01-1.02]), African-American or non-Caucasian (2.24 [2.02-2.49]; 1.74 [1.53-1.98]), HIV tested (4.25 [3.65-4.94]), HIV-infected (8.37 [4.77-14.70]), HBV-infected (1.45 [0.778-2.719]), or had private insurance (1.51 [1.37-1.66]). In review of HCV positive pregnancies, 70% were Caucasian, none had HIV, 2% had HBV, 59% had an opioid use disorder, 64% had IVDU history, 80% had ≥1 HCV risk factors; 5% completed HCV treatment, and 11% had fibrosis assessments (all F0). Pregnant women were more likely to be HCV antibody positive if they were Caucasian (ORadj 11.44 [CI95 3.99-32.82]), HBV-infected (15.27 [2.32-100.46]), or living in Maryland vs. DC (2.93 [1.17-7.32]).

CONCLUSION:

Our results identify racial disparities between HCV testing and positivity, and the need for improved HCV screening and treatment.
Evaluating Practice Patterns of Late Preterm Antenatal Steroid Administration and Adherence to Recommendations [8K]
Authors: Umesh Vaibhavi , Dinglas Cheryl , Garretto Diana , Herrera Kimberly
Published: May 2019

INTRODUCTION:

After the Antenatal Late Preterm Steroids trial, ACOG recommended steroids in women with a singleton pregnancy at 34 weeks to 36 weeks 6 days following strict guidelines. Few studies have assessed the implementation of these recommendations and their impact on maternal/neonatal outcomes.

METHODS:

An IRB-approved retrospective cohort study was performed from October 2016 to October 2017. Records were reviewed to determine whether women fit criteria (singleton gestation, likely to remain pregnant >12 hours, no prior course of steroids, no pre-gestational diabetes, no signs of infection or other contraindications). Maternal, perinatal, delivery characteristics, and neonatal outcomes were obtained. Outcomes were compared using Chi-squared and Fisher exact test.

RESULTS:

Among 61 women who received late preterm steroids, 49 (80.3%) received them according to recommended guidelines. Among the 12 women (19.7%) who did not fit criteria: 6 (50%) were multiple gestations, 1 (8.3%) had preexisting diabetes, 3 (25%) had previously received a course of steroids and 4 (30%) had an imminent delivery. When comparing the two groups of women, there were no differences in age, race, body mass index and gestational age at delivery. However, there were higher rates of neonatal intensive care unit (NICU) admission, neonatal hypoglycemia and hyperbilirubinemia in those women who received steroids outside of recommended guidelines.

CONCLUSION:

In women who received late preterm steroids outside of recommended guidelines, there was a higher rate of poor neonatal outcomes. Providers should ensure proper administration of late preterm steroids based on the recommended guidelines until larger studies are done.
Increased Carrier Detection With Expanded Carrier Screening in Multiple Ancestries [7O]
Authors: Griswold Catherine , Yao Xinxin (Shirley) , Susswein Lisa R. , Fagbemi Adebanke F. , Pollevick Guido D. , Klein Rachel T.
Published: May 2019

INTRODUCTION:

While ACOG, ACMG and NSGC recommend reproductive carrier screening for cystic fibrosis (CF) and spinal muscular atrophy (SMA), there are no guidelines to date routinely recommending expanded carrier screening for all reproductive patients. We sought to assess, by ancestry, the proportion of additional individuals who would be identified via an expanded panel compared to CF/SMA alone.

METHODS:

We deduced the expected observation rate for CF and SMA based on published literature and our laboratory's detection rate for individuals of Hispanic, Caucasian, African American (AA), and Asian descent. We also reviewed observed detection rates for the same patient populations from a 180‐disorder expanded carrier screen completed over an 18 month period.

RESULTS:

Expanded carrier screening was performed on 2,468 self-reported Hispanic, 921 Caucasian, 339 AA, and 174 Asian individuals. Combining expected carrier frequencies for CF and SMA and observed frequencies for all other diseases on the expanded panel, 1 in 2 Caucasians and 1 in 5 individuals of other backgrounds would be expected to be positive. Compared with the expected carrier frequencies of CF and SMA alone, an expanded carrier screen increased the probability of identifying carriers by 10-, 7-, 9-, and 9-fold, respectively, for the four patient populations.

CONCLUSION:

Compared to testing for CF and SMA alone, an expanded carrier screen increased the probability of detecting a carrier for a disorder by 7- to 10-fold. Expanded carrier screening will identify a substantially greater number of carriers among various ancestries compared to testing according to current guidelines alone.
Maternal Sleep, Depressive Symptoms, and Risk for Spontaneous Shortened Gestation in Black and White Women [10O]
Authors: Webber Shannon , Gillespie Shannon , Porter Kyle , Christian Lisa
Published: May 2019

INTRODUCTION:

Depressive symptoms and poor sleep quality have been associated with an increased risk of preterm birth (<37 weeks gestation). In 2013, the American College of Obstetrics and Gynecology (ACOG) redefined “term birth,” in recognition that early term birth (37 0/7 - 38 7/8 weeks gestation) also confers risk. Effects of these behavioral exposures on risk of shortened gestation - inclusive of both preterm and early term birth - have not been clearly defined.

METHODS:

To address this gap, this study examined the association between maternal depressive symptoms, self-reported sleep quality and spontaneous shortened gestation. The impact of race was also considered. Analyses included 317 women (135 Black, 182 White) who completed the Center for Epidemiologic Studies-Depression Scale (CES-D) and Pittsburgh Sleep Quality Index (PSQI) questionnaires during the second trimester of pregnancy. Reason for shortened gestation was confirmed by medical record review and only spontaneous cases were included.

RESULTS:

A significant race effect was observed; Black women were 2.35 times more likely than White women to have spontaneous shortened gestation (95% CI 1.34-4.11). In addition, a multivariable logistic regression analysis showed that women with both elevated CES-D scores (≥16) and PSQI scores (>6) were 3.29 times more likely to have spontaneous shortened gestation (95% Cl 1.33-8.15), compared to 2.26 times more likely (95% CI 1.19-4.31) when only elevated CES-D scores were present.

CONCLUSION:

Due to this additive risk factor effect, increased awareness and interventions targeting maternal sleep and mental health could contribute to reduction in risk of both preterm and early term birth.
Predicting the Likelihood of Delivering Preterm Using Data Collected From a Pregnancy Mobile App [13O]
Authors: Bradley Danielle , Landau Erin , Wolfberg Adam , Baron Alex
Published: May 2019

INTRODUCTION:

The objective of this research was to create a predictive model for the identification of preterm delivery risk.

METHODS:

A predictive model to identify risk of delivering preterm was created using a supervised machine learning algorithm, specifically, a Gradient Boosting Decision Tree algorithm, as well as data from 121,740 users of a pregnancy mobile app. Data collected from users prior to the 26th week of pregnancy were used in the model. This allowed the model to predict risk of preterm delivery beginning at week 26.

RESULTS:

Of the total sample used to train the model, 46% delivered prior to 37 weeks. The model used 5,770 different features to model preterm birth likelihood. Self-report data, as well as in-app calculations based on reported data, were used to create the model. The features most influential to the model were 'daily data' such as, health symptoms and moods; characteristics of the current pregnancy including whether it was a single or multiple gestation; the frequency and type of healthcare appointments scheduled; personal health history information; and personal demographic information including age and BMI (height and weight). The model's positive predictive value was 0.75, with 0.41 sensitivity.

CONCLUSION:

This model based on patient-reported data could predict risk for delivering preterm, a serious obstetric complication, with accuracy levels sufficient to guide clinical action and screening by healthcare providers and health plans.
Safety of Taxane Chemotherapy in Breast Cancer During Pregnancy [28O]
Authors: O'Laughlin Andie , So Samantha , Fleischer Lindsay , Akoto Serwaa , Cardonick Elyce
Published: May 2019

INTRODUCTION:

Breast cancer is the most common malignancy in pregnancy. Paclitaxel/Docetaxel (Taxanes) are standard treatment for high-risk early stage and advanced/metastatic breast cancer outside of pregnancy, with a better response rate and longer time to progression than standard anthracycline-based (AC) regimens. In pregnancy, women receive AC without taxanes even when sufficient time remains before delivery. This study compares neonatal outcomes in women receiving taxanes with those who delayed taxanes to the postpartum period.

METHODS:

This is a retrospective cohort study of women with breast cancer during pregnancy who completed anthracycline based therapy prior to delivery with/without the addition of taxanes identified from the IRB approved Cancer and Pregnancy Registry. Neonatal outcomes including birthweight, anomalies, and postnatal medical problems were compared between taxane and nontaxane exposed infants. In some cases, neonatal developmental and behavioral assessments were performed. Pregnancy complications for the women were compared.

RESULTS:

Fifty women who completed AC also received taxanes before delivery and are compared to 57 women electively delaying taxane therapy until postpartum. Gestational age, birthweight, growth restriction, and congenital anomalies were not statistically different between exposure groups. Pregnancy complications including spontaneous preterm birth or rupture of membranes were not statistically different. Twenty six children underwent developmental/behavioral assessment, 13 in each group. No difference in developmental or behavioral assessments were found, nor medical disorders diagnosed at a mean age of 44 months.

CONCLUSION:

Taxane use in pregnancy does not increase perinatal complications for the mother or infant, nor impact neonatal developmental/behavior when compared with conventional chemotherapy for breast cancer in pregnancy.
IUD Usage Among Transgender and Gender Diverse Individuals [1P]
Authors: Abern Lauren , de Guzman Glendell , Kiely Kristen , Cook Jake , Maguire Karla
Published: May 2019

INTRODUCTION:

Although usage of the intrauterine device (IUD) is increasing, the prevalence among transgender and gender diverse individuals assigned female at birth is unknown. Our goal is to determine the reasons these individuals are choosing IUDs and if they are satisfied.

METHODS:

Transgender and gender diverse individuals assigned female at birth ages 18-64 participated in an online survey about their experiences with an IUD.

RESULTS:

104 surveys were completed. The mean age was 26.2 (SD 4.8). 21 (20%) identified as transgender, and 83 (80%) identified as genderqueer or non-binary. 26 (25%) were bisexual, 8 (8%) gay/lesbian, 28 (27%) pansexual, and 32 (31%) queer. The majority (84%) was white and had a college education (59%). 88 (85%) were sexually active, and 77 (88%) were at risk for pregnancy. 84 (81%) currently have an IUD. 66 (79%) have a progestin and 17 (20%) a copper IUD. Most common influential factors in choosing a specific IUD were menstrual manipulation (66%), duration (67%), and to avoid side effects experienced with other contraceptive methods (49%). 36 (35%) had an IUD in the past. Of these, 20 (56%) did not choose another IUD. 6 (30%) disliked side effects, 3 (15%) initiated testosterone, 2 (10%) experienced expulsion, and 2 (10%) had a hysterectomy. 2 (10%) became pregnant with an IUD. 1 (5%) desired pregnancy.

CONCLUSION:

IUDs are an excellent form of contraception and menstrual manipulation for transgender and gender diverse individuals, with few desiring removal. Providers should not overlook counseling this population in regards to the benefits of an IUD.
Understanding Barriers and Facilitators to Prenatal Care in African American and Hispanic Women [12P]
Authors: Valerio Melissa , Elerian Nagla , McGaha Paul , Krishnaswami Janani , French Lesley , Patel Divya A.
Published: May 2019

INTRODUCTION:

Understanding individual, provider and community level barriers and facilitators to on-time entry into prenatal care is crucial to the elimination of disparities in the mortality and morbidity of women. The Healthy Families initiative, a state-funded collaboration, seeks to understand the association between maternal risk factors and infant death within community settings to improve birth outcomes. We examined needs in two communities of Black women (East Texas) and Hispanic women (South Texas).

METHODS:

Six focus group sessions were conducted with pregnant women and women who recently delivered. Qualitative methods were used to analyze data. Quantitative demographic and behavioral data were collected for sixty-four participating women. Across both sites, mean age of participants was 24 years, 56% had at least some college education; 50% were currently insured; and 55% were single.

RESULTS:

Data analyses identified four specific themes: 1) stress and perceived discrimination, 2) clinical and organizational-level experiences, 3) family and support, and 4) fathers and their roles. Some unexpected themes, such as maternal mental health and child's health outcomes were also identified. Women at both sites reported racial/ethnic disparities in accessing care, and needs for programs to facilitate linkages to services.

CONCLUSION:

Findings from focus groups were immediately incorporated into program planning for the collaboration. Changes to programming based on findings included: offering of group prenatal care, increasing access contraceptives through mobile health; strengthening linkages to existing resources through community health workers; increasing partnerships with nurse home visiting services; cultural competency/humility training for providers and front-end staff.
Risk Factors for Neonatal Intensive Care Unit Admission Among Growth Restricted Fetuses [25P]
Authors: Schmitz Jourdan E. , Nwabuobi Chinedu K. , Pargas Anaisy , Camisasca-Lopina Hannah , Sinkey Rachel G. , Odibo Anthony O.
Published: May 2019

INTRODUCTION:

Growth restricted fetuses are at risk for admission to the neonatal intensive care unit (NICU). NICU admission is a proxy for long-term health consequences and societal costs. We aimed to assess risk factors for NICU admission among pregnancies complicated by fetal growth restriction.

METHODS:

This is a retrospective cohort study of non-anomalous, singleton, growth restricted fetuses - defined as estimated fetal weight (EFW) less than the 10th percentile - delivered in a single tertiary referral center from 01/2011 to 12/2016. Institutional Review Board approval was obtained. Factors significantly associated with NICU admission were identified using univariate analyses (P<.1). Multivariable logistic regression analysis was used to determine the final risk factors and to estimate adjusted odds ratios.

RESULTS:

594 pregnancies with fetal growth restriction met inclusion criteria. 204 (34.3%) resulted in NICU admission. Significant risk factors for NICU admission were smoking, EFW < 5th percentile, method of labor induction, non-reassuring fetal heart tracing, and gestational age at delivery. Labor induction with oxytocin or prostaglandins and higher gestational age at delivery appeared to be protective from NICU admission. If these risk factors were used to develop a prediction model, the area under the receiver-operator curve would be 0.83 (95% CI 0.79-0.86). The model would have a sensitivity of 50.0%, specificity of 92.3%.

CONCLUSION:

We identified several significant risk factors for NICU admission among growth restricted fetuses, which could be helpful in anticipating need for additional neonatal support at the time of delivery and for counseling women with growth restricted fetuses about risk of NICU admission.
Perceptions and Utilization of Prescription Drug Monitoring Programs: A Survey of ACOG members [1Q]
Authors: Roussos-Ross Dikea , Delcher Chris , Goodin Amie , Brown Joshua , Bae Jungjun
Published: May 2019

INTRODUCTION:

ACOG Committee Opinion 711 addresses opioid use in pregnancy and recommends utilization of Prescription Drug Monitoring Programs (PDMPs) before prescribing opioids to any patient. According to the US Centers for Disease Control and Prevention, PDMPs (electronic databases that track controlled substance prescriptions) can inform clinical practice and are primary prevention tools for drug abuse/diversion and neonatal abstinence syndrome (NAS). An increasing number of states mandate PDMP use; however, little is known about how specific physician specialties perceive and use PDMPs. The purpose of this study was to query ACOG member perceptions and utilization of their state PDMP.

METHODS:

ACOG District XII Committee on Health Care for Underserved Women distributed a voluntary anonymous email survey to 5,000 ACOG members (adjusted participants n=1,470, minus unread/bounced/opt-out). The survey instrument was developed by an OB/GYN and health services researcher workgroup to assess perceptions and utilization of PDMPs. Adjusted response rate=27% (n=397).

RESULTS:

Most (78%) were registered with their PDMP and 52% agreed that ...mandating physician use of the PDMP was a “good idea.” Most respondents agreed that the PDMP is a primary prevention tool for drug abuse/diversion (70%), addiction (68%), and/or doctor shopping (63%), but few agreed that it was an NAS primary prevention tool (22%). Respondents use the PDMP for patients currently using opioids (33%), and for patients suspected of drug abuse (29%). In qualitative responses, some reported frustration with PDMPs.

CONCLUSION:

ACOG members are diverse in their perceptions regarding the utility and purpose of PDMPs. Increased education is needed regarding clinical utility of PDMPs.
Tracking and Reminder Systems in OB/GYN Practice: A Survey of Practitioners [6Q]
Authors: Booher Morgan , White Chase , Goldberg Jay
Published: May 2019

INTRODUCTION:

In 2006, ACOG initially published a committee opinion which recommends that each office establish a simple, reliable tracking and reminder system to improve patient safety and quality of care and to minimize missed diagnoses. We surveyed current OB/GYN practitioners on their tracking and reminder systems.

METHODS:

A paper survey was distributed during a risk management talk at the 2018 ACOG Annual Clinical Meeting. Data were summarized, and groups were compared using chi-squared test for independence and Fisher's exact test.

RESULTS:

53 OB/GYN practitioners completed the survey. 30% were familiar with the ACOG committee opinion for tracking and reminder systems. 51% had been sued. 79% thought that patients were always responsible for obtaining ordered tests and referrals, whereas 40% thought that providers were. Providers who had been sued were more likely to think that providers were responsible for following up on results. Belonging to a practice with > 11 providers was associated with being less likely to believe providers were responsible for tracking results. Working at an academic center was associated with being less likely to tracking results. Overall, 75% had a tracking system for pap smears; 68% for biopsies; 55% for lab tests; 62% for screening mammograms; 58% for diagnostic mammograms; 42% for ultrasounds; and 28% for specialist referrals.

CONCLUSION:

OB/GYN providers inconsistently follow the ACOG committee opinion recommendations for tracking and reminder systems. The majority believed that patients were primarily responsible for obtaining ordered tests and referrals.
The Case for Universal Endocervical Sampling at Colposcopy for High-Grade Cervical Dysplasia [10Q]
Authors: Chiavetta Danielle Marie , Garcia Lisa Marie , Holschneider Christine H. , Aoyama Chisa
Published: May 2019

INTRODUCTION:

Using a population of patients with high-grade cervical dysplasia (CIN2+) who underwent universal endocervical sampling (ECS) at colposcopy, we sought to determine the rate of high-grade ECS at time of colposcopy and presence of endocervical disease at time of treatment in two patient cohorts: patients for whom ECS at the time of colposcopy is preferred by ASCCP (pECS) versus patients for whom ASCCP denotes performance of ECS as acceptable (aECS).

METHODS:

Retrospective review of a consecutive cohort of women with biopsy-proven CIN 2+ for which they underwent excisional treatment between 2005 and 2015. Endocervical disease at time of procedure was defined as positive top hat loop electrosurgical excision procedure specimen, positive endocervical margin of cold knife cone, or positive ECC at time of excision. Fisher's exact and student's t-tests were used to examine clinical outcomes.

RESULTS:

390 women who underwent universal ECS at time of colposcopy received treatment for CIN2+. The frequency of a positive ECS is somewhat less in the aECS than in the pECS cohort (42.4% v 53.1%, p 0.048); yet, the frequency with which a positive ECS is associated with high-grade endocervical disease in final pathology after excisional treatment is equivalent (28.5% of pECS v 28.6% of aECS, p 0.987), regardless of patient age, parity, immunosuppression, menopausal status, or prior treatment.

CONCLUSION:

A positive ECS result at time of colposcopy is predictive of endocervical disease whether ASCCP preferred or ASCCP acceptable ECS was performed, thus suggesting the value of universal ECS at time of colposcopy.
The Performance of Endometrial Biopsy and Transvaginal Sonogram in Endometrial Polyp Diagnosis [12Q]
Authors: Doulaveris Georgios , Chen Alice , Christou Georgios , Escobar Pamela , Dar Pe'er , Rotenberg Ohad
Published: May 2019

INTRODUCTION:

To assess and compare the performance of endometrial biopsy (EMB) and transvaginal ultrasound (TVS) in endometrial polyp detection in postmenopausal women.

METHODS:

Retrospective study of 1808 women, aged 55 and older, who underwent EMB between 1/1997 and 12/2008. Data was collected until 2015 for long term surveillance. We assessed EMB and TVS utilization and performance in diagnosis of endometrial polyps. A cutoff of ≥5 mm was used for “thickened endometrial echo (EE).”

RESULTS:

1808 women underwent EMB in the study period and 676/1808 (37.4%) had final diagnosis by surgery. 195/676 (28.8%) had polyp as final diagnosis and 98/195 (50.3%) cases had concurrent TVS assessment. In 23/195 (11.8%) EMB failed to obtain tissue compared to 1/98 (1.0%) of concurrent TVS that failed to visualize the EE adequately (p=0.001). Endometrial polyp histology was diagnosed in 17/195 (8.7%) of EMB and 12/98 (12.2%) of TVS. Thick EE was diagnosed in 84/98 (85.7%) of TVS. EMB had a sensitivity of 8.7%, specificity of 96.7%, NPV of 72.3% and PPV of 51.5% in diagnosis of polyps. TVS had a sensitivity of 12.2%, specificity of 92.9%, NPV of 64.8% and PPV of 50% in diagnosis of polyps. Thick EE seen in TVS had significantly higher sensitivity (85.7% vs 8.7%, p<0.0001) but lower specificity (28.2% vs 96.7%, p<0.0001) than EMB for polyp detection.

CONCLUSION:

Both EMB and TVS had similarly high specificity, but very low sensitivity for polyp diagnosis. The high sensitivity of TVS endometrial thickening may be essential in polyp detection.
Patterns of Magnesium Sulfate Administration in Women With Preeclampsia Without Severe Features [34C]
Authors: Wang Ann A. , Hsueh Jessica , Jensen Rachel , Fullerton Angelica F. , Miller Emily Stinnett
Published: May 2019

INTRODUCTION:

In 2013, the American College of Obstetricians and Gynecologists (ACOG) guidelines changed to recommend magnesium “not be administered universally” for seizure prophylaxis in women with preeclampsia without severe features. We explored whether these guidelines were associated with a change in magnesium prescribing, and whether patient characteristics predicted ongoing magnesium use.

METHODS:

This retrospective cohort study included all women diagnosed with preeclampsia without severe features from 2013 to 2018 at a single academic center. Women were excluded if they received magnesium for fetal neuroprotection. Maternal data were abstracted from the electronic medical record. The primary outcome was initiation of magnesium. Non-parametric tests of trend, bivariable analyses, and multivariable analyses were performed to identify whether magnesium use was associated with time or maternal characteristics.

RESULTS:

Of the 338 patients who met inclusion criteria, 126 (37.3%) received magnesium. The proportion of patients given magnesium declined over time, from 73.8% in 2013 to 10.5% in 2018 (P<0.001). Women receiving magnesium were younger, were more likely to self-identify as a racial/ethnic minority, had higher peak blood pressures, and had higher preeclampsia laboratory values. Women diagnosed with chorioamnionitis were less likely to receive magnesium. After adjusting for confounders, maternal age, Hispanic ethnicity, and chorioamnionitis remained significantly associated with magnesium administration.

CONCLUSION:

Obstetricians adjusted prescribing behavior over time in accordance with the 2013 ACOG guidelines change. Providers were more likely to give magnesium to younger women and Hispanic women, and less likely to women with chorioamnionitis. These differences may be related to perceived risk of eclampsia and postpartum hemorrhage.
Seeking Help: Trends in Emergency Department Visits Among Women With Postpartum Mental Disorders [18D]
Authors: Batchelor Jourdin , Baker Regina , Giuliani Emma , Townsel Courtney , Marsh Erica
Published: May 2019

INTRODUCTION:

Postpartum mental disorders (PPMD) are associated with adverse outcomes including impaired breastfeeding and maternal-child bonding. For many, the emergency department (ED) is a healthcare entry point, but factors surrounding these visits are unknown.

METHODS:

This was a retrospective cross-sectional analysis using the Nationwide Emergency Department Sample, (Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality) to assess national estimates of ED visits of women aged ≥years with a primary diagnosis of PPMD (ICD-9 codes 648.42 or 648.44) between 2006 and 2014. Variables included demographic and hospital characteristics. SAS 9.4 (Cary, NC) was used to perform all analyses.

RESULTS:

PPMD related ED visits remained stable between 2006 and 2014 (5,153 to 5,453 respectively). Approximately 2/3 of visits were by patients <30 years old. Total and mean ED charges per visit increased from $6.5 to 13.4 million and from $1,255 to 2,460 respectively (P<.0001). In 2014, the largest proportion of ED visits were in the South (37.5%) and in metropolitan areas (86.8%). Although 28.1% of visits were by women from the lowest zip code income quartile, over half of visits were funded by Medicaid (52.9%). Admission rates were approximately double those of age-matched women with all other primary diagnoses (29.7% vs 15.0%).

CONCLUSION:

Despite a stable number of visits, ED charges for PPMD increased from 2006 to 2014, indicating a growing economic and social burden. High admission rates represent an opportunity for optimization of outpatient screening and treatment. The high proportion of Medicaid funded visits suggest a policy opportunity for PPMD stakeholders.
The Effect of Antenatal Corticosteroids on Survival in Extreme Prematurity [22D]
Authors: Sivaram Mollie , Nguyen Julie , Barrett Jon FR. , Ladhani Noor Niyar N.
Published: May 2019

INTRODUCTION:

The decision to administer antenatal corticosteroids (ACS) to women who in preterm labor prior to 25 weeks remains controversial. Recent studies suggest reduction in morbidity and mortality with administration of ACS prior to 25 weeks. Our primary objective was to evaluate the effect of ACS on survival in extreme prematurity. Our secondary objective was to assess the effect of ACS on morbidities such as respiratory distress syndrome (RDS), chronic lung disease (CLD), intraventricular hemorrhage (IVH), and necrotizing enterocolitis (NEC).

METHODS:

A retrospective chart review was conducted on patients who delivered between gestational ages (GA) of 23-25 weeks at a large tertiary academic center between Jan 1st 2003 and Dec 31st 2017. Multiple gestation pregnancies, terminations, and patients who declined neonatal resuscitation were excluded. Logistic regression was used to assess the effect of ACS treatment on neonatal mortality and morbidity, while controlling for maternal age, GA, and maternal complications.

RESULTS:

A total of 407 singleton births met criteria, with 394 (96.8%) mothers receiving at least one dose of ACS and 13 (3.2%) receiving no ACS. Neonatal mortality was significantly lower for infants exposed to a full course of ACS (OR=0.30, 95% CI=0.09-0.99). Administration of ACS did not show any significant effect on morbidity, but did show a reduction in IVH (OR=0.63, 95% CI=0.15-2.64), increase odds of CLD (OR=1.51, 95% CI=0.43-5.30), and NEC (OR=1.14, 95% CI=0.22-5.93).

CONCLUSION:

Treatment with ACS for infants born at 23 to 25 weeks gestation was associated with a lower rate of neonatal mortality. No significant effect on morbidity was demonstrated.
The Home Team: How an Academic Practice Used Innovation Principles to Create a Novel Prenatal Model [24D]
Authors: Graseck Anna S. , Vasquez Peter J. , Power Maggie , Labora Amanda , Mahraj Katy
Published: May 2019

INTRODUCTION:

The laborist model of obstetric care has benefits to patient safety and provider lifestyle, but requires a large group of providers to sustain. Our academic practice of 16 providers observed a disparity in patient satisfaction scores between obstetric and gynecologic patients, even for the same provider. Contextual inquiry attributed this finding to a lack of continuity for obstetric patients. Partnering with the Center for Healthcare Innovation, we designed and tested a novel team-based prenatal care model. Our hypothesis was that this would increase continuity and satisfaction for both patients and providers.

METHODS:

We utilized the “double diamond” methodology characterized by two rounds of divergent and convergent thinking. We first defined the problem by shadowing and interviewing stakeholders. Next, we prototyped, tested, and iterated multiple interventions, ultimately creating a team-based prenatal care model. Our pilot team consisted of two obstetricians and a nurse midwife who managed a panel of patients. We monitored the program with Press-Ganey data as well as a 5-question survey of patients and providers evaluating continuity and satisfaction.

RESULTS:

The “Home Team” enrolled 284 patients over 9 months. Both providers and patients in the pilot were more likely than non-participants to agree that they experienced continuity and rapport in prenatal care. Press-Ganey data (n=327) showed that pilot participants were more likely to recommend the practice (76.2% vs. 69.6%).

CONCLUSION:

Innovation principles provide an effective framework for problem-solving in healthcare. Using innovation techniques, our academic practice successfully piloted and implemented a team-based prenatal care model that improved patient and provider satisfaction.
Microbial Analysis of Peritoneal Fluid as a Screening Tool for Epithelial Ovarian Cancer [28D]
Authors: Gibson Kaitlin , Pratt Katelyn Nicole , Zhu Ruoqing , Cregger Melissa , Brard Laurent , Braundmeier-Fleming Andrea
Published: May 2019

INTRODUCTION:

Epithelial ovarian cancer (OC) is typically diagnosed at advanced stages and accounts for more deaths than any other gynecological cancer. Early detection of OC may improve prognosis. Microbial profiling has identified various diseases and may be utilized to detect OC. We hypothesize that patients with OC have a unique microbial profile, which in conjunction with biomarkers Cancer Antigen-125 (CA-125) and Human Epididymis protein 4 (HE4), would enable a novel screening mechanism to effectively detect OC.

METHODS:

Inclusion: Consented patients ≥30 yrs presenting at SIU Gynecologic/Oncology for management of an adnexal mass or suspected OC. Exclusion: patients with a previous malignancy, pregnant/intending to conceive. CA-125/HE4 were analyzed in serum and peritoneal fluid (PF). Extracted DNA from PF was sequenced (V4 region of bacterial 16S rRNA gene), then identified using Greengenes database and clustered into operational taxonomical units (OTUs). Microbial profile associations with CA-125/HE4 in serum and PF were calculated utilizing machine learning models for biomarker discovery.

RESULTS:

CA-125 and HE4 levels were elevated in serum and PF from patients with OC. Patients with OC also exhibited microbial profile clustering. Machine learning models identified 37 microbial features correlative with OC. Overall, performance of biological features (age, BMI, serum [CA-125/HE4], PF [CA-125/HE4], OTUs [taxa]), indicated that serum [CA-125/HE4]+age/BMI had the highest (0.96) accuracy for OC detection. Interestingly, OTUs [family/genus level+age/BMI] (0.87) outperformed PF [CA-125/HE4+age/BMI] (0.78).

CONCLUSION:

Microbial feature analysis may improve OC screening modalities and warrants further investigations into the urogenital and/or gastrointestinal microbiome profiles to improve detection/survival rates for OC.
Perinatal Outcomes of Gestational Impaired Glucose Tolerance Without Diagnosis of Gestational Diabetes [21E]
Authors: Enakpene Christopher A. , Jones Tiffany N. , Della Torre Micaela , Knazze Lauren R. , Jin Ming , DiGiovanni Laura M.
Published: May 2019

INTRODUCTION:

HAPO study showed continuous associations of maternal glucose levels with increased birth weight and cord C-peptide levels. This study aimed to compare perinatal outcomes of women with GIGT and those with normal 1-hour GCT.

METHODS:

Retrospective cohort study of pregnant women with GIGT and randomly selected women with normal 1-hour GCT at the University of Illinois at Chicago from January 2015 to April 2018. Primary outcome was LGA and secondary outcomes were preeclampsia, primary cesarean section, 3rd or 4th degree perineal lacerations, shoulder dystocia, NICU admission and composite neonatal outcomes. Chi square with Yates correlation, student-t test, and multiple regression analysis were used to compare the outcome variables.

RESULTS:

There were 615 subjects in the study; 366 had GIGT and 249 had normal 1-hour GCT. Mean age, maternal weight and BMI were significantly higher in the GIGT group. The primary outcome, LGA was significantly higher in the GIGT group, 27 (7.4%) versus 4 (1.6%), OR: 4.8 (1.7-14.0, p=.002). Birth weight was significantly higher in the GIGT group; 3278.7±571 versus 3099±546, p=.002 and it increased by 89 gm for every 1 mg/dL increase in 1-hour GCT, p=.013 in dose-response manner. After controlling for covariates, the likelihood of LGA was significantly greater in the GIGT group, OR: 5.1, (95% CI: 1.43-18.03, p=.012).

CONCLUSION:

GIGT is associated with increased likelihood of LGA and increased birth weight in a dose-response manner, but it did not significantly affect the overall perinatal outcomes.
Postpartum Care for Mothers of Preterm Infants Requiring Intensive Care: A Qualitative Study [26E]
Authors: Chen Melissa Joy , Kair Laura , Schwarz Eleanor Bimla , Creinin Mitchell D. , Chang Judy
Published: May 2019

INTRODUCTION:

Postpartum care can be fragmented, especially among women with premature infants in the Neonatal Intensive Care Unit (NICU). We aimed to explore women's goals for and experiences with postpartum care.

METHODS:

We conducted a qualitative study using semi-structured interviews to ask women between 2 and 8 weeks after delivery of preterm infants in the NICU about their preferred topics of discussion at the postpartum visit and experiences with postpartum care. We analyzed transcripts using thematic analysis. IRB approval obtained.

RESULTS:

We enrolled 16 mothers who delivered between 25 and 34 weeks gestation (11 by Cesarean). At interview time (14-55 days postpartum), 4 women had attended a postpartum visit, 2 had missed their visit, and 10 had an upcoming appointment scheduled. Reasons for not attending a visit included distance of clinic from NICU, a desire to focus on their infant's health, and insurance changes. Participants identified several topics of importance for postpartum visits: assessing physical recovery after delivery (e.g., incision care, management of ongoing medical conditions), lactation support, and implications of preterm delivery for future pregnancies. One theme women described was feeling traumatized by the delivery or NICU experience and expressing concern about postpartum depression or anxiety. Participants suggested scheduling a visit soon after delivery (e.g., within 3 weeks postpartum) to assess mood.

CONCLUSION:

Women with premature infants requiring NICU hospitalization are at risk for delayed or inadequate postpartum care given concern for their infants' health. Arranging short-term follow-up after delivery allows clinicians to perform early assessments and offer anticipatory guidance for postpartum depression.
Should Endometrial Biopsy be Used for Diagnosing Polyps? [33E]
Authors: Bastow Brittney , Conageski Christine , Huguelet Patricia
Published: May 2019

INTRODUCTION:

Abnormal uterine bleeding (AUB) accounts for more than 70% of visits to gynecologists. American College of Obstetricians and Gynecologists (ACOG) recommends endometrial sampling for women above age 45. This is done in clinic with an endometrial biopsy. One known limitation of the biopsy is limited sampling as only 4% of the cavity is sampled. Past studies demonstrate limitations in using endometrial biopsy to diagnose polyps, with biopsy missing 15/16 polyps. Our study sought to evaluate when the biopsy diagnoses a polyp. Is the specificity sufficient to proceed to the operating room, or are there other imaging or patient characteristics that can guide management?

METHODS:

This was a retrospective cohort study that identified patients with AUB who underwent endometrial biopsy and a confirmatory procedure of hysteroscopy or hysterectomy at the University of Colorado Hospital from 2005-2010. Patients were identified as having an endometrial biopsy, hysterectomy, or hysteroscopy with CPT codes, and ICD9 codes were used to eliminate women without AUB.

RESULTS:

A total of 216 charts were reviewed with mean age of 44 and BMI of 30.49 kg/m^2. The specificity of using endometrial biopsy to diagnose polyps was 87.2%, and we confirmed poor sensitivity at 30%. Vaginal ultrasound had a higher specificity at 94%. Logistic regression analyses will be utilized to identify patient factors, patient bleeding profile, and procedures to determine how best to triage patients for operative management of endometrial polyps.

CONCLUSION:

Endometrial biopsy should not be the only factor in determining a patient's need for operative management of AUB associated with polyps.
Concurrent Cervical and Vulvar Dysplasia and/or Cancer—High Likelihood in the Immunocompromised [38E]
Authors: Meinhardt Summer Sanford , Grubman Jessica , Nambiar Anjali , Lea Jayanthi
Published: May 2019

INTRODUCTION:

Dysplastic lesions of the vulva and cervix have similar risk factors; however, the incidence of cervical dysplasia is 10 times that of vulvar dysplasia suggesting HPV induced transformation of the vulvar epithelium occurs less often than cervical epithelium. This implies there are novel factors required for the progression of vulvar dysplasia. The aim of this study was to evaluate clinicopathologic characteristics that predispose women to concurrent cervical and vulvar dysplasia and/or cancer.

METHODS:

We performed a retrospective review of 780 women from January 2010 to October 2013 with cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ (AIS) and/or invasive cancer on excisional biopsy. Twenty-four developed concurrent vulvar dysplasia and/or cancer. Clinical variables were studied and SPSS software calculated the odds ratio (OR) for binary dependent variables.

RESULTS:

The rate of concurrent disease was 3%. Approximately 78% of patients with isolated cervical pathology were HPV+ compared to 100% of those with concurrent vulvar disease. There was no statistical difference in the use of tobacco, alcohol, illicit drugs or OCPs, hypertension, hyperlipidemia, diabetes or depression between study groups. Immunocompromised patients with: chronic steroid or immunosuppressant use, AIDS/HIV, a prior transplant, or non-gynecologic malignant processes revealed an OR 20.1521 (95% CI 11.3341-51.8172) and P value <0.0001 collectively. Those with HIV/AIDS had an OR 17.4458 (95% CI 8.7290-41.6923) and a P value <0.0001.

CONCLUSION:

Immunocompromised patients have a higher likelihood of developing concurrent cervical and vulvar dysplasia and/or cancer. This underscores the significance of a complete examination of the lower genital tract in the immunocompromised.