bluuebunny/crossref_metadata_2025 huggingface dataset:
Bishop Score as a Measurement Instrument [30H]
Authors: D'Souza Rohan D.
Published: May 2019

INTRODUCTION:

The aim of this study is to determine how the Bishop Score (BS) fares as a measurement tool.

METHODS:

The literature was reviewed to identify publications reporting the derivation and measurement properties of the BS. Its sensibility and reliability were assessed using 19/21 Feinstein principles and weighted kappa respectively.

RESULTS:

BS was derived with the intention of selecting multiparous women most likely to have a vaginal birth within four hours of commencing induction of labor (IOL) based on a score ≥9, and not for predicting the success of IOL. With regard to sensibility, the score performed well on 12/19 attributes encompassing domains of purpose and framework, comprehensibility and ease of usage; moderately on 1/19 attribute related to face validity and poorly on 6/19 attributes related to replicability, suitability and content validity. Areas of greatest concern included omissions of important variables known to influence the success of IOL as well as inclusion and equal weighting of five highly correlated components. Kappa values varied between 0.35 and 0.69.

CONCLUSION:

Although intended to be a discriminative index in multiparous women, BS is widely used as a prediction tool to determine the success of IOL in all women. Despite concerns regarding its derivation, sensibility and reliability, meta-analyses show that it is the best available tool to determine the success of IOL. With recent studies showing that cervical favorability is a poor determinant of the success of IOL, BS needs to be replaced by a prediction tool derived using sound statistical principles and validated in global settings.
Effect of Hypertensive Disorders of Pregnancy on Clinical Outcomes in Peripartum Cardiomyopathy [39I]
Authors: Sangtani Ajleeta , Alrahmani Layan , Parikh Pavan
Published: May 2019

INTRODUCTION:

The influence of concurrent hypertensive disorders of pregnancy (HDP) on clinical outcomes of patients with peripartum cardiomyopathy (PPCM) remains incompletely characterized, with authors describing harmful and beneficial relationships with regards to maternal mortality or requirement for cardiac transplantation.

METHODS:

Ovid Medline, EMBASE, CENTRAL and Scopus were searched for combinations of the following terminology: hypertension, preeclampsia, cardiomyopathy, peripartum, postpartum or puerperium. Eligibility criteria included all articles addressing mortality rates of PPCM with and without HDP using a combination of the European Society of Cardiology 2010 and the National Heart Lung Blood Institute 2000 diagnostic criteria. Two independent reviewers analyzed abstracts and article text to determine eligibility and risk of bias. Risk of bias was determined using the Newcastle-Ottawa scale and a Peto fixed effects model was used to combine odds ratios in a meta-analytic fashion due to the relatively rare frequency of these events.

RESULTS:

1838 articles were identified using the search strategy; 148 full text articles were reviewed for eligibility, with 10 observational studies meeting criteria. There was substantial agreement between the two raters for selection (K: 0.799) and for risk of bias (K: 0.851). An overall protective effect was identified [0.565 (95% CI 0.327, 0.974)], with a low degree of heterogeneity (I2 17.66%). No significant differences were found between subgroups-chronic hypertension, access to social medicine, high-income countries and post-diagnosis duration of care greater than 12 months.

CONCLUSION:

Although the strength of association is weak, concurrent HDP appears to be protective against mortality and need for cardiac transplantation in PPCM.
A Phase 2b, Dose-Finding Study Evaluating Oral Ibrexafungerp vs Fluconazole in Vulvovaginal Candidiasis (DOVE) [24J]
Authors: Cadet Rebecca , Tufa Mihaela , Angulo David , Nyirjesy Paul
Published: May 2019

INTRODUCTION:

Ibrexafungerp (IBX, formerly SCY-078) is a novel IV/oral antifungal currently in development for the treatment of invasive and mucocutaneous fungal infections. IBX has broad activity against Candida spp., including azole-resistant strains. A phase 2b, dose-finding study was conducted to evaluate the safety and efficacy of oral IBX in subjects with moderate to severe vulvovaginal candidiasis (VVC).

METHODS:

Randomized, double-blind, double-dummy study including 5 oral IBX treatment groups (750mg-QD 1 day, 300mg-BID 1 day, 450mg-BID 1 day, 150mg-BID for 3 days, and 300-BID for 3 days) and an active comparator (oral fluconazole [FLU] 150mg single dose). Subjects were evaluated at Day-10 and Day-25 for clinical cure and mycological eradication. Informed consent/IRB approval was obtained.

RESULTS:

153 subjects with culture-confirmed VVC composed the primary population for analysis (mITT). The IBX dose of 300mg BID for 1 day (600 mg-dose) showed the best combination of clinical efficacy and tolerability. At Day-10, clinical cure, defined as complete resolution of all signs and symptoms, was observed in 14 of 27 (52%) subjects in the IBX 600mg-dose arm and 14 of 24 (58%) subjects in the FLU arm. At Day-25, the rate of clinical cure in the IBX 600 mg-dose arm reached 70% compared to 50% in the FLU arm. At Day-10 and Day-25, the mycological eradication rates were 63% and 48% for the IBX 600mg-dose arm and 63% and 38% for the FLU arm. The most common AEs were mild nausea and diarrhea.

CONCLUSION:

These results support the selection of IBX 600mg-dose for Phase 3 registration studies in VVC.
Ibrexafungerp, a Novel Oral Antifungal, Demonstrates No Reproductive or Developmental Harm in Preclinical Models [25J]
Authors: Carruthers Christina , Barat Stephen , Angulo David , Thomas Porsha , Lewis Elise , Sobel Ryan
Published: May 2019

INTRODUCTION:

The treatment of fungal infections, like Vulvovaginal Candidiasis (VVC), during pregnancy is difficult due to the teratogenicity associated with existing anti-fungal treatment options. VVC, also known as yeast infection, is especially common during pregnancy. Fluconazole, the oral standard of care, is not approved for use in pregnancy due to safety concerns. Ibrexafungerp (formerly SCY-078) is a novel triterpenoid glucan synthase inhibitor, with proven anti-fungal activity against Candida, Aspergillus, and Pneumocystis spp. in development for the treatment of fungal infections, including VVC.

METHODS:

A full developmental and reproductive toxicity package for ibrexafungerp was recently conducted in rats and/or rabbits as required for approval and labeling of prescription medications. These preclinical studies included evaluation of the effect of ibrexafungerp on a) fertility and libido of adult males and females during treatment: b) effects on conception, implantation, and development of embryos; c) development of fetuses; d) parturition, survival, lactation; and the development of offspring from birth through sexual maturation; e) the ability of the offspring to mate and conceive a second-generation post exposure.

RESULTS:

The studies indicate that ibrexafungerp does not result in reproductive harm to adult animals nor does it result in developmental harm to offspring.

CONCLUSION:

With proven anti-fungal activity against a broad spectrum of pathogenic fungi, ibrexafungerp shows great promise in treating fungal infections. The lack of reproductive harm in these animal studies provide support for ibrexafungerp as an alternative treatment of fungal infections in women of child-bearing age.
Safety and Efficacy of Sofosbuvir/Velpatasvir for the Treatment of Hepatitis C in Reproductive Aged Women [28J]
Authors: Sperling Rhoda S. , Abramov Frida , Williams Laurie , Habibi Darya , Kushner Tatyana , Dieterich Douglas
Published: May 2019

INTRODUCTION:

Over the past decade, incident hepatitis C (HCV) infection has significantly increased among reproductive aged women nationwide mirroring the opioid epidemic. HCV infected women are at risk for chronic progressive liver disease as well as perinatal transmission. Recent (2018) liver disease and infectious disease societies (AASLD/IDSA) HCV guidelines recommend routine HCV screening during pregnancy as well as preconception treatment. The aim of this analysis was to retrospectively evaluate the use of sofosbuvir/velpatasvir (SOF/VEL), a pan-genotypic directly acting antiviral (DAA) regimen, for a 12 week treatment duration, in reproductive aged female patients.

METHODS:

Eight open-label phase 3 clinical trials evaluated the safety and efficacy of SOF/VEL for the treatment of HCV. Sustained virological response at 12 weeks (SVR 12) and treatment-emergent adverse events (TEAEs) were analyzed in female patients age 18 to 44 years.

RESULTS:

Of the 1938 patients enrolled, only 187 (10%) were female age 18 to 44. Among these patients, the SVR 12 rate was 98% (184/187). There were no patients with virologic failure. The rate of TEAEs was 63%; 2% had a grade 3 or 4 TEAE, and 2% had a serious TEAE; no serious TEAEs were treatment related. The most common adverse events that occurred in 10% of patients were headache (23%), fatigue (19%) and nausea (12%).

CONCLUSION:

Consistent with the overall results of the phase 3 clinical trials, SOF/VEL was safe and effective for treatment of HCV in reproductive-aged women. Further studies with DAAs are needed to develop appropriate public health policies to control HCV spread among this population.
Hemoglobinopathy Evaluation in Routine Carrier Testing: Results to Inform Guidelines and Protocols [5O]
Authors: Adamski Craig , Terhaar Catherine , DaRe Jeana , Fernandes Priscilla , Settler Christina , Dohany Lindsay
Published: May 2019

INTRODUCTION:

ACOG guidelines recommend red blood cell indices followed by hemoglobin electrophoresis to assess carrier status for hemoglobinopathies. However, data is limited on outcomes of these recommendations, and the role of DNA testing.

METHODS:

Our database was queried for abnormal hemoglobin evaluations from 42,166 consecutive samples of mixed ethnicities. Hemoglobin evaluation consisted of red blood indices and, high-performance liquid chromatography followed by, if necessary, hemoglobin electrophoresis. A subset (n= 2,863) also had DNA genotyping. Abnormal reports were evaluated individually, and test metrics and interpretations were tabulated.

RESULTS:

Of the 42,166 samples, 2,278 (5.4%) had abnormal hemoglobin evaluation results. Of the 2,278 abnormal results, the most common interpretation (32%) was 'possible alpha thalassemia trait', followed by 'sickle cell trait' (22%), 'possible beta thalassemia trait' (10%), 'elevated hemoglobin F' (10%), and 'hemoglobin C trait' (5%). Of the 2,863 samples that had genotyping, 146 (5.1%) had abnormal molecular results. Genotyping confirmed 100% (5/5) of samples with abnormal hemoglobin evaluation indicating 'consistent with alpha thalassemia trait' and 41% (17/41) indicating 'possible alpha thalassemia trait'. Sixteen percent (14/89) of samples with abnormal molecular results, and normal hemoglobin evaluation for alpha thalassemia, were silent alpha thalassemia carriers.

CONCLUSION:

Our study estimates a 5% positivity rate for hemoglobin evaluation. However, some results are non-specific and require molecular follow up. Forty-one percent of hemoglobin evaluation results interpreted as 'possible alpha thalassemia trait' were confirmed as genetic carriers. Concurrent DNA testing provides information and results more quickly to patients, and better identifies those patients truly at risk to be carriers of alpha thalassemia.
Racial Disparities in Preterm Birth: Does a History of Preterm Birth Level the Playing Field? [15O]
Authors: Fonge Yaneve , Sciscione Anthony C. ,   On behalf of the EQUATE Consortium
Published: May 2019

INTRODUCTION:

Studies have shown that African-American (AA) women have a 50% higher rate of spontaneous preterm birth (sPTB) than white women. We sought to determine if the racial disparities seen in sPTB in the general population persist in women with prior sPTB.

METHODS:

This is a secondary analysis of the EQUATE trial, a prospective study evaluating the utility of quantitative fFN in assessing the risk of sPTB in asymptomatic at risk women. We looked at asymptomatic women with prior sPTB and sonographic cervical length >25mm at 16-22 weeks. Exclusion criteria included multiple gestations, prior cervical surgery, age <18, contraindications to fFN collection, congenital fetal anomalies, and congenital uterine malformations. Racial groups were determined by self-identification. Logistic regression analysis and linear models were used to compare racial groups on rates of sPTB, gestational age, birth weight, NICU admission, NICU length of stay, and a composite neonatal score.

RESULTS:

776 women were eligible for our study. 350 identified as AA and 426 as White. The groups had similar parity, tobacco, alcohol, or illicit drug use. AA women were younger (p=<0.001) and had more total pregnancies (p=0.002), term deliveries (p=<0.001), and prior sPTB (p=0.004). There was no difference in overall sPTB rates between AA and White women with prior sPTB (34% vs 30%, respectively; p=0.240) or in neonatal outcomes. However, AA women had more deliveries <32 weeks (p=0.006). AA women were more likely to have LBW babies (p=0.002).

CONCLUSION:

These findings show that even in women who share the strongest risk factor for sPTB, racial inequalities persist.
Do You PrEP? Knowledge and Practice Among Obstetrician and Gynecologists in an Inner City Hospital [16Q]
Authors: Kole Monica , Scott Megan , Brar Indira , Sangha Roopina
Published: May 2019

INTRODUCTION:

According to the CDC, pre-exposure prophylaxis (PrEP), when taken consistently, can reduce HIV transmission via sexual intercourse by more than 90% in serodiscordant couples, and by more than 70% in intravenous drug users. The aim of this study was to assess OB/GYN providers' current level of knowledge, as well as barriers and willingness to prescribe PrEP for the prevention of HIV infection in at-risk patients.

METHODS:

An anonymous survey was administered to all senior staff and residents within the OB/GYN department at Henry Ford Hospital and its affiliates with IRB approval.

RESULTS:

Of the 56 surveys administered, there were 28 responses. Of the 28, 50% were senior staff and 50% were residents. While 68% of providers had heard of PrEP, only 3% had prescribed it, even though 78% of providers considered their patient population to be at-risk for HIV infection. As many as 71% of providers reported they did not feel comfortable with the current research on safety and efficacy of PrEP and 35% were unsure if PrEP could be continued in a pregnant patient.

CONCLUSION:

The majority of OB/GYN providers at the studied hospital are not comfortable with prescribing PrEP or managing patients taking PrEP. This seems to stem from lack of knowledge of PrEP. Information from the survey will be utilized to create a targeted curriculum to improve provider ease with prescribing PrEP in concordance with the CDC guidelines and to improve provider competence and patient health.
Obstetric Hospitalists: Impact on the Vaginal Birth After Cesarean Delivery Rate [24Q]
Authors: Boardman Lori A. , Zeinomar Maryam , Hale Valerie
Published: May 2019

INTRODUCTION:

Florida continues to have one of the lowest VBAC rates in the U.S. In 2016, an obstetric hospitalist program was launched with the goals of improving safety, quality and cost. The purpose of this study was to evaluate the VBAC rate and assess adverse maternal and neonatal outcomes before and after program implementation.

METHODS:

This is a before-after retrospective cohort study at a non-academic tertiary care hospital located in Central Florida. In March 2016, AdventHealth for Women-Orlando instituted a full-time obstetric hospitalist program. For the primary outcome, pregnant women with a history of prior cesarean managed before the hospitalist program (2015) were compared to those managed after full program deployment (2017). Secondary outcomes included the cesarean delivery rate, maternal and neonatal outcomes.

RESULTS:

Between 2015 and 2017, the VBAC rate rose from 5.4% to 13.5% (OR 2.8 95% CI 1.8-4.1). Hospitalists had significantly higher rates than non-hospitalists (27.5% vs 7.3%; OR 4.8 95% CI 3.3-7.2). The cesarean delivery rate decreased from 43.7% to 38.4% (OR .80 95% CI .72-.89). For VBAC patients, uterine rupture was rare (0.8% in 2017); for failed trials of labor, the rupture rate was not significantly different (4.0% vs 4.8%; OR 1.2 95% CI .03-19.5). No unplanned hysterectomies occurred in either group. Neonatal ICU admissions for VBAC patients trended upward from 15.6% to 18.3% (OR 1.2 95% CI .42-3.5); in failed TOLACs, admissions declined (52.8% to 36.8%, OR .51 95% CI .26-1.04).

CONCLUSION:

The addition of obstetric hospitalists led to significant improvement in both VBAC and cesarean delivery rates, while maintaining patient safety goals.
Induction of Labor Versus Expectant Management in Patients With Non-anomalous Idiopathic Polyhydramnios [16E]
Authors: Backley Sami , Orr Lauren , Knee Alexander , Schoen Corina
Published: May 2019

INTRODUCTION:

Polyhydramnios is associated with increased risk of stillbirth at term, but is historically associated with higher risk of cesarean section. The objective was to determine if induction of labor at 38-39 weeks gestation reduces the risk of cesarean compared to expectant management for women with polyhydramnios at term.

METHODS:

This was a single center, retrospective cohort study of singleton, vertex patients with a diagnosis of polyhydramnios at 38 weeks gestation between July 2014 and March 2018. IRB approval obtained. Women with planned induction at 38 0/7 to 39 6/7 weeks were compared to those expectantly managed. Patients with placental or uterine pathology, significant fetal anomaly, and women undergoing an induction of labor for a medical indication (e.g. diabetes, chronic hypertension) were excluded. Induction time period spanned from 38 0/7 to 39 6/7 weeks. The primary outcome was cesarean section.

RESULTS:

168 singleton non-anomalous idiopathic polyhydramnios pregnancies met the inclusion criteria. 97 were induced and 71 were expectantly managed. Cesarean delivery was reduced for women induced compared to those expectantly managed (18.8% vs 35.7%, p=0.015). There were no differences in maternal or neonatal secondary outcomes. There was one case of cord prolapse and one cesarean hysterectomy in the induction group. One case of stillbirth was diagnosed in the expectant group which placental pathology revealed multiple chorangiomas and cardiomegaly on fetopsy.

CONCLUSION:

Induction of labor is associated with reduced risk of cesarean section in non-anomalous polyhydramnios compared to expectant management. Given the increased risk of stillbirth, induction is preferred over expectant management.
Patient Reported Outcomes on the Use of Virtual Reality for Pain Management in Labor [17E]
Authors: Wong Melissa Spring , Gregory Kimberly D.
Published: May 2019

INTRODUCTION:

Virtual reality (VR) has been shown to be effective in reducing both chronic and procedural pain among patients. The objective of this pilot study is to characterize patient reported outcomes regarding the use of VR in labor and delivery (L&D).

METHODS:

A descriptive study within an RCT of VR for reduction of pain during labor. Patients were included if they were nulliparous, term, contracting every 5 minutes with a pain score of 4-7. Patients were excluded if they had received pharmacologic pain management. All patients underwent a pre-survey with a quantitative assessment: NIH PROMIS Global Health Survey and Childbirth Self-Efficacy Inventory (CBSEI). All used VR for up to 30 minutes then completed a Quantitative survey and a Qualitative guided interview.

RESULTS:

10 subjects have received the VR intervention. All subjects reported good health with average PROMIS Global Physical and Mental Health scores in the 51st percentile. Mean adjusted CBSEI scores for the group were 94.57, corresponding to lower than average self-efficacy. Following the intervention, the patient's perceived degree to which VR would improve their CBSEI was high, with respondents scoring an adjusted 118.7. Qualitative interviews revealed that patients found the experience relaxing and increased control and focus on birth and the baby. 57% believed VR reduced their pain. 100% felt it reduced their anxiety and 100% would recommend it for laboring women.

CONCLUSION:

In this pilot study of patients' perception of the use of VR in L&D, most women experienced an increase in self-efficacy and a reduction in pain and anxiety.
Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study (TAPPAS): A Randomized Trial [22E]
Authors: Kremer Mallory , Cortez Cynthia
Published: May 2019

INTRODUCTION:

Intravenous tranexamic acid (TXA) is routinely used in orthopedic and cardiac surgery to reduce blood loss. There is growing evidence supporting off-label use in obstetrical hemorrhage, yet no prior studies have investigated TXA for deliveries complicated by placenta previa and/or accreta.

METHODS:

This was a single site, randomized, placebo-controlled, double blind pilot study from 11/2016 to 7/2018. Eligible participants were women with suspicion of morbidly adherent placenta (accreta) on imaging, or women with placenta previa and two or more cesareans (CS). Subjects were randomized to receive 1 gram of IV TXA vs placebo at cord clamping during their cesarean or cesarean hysterectomy (CH).

RESULTS:

The TXA (n=6) and placebo (n=5) groups were well matched for age, parity and number of prior cesareans. Mean gestational age was 35w0d in the TXA group and 34w2d for placebo. The TXA group had 2 CH for accreta and 4 CS for previa, while the placebo group had 4 CH and 1 CS. Mean estimated blood loss (EBL) was 3,116 cc (SD 3,947) in the TXA group and 9,420 cc (SD 12,474) in the placebo group (P>.3). The mean pRBCs units given intraoperatively was 5.2 (SD 8) in TXA group and 17.6 (SD 25) for placebo. In all study participants, no thrombotic events occurred.

CONCLUSION:

The sample size was insufficient to evaluate the primary endpoint of EBL. However, no complications attributable to giving TXA at cord clamping were encountered. Power analysis suggests n=36 in both groups would be sufficient in future studies to detect a difference in EBL.
The Impact of Resident Education on Clinical Outcomes in Vaginal Hysterectomies [3F]
Authors: Lababidi Suzanne , Winfrey Olivia K. , Shammout Fadel
Published: May 2019

INTRODUCTION:

Resident involvement in surgical procedures is a critical component of resident education. As learners train, it is important to recognize the impact this has on patient outcomes. This project aims to describe the association between resident involvement in vaginal hysterectomies and patient outcomes.

METHODS:

The National Surgical Quality Improvement Project database was used to collect data on patients who underwent a vaginal hysterectomy from 2007 and 2012. Patients with incomplete data were excluded. Logistic and linear regression models were used for analysis. Significance was set at P=.05.

RESULTS:

A total of 7,838 patients were included. Of those, 38.6% of procedures included a resident and 61.4% were performed by an attending alone. Resident participation was associated with an increase in operative by 36.5 minutes, on average (P<.001, 95% CI 34.1-39.0). Resident involvement had no effect on post-operative length of stay (P=.953, OR 0.003, 95% CI -0.79-0.84), superficial surgical site infection (SSI) (P=.395, OR 1.285, 95% CI 0.722-2.287), organ space SSI (P=.135, OR 1.425, 95% CI 0.895-2.269), wound dehiscence (P=.182, OR 3.178, 95% CI 0.582-15.362), bleeding complications requiring transfusion (P=.540, OR 1.135, 95% CI 0.755-1.709), peripheral nerve injury (P=.342, OR 2.383, 95% CI 0.398-14.269), reoperation (P=.937, OR 1.042, 95% CI 0.376-2.890), or readmission (P=.725, OR 1.128, 95% CI 0.576-2.207).

CONCLUSION:

Inclusion of residents in surgical cases was not associated with any differences in complications measured with only a minor increase in operative time. This demonstrates the minimal impact of resident education on clinical outcomes, further arguing the need to include residents in cases whenever possible.
Barriers to Prenatal Care by Race/Ethnicity in Multiparous Women [27F]
Authors: Fryer Kimberly E. , Munoz Chris , Rahangdale Lisa , Stuebe Alison M.
Published: May 2019

INTRODUCTION:

Patients who are late to prenatal care miss valuable opportunities for health interventions, and are at increased risk for pregnancy-related complications. In our study, we aimed to describe barriers to prenatal care experienced by multiparous women with an interconceptional period of less than two years by race/ethnicity.

METHODS:

After IRB approval, we performed a secondary analysis of the Community Child Health Research Network Study, a multi-site prospective cohort study of pregnant women from 2008 to 2012 recruited from Baltimore, Chicago, North Carolina, Los Angeles and Washington, D.C. Participants who experienced a repeat pregnancy in the two-year follow up period were asked if they encountered any of eight prespecified potential barriers to prenatal care. A multilevel mixed effects Poisson regression was performed to evaluate the association between race/ethnicity and number of prenatal barriers encountered.

RESULTS:

We included 298 participants in our analysis, with 151 self-identifying as African American, 72 White, and 75 Latina. The most frequent barrier was the inability to obtain an appointment. Overall, 43% of African American, 35% of Latina, 23% of White participants reported barriers to care. After adjusting for study site, maternal education, language, and maternal age, African American and Latina women reported almost twice as many barriers to prenatal care as White women (OR 1.89 [1.2, 3.0]; 2.00 [1.1,3.8], respectively).

CONCLUSION:

In our secondary data analysis of a multisite, longitudinal cohort, multiparous African American and Latina women reported encountering more barriers to obtaining prenatal care. Additional interventions are needed to address these barriers and achieve health equity.
Difference in Glycemic Profile With the Pump vs Multiple Daily Injections in Treating Type 1 Diabetes in Pregnancy [32F]
Authors: Smrz Stacy , Finneran Matthew M. , Landon Mark B. , Gabbe Steven G.
Published: May 2019

INTRODUCTION:

Previous literature suggests that patients with type 1 diabetes (T1DM) utilizing continuous subcutaneous insulin infusion (CSII) have lower hemoglobin A1c values compared to multiple daily injections (MDI). Despite improved glycemic control, rates of large for gestational age (LGA) infants are not different between these groups. This study investigates differences in glycemic profiles between CSII and MDI glucose logs.

METHODS:

Retrospective cohort study of all singleton pregnancies complicated by T1DM from 2012-2016. Patients were separated into groups by insulin delivery method. Glucose logs were reviewed for each trimester and a median glucose, interquartile range (IQR), and glycemic variability (IQR/median glucose) were calculated. Continuous data was compared using the Wilcoxon rank sum test. Spearman correlation coefficients were calculated comparing trimester specific median glucose and glycemic variability with neonatal birth weight percentile.

RESULTS:

117 patients met inclusion criteria with 37,262 fasting and post-prandial values recorded. The rate of LGA was not different between groups (CSII: 57%, MDI: 49%; p=.370) despite CSII users having both a lower early A1c (<20 weeks [6.8% vs. 8.6%; <.001]) and late A1c (>26 weeks [6.5% vs. 6.9%; p=.008]) when compared to MDI users. Median reported glucose values were similar between groups, but glycemic variability was substantially increased in CSII users. However, glycemic variability did not correlate with birthweight percentile in any trimester independent of insulin delivery method.

CONCLUSION:

Patients using CSII have lower A1c values, but significantly more glycemic variability when compared to MDI users. However, degree of glycemic variability does not correlate with neonatal birthweight percentiles.
Who Is Harmed When Labor Floors Are Busy? A Racial Disparities Analysis [27T]
Authors: Gourevitch Rebecca A. , Plough Avery , Donato Katherine , Shah Neel
Published: May 2019

INTRODUCTION:

Busyness on labor and delivery floors is associated with higher odds of interventions and adverse maternal outcomes. Other studies suggest that providers' implicit biases are activated during busy times. We test the hypothesis that the “busyness effect” is more pronounced for black women than for white women.

METHODS:

We ran race-stratified logistic regressions to estimate whether delivering at busier times was associated with higher odds of birth interventions or adverse outcomes for the mother or neonate, controlling for hospital and other factors. The data included linked birth certificate and claims data for all births at 21 hospitals in Philadelphia from 1996-2010 (n=290,169 births).

RESULTS:

Within a hospital, delivering at a busy time is associated with increased odds of interventions for both white women (OR=1.08, 95% CI (1.03,1.14)) and black women (OR=1.07, 95% CI (1.04,1.12)); however, it is only associated with increased odds of adverse maternal outcomes for black women (OR=1.06, 95% CI (1.02,1.10)), not for white women (OR=1.01, 95% CI (0.96,1.06)). Busyness is not associated with adverse outcomes for neonates. These results hold after excluding hospitals with racially homogenous patient populations.

CONCLUSION:

Busyness on labor and delivery floors is associated with increased odds of adverse maternal outcomes for black women, but not for white women, which could contribute to racial disparities in maternal outcomes. Further research is needed to better understand this association.
Dorsal Root Ganglion Stimulation for Chronic Pelvic Pain [39T]
Authors: Patel Kiran V.
Published: May 2019

INTRODUCTION:

Historically, pelvic pain has been a difficult condition to treat partially due to the complex nature of the pelvic neuroanatomy. The pelvis receives the majority of its innervation from the sacral plexus, with contributions from the lower lumbar nerve roots, and hypogastric plexus autonomic fibers. Dorsal root ganglion (DRG) stimulation at L1 and S2 (an off label indication) allows for targeted coverage of pelvic pain and referred pain commonly felt into the lower back and groin areas.

METHODS:

We report a case series of 15 patients with various etiologies of chronic pelvic pain. Percutaneous DRG leads were placed at L1 and S2. Following a 7 day trial of a temporary device, all patients elected to proceed with permanent implantation of bilateral L1 and S2 leads. NRS and modified ODI scores were followed pre-trial, trial, 3, 6, 9, 12 and 18 months post implant (where applicable).

RESULTS:

At 3 months post implant, all 15 patients reported an improvement from crippled to minimal disability and a 70-90% decrease in NRS. All patients reported improving symptoms and less interference of pain with activities of daily living. As patients were followed to 6, 9, 12, and 18 months respectively the decrease in modified ODI and NRS remained consistent or displayed further improvement. 13 out of 15 patients, were able to stop taking opioid medication following the initiation of DRG therapy for pelvic pain.

CONCLUSION:

DRG therapy may provide a reproducible, specific and effective treatment for patients with chronic pelvic pain syndromes that have previously failed conservative therapies.
Why Do You Want It Out?: Provider Perspectives on Early LARC Removal [7S]
Authors: Isley Michelle Marie , Brown Melissa , Rivlin Katherine , Keder Lisa M. , Norris Alison
Published: May 2019

INTRODUCTION:

Providers promote long-acting reversible contraception (LARC) because LARCs are highly effective at preventing pregnancy. The FDA recommends a maximum length of time for LARC use, but not a minimum. When women requesting early LARC removal perceive resistance from their providers, frustration and damaged patient-provider relationships can result. Understanding provider attitudes and practices about LARC removal is vital to patient-centered care.

METHODS:

Ten interviews were conducted with LARC providers and analyzed using qualitative techniques. LARC providers included physicians and mid-level providers in Ob/Gyn, pediatrics, and family medicine, in academic and community settings. Transcribed interviews were coded for themes and analyzed using a modified grounded theory approach. NVivo software was used for analysis.

RESULTS:

Providers defined early LARC removal as two weeks after insertion to anything prior to device expiration. Providers highlighted the importance of respecting patient autonomy when early LARC removal was requested, but many felt that patients should try LARC for a minimum amount of time to acclimate to the device or because of cost. Providers want to know why LARC removal is desired so that patient can be reassured and side effects can be treated to possibly delay or prevent removal. Many providers expressed internal conflict about early removal. They felt strongly about the benefits of LARC and disappointment or irritation with patients when LARC is removed early.

CONCLUSION:

Providers feel conflicted between their desire to promote effective birth control and patient requests for early LARC removal. Training around LARC provision and removal should include emphasis on the importance of patient-centered care.
Cost-Effectiveness of Prophylactic Tranexamic Acid Use in Women at Increased Risk of Postpartum Hemorrhage [22B]
Authors: Howard Dagnie C. , Skeith Ashley , Caughey Aaron B.
Published: May 2019

INTRODUCTION:

Postpartum hemorrhage (PPH) is a leading cause of pregnancy-related morbidity and mortality. Tranexamic acid (TXA), an antifibrinolytic agent, has been shown to reduce morbidity and mortality as a treatment for active hemorrhage. However, the incidence of postpartum hemorrhage varies widely and is heavily influenced by a number of risk factors. Our objective was to determine the rate of postpartum hemorrhage at which the use of prophylactic TXA becomes cost-effective.

METHODS:

A decision analytic model was designed using TreeAge software in order to compare the outcomes and costs of TXA use in the prevention of PPH associated morbidity and mortality. The outcomes analyzed in the model were death due to hemorrhage and need for surgical intervention to control bleeding. Probabilities, utilities, and costs were derived from the literature.

RESULTS:

A one-way sensitivity analysis was done to look at the cost-effectiveness of TXA prophylaxis based on risk of postpartum hemorrhage. TXA prophylaxis was shown to be cost effective at risks of 0.0034 or greater based on a willingness-to-pay threshold of $100,000 per QALY. Additionally, in women at high risk of PPH due to morbidly adherent placenta, prophylactic TXA administration in a theoretical cohort of 100,000 women would prevent 270 maternal deaths due to hemorrhage. This amounts to an increase in 7,332 QALYs at a cost/QALY of $458.

CONCLUSION:

Prophylactic administration of TXA is a cost-effective strategy for reducing maternal morbidity and mortality in women at increased risk of PPH.
Interpregnancy Intervals, LARC Use, and Preterm Birth: A Retrospective Cohort Study [8M]
Authors: Sanders Jessica , Simonsen Sara E. , Leiser Claire , Hanson Heidi , Lynen Richard F. , Law Amy
Published: May 2019

INTRODUCTION:

Preterm birth (PTB, defined as a live birth at <37 weeks' gestation) is a major determinant of poor neonatal outcomes. Short interpregnancy interval (IPI, defined as <18 months) is an important risk factor for PTB. A growing number of U.S. women use highly-effective, long-acting reversible contraception (LARC) to space pregnancies. In this retrospective cohort study, we examined the association between interpregnancy LARC use, IPI, and PTB.

METHODS:

Electronic medical records from two health systems were probabilistically linked to birth and fetal death records. Women with a first and second live birth (2005-2015) who received non-emergent care within 10 years of the first birth were included. Data on contraceptive encounters were abstracted using ICD-9/10 and CPT codes; birth outcome data came from state birth certificates. Multivariable regression was used for data analysis, adjusting for IPI, education, presence of father, mother's age, Hispanic ethnicity, fetal anomalies, and PTB history.

RESULTS:

Of 35767 women in the cohort, 3063 had evidence of interpregnancy LARC exposure, 901 had a non-LARC contraceptive encounter and 31803 had no record of any contraceptive-related care. Women with LARC exposure were significantly less likely to have short IPIs (p<.0001). Preterm birth occurred in 6.40% of second births (n=2288). Women with interpregnancy LARC did not have a decreased risk for PTB (1.054 adjusted OR, 0.905-1.229 95%CI) compared to women with no contraceptive encounters.

CONCLUSION:

LARC exposure is associated with a reduction in short IPIs, but LARC use between the first and second birth had no effect on preterm birth when controlling for IPI.
A Novel Device Improves Vaginal Tissue Retraction & Patient Comfort in Gynecological Exams [10M]
Authors: Warhus Damon A. , Kellogg Spencer
Published: May 2019

INTRODUCTION:

Excess vaginal tissue is present in multiparous women limiting clinician access/visualization of cervix. Clinicians often use longer/larger speculum or cut the tip of a condom/glove and position it on the speculum with limited success. A novel class-II FDA-exempt device can be used with most speculum to retract sidewalls.

METHODS:

An IRB-approved (ClinicalTrials. gov, # NCT03123367) interventional, randomized, controlled, parallel-assignment study evaluated the device (Nella VuSleeve) across two sites. 40 women were enrolled (n=20 device, n= 20 control) with BMI between 20-50 (mean 33) or with two or more vaginal births. Of the 40-patients, results for 32 with BMI ≥30 are presented, of which 15 were in device-arm, and 17 in control-arm. Control-arm used a speculum without novel device. Study-patients all signed an informed consent form.

RESULTS:

Clinicians strongly-agreed/agreed that novel device helped them in a) 100% of exams to retract patient's vaginal tissue better than if it had not been used. b) In 80% of exams to visualize and access the cervix better than if it had not been used. 100% of patients in device-arm strongly-agreed/agreed that the speculum was comfortable overall as compared to 88% in control-arm. 80% of patients in device-arm also stated that their exam was significantly-better/better than their previous exam, compared to 59% in control-arm.

CONCLUSION:

In women with elevated BMI, the new device successfully retracted vaginal sidewalls helping to improve visualization/access to the cervix. The device also helped increase patient comfort that could lead to better patient satisfaction scores (an important quality metric) and visit compliance.
Association Between History of Sexual Trauma and Unstable Housing [14M]
Authors: Leigh Jennifer , Pearson-Ayala Savannah , Rajeev Pournami , Torresan Mirella , Ades Veronica
Published: May 2019

INTRODUCTION:

Socioeconomic stress can serve as both a risk factor for or consequence of experiences of sexual violence, affecting survivors' ability to access and engage with medical care. This study examines whether survivors of sexual violence recruited in a New York City hospital setting are more likely to report socioeconomic stress than patients who have not experienced sexual violence, and which stressors survivors are most likely to report.

METHODS:

This is a secondary analysis of a cross-sectional cohort study comparing women with known sexual trauma to unexposed controls. IRB approval and patient informed consent were obtained. Participants were administered a structured interview using several questionnaires, including the traumatic life experiences questionnaire and questionnaires on economic hardship. Data were analyzed via REDCap.

RESULTS:

Of 21 women examined, 10 (48%) had experienced sexual trauma (exposed), and 11 (52%) had not (control). Difficulty finding affordable housing was reported by 7 (70%) exposed women and 3 (27%) control women (p=0.07). 9 (90%) exposed women reported having to stay with family, friends, or in a shelter compared to 1 (9%) control woman (p<0.0001). 2 (20%) exposed women and none of the control women had been evicted (p=0.14). When the three measures were examined as a composite variable of unstable housing, 9 (90%) exposed women had experienced unstable housing, while 3 (27%) control women had (p=0.04).

CONCLUSION:

The findings of this study suggest that survivors of sexual violence are more likely to have unstable housing compared to women who have not experienced sexual violence, though a larger study is needed.
A Case Series of Patient Complications Following Vaginal Laser Treatment for Atrophy [17M]
Authors: Gordon Catherine , Bell Stacie , Hauser Henry , Krychman Michael L.
Published: May 2019

INTRODUCTION:

Approximately 40-80% of postmenopausal women endure a variety of symptoms associated with genitourinary syndrome of menopause (GSM). Currently, many treatment options exist for this condition, including laser treatment. While the FDA has cleared fractional CO2 laser for a variety of indications, lasers have not to date, been approved for use for vaginal atrophy or dyspareunia. Randomized, sham-controlled clinical study data showing efficacy and safety remains sparse.

METHODS:

Two case studies referred to a tertiary sexual medicine center regarding laser treatment complications are reported.

Case 1: After completing 3 CO2 vaginal laser treatments, the 62-year-old woman was given approval for sexual intercourse. Immediately following intercourse, she reported heavy bleeding and went to the hospital. Upon examination, two vaginal wall lacerations were noted and repaired. Currently, she has a moderate amount of vaginal fibrosis and can only engage in sexual intercourse utilizing several treatment options.

Case 2: A 63-year-old woman complaining of painful intercourse following the first of 3 CO2 vaginal laser treatment which got progressively worse following the remaining two treatments. The patient reports a sharp decline in sexual life. Currently she is undergoing aggressive vaginal rehabilitation.

CONCLUSION:

While vaginal laser therapy shows promise for GSM treatment in some women, no intervention is without potential adverse events. Complications of fibrosis, scarring, and penetration injury are emerging following laser treatments. Currently, FDA approved products for GSM should be considered front line treatments for GSM and long-term, randomized, sham-controlled clinical trials should be conducted to ascertain the efficacy and safety of novel GSM treatments.
Spiking in the Second Stage: The Significance of Isolated Maternal Fever During Labor [16A]
Authors: Smith Megan , Daifotis Helen , Denoble Anna Elisabeth , Dotters-Katz Sarah Kathleen
Published: May 2019

INTRODUCTION:

ACOG recommends management of isolated maternal fever (IMF) be at the provider's discretion. However, signs of infection are difficult to interpret in the 2nd stage of labor; patients with IMF may be less likely to receive treatment for presumed infection. Our study compares postpartum maternal outcomes between women who received and did not receive antibiotics for IMF in the 2nd stage.

METHODS:

Retrospective cohort study of women experiencing IMF (38.0-38.9C) during the second stage of labor at a tertiary institution who didn't meet criteria for intraamniotic infection. Singleton and twin vaginal deliveries included. Women who received antibiotics (treated) were compared with untreated subjects. Primary outcome was maternal morbidity: postpartum infection (endometritis, perineal infection, sepsis), blood transfusion, dilation and curettage, postpartum venous thromboembolism, or hospital readmission. Data compared using bivariate statistics. Logistic regression included statistically significant variables. This study was IRB approved.

RESULTS:

Among 127 women, 84 (66.1%) received antibiotics. Demographic data, antepartum complications, timing of delivery, and delivery characteristics did not differ. Nineteen women (15.0%) had adverse maternal outcomes: 10 (11.9%) in the antibiotic group and 9 (20.9%) in the untreated group (P=0.20). Five women in each group had postpartum infections (P=0.31). Three (7.1%) untreated, and 2 (2.4%) treated women received a blood transfusion (P=0.33). Readmission was twice as common in the treated group (4.8% vs 2.3%, P=0.66). When controlling for delivery BMI, antibiotic receipt was not associated with decreased odds of adverse maternal outcomes (aOR 0.76, 95% CI 0.26, 2.23).

CONCLUSION:

Nearly 1/6 women experienced an adverse postpartum outcome after IMF in the 2nd stage of labor. Antibiotic receipt didn't protect against these outcomes.
The Uterine Fibroid Disease Burden in a Tertiary Care Setting in Ghana: Prevalence, Cost, and Policy Implications [7C]
Authors: Ofori-Dankwa Zenobia , Ibine Bolade , Ganyaglo Gabriel Y. K.
Published: May 2019

INTRODUCTION:

Over 20,000 publications examine uterine fibroids, however only few originate from West Africa. More research from this region is warranted because African-American women, many with ethnic origins to this region, are three times more likely to develop fibroids than other races in the United States.

METHODS:

This study was conducted through the Department of Obstetrics and Gynecology at Korle Bu Teaching Hospital in Accra, Ghana. It examined the prevalence, cost, and policy implications of fibroids through a retrospective chart review of all 656 women reporting from January 1, 2017 to June 30, 2017. The study divided women into two categories based on admission diagnoses: fibroid and non-fibroid.

RESULTS:

The results highlight the prevalence of fibroids given that 175 women (26.68%) were fibroid, 431 women (65.70%) were non-fibroid, 49 women (7.47%) were excluded due to ambivalent admission diagnoses, and one woman (0.15%) had no admission diagnosis. There were no significant differences within key demographics such as religion, occupation, and marital status. In addition, 78% of fibroid underwent surgical treatment compared to 64% of non-fibroid. After surgery, most women stayed 1 week (77.21% fibroid vs 77.26% non-fibroid), however within that week, 94.3% fibroid vs 50% non-fibroid stayed 4-7 days.

CONCLUSION:

These findings suggest the high disease burden of fibroids in Ghana due to the prevalence and likely increased medical cost given the amount of surgical treatment and length of stay. Policy implications to consider include further research, establishment of a robust database, and screening protocols.