bluuebunny/crossref_metadata_2025_split 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.