bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effects of TX-001HR in Women With Menopause [19J]
Authors: Kagan Risa , Constantine Ginger , Graham Shelli , Bernick Brian , Mirkin Sebastian 
Published: May 2019

INTRODUCTION:
In the REPLENISH trial, women with ≥50 moderate to severe hot flushes (HF)/week (VMS substudy [efficacy population; consistent with FDA guidance]) treated with TX-001HR (17β-estradiol [E2]/progesterone [P4]) had significant improvements in HF frequency and severity compared with placebo at weeks 4 and 12. This post hoc analysis evaluated HFs with TX-001HR in women with <50 moderate to severe HF/week.

METHODS:
REPLENISH (NCT01942668) was a phase 3, randomized-controlled trial of postmenopausal women (40–65 years; intact uterus). Women not in the VMS substudy (with <50 moderate to severe HF/week) were randomized 1:1:1:1 to daily E2/P4 (mg/mg) of 1/100 (n=275), 0.5/100 (n=273), 0.5/50 (n=274), 0.25/50 (n=269). Changes and percent changes from baseline in frequency and severity of HF at weeks 4 and 12 were determined.

RESULTS:
The mean number was 24.4–27.6 HF/week and mean severity score was 2.28–2.36 (ie, moderate to severe) at baseline. Women treated with E2/P4 doses had improvements from baseline in frequency of 11.8–16.2 HFs at week 4 and 16.6–19.5 HFs at week 12, corresponding to percent changes of 48%–66% and 67%–80%, respectively. Improvements from baseline in severity were 0.64–0.88 points at week 4 and 0.97–1.37 points at week 12, corresponding to percent changes of 28%–38% and 43%–60%, respectively.

CONCLUSION:
The magnitude of improvements in frequency and severity observed with TX-001HR in women with <50 HF/week was similar to the significant improvements observed in women with ≥50 HF/week for frequency (67%–75%) and severity (30%–44%) at week 12. The benefits of TX-001HR may extend to women who have less frequent HF.
Sustained Improvements in Anemia and Fatigue of AUB after a Single Course of Ferumoxytol: 6-Month Follow-up [20J]
Authors: Dahl Naomi V. , Moore Anne , Jiang John , Strauss William E. 
Published: May 2019

INTRODUCTION:
Iron deficiency anemia (IDA) associated with abnormal uterine bleeding (AUB) negatively impacts patients' health-related quality of life (HRQOL). A Phase 3 double-blind, placebo-controlled trial (NCT01114139) previously found that patients unsuccessfully treated with oral iron had very poor baseline HRQOL scores associated with fatigue, and that IV iron treatment resulted in significant, clinically meaningful improvement. This subgroup analysis reports the impact of a single course of IV iron in women with AUB during the following 6-month extension study (NCT01114217).

METHODS:
Patients with persistent or recurrent IDA (Hgb <11.0 g/dL and TSAT <20%) at any time during the extension study received ferumoxytol (2x510 mg IV, 3 to 8 days apart). Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue), and Linear Analogue Scale Assessment (LASA) -Energy, -Activities of Daily Living (ADL) and -HRQOL were administered at each monthly visit. The study was IRB-approved.

RESULTS:
Most patients in the extension study did not require further doses, including 56% (119/212) of those with AUB. At Baseline of the double-blind trial (Hgb 9.0±0.9 g/dL) their FACIT-Fatigue scores were lower (23.6±11.85) than general (non-anemic) US population norms (40.1-43.6), and comparable to scores of anemic cancer patients receiving chemotherapy (23.9). By Week 5 FACIT-Fatigue increased significantly (37.4±10.84), and was sustained over 6 months (Month 7 score 40.7±11.53, Hgb 11.9±1.23). Significant improvements in all the LASA domains were also maintained.

CONCLUSION:
This study found that for the majority of patients, significant improvements in fatigue and quality of life domains were achieved and sustained for 6 months following a single treatment of ferumoxytol.
Brexanolone Injection Administration to Lactating Women: Breast Milk Allopregnanolone Levels [30J]
Authors: Hoffmann Ethan , Wald Jeffrey , Dray Danielle , Colquhoun Helen 
Published: May 2019

INTRODUCTION:
Brexanolone injection (BRX), an investigational, intravenous formulation of the GABAA receptor positive allosteric modulator allopregnanolone is in development for postpartum depression (PPD) pharmacotherapy. Allopregnanolone levels were evaluated in breast milk and plasma from healthy lactating women administered BRX.

METHODS:
IRB approval was obtained. Informed consent was required for enrollment. Subjects (n=12) received a 60-hour inpatient BRX infusion (titration to 90 µg/kg/h followed by a taper phase) and were followed through Day 7 as outpatients. Breast milk and plasma allopregnanolone were quantified using liquid chromatography-mass spectrometry (limits of quantitation: milk = 5 ng/mL, plasma = 1 ng/mL). Subjects pumped breast milk as needed. All breast milk was collected. PopPK model structures were considered to account for milk sample frequency and the lack of strict alignment between pumping and plasma collection. The most parsimonious model was used to describe milk concentrations as the product of a constant partition coefficient and plasma allopregnanolone concentration. Modeling accounted for milk and plasma values below the limit of quantitation.

RESULTS:
The model characterized milk and plasma data well; allopregnanolone concentrations increased during titration and declined during taper for plasma and milk, in parallel. Milk concentrations were 1.36 times higher than plasma. Modeling predicts that 95% of patients with 90 µg/kg/h dosing will have milk allopregnanolone levels <10 ng/mL 36 hours after treatment cessation. The calculated relative infant dose (RID) was 1.3%.

CONCLUSION:
Following BRX dosing, PopPK modeling characterized allopregnanolone concentrations in milk and plasma and suggests that the RID for BRX is associated with low risk to breastfed infants.
Clinical Experience for Noninvasive Prenatal Screen in Assisted Reproductive Technology Pregnancies [34J]
Authors: Hancock Susan , Ben-Shachar Rotem , Adusei Christa , Haverty Carrie , Goldberg Jim 
Published: May 2019

INTRODUCTION:
Describe clinical performance of a whole genome sequencing-based noninvasive prenatal screen (NIPS) in pregnancies achieved via assisted reproductive technology (ART).

METHODS:
After securing IRB-exempt status, we retrospectively analyzed results from 58,105 patients who underwent NIPS during a nine-month period to assess clinical performance of Trisomy 21, 18, and 13 in singleton pregnancies. Four percent (2,435 pregnancies) reported being conceived via ART. Fetal fraction (FF) was measured for all patients but was not used as a stand-alone reason for test failure. We sought pregnancy outcomes for all patients who screened positive and for 10% of those who screened negative. Voluntarily reported outcomes were also accepted. Concordance of results was determined with respect to pregnancy outcome. Clinical sensitivities and specificities were calculated, adjusting cohort size for ascertainment bias.

RESULTS:
The total patient cohort included average-risk (43%, n=24,751) and high-risk patients (57%, n=33,354). For the ART population, median maternal age was 36 years and median gestational age was 12.0 weeks. The screen yielded a result for 99.7% of ART patients; no result was issued for the remaining 0.3% of samples (n=7). Screen positive rate was 0.7%. Informative outcomes were received for 50% of positive results in the ART cohort; nine true positives and one false positive. Observed sensitivities for Trisomy 21 and Trisomy 18 were 100% and 100%, respectively, in ART pregnancies. No patients screened positive for Trisomy 13. No false negatives were reported.

CONCLUSION:
Results demonstrate that NIPS in our laboratory achieves high accuracy while maintaining a low test-failure rate in pregnancies conceived via ART.
Effect of Smoking History on Inpatient Postpartum Opioid Use [2K]
Authors: Blitz Matthew J. , Prasannan Lakha , Greenberg Meir , Marchbein Harvey , Rochelson Burton L. 
Published: May 2019

INTRODUCTION:
To determine if inpatient postpartum opioid utilization is affected by smoking history.

METHODS:
Retrospective cohort of singleton deliveries at ≥37 weeks of gestation in which smoking status was documented on admission at a tertiary hospital from 2013-2016. Patients were excluded for NSAID or opioid allergies, drug abuse history, positive urine toxicology, general anesthesia for delivery, and incomplete records. Outcomes evaluated were mode of delivery, medications administered for postpartum analgesia, and total doses received.

RESULTS:
A total of 17,280 pregnancies were included: 83 current, 890 former and 16,307 non-smokers. The cesarean delivery rate was higher among current or former smokers compared to non-smokers (45.9% vs. 34.3%, P<0.0001). After cesarean delivery, current or former smokers were more likely to receive oxycodone (82.3% vs. 75.8%, P<0.002), to have it administered at higher total amounts (98 vs. 84 grams, P<0.001), and to exceed the 90th percentile for consumption (12.5% vs. 8.3%, P<0.009). After vaginal delivery, current or former smokers were also more likely to receive oxycodone (41.8% vs. 31.3%, P<0.0001), to have it administered at higher total amounts (54 vs. 42 grams, P<0.0001), and to exceed the 90th percentile for consumption (15.9% vs. 9.2%, P<0.003). There was no difference in the rate of additional breakthrough opioid medications based on smoking history.

CONCLUSION:
Women who are current or former smokers are more likely to receive oxycodone for postpartum analgesia compared to non-smokers, and at increased amounts. A precision medicine approach using personalized treatment algorithms may improve pain management in this population.
Effects of Methadone and Buprenorphine Use During Pregnancy on Neonatal and Maternal Outcomes [4K]
Authors: Moustafa Ahmed S. Z. , Kumar Navin , Masten Megan , Bruder Adrienne , Rocha Frederico , Adekola Henry 
Published: May 2019

INTRODUCTION:
The opioid epidemic in continues to be a major public health concern. Opioid use during pregnancy increases risks of adverse neonatal and maternal outcomes, including neonatal abstinence syndrome (NAS). Methadone and Buprenorphine are used as maintenance therapy for opioid dependence during pregnancy. Our objective is to compare effects of Methadone and Buprenorphine on maternal and neonatal outcomes.

METHODS:
This is a retrospective cohort study that included patients with a singleton pregnancy who received opioid maintenance therapy and delivered at Hurley Medical Center from 2012 - 2017. IRB approval was obtained. Primary outcome was length of neonatal stay. Demographic characteristics, illicit drug use, and tobacco smoking were among variables analyzed in the Methadone and Buprenorphine groups.

RESULTS:
The study included 228 participants. 47 were on Buprenorphine and 181 on Methadone. Of the neonates, 71% required treatment for NAS. The median length of treatment in days was significantly less in Buprenorphine group (p= 0.001; 10 vs 16), along with median length of stay (p= 0.000001; 12 vs 20). There was no association between Buprenorphine dose and NAS treatment. In the Methadone group, the median dose increased with the level of treatment (p=0.004). After correcting for potential confounders, we noted that gestational age, dose of methadone, and illicit drug use, were associated with higher risk of requiring NAS treatment.

CONCLUSION:
Neonates exposed to Buprenorphine had significantly lower rates of NAS and shorter NICU stay compared to Methadone. Gestational age at delivery, Methadone dose, and illicit drug use seem to be associated with increased NAS treatment.
Establishing a Lower Cutoff Value for Early Gestational Diabetes Screening [6K]
Authors: Loehr Frederick W. , Mackeen Awathif D. , Paglia Michael J. , Nordberg Cara 
Published: May 2019

INTRODUCTION:
Women who are not diagnosed with gestational diabetes mellitus (GDM) on early screening prior to 20 weeks go on to complete routine screening at 24-28 weeks. The aim of this study was to establish a low cutoff value for the early one-hour, 50-g glucose test (Glucola) under which no subsequent testing would be necessary.

METHODS:
This was an IRB-approved retrospective cohort study whereby electronic medical records in the Geisinger system between 1/1/2010 and 12/31/2016 were searched for all women who had an early Glucola and completed all subsequent indicated testing for GDM. For women with a result on the early Glucola less than 130 mg/dL, the risk of developing GDM for a given value was examined to identify a level below which further testing for GDM in the pregnancy may not be necessary. The primary outcome was percentage of women diagnosed with GDM at any point in the pregnancy for a given result on the early Glucola.

RESULTS:
There were 3040 women identified as having completed an early Glucola and 2405 women had a result less than 130 mg/dL. 174 of these women were subsequently diagnosed with GDM at some point in the pregnancy. The negative predictive value (NPV) for not developing GDM was greater than 90% for any one-hour glucose result less than 130 mg/dl. A result less than 114 mg/dL was shown to have a 95% NPV for not developing GDM.

CONCLUSION:
Forgoing routine screening in women with an early one-hour Glucola result below 114 mg/dL may be a viable option.
Healthcare Resource Utilization and Costs Among Young Children of Women With Postpartum Depression (PPD) [4O]
Authors: Huang Ming-Yi , Packnett Elizabeth , Zimmerman Nicole M. , Moynihan Meghan , Eldar-Lissai Adi , Simas Tiffany Moore 
Published: May 2019

INTRODUCTION:
A retrospective cohort analysis was conducted using claims-based data from IBM MarketScan® Research Databases to assess healthcare resource utilization and costs (HRUC) in children of mothers with presence or absence of postpartum depression (PPD).

METHODS:
Women with live births from January 1, 2010 to September 30, 2015 (index date=delivery date) were identified and linked to their newborns. The mother-child pairs were divided into PPD and non-PPD cohorts based on medical and pharmacy claims for depression, mood or adjustment disorders, or anxiety identified in the mother between 15 to 365 days after delivery. Children were required to have 24 months of continuous enrollment following delivery. Propensity score matching (1:3) was used to adjust for underlying differences in the PPD and non-PPD cohorts.

RESULTS:
135,678 matched mother-child pairs (PPD: 33,314; non-PPD: 102,364), were analyzed. In the first 24 months of life, children of mothers with PPD had significantly higher healthcare resource utilization across most service categories compared to those without PPD. Among outpatient services, the percentage of children with a physician specialist service, early-intervention screening, and an emergency room visit were 3-7% greater in children of mothers with PPD (p<0.001). In the first 24 months of life, children of mothers with PPD incurred a 12% higher total healthcare costs compared to children of mothers without PPD ($24,572 versus $21,946; p<0.001).

CONCLUSION:
In children of mothers with claims-based evidence of PPD in the first postpartum year, healthcare resource utilization and costs in the first 24 months of life exceeded that of children of mothers without evidence of PPD.
Is the Shirodkar a Better Technique for Ultrasound Indicated Cerclages? [9O]
Authors: McColm Jordan , Lindsay Kathryn , Brooks Jennifer , Hwang Joseph , Ta-Chung Lee Gene 
Published: May 2019

INTRODUCTION:
Studies comparing the Shirodkar vs McDonald technique for an ultrasound indicated cerclage are limited, but suggest improved outcomes with Shirodkar. We sought to compare our real-world experiences using either technique with reported outcomes from clinical trials. We specifically compared these 2 techniques in the context of a ultrasound indicated cerclage for short cervix.

METHODS:
A retrospective study at 2 hospitals was conducted. IRB approval was obtained. A query for patients with a short cervix (<25 mm) diagnosed by TVUS before 24w0d was conducted. (KUMC between 1/1/2008 - 6/1/2016, and VMC-UW Medicine between 1/2016 - 5/2018). Patients who underwent an ultrasound-indicated cerclage were then analyzed and grouped by surgical technique. Primary outcome was length of time from cerclage until delivery (days). Data was analyzed by T-tests.

RESULTS:
A total of 51 patients were analyzed. There were demographic and clinical differences between the groups. The Shirodkar group was white and Asian, and did not include Hispanic or African American ethnicity. The gestational age at diagnosis was later (154 vs 139 days), and the TVCL was longer (11.4 vs 7.7 mm). The Shirodkar group had better outcomes. The length of time from cerclage until delivery was longer (109 vs 90 days), the gestational age at delivery was older (263 vs 228 days), and the newborn birthweight was larger (2990 vs 2155 gm).

CONCLUSION:
The Shirodkar group had better outcomes, but they also appeared to be a fundamentally lower risk pregnancy. The benefit of Shirodkar technique remains unclear. Analysis by multiple regression is pending.
Patient Perceptions of Medications That Reduce the Risk of Preterm Delivery and Preeclampsia [12O]
Authors: Bradley Danielle , Cobb Christina , Landau Erin , Wolfberg Adam 
Published: May 2019

INTRODUCTION:
The objective of this study was to understand patient perceptions of the safety and efficacy of medications (progesterone and low-dose aspirin) for the purpose of avoiding a preterm delivery and preeclampsia.

METHODS:
A survey about perceptions of progesterone and a survey about low-dose aspirin use and safety during pregnancy were sent to users of a pregnancy mobile app. Respondents were age 18 or older and pregnant.

RESULTS:
Among respondents who were not prescribed progesterone (n=4,421), but indicated a history of preterm delivery (n=115, 3%) or a short cervix (n=20, 0.05%), barriers cited for obtaining a progesterone prescription were disbelief in the efficacy of the medication, concerns about cost, and discomfort discussing with their provider. Prior to reading information about progesterone efficacy, 35% agreed that progesterone can help prevent preterm delivery, compared to 60% agreement after reading the information. The results of the low-dose aspirin survey showed that 200 women (19%) agreed that taking low-dose aspirin during pregnancy was safe, while 435 women (43%) had concerns about taking it during pregnancy. When asked the extent to which they agreed that taking low-dose aspirin during pregnancy can reduce the risk of delivering preterm and developing preeclampsia, 10% and 13% agreed, respectively. Nearly half (48%) reported that they would take a medication recommended by their provider without hesitation.

CONCLUSION:
Patients are skeptical of the efficacy and safety of low-dose aspirin and progesterone during pregnancy. Results indicate that more can be done to educate patients about medications that have demonstrably shown to reduce risk of obstetric complications.
PLGF Predicts Latency to Delivery for Patients Undergoing Evaluation for Hypertension [14O]
Authors: Martinez-King Lorena Carolina , Adami Rebecca Recker , Roeder Hilary Alpert , Ballas Jerasimos , Woelkers Douglas Andrew , Laurent Louise 
Published: May 2019

INTRODUCTION:
Preeclampsia (PE) is a pregnancy-specific syndrome of vascular dysfunction characterized by hypertension and end-organ injury. The traditional evaluation of PE requires time-consuming assessment of nonspecific findings which can lead to prolonged, and possibly unnecessary, hospitalization. Placental growth factor (PLGF) has shown promise as a novel biomarker for PE. We hypothesize that levels of PLGF will correlate with latency to delivery and that PLGF levels will differ between women who received a short (0-8 hours) triage evaluation and those who received a long (>8 hours) evaluation or were admitted to the hospital.

METHODS:
Women undergoing evaluation for signs or symptoms of PE at UCSD OB Triage who were between 20 0/7-37 0/7 weeks gestation were prospectively recruited. Maternal plasma was collected at the time of evaluation and stored. PLGF was quantified using an ELISA assay (Alere). The pregnancy outcome diagnosis for each subject was adjudicated.

RESULTS:
132 study subjects undergoing evaluation for hypertension at UCSD between 8/2015 and 3/2018 were enrolled. Subjects with a positive PLGF were significantly more likely to have a 1 week latency to delivery (77.0% vs 37.5%; p<0.01), yielding an odds ratio of 3.2 (1.2 - 8.5); p<0.05).

CONCLUSION:
When evaluating a patient for preeclampsia, the presence of PLGF in the maternal plasma is reassuring and indicative of at least a 1 week latency to delivery. The use of PLGF to aid in decision-making may lead to decreased time spent during triage evaluation, decreased days of hospitalization, and optimal use of antenatal steroids in patients presenting for evaluation for preeclampsia.
The Effect of Prophylactic Intravascular Balloon Catheterization on Surgical Outcomes in Morbid Adherent Placenta [18O]
Authors: Abdelrahman Hisham , Babarinsa Isaac , Raughley Moune Jabre 
Published: May 2019

INTRODUCTION:
The target was to determine the effect of using internal iliac artery balloon catheterization (IIABC) in morbidly adherent placenta previa on surgical outcomes during cesarean section.

METHODS:
A retrospective comparative study was conducted from January 2013 till Oct 2016. From 67 women with morbidly adherent placenta during this time period- 33 underwent IIBAC before cesarean section (study group) and 34 underwent cesarean section without (control group). The outcomes measured were intra-operative blood loss, units of blood transfusion, loss in hemoglobin and hematocrit, total operative time, hemostatic medications and surgical procedures used, and the duration of hospital stay.

RESULTS:
The demographics were comparable, with no difference in maternal age (P=1), nationality (P=.86), BMI (P=.8), parity (P=.26), gestation (P=.31), pre-op hemoglobin (P=.736) and maternal co-morbidities like anemia (P=.7), diabetes (P=.5) and hypertension (P=.08). No significant difference was noted in the mean intra-operative blood loss (3115±1745 vs. 3447±2352, P=.515), transfusion ≥-6 units (30.3% vs. 41.17%, P=.357), duration of hospital stay (6.18±3.32 vs. 5.61±3.48, P=.495), loss in hemoglobin (2.158±1.758 vs. 1.68±1.69, P=.26) and the use of medications and surgical procedures. The use of general anesthesia was more in the study group (P=.049), with no difference in the neonatal factors.

CONCLUSION:
The use of IIABC as a means to reduce the intra-operative maternal morbidity is questionable, since the evidence proving the benefit is limited. In this case series, there were no statistical difference in the hemorrhagic outcome between women in whom it was used.