bluuebunny/crossref_metadata_2025_split huggingface dataset:
Does Introduction of Normal Saline Tip the Electrolyte Balance in Preeclampsia? [33I]
Authors: Yule Casey S. , Ambia Anne M. , Duryea Elaine L. , McIntire Donald D. , Nelson David B. 
Published: May 2019

INTRODUCTION:
Due to a nationwide shortage of Ringer's lactate, normal saline became the intravenous fluid of choice at our institution in 5/2018. Recent studies have raised concern on safety of administration of normal saline in critically ill patients. We sought to evaluate the impact of normal saline on the outcomes of women with preeclampsia receiving magnesium sulfate.

METHODS:
Prospective observational study of women with preeclampsia with severe features receiving normal saline. The amount of normal saline administered was calculated and a basic metabolic panel was surveyed approximately 12 hours after initiation of magnesium sulfate prophylaxis. Laboratory analytes were examined according to the amount of intravenous fluid received.

RESULTS:
From 5/2018 to 7/2018, a total of 124 patients were identified. The mean intravenous fluid volume received was 1.84 ± 0.9 L. Serum creatinine and chloride levels remained unchanged over time and across quartiles of amount of fluid received (p=0.322 and p=0.822, respectively). Incidentally, a significant relationship was found between calcium levels and both the amount of normal saline received (p=0.0003) and concurrent magnesium levels (p<.0001). When testing for interaction between calcium, magnesium, and normal saline, both of the latter contributed to an increased risk of hypocalcemia.

CONCLUSION:
There does not appear to be a significant consequence to either chloride levels or renal function when utilizing normal saline in women with preeclampsia receiving magnesium sulfate. Coincidentally, calcium levels significantly declined as the amount of intravenous fluid increased, which given the association with magnesium levels is suspected to be a function of magnesium sulfate exposure.
Does Universal Cervical Length Screening Impact Cerclage Practice Patterns? [36I]
Authors: Griffin Myah Maria-Nelson , Hogg James Preston , Stephenson Courtney D. , Temming Lorene Atkins , Pollack Rebecca Epstein 
Published: May 2019

INTRODUCTION:
We sought to evaluate the impact of universal cervical length screening (UCLS) on the placement rate of history-indicated (HIC), ultrasound (USIC)-indicated, & physical exam (PEIC)-indicated cerclages.

METHODS:
A retrospective cohort study compared women with a CL of <3 cm on US between 16 and 20 weeks for 2 years before and after implementation of UCLS at a single institution from April 2013 to April 2017. Multivariable logistic regression was used to evaluate the changes in the rate of overall cerclage placement and types of cerclages along with impact on preterm birth (PTB) rates.

RESULTS:
4350 were evaluated in the pre-screening period and 3959 in the post-screening period. Detection rate of short cervix was increased after implementation of screening, but rates of cerclage placement were similar (P=0.11). Among 67 patients with cerclages, demographics (race, BMI, prior PTB, CL, tobacco use) were similar. There was decrease in HIC placement post implementation (RR 0.6 95% CI 0.4-0.9) and a non-significant trend toward an increased placement rate of USIC (RR 1.9 95% CI 0.9-3.9). The rate of PE-indicated cerclages was similar. Among women with cerclage, there were no differences in PTB before and after screening implementation.

CONCLUSION:
Cerclage placement rate was unchanged with UCLS. Rates of USIC and PEIC were unchanged, while the rate of HIC was significantly decreased. This was likely related to increased reliance on US screening. While this may have increased utilization of ultrasound, this change in practice pattern did not impact rates of PTB.
Safety of AG200-15, an Investigational Transdermal Patch, in Three Phase 3 Studies [1J]
Authors: Nelson Anita L. , Kaunitz Andrew M. , Kroll Robin , Simon James A. , Castano Paula M. , Garner Elizabeth I. O. 
Published: May 2019

INTRODUCTION:
AG200-15 (Twirla®) is an investigational transdermal contraceptive delivery system (TCDS), which delivers daily exposure of approximately 120 µg of levonorgestrel and 30 μg of ethinyl estradiol. We report the safety from three Phase 3 studies - the SECURE (ATI-CL23) study, ATI-CL12, and ATI-CL-13.

METHODS:
SECURE was a single-arm, 13-cycle, open-label study conducted in 2014-2016. ATI-CL12 (13-cycles) and ATI-CL13 (6-cycles) were conducted in 2010-2011 and were open-label, randomized, active-controlled (an approved oral contraceptive (OC)) safety and efficacy studies. Subjects reported all treatment emergent adverse events (TEAEs) and serious adverse events (SAEs). TEAEs were defined as adverse events with an onset date on or after the first patch application through Day 28 of the subject's final treatment cycle. The results reported represent combined safety data.

RESULTS:
For AG200-15 in all studies combined, 54% of 3,481 subjects had at least one TEAE, 26% had at least one study drug-related TEAE, 5% had TEAEs of severe intensity, and 11% had TEAEs resulting in study drug discontinuation. Fewer than 2 percent of subjects (n=56) had SAEs, and 0.5% (n=18) had study drug-related SAEs. The SAEs occurring in >2 subjects were cholelithiasis (n=4), deep vein thrombosis (3), pulmonary embolism (3), and depression (3). No deaths were reported. The most common TEAEs (≥-2%) included nasopharyngitis (5.7%), upper respiratory tract infection (4.5%), nausea (4.3%), headache (3.6%), and urinary tract infections (3.5%).

CONCLUSION:
The percentages of TEAEs and SAEs were generally similar across the Phase 3 studies. The adverse event profile of AG200-15 appears to be similar to approved OCs.
A Novel Skin Closure Device for Minimally Invasive Surgery: Patient and Provider Assessments [2J]
Authors: Mihalov Linda S. , Berenson Ronald 
Published: May 2019

INTRODUCTION:
Patient and surgeon experience with a novel skin closure device combining microstaples with adhesive film for multiport laparoscopic surgery (general, urologic or gynecologic) evaluated.

METHODS:
Case cohort prospective observation study, 18 patients served as their own controls. Each surgeon closed at least one incision with their standard suture and at least one with the device. Day 0, surgeons rated ease of use and speed of application of the device and sutures. POD 10 and 30, patients rated comfort of the incisions, comfort of device removal, wound appearance, surgeons rated wound appearance.

RESULTS:
Surgeons rated the device as much (28%) or somewhat better (56%) than suture for ease of use, much (44%) or somewhat (34%) better for wound closure speed. On day 30, surgeons rated appearance of device-closed wounds as much (36%) or somewhat (57%) better than suture, none rated appearance as worse than sutured wounds. On day 30, patients rated device-closed incision comfort as much (19%) or somewhat (38%) better, comfort of removal of the device as much (18%) or somewhat (29%) better, and overall appearance as much (58%) or somewhat (33%) better than the sutured incisions. Nine percent of patients rated the appearance of the wounds as the same, and none rated the device-closed incisions as worse than sutured on any measure.

CONCLUSION:
Laparoscopic skin incision closure speed and ease and patient comfort and wound appearance can still be improved. This novel device incorporates the strength of staples with adhesive film and was highly acceptable to both surgeons and patients.
Safety of AG200-15, an Investigational Transdermal Patch, in Three Phase 3 Studies [1J]
Authors: Nelson Anita L. , Kaunitz Andrew M. , Kroll Robin , Simon James A. , Castano Paula M. , Garner Elizabeth I. O. 
Published: May 2019

INTRODUCTION:
AG200-15 (Twirla®) is an investigational transdermal contraceptive delivery system (TCDS), which delivers daily exposure of approximately 120 µg of levonorgestrel and 30Î1/4 g of ethinyl estradiol. We report the safety from three Phase 3 studies - the SECURE (ATI-CL23) study, ATI-CL12, and ATI-CL-13.

METHODS:
SECURE was a single-arm, 13-cycle, open-label study conducted in 2014-2016. ATI-CL12 (13-cycles) and ATI-CL13 (6-cycles) were conducted in 2010-2011 and were open-label, randomized, active-controlled (an approved oral contraceptive (OC)) safety and efficacy studies. Subjects reported all treatment emergent adverse events (TEAEs) and serious adverse events (SAEs). TEAEs were defined as adverse events with an onset date on or after the first patch application through Day 28 of the subject's final treatment cycle. The results reported represent combined safety data.

RESULTS:
For AG200-15 in all studies combined, 54% of 3,481 subjects had at least one TEAE, 26% had at least one study drug-related TEAE, 5% had TEAEs of severe intensity, and 11% had TEAEs resulting in study drug discontinuation. Fewer than 2 percent of subjects (n=56) had SAEs, and 0.5% (n=18) had study drug-related SAEs. The SAEs occurring in >2 subjects were cholelithiasis (n=4), deep vein thrombosis (3), pulmonary embolism (3), and depression (3). No deaths were reported. The most common TEAEs (≥-2%) included nasopharyngitis (5.7%), upper respiratory tract infection (4.5%), nausea (4.3%), headache (3.6%), and urinary tract infections (3.5%).

CONCLUSION:
The percentages of TEAEs and SAEs were generally similar across the Phase 3 studies. The adverse event profile of AG200-15 appears to be similar to approved OCs.
Early Postpartum Perineal Repair or C-Section Suture Removal Reduces Pain Without Wound Complications [7J]
Authors: Chan Anthony K. 
Published: May 2019

INTRODUCTION:
To describe postpartum sutures or staples related pain resolution and wound healing in patients with perineal repair or C-section who underwent early sutures or staples removal.

METHODS:
All patients in an outpatient obstetric clinic who delivered between June 1, 2016 to June 30, 2017 and received sutures or staples in wound closure were invited to participate in this prospective observational study of early sutures or staples removal by day four to seven postpartum. Pain scores were recorded for activities of standing, walking, and sitting from a preset scale of zero to five before and after sutures or staples removal. With six weeks postpartum visit, wound healing was evaluated. Pictures were taken from those who consented.

RESULTS:
A total of 68 participants were included in this prospective observational study. 52 participants underwent vaginal deliveries with perineal repair and 16 participants underwent C-sections prior to inclusion of this study. When pain scores were three or above, there was reduction of pain scores of two or more. Excellent wound healing was observed at six-week postpartum visits.

CONCLUSION:
Early sutures or staples removal in postpartum patients reduced pain without compromising wound healing. This suggests the utility of early sutures or staples removal in postpartum patients can reduce analgesic use and improve quality of life.
Elagolix Treatment in Women With Uterine Fibroids: Secondary, 6-Month, Phase 3 Efficacy Results [11J]
Authors: Bradley Linda D. , Feinberg Eve C. , Liu Ran , Owens Charlotte D. , Rodriguez-Ginorio Henry , Simon James A. 
Published: May 2019

INTRODUCTION:
Objective was to evaluate the effect of elagolix with add-back, as compared with placebo, on menstrual blood loss (MBL), suppression of bleeding, and hemoglobin concentration in women with heavy menstrual bleeding (HMB, >80mL/cycle MBL) associated with uterine fibroids (UF).

METHODS:
These were two replicate, investigational, double-blind, randomized, placebo-controlled, 6-month (M), phase 3 studies (Elaris UF-1/Elaris UF-2) where patients were randomized 1:1:2 to placebo, elagolix 300mg twice daily (BID) alone and elagolix 300mg BID in combination with 1mg estradiol (E2)/0.5 mg norethindrone acetate (NETA) once daily add-back. Patients were premenopausal, 18-51 year-old women. Secondary efficacy endpoints included change from baseline in MBL volume at M1, M3, M6 and Final Month, suppression of bleeding (no bleeding days, spotting allowed) at Final Month, and M6 hematological improvement. Endometrial biopsies were performed at baseline and M6. IRB approval obtained.

RESULTS:
In Elaris UF-1, 412 women were randomized/treated and 328 completed treatment. For Elaris UF-1, elagolix+E2/NETA reduced MBL volume from baseline at M1, M3, M6 and Final Month (Final Month mean [SE] MBL change from baseline: elagolix+E2/NETA=-176.7 mL [10.4], P<0.001; placebo=0.8 [14.9]). A greater percentage of elagolix+E2/NETA-treated women had suppression of bleeding at Final Month compared with placebo (elagolix+E2/NETA=56.8%, P<0.001; placebo=4.4%). The percentage of women with a baseline ≤10.5 g/dL and increase from baseline >2 g/dL at M6 in hemoglobin concentration was significantly greater for elagolix+E2/NETA compared with placebo (elagolix+E2/NETA=61.5%, P<0.001; placebo=16.1%). There was no endometrial hyperplasia or malignancy among elagolix-treated women. Elaris UF-2 results were similar.

CONCLUSION:
Elagolix+E2/NETA treatment met all ranked secondary endpoints including reduced MBL volume, suppression of bleeding, and increased hematologic parameters in women with HMB associated with UF.
Elagolix Versus Laparoscopic Surgery for Treatment of Pain Due to Endometriosis: A Cost-Effectiveness Analysis [12J]
Authors: Movilla Peter 
Published: May 2019

INTRODUCTION:
The objective was to assess the cost-effectiveness Elagolix versus laparoscopic conservative surgery as the primary treatment of moderate to severe pain due to endometriosis.

METHODS:
A Markov model was developed comparing primary treatment with Elagolix to primary laparoscopic conservative surgery for patients with moderate to severe pain due to endometriosis. Clinical and surgical data were obtained from published literature. Medical costs were obtained utilizing contemporary charges for standard treatments. The medical and financial outcomes were evaluated from time of patient presentation with moderate to severe pain, until time of patient death. A sensitivity analysis was performed to evaluate the significance of various medical and financial parameters designated within the model on disease specific outcomes. Main outcome was measured in quality-adjusted life years (QALYs) and costs from a national healthcare perspective.

RESULTS:
Laparoscopic conservative surgery was a strongly dominant treatment strategy when compared to Elagolix for the purpose of primary treatment for moderate to severe pain from endometriosis based on our Monte-Carlo microsimulation cost-effectiveness analysis. A second order probabilistic sensitivity analysis demonstrated that laparoscopic conservative surgery for endometriosis is cost-effective when compared to Elagolix for primary treatment of moderate to severe pain from endometriosis, with a willingness to pay threshold of $410.35 per QALY over all ranges of varying utilities and costs utilized.

CONCLUSION:
From a national healthcare perspective, laparoscopic conservative surgery for endometriosis is more cost-effective than Elagolix for the primary treatment of moderate to severe pain from endometriosis that has been refractory to standard medical care.
Impact of Elagolix on Quality of Life Among Endometriosis Patients: A Pooled Analysis of 2 Phase III Clinical Trials [13J]
Authors: Taylor Hugh S. , Soliman Ahmed M. , Palac Hannah , Surrey Eric S. 
Published: May 2019

INTRODUCTION:
Endometriosis-associated symptoms are associated with reduction in health-related quality of life (HRQL). This analysis evaluated the impact of Elagolix, an oral gonadotrophin releasing-hormone antagonist, on the HRQL of women with moderate to severe pain associated with endometriosis.

METHODS:
Data were pooled from two phase III randomized, placebo-controlled trials of elagolix (150mg once daily “Elagolix QD” or 200 mg twice daily “Elagolix BID”) in premenopausal women with moderate-to-severe endometriosis-associated pain. The Endometriosis Health profile (EHP-30), HRQL questionnaire was administered at baseline and months 1, 3 and 6 of treatment. Changes in the 5 core scales (pain, control and powerlessness, social support, emotional well-being, and self-image) and sexual intercourse modular scale scores of EHP-30 from baseline to month 3 and 6 were compared between each Elagolix dose and placebo using ANCOVA models that controlled for baseline scores.

RESULTS:
Final sample included 1686 patients. Both doses of elagolix exhibited a significantly greater reduction in all 6 scale scores than placebo (lower scores indicate better HRQL) at Month 3 in a dose-dependent fashion (pain: -18.49, -26.79, -35.59; control and powerlessness:-24.86, -32.81, -42.28; emotional well-being:-13.67, -17.75, -21.15; social support: -12.54, -18.0, -24.14; self-image:-11.16, -16.54, -21.08 and sexual intercourse: -13.54, -17.22 and -25.85 for placebo, Elagolix QD and Elagolix BID respectively; P <0.05 for all Elagolix group comparisons to placebo). Larger reductions were also observed for Elagolix groups at month 6 which were statistically significant for all scales except for self-image and sexual intercourse.

CONCLUSION:
Elagolix significantly improves HRQL among women with moderate to severe pain associated with endometriosis.
Intrauterine Device Perforation and Adhesion Formation [14J]
Authors: Narayanamoorthy Sujatha , Christensen Ashley Rachelle , Apostol Radu 
Published: May 2019

INTRODUCTION:
The intrauterine device (IUD) is one of the most popular methods of contraception used globally. There are 2 classes of IUDs available worldwide: metal containing and levonorgestrel releasing. Limited data exists on complications associated with IUD. However, to date there is no data available on the risk of adhesion formation and associated morbidities, if a perforation occurs with metal containing versus levonorgestrel releasing IUD. The primary purpose of this systematic review was to compare the potential for adhesion formation between metal containing and levonorgestrel releasing IUD.

METHODS:
A PubMed electronic search with key words and subject heading “intrauterine device” and “perforation” was performed. Patient demographics, class of IUD, site of adhesion formation and the description of these adhesions were tabulated. The adhesions were classified into 3 groups: Group I, II and III based on the degree of the adhesions (dense/severe to filmy). The degree of intra-peritoneal adhesion formation and the class of IUD was analyzed.

RESULTS:
Seventy five articles describing 85 cases were included in the study. Metal containing devices were found to have a statistically higher number of dense adhesions compared to levonorgestrel releasing IUD (P=.000056). The sigmoid colon (22%) was found to be the most common site of adhesions formation following perforation of IUD. Laparotomy was performed in 59% of cases in which a metal containing IUD had perforated.

CONCLUSION:
The degree of intra peritoneal adhesions following IUD perforation depends on whether the IUD is metal containing. Further studies are warranted to establish the significance of this in patient selection criteria.
Novel Use of Viable Cryopreserved Umbilical Tissue in Posterior Colporrhaphy in High Risk Patients [16J]
Authors: Karon Magdalene , Trimpe Darcy M. 
Published: May 2019

INTRODUCTION:
Rectocele is a common finding in parous women. While mild to moderate cases are asymptomatic, once a rectocele becomes symptomatic it carries a high risk of recurrence following surgical correction. The prolonged and inefficient healing in this region may be due to the constant bacterial exposure and pressure from straining. This risk is increased in patients who are smokers, diabetic, or immune compromised. An ideal adjunct would promote endogenous regeneration of the tissue defect, minimize inflammatory scar tissue formation, have antimicrobial factors, growth factors, and improve neovascularization. We present a novel use of viable cryopreserved umbilical tissue (vCUT) in posterior colporrhaphy. vCUT is a human tissue allograft regulated by the FDA under 21 CFR part 1271 part 361 human cells, tissue and cellular/tissue based products. It can be utilized for acute and chronic wounds of various etiologies at any location in the body.

METHODS:
Ten patients were followed for up to a year following posterior colporrhaphy with vCUT incorporated into the closure.

RESULTS:
Our data showed patient satisfaction with healing. Patient satisfaction included post-operative complaints, such as pain, discharge, and symptomatic relief of rectocele symptoms. Physical examination showed minimal symptomatic granulation tissue that caused bleeding or discharge. There were no break downs of sutures or infection complications requiring antibiotics.

CONCLUSION:
vCUT is a commercially available product that shows promise in improving rectocele healing. Our small study showed no recurrence for up to a year post surgery and no complications to date have been reported that are attributed to the use of vCUT.
Predictors of Chronic Opioid Use Among Women With Endometriosis [18J]
Authors: Chiuve Stephanie E. , Kilpatrick Ryan D. , Petruski-Ivleva Natalia , Wegrzyn Lani R. , Snabes Michael C. , Bateman Brian T. 
Published: May 2019

INTRODUCTION:
Women with endometriosis are prescribed opioids for pain relief but may have other risk factors for chronic opioid use. The identification of predictors of chronic use in this population may provide clinical guidance for treatment selection.

METHODS:
Women with an initial claim for endometriosis (N=39,513) aged 18-50 years were identified from a US commercial insurance claims database and followed for 2 years. Chronic opioid use was defined as ≥10 fills or ≥120 days covered in 365 days. Multivariable logistic regression models were used to identify potential predictors of chronic opioid use.

RESULTS:
Over 2 years, 4.4% of women with endometriosis became chronic opioid users. Risk factors for chronic use included fibromyalgia (OR 1.54; 95% CI 1.12-2.10), back pain (OR 1.42; 95% CI 1.15-1.75), migraines (OR 1.39; 95% CI 1.07-1.81), tobacco use (OR 1.56; 95% CI 1.22-2.00), antidepressants (OR 1.69; 95% CI 1.39-2.05), antipsychotics (OR 2.03; 95% CI 1.41-2.91), benzodiazepine (OR 1.57; 95% CI 1.27-1.94) and prior use of opioids (OR 4.83; 95% CI 4.02-5.81). These characteristics were more frequent in women with than without endometriosis: fibromyalgia (4% vs 2%), back pain (14% vs 8%), migraines (6% vs 2%), tobacco use (4% vs 2%), antidepressants (19% vs 13%), antipsychotics (2% vs 1%), benzodiazepine (11% vs 5%) and prior use of opioids (34% vs 13%) (p<0.01).

CONCLUSION:
Women with endometriosis who are exposed to opioids and are at high-risk for chronic opioid use may be identified based on comorbidities and concomitant medication use. Opioid prescribing should be carefully considered among high-risk women.