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Biomedical subjects

Kurt T Barnhart

Publications and source records attributed to Kurt T Barnhart.

At least 19 recordsLinked to original sources
PubMed2006

Establishing a human chorionic gonadotropin cutoff to guide methotrexate treatment of ectopic pregnancy: a systematic review.

OBJECTIVE: Successful medical management of an ectopic pregnancy is inversely associated with initial hCG level. The purpose of this publication is to assess whether there is a level of hCG above which failure rate substantially increases. DESIGN: A systematic review and summary analysis was performed, including studies reporting methotrexate treatment outcomes as stratified by various hCG ranges. SETTING: Academic medical center. PATIENT(S): Review of published information regarding patients treated with methotrexate. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Success and failure rate of medical management. RESULT(S): Five observational studies, including 503 women, were found that reported successes in using single-dose methotrexate stratified by initial hCG concentration. Failure rates increase with increasing hCG levels. A substantial and statistically significant increase in failure rates is seen when comparing patients who have initial hCG levels of >5,000 mIU/mL with those who have initial levels of <5,000 mIU/mL (odds ratio: 5.45; 95% confidence interval: 3.04, 9.78). The failure rate for women who had an initial concentration between 5,000 and 9,999 mIU/mL was significantly higher than that for those who had initial levels between 2,000 and 4,999 mIU/mL (odds ratio: 3.76; 95% confidence interval: 1.16, 12.33). CONCLUSION(S): Results support a substantial increase in failure of medical management with single-dose methotrexate when the initial hCG is above 5,000 mIU/mL. Methotrexate should be used with caution in patients with ectopic pregnancy who present with hCG levels above this level.

Chorionic Gonadotropin↗
PubMed2006

Factors influencing adverse perinatal outcomes in pregnancies achieved through use of in vitro fertilization.

OBJECTIVE: To determine the associations of specific components of IVF treatment with abnormal perinatal outcomes. DESIGN: Case-control study. SETTING: University-based and community-based infertility centers. PATIENT(S): All viable pregnancies achieved through IVF procedures performed between January 1999 and March 2004. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Infertility etiology, gonadotropin exposure, embryo manipulation, and quality. RESULT(S): Of 455 viable pregnancies identified during the study period, 435 met inclusion criteria. While adjusting for maternal age, race, parity, body mass index, infertility center, and year of IVF procedure, multiple gestations were associated with a 12-fold increased risk of poor perinatal outcome compared to singletons. Ovarian hyperstimulation syndrome significantly increased the risk more than 3-fold (odds ratio = 3.14; 95% confidence interval, 1.08-9.14), while endometrial thickness was found to have a significant protective effect (odds ratio = 0.89; 95% confidence interval, 0.80-0.99). We found no effect of etiology of infertility, dose or type of medication used for stimulation, use of embryo-manipulation techniques, or quality on perinatal outcome. CONCLUSION(S): These data confirm and quantify the risk of perinatal morbidity associated with multiple births. After adjusting for multiple births, ovarian hyperstimulation syndrome and suboptimal endometrial development are associated with adverse outcomes in pregnancies achieved through IVF. Our findings suggest that it may be the endometrium rather than the embryo that influences fetal growth and perinatal outcomes after IVF.

Adult↗
PubMed2006

Application of redefined human chorionic gonadotropin curves for the diagnosis of women at risk for ectopic pregnancy.

OBJECTIVE: To validate recently characterized curves of hCG rise and fall that are seen in viable and nonviable pregnancies in a population of women who have pregnancies of unknown location. DESIGN: Historical cohort study. SETTING: University hospital. PATIENT(S): One thousand two hundred forty-nine women with symptomatic early pregnancies. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Comparison of observed hCG values to predicted hCG values; time to diagnosis of ectopic pregnancy; accuracy of diagnosis. RESULT(S): Of the 1,249 patients included in this study, 196 had ectopic pregnancy (EP); 261, intrauterine pregnancy (IUP); and 792, spontaneous abortion (SAB). By determining the rate of change in hCG values from two consecutive visits and comparing them with a minimal rise of 35% in 2 days (the bound that is defined by the 99.9% confidence interval [CI] for the rise of hCG in an IUP) or a minimal fall of 21%-35% (the bound that is defined by the 90% CI for the fall of hCG in an SAB), we were able to make the diagnosis of EP an average of 2.5 days sooner than by standard clinical practice. Only 12% of patients had an EP go undiagnosed by using these rules, because the curve of rise or fall of their hCG mimicked that of a non-EP gestation. CONCLUSION(S): Recently redefined curves of rise and fall in hCG for IUP and SAB are valid for clinical use on the basis of our application to this large cohort of patients. Using them can shorten the time needed to make the diagnosis of EP. Use of a more conservative cutoff for minimal rise in hCG, one as slow as 35% over 2 days, to characterize a potentially viable gestation would minimize potential interruption of a desired pregnancy.

Abortion, Spontaneous↗
PubMed2006

Risk factors for ectopic pregnancy in women with symptomatic first-trimester pregnancies.

OBJECTIVE: To evaluate the association between ectopic pregnancy (EP) and clinical and historical factors among women presenting with pain and/or bleeding in early pregnancy. DESIGN: Nested case-control study. SETTING: University medical center. PATIENT(S): Women with symptomatic early pregnancies of unknown location presenting for care between January 1, 1990 and July 31, 1999. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Clinical and historical risk factors were compared between women with EP and women with ongoing intrauterine pregnancies or spontaneous abortions. RESULT(S): The following factors were associated with increased risk of EP: prior EP (odds ratio, 2.98 [95% confidence interval, 1.88-4.73] for one prior EP and 16.04 [5.39-47.72] for 2 or more), pelvic inflammatory disease history (1.5 [1.11-2.05]), pain at presentation (1.42 [1.06-1.92]), vaginal bleeding at presentation (1.42 [1.04-1.93]), and hCG of 501-2,000 mIU/mL (1.73 [1.24-2.42]). Age younger than 25 years (0.59 [0.41-0.85]) and a history of abortion were protective from EP (0.58 [0.38-0.90]). Prior nontubal pelvic surgery, past intrauterine device use, prior cesarean section, and current cervical infection demonstrated no association with EP. CONCLUSION(S): Evaluation of women with a symptomatic early pregnancy confirms and refutes some of the classical risk factors for EP. Prior EP is a strong risk factor, whereas pelvic inflammatory disease has an unexpected weak association. Previous abortion was found to have a negative association, whereas nontubal surgery, cesarean section, and a history of or concomitant cervical infection have no association. Knowledge of historical and clinical factors associated with EP may aid in early diagnosis.

Adult↗
PubMed2006

Baseline dimensions of the human vagina.

BACKGROUND: Vaginal anatomy has been poorly studied. This study aimed to measure baseline dimensions of the undistended vagina of women of reproductive age. METHODS: We combined baseline information collected from five clinical trials using magnetic resonance imaging (MRI) to quantify distribution of a vaginal gel. Seventy-seven MRI scans were performed on 28 women before gel application to establish baseline vaginal measurements. Average dimensions were calculated for each woman and for the population. The influence of potential covariates (age, height, weight and parity) on these dimensions was assessed. RESULTS: MRI measurements are reproducible. The SD surrounding the mean at each anatomical site, and with summary measurements, was significantly smaller with each subject compared with the population. Mean vaginal length from cervix to introitus was 62.7 mm. Vaginal width was largest in the proximal vagina (32.5 mm), decreased as it passed through the pelvic diaphragm (27.8 mm) and smallest at the introitus (26.2 mm). Significant positive associations were parity with vaginal fornix length, age with pelvic flexure width and the height with width at the pelvic flexure. CONCLUSION: No one description characterized the shape of the human vagina. Although there is variation among women, variables such as parity, age and height are positively associated with differences in baseline dimensions.

Adolescent↗
PubMed2006

The challenge and enjoyment of the interpretation of epidemiologic data.

The trend toward a decline in the percentage of women with infertility in the United States appears real. While the factors associated with this trend are likely many, complex, and interrelated, we cannot overlook the positive impact of those individuals who practice in the field of reproductive medicine.

Adolescent↗
PubMed2006

Effects of long-term use of nonoxynol-9 on vaginal flora.

OBJECTIVE: Products containing nonoxynol-9 have been used as spermicidal contraceptives for many years, but limited data have been published describing the long-term effects of nonoxynol-9 use on the vaginal microbial ecosystem. This longitudinal study was conducted to examine the effects of nonoxynol-9 on the vaginal ecology. METHODS: Vaginal swabs were obtained from 235 women enrolled in a randomized clinical trial before initiation of use of 1 of 5 different formulations of nonoxynol-9 for contraception, and up to 3 more samples were gathered over 7 months of use. The swab samples were evaluated in a single laboratory. The prevalence of several constituents of the normal vaginal flora was evaluated. The associations between nonoxynol-9 dosage, formulation, average product use per week, and number of sex acts per week were calculated. RESULTS: The changes in prevalence of vaginal microbes after nonoxynol-9 use were minimal for each of the different nonoxynol-9 formulations. However, when both nonoxynol-9 concentration and number of product uses are taken into account, nonoxynol-9 did have dose-dependant effects on the increased prevalence of anaerobic gram-negative rods (odds ratio [OR] 2.4, 95% confidence interval [CI] 1.1-5.3), H2O2-negative lactobacilli (OR 2.0, 95% CI 1.0-4.1), and bacterial vaginosis (OR 2.3, 95% CI 1.1-4.7). CONCLUSION: This study demonstrated that most nonoxynol-9 users experienced minimal disruptions in their vaginal ecology. There were no differences between the different formulations evaluated with respect to changes in vaginal microflora. However, independent of the nonoxynol-9 formulation, there was a dose-dependent effect with increased exposure to nonoxynol-9 on the risk of bacterial vaginosis and its associated flora. LEVEL OF EVIDENCE: II-2.

Administration, Intravaginal↗
PubMed2006

Suspected ectopic pregnancy.

Women who present with pain and bleeding in the first trimester are at risk for ectopic pregnancy, a life-threatening condition. Conditions that predispose a woman to ectopic pregnancy are damaged fallopian tubes from prior tubal surgery or previous pelvic infection, smoking, and conception using assisted reproduction. Many women without risk factors can develop an ectopic pregnancy. A diagnostic algorithm that includes the use of transvaginal ultrasonography, human chorionic gonadotropin (hCG) concentrations, and, sometimes, uterine curettage can definitively diagnose women at risk in a timely manner. The absence of an intrauterine pregnancy above an established cut point of hCG is consistent with an abnormal pregnancy but does not distinguish a miscarriage from an ectopic pregnancy. When the initial hCG value is low, serial hCG values can be used to determine whether a gestation is potentially viable or spontaneously resolving. The minimal rise in hCG for a viable pregnancy is 53% in 2 days. The minimal decline of a spontaneous abortion is 21-35% in 2 days, depending on the initial level. A rise or fall in serial hCG values that is slower than this is suggestive of an ectopic pregnancy. Women diagnosed with an unruptured ectopic pregnancy are potential candidates for medical management with methotrexate. Intramuscular injection with methotrexate can be used to safely treat an ectopic pregnancy with success rates, tubal patency rates, and future fertility that are similar to those obtained with conservative surgery. Success rates using methotrexate are inversely rated to baseline hCG values and are higher using "multidose" compared with "single-dose" regimens. Surgical treatment may be conservative or definitive and should be attempted in most cases via laparoscopy.

Abortifacient Agents, Nonsteroidal↗
PubMed2005

Defining the rise of serum HCG in viable pregnancies achieved through use of IVF.

BACKGROUND: We aimed to characterize the rate of HCG rise associated with viable IVF pregnancies, and to evaluate the association between HCG rise and potentially influential factors. METHODS: We performed a retrospective cohort analysis of all viable pregnancies achieved through IVF at two centres between January 1999 and March 2004. RESULTS: Of the 455 pregnancies resulting in live births, 391 met inclusion criteria and contributed a total of 1052 HCG values. Using random effects models, the best pattern to describe the rise of log HCG was quadratic with the rate of increase slowing at 24 days post-oocyte retrieval. Limiting the analysis to measurements below the discriminatory zone, the linear model adequately characterized the profile. The average slope was 0.403, yielding a predicted increase of 1.50 (50% increase) in 1 day and 2.24 (124%) in 2 days. In the final model, absolute HCG values, but not rate of rise, were significantly higher for twins and triplets and significantly lower for patients with BMI>30 kg/m2. CONCLUSIONS: The HCG profile of viable pregnancies conceived with IVF is quadratic with an earlier plateau than has been reported for non-IVF pregnancies. The average rate of rise is comparable to previous estimates in symptomatic spontaneous conceptions.

Biomarkers↗
PubMed2005

The optimal analysis of MRI data to quantify the distribution of a microbicide.

OBJECTIVE: The objective of this study was to systematically review the use of MRI for the evaluation of deployment characteristics of vaginal microbicides and to understand the relationship of gel spread with potential influencing factors. METHODS: Data from four clinical trials that used MRI to assess the deployment of a vaginal gel were combined. A linear mixed model best represented the spread of gel over time. Significant covariates that influence vaginal gel spread are baseline dimensions of the vagina, time from insertion, gel type, ambulation and volume of gel. RESULTS: These data demonstrate that MRI has outstanding intraperson validity and reproducibility. Therefore, paired design, using linear modeling adjusting for significant covariates, is the most efficient study design for comparison of products or volumes. Division of the vagina into two distinct anatomical regions best explains difference in gel spread, i.e., upper area (above the pelvic diaphragm) and lower area (below pelvic diaphragm). CONCLUSION: We conclude that the concept of spread from the cervix to the introits, in one dimension, is inadequate to explain spread of gel due to the complex shape of the vagina.

Adolescent↗
PubMed2005

Occupational exposures and male infertility.

The purpose of this study was to determine the association between male occupational exposures and infertility. A retrospective case-control study was performed using data collected between 1991 and 1997 at nine US clinical sites as part of a previously conducted large multicenter trial. Cases were defined as infertile males whose partner had an infertility evaluation with normal results, and controls were defined as fertile males whose partner became pregnant within 2 years. Exposures were assessed by means of self-report questionnaires. Bivariate, stratified, and multivariable analyses were performed. A total of 650 infertile cases and 698 fertile controls were compared. In the final model, a protective association with infertility was observed for occupational exposures to radiation (odds ratio=0.21, 95% confidence interval: 0.06, 0.77) and video display terminals (odds ratio=0.30, 95% confidence interval: 0.13, 0.68). No significant associations were noted between infertility and exposure to shift work, metal fumes, electromagnetic fields, solvents, lead, paint, pesticides, work-related stress, or vibration. Overall, no clear, clinically important associations between occupational exposures and male infertility could be identified in this study.

Adult↗
PubMed2005

Distribution of a 3.5-mL (1.0%) C31G vaginal gel using magnetic resonance imaging.

C31G (Savvy) has been developed as a topical vaginal microbicide with broad-spectrum antibacterial and antiviral properties. The objective of this study was to evaluate the distribution of a 1.0% concentration of (3.5 mL) C31G vaginal gel in the human pelvis using magnetic resonance imaging (MRI). Gel delivery with a standard applicator was primarily to the upper vagina and was well tolerated. Vaginal mucosal coverage at 18 min was excellent with 92% linear coverage and 75% surface contact coverage of the vagina. The upper vagina was almost completely covered and gel was also noted in the lower vagina. Coverage 6 h after application was substantially decreased, with 60% of maximal linear coverage and 41% surface contact. There was a very minimal coverage of the vaginal mucosa noted 24 h following insertion. Simulated intercourse resulted in relatively little change in overall distribution at all three time points. Repeat application of the gel may be necessary if intercourse has not occurred within the first few hours after initial insertion.

Administration, Intravaginal↗
PubMed2005

Acceptability of five nonoxynol-9 spermicides.

OBJECTIVE: To examine the acceptability of five nonoxynol-9 (N-9) spermicides. METHODS: We analyzed data from a randomized trial of five products, including three gels containing different amounts of N-9 per dose, a film and a suppository. In the trial, 1536 participants were asked to use the assigned spermicide for 7 months and to complete questionnaires 4 weeks after admission and at discontinuation. RESULTS: Overall, 43% of participants liked their spermicide "very much." This proportion was higher in the three gel groups than in the suppository and film groups. Difficulty with insertion, messiness and discontent with timing of insertion were common complaints in all groups. After adjustment for selected baseline factors, acceptability on the first questionnaire was not related to duration or consistency of subsequent spermicide use or to subsequent time to pregnancy. CONCLUSIONS: In this study, all five spermicides were considered acceptable by most users. Acceptability did not appear to influence spermicide use or pregnancy risk.

Adult↗
PubMed2005

Vaginal distribution of two volumes of the novel microbicide gel cellulose sulfate (2.5 and 3.5 mL).

This was a blinded crossover study to determine the in vivo distribution of 2.5 and 3.5 mL of 6% cellulose sulfate gel. This potential vaginal microbicide was mixed with dilute gadolinium chelate and inserted into the vagina. Magnetic resonance imaging was performed at baseline and repeated after 5, 20, 35 and 50 min with subjects either resting or ambulating between data acquisitions. Use of 2.5 mL with no ambulation gave low linear spread (53.1% of vaginal length) and surface contact (61.7%) at 50 min. Using 3.5 mL of gel with ambulation improved linear spread (84.5%) and surface contact (85.9%) of the gel in the same time interval without significant leakage. Most linear spreading took place in the first 5 min after insertion, although lateral spreading continued to increase with time especially when ambulation took place. Leakage and gel was not a significant problem at either volume.

Administration, Intravaginal↗
PubMed2005

In vivo assessment of NuvaRing placement.

NuvaRing, a combined contraceptive vaginal ring 54 mm in diameter, offers many advantages over oral contraceptives. To better delineate in vivo placement, we performed MRI to confirm its anatomical position. Two healthy users, one nulliparous and one parous, underwent a series of MRI: preinsertion, immediately postinsertion and after ambulation. Three-dimensional imaging of the human vagina demonstrates that in vivo, NuvaRing is located superior to the urogenital diaphragm (UGD), surrounding the cervix. The superior-most aspect of the ring lies behind (posterior) the cervix, at a level superior to the external os. The inferior aspect of the ring also lies in the vaginal canal above the UGD. The entire cervix rests inside the ring. The preambulation image in the nulliparous woman was the only exception. In this case, the upper portion of the ring was at the level of the lower-mid cervix and the lower aspect below the UGD. After ambulation, the ring moved cephalad and surrounded the cervix. In all instances, ambulation resulted in lower aspect of NuvaRing moving away from the introitus. In vivo, NuvaRing is compressed laterally forming a gentle oval in the anterior-posterior direction (5-7 mm longer than wide), an effect that is seen more in nulliparous women.

Adult↗
PubMed2005

Cost-effectiveness of presumptively medically treating women at risk for ectopic pregnancy compared with first performing a dilatation and curettage.

OBJECTIVE: To compare the cost and complication rate of two alternative strategies for the diagnosis and medical management of ectopic pregnancy when ultrasound is nondiagnostic. DESIGN: A decision tree was constructed to compare [1] dilatation and curettage (D&C) followed by treatment of all ectopic pregnancies with methotrexate versus [2] empiric treatment of all patients with possible ectopic pregnancies with methotrexate without D&C. SETTING: University setting. PATIENT(S): Ten thousand hypothetical women with nonviable pregnancies and a known incidence of ectopic pregnancy were entered into a computer model. MAIN OUTCOME MEASURE(S): The two approaches were compared with respect to the number of missed ectopic pregnancies, complications, procedures performed, admissions to the hospital, and cost. RESULT(S): The D&C group had 1% more failed managements of ectopic pregnancies and 13.4% fewer patients with a miscarriage undergo a second treatment for resolution. The D&C group had 13.7% fewer complications including 6.3% fewer hospitalizations. D&C costs $173 to $223 more than empiric use of methotrexate per patient. CONCLUSION(S): Empirically treating women at risk for ectopic pregnancy with methotrexate does not reduce complications or save money. In the absence of such savings, the desire to make an accurate and definitive diagnosis, allowing objective prognosis on future fertility and risk of repeat ectopic pregnancy, supports the need to distinguish a miscarriage from ectopic pregnancy before treatment with methotrexate.

Abortifacient Agents, Nonsteroidal↗
PubMed2005

Supplementation with DHEA: effect on muscle size, strength, quality of life, and lipids.

OBJECTIVE: To evaluate the effects of combination estrogen/androgen therapy on muscle mass, strength and endurance, serum hormone and lipid profiles, and quality of life measures in postmenopausal women. METHODS: Prospective, randomized, placebo-controlled pilot study at a tertiary care medical center. Fifty postmenopausal women were randomized to a 12-week course of (1) dehydroepiandrostenedione (DHEA) 50 mg daily, (2) conjugated equine estrogen (CEE) 0.625 mg daily, (3) DHEA 50 mg+CEE 0.625 mg daily, or (4) placebo. Main outcome measures of lower extremity muscle (calf) mass, functional muscle parameters, serum hormone and lipid levels, and quality of life (QOL) were obtained at baseline and after treatment. Statistical analysis compared percent change from baseline values and treatment differences among outcomes. RESULTS: Significant increases in mean DHEA, DHEA sulfate (DHEA-S), testosterone, and androstenedione levels were noted with DHEA alone or combined DHEA/CEE treatments when compared with placebo. Compared with no hormone therapy, none of the supplemental hormone groups caused significant changes in muscle mass, muscle strength, muscle endurance, feelings of well-being, sleep, or sexual function. CONCLUSIONS: Androgen replacement therapy, with DHEA, to menopausal women increases serum androgen levels without any appreciable effect on muscle cross-sectional area, muscle strength, muscle function, or improvement in health-related QOL.

Aged↗