Targeting pregnancy-related weight gain to reduce disparities in obesity: Baseline results from the Healthy Babies trial.

BACKGROUND: Obesity affects African American women more than any other group in the US. Pregnancy represents a critical life stage of heightened vulnerability for new or persistent obesity, yet few interventions have been effective in reducing excessive gestational weight gain among African American women. We describe the design and baseline findings of Healthy Babies, a two-arm randomized controlled trial testing a mobile health intervention to minimize excessive gestational weight gain versus usual care in this high risk group. METHODS: African American women in early pregnancy were recruited from two large obstetric practices as well as Philadelphia Women, Infants, and Children's clinics. Participants randomized to the intervention received behavior change goals, daily text messages with feedback, web-based weight gain graphs, health coaching, and a Facebook support group. Data collection included baseline (<22 weeks' gestation), 36-38 weeks' gestation, and 6-month postpartum anthropometric measures and assessments of demographics, contextual factors and behavioral targets. The primary outcome was prevalence of excessive gestational weight gain. RESULTS: Among participants at baseline (n = 262), the majority met criteria for obesity (63%), were multiparous (62%), single (77%), and were on average 25.6 ±â€¯5.4 years old with a gestational age of 13.9 ±â€¯4.1 weeks. While 82% completed high school, 61% met criteria for inadequate health literacy. Nearly 20% were food insecure. Eighty-eight percent reported a gestational weight gain goal discordant with Institute of Medicine guidelines. There were no significant differences in baseline characteristics between study arms. CONCLUSIONS: Participants represent a high-risk group for excessive gestational weight gain with demonstrated need for intervention.

Accuracy and reliability of fetal heart rate monitoring using maternal abdominal surface electrodes.

OBJECTIVE: Compare the accuracy and reliability of fetal heart rate identification from maternal abdominal fetal electrocardiogram signals (ECG) and Doppler ultrasound with a fetal scalp electrode. DESIGN: Prospective open method equivalence study. SETTING: Three urban teaching hospitals in the Northeast United States. SAMPLE: 75 women with normal pregnancies in labor at >37 weeks of gestation. METHODS: Three fetal heart rate detection methods were used simultaneously in 75 parturients. The fetal scalp electrode was the standard against which abdominal fetal ECG and ultrasound were judged. MAIN OUTCOME MEASURES: The positive percent agreement with the fetal scalp electrode indicated reliability. Bland-Altman analysis determined accuracy. The confusion rate indicated how frequently the devices tracked the maternal heart rate. RESULTS: Positive percent agreement was 81.7 and 73% for the abdominal fetal ECG and ultrasound, respectively (p = 0.002). The abdominal fetal ECG had a lower root mean square error than ultrasound (5.2 vs. 10.6 bpm, p < 0.001). The confusion rate for ultrasound was 20-fold higher than for abdominal ECG (8.9 vs. 0.4%, respectively, p < 0.001). CONCLUSION: Compared with the fetal scalp electrode, fetal heart rate detection using abdominal fetal ECG was more reliable and accurate than ultrasound, and abdominal fetal ECG was less likely than ultrasound to display the maternal heart rate in place of the fetal heart rate.

Douching for perceived vaginal odor with no infectious cause of vaginitis: a randomized controlled trial.

OBJECTIVE: To demonstrate the effectiveness of medical-grade stainless steel Water Works Douching Device for treating abnormal vaginal odor in comparison with a commercially available over-the-counter plastic douching device. MATERIALS AND METHODS: In a multicenter study, 140 women with perceived vaginal odor with no vaginal infection were randomized to either Water Works or control group in a 1:1 ratio and were douched daily for 4 weeks. A visual analog scale (VAS) was used to assess the intensity of vaginal odor. Primary outcome included subject assessment of odor improvement and Nugent Gram stain score of vaginal secretions. Secondary outcome compared the efficacy and safety of Water Works with control douching device. Each patient underwent baseline, week 2, and week 4 visits. RESULTS: The final analytic sample consisted of 96 women. Success score at 4 weeks was 78% for the Water Works group and 38.5% for the control group. Mean VAS was significantly reduced, and Nugent and Lactobacillus scores were maintained in both groups. In the Water Works group, VAS was reduced from 7.3 ± 0.3 to 1.8 ± 0.6 (p < .001) after 4 weeks. In the control group, baseline versus 4 weeks VAS was 7.2 ± 0.3 and 3.4 ± 0.8 (p < .003). CONCLUSIONS: Women reported significant reduction of vaginal odor after douching with water for 4 weeks without any alteration of vaginal flora. The Water Works Douching Device was superior to over- the-counter device in reducing vaginal odor.

Preterm labor and bacterial vaginosis-associated bacteria among urban women.

AIMS: Bacterial vaginosis (BV) affects millions of women, is extremely prevalent and is frequently chronic. We recognize numerous microbiologic variations among women with BV and this variability may explain the limited effectiveness of metronidazole in curing BV and/or reducing the risk of spontaneous preterm birth (SPTB) among BV-positive pregnant women. We assessed the independent role of seven common BV-associated bacteria on the risk of spontaneous preterm birth (SPTB) among urban pregnant women. METHODS: This prospective cohort study was conducted within an urban obstetrics practice at Temple University Hospital in Philadelphia, PA. Fifty pregnant women with documented singleton pregnancies between 25-36 weeks' gestation from February 2007 through June 2007 who presented to the Labor and Delivery Unit for evaluation of uterine contractions/preterm labor were enrolled. RESULTS: We found that high median levels of Gardnerella vaginalis and low median levels of Lactobacillus crispatus were significantly predictive of SPTB. Slightly higher levels of Megasphaera-like species were also found among the group of women experiencing a SPTB during the follow-up period. CONCLUSIONS: Further identification of the individual attributable risk for separate BV-associated bacteria may be most useful in developing successful treatments to prevent SPTB among BV positive women.

The inhibition of tube formation in a collagen-fibrinogen, three-dimensional gel by cleaved kininogen (HKa) and HK domain 5 (D5) is dependent on Src family kinases.

Cleaved high molecular weight kininogen (HKa), as well as its domain 5 (D5), inhibits migration and proliferation induced by angiogenic factors and induces apoptosis in vitro. To study its effect on tube formation we utilized a collagen-fibrinogen, three-dimensional gel, an in vitro model of angiogenesis. HKa, GST-D5 and D5 had a similar inhibitory effect of tube length by 90+/-4.5%, 86+/-5.5% and 77+/-12.9%, respectively. D5-derived synthetic peptides: G440-H455 H475-H485 and G486-K502 inhibited tube length by 51+/-3.7%, 54+/-3.8% and 77+/-1.7%, respectively. By a comparison of its inhibitory potency and its sequences, a functional sequence of HKa was defined to G486-G496. PP2, a Src family kinase inhibitor, prevented tube formation in a dose-dependent manner (100-400 nM), but PP3 at 5 microM, an inactive analogue of PP2, did not. HKa and D5 inhibited Src 416 phosphorylation by 62+/-12.3% and 83+/-6.1%, respectively. The C-terminal Src kinase (Csk) inhibits Src kinase activity. Using a siRNA to Csk, expression of Csk was down-regulated by 86+/-7.0%, which significantly increased tube length by 27+/-5.8%. The addition of HKa and D5 completely blocked this effect. We further showed that HKa inhibited Src family kinase activity by disrupting the complex of uPAR, alphavbeta3 integrin and Src. Our results indicate that the anti-angiogenic effect of HKa and D5 is mediated at least in part through Src family kinases and identify a potential novel target for therapeutic inhibition of neovascularization in cancer and inflammatory arthritis.

Rapid testing for vaginal yeast detection: a prospective study.

OBJECTIVE: The purpose of this study was to determine the accuracy of rapid vaginal yeast detection assay compared with yeast cultures for the diagnosis of vulvovaginal candidiasis. STUDY DESIGN: This was a prospective study that involved 104 subjects, 34 asymptomatic women and 70 symptomatic women with vaginitis. Vaginal swabs were obtained from all subjects for wet mount, yeast culture, and the rapid yeast detection test. Overall, the prevalence rate was 39.4%, based on positive yeast cultures. The rapid yeast test performed by the physician was positive in 30 of 41 subjects with positive cultures and 13 of 63 subjects with negative cultures. RESULTS: The rapid yeast test had 73.1% sensitivity and 82.0% negative predictive value compared with the wet mount, which had 43.9% sensitivity and 70.9% negative predictive value. In symptomatic patients, the test had 77.4% sensitivity and 81% negative predictive value compared with wet mount, which had 51.6% sensitivity. Patient-performed test results were identical to the tests that were performed by the physicians. The cost of the rapid yeast test kit is estimated to be <$10, compared with a mean of $65 for the yeast culture. CONCLUSION: Rapid yeast detection assay is accurate and affordable compared with the gold standard yeast culture in the diagnosis of vulvovaginal candidiasis. Relative to the wet mount, it is more sensitive, cheaper, and accurate for the rapid diagnosis of vaginal yeast infection.

Antithrombotic activity of kininogen is mediated by inhibitory effects of domain 3 during arterial injury in vivo.

High-molecular-weight kininogen (HK) and its domain 3 (D3) exhibit anticoagulant properties and inhibit platelet activation at low thrombin concentration in vitro. We hypothesized that the rapid occlusive thrombosis in HK-deficient (HKd) rats following endothelial injury of the aorta results from enhanced platelet aggregation by thrombin. The effects of D3 (G235-M357) or D3-derived peptides on thrombosis in vivo were tested. D3 and its exon 7C terminal peptide (E7CP, K270-Q292), expressed as glutathione S-transferase (GST) fusion proteins (GST-D3, GST-E7CP), or GST alone, as well as cleaved HK (HKa) or synthetic peptide E7CP, were infused intravenously 10 min before endothelial injury. Blood flow was reduced down to 10% of baseline flow within 28 +/- 5.2 min by a platelet-fibrin thrombus in GST-treated HKd rats compared with >240 min in GST-treated normal HK rats (wild type). GST-D3, GST-E7CP, HKa, or E7CP infusion prolonged the flow time to 233, >240, 223, and >240 min, respectively, in HKd rats. When GST-E7CP was infused 10 min after the injury, blood flow was maintained for >240 min. Thrombin-antithrombin concentrations were elevated by injury in HKd rats receiving GST from 35 to 55 microg/l and decreased with GST-E7CP, HKa, or E7CP reconstitution to 40, 15, and 9 microg/l, respectively. We conclude that HKd rats are prothrombotic and that HKa, kininogen D3, and its fragment E7CP modulate arterial thrombosis after endothelial injury.

Douching with Water Works device for perceived vaginal odor with or without complaints of discharge in women with no infectious cause of vaginitis: a pilot study.

OBJECTIVE: To determine if douching with Water Works device for 1 month can (1) lower or eliminate perceived vaginal odor by subject; (2) have any effects on vaginal ecosystem. METHODS: Ten women with perceived vaginal odor with or without discharge, douched every day for 4 weeks in an open-label, nonrandomized pilot study. Primary outcome measures included perceived vaginal odor by subject, lactobacilli score from Nugent slide, and acceptance of the Water Works douching system. Secondary outcome included the safety of using this douching device. RESULTS: At week 4, there was improvement in vaginal odor (P=.0006) and there was no significant change in lactobacilli score. CONCLUSION: Douching with Water Works device is associated with reduction or elimination of vaginal odor without adversely affecting the vaginal ecosystem.

CardioClasp changes left ventricular shape acutely in enlarged canine heart.

BACKGROUND: In dilated cardiomyopathy (DCM), eliminating or reducing extra-geometric burden to the myocardial cells would directly reduce myocardial wall stress leading to improved LV systolic performance. In acute experiments, we tested whether a passive non-blood contacting CardioClasp device, which employs two indenting bars to reshape the left ventricle (LV), could reduce extra-geometric burden, LV wall stress (LVWS) and improve LV systolic function and contractility without decreasing arterial blood pressure. METHODS: In mongrel dogs (n = 5), 4 weeks of right ventricular pacing (210-220-230-240 ppm) induced DCM with severe heart failure. After placing the CardioClasp device, LV performance was evaluated immediately by measuring hemodynamics, echocardiography, and Sonometrics crystal data. Eleven sonometric crystals were placed into endocardial positions (8 in anterior, posterior, mid-anterior, mid-posterior, apex, base, free and septal wall) and in myocardial (2 as regional) and epicardial (1) positions to assess the LV end-systolic pressure-segment length relationships (ESPSR) and cross-sectional area (ESPAR) relationship. RESULTS: CardioClasp decreased the LV end-diastolic anterior-posterior (A-P) dimensions at two levels (15% and 25%). With CardioClasp, LVWS decreased from 93.1 +/- 7.2 to 59.1 +/- 3.2 g/cm2 (P < 0.05) and fractional area of contraction (FAC) increased from 27.6 +/- 3.8 to 33.1 +/- 3.7% (P < 0.01). Peak LV and arterial pressures, LV +dP/dt, LV -dP/dt, and cardiac output were unaltered with CardioClasp. CardioClasp placement significantly increased the slopes of LV pressure versus anterior-posterior segment relationship from 7.3 +/- 0.6 to 15.8 +/- 1.8 mmHg/mm and septal-free wall segment relationship from 6.3 +/- 0.9 to 9.8 +/- 0.5 mmHg/mm. At both 15% and 25% LV A-P dimension reductions, the slopes of ESPAR showed significant steepening and increased from 10.1 +/- 0.7 (baseline) to 15.5 +/- 1.7 (15% reduction) and 19.0 +/- 1.4 mmHg/cm2 (25% reduction). The larger the reduction, the greater was the steepening of the slopes of ESPSR and ESPAR. CONCLUSIONS: CardioClasp reduced LV diameter and thereby decreased LVWS and increased FAC. CardioClasp was able to reshape the left ventricle, while preserving the contractile mass, which increased the slopes of ESPSR and ESPAR. This reshaping was associated with maintained systolic pressures, cardiac output, and increased contractility.

Left ventricular reshaping: effects on the pressure-volume relationship.

OBJECTIVE: We tested whether the CardioClasp device (CardioClasp, Inc, Cincinnati, Ohio), a non-blood contact device, would improve left ventricular contractility by acutely reshaping the left ventricle and reducing left ventricular wall stress. METHODS: In dogs (n = 6) 4 weeks of ventricular pacing (210-240 ppm) induced severe heart failure. Left ventricular function was evaluated before and after placement of the CardioClasp device, which uses 2 indenting bars to reshape the left ventricle. Hemodynamics, echocardiography, and Sonometrics crystals dimension (Sonometrics Corporation, London, Ontario, Canada) were measured at steady state and during inferior vena caval occlusion. RESULTS: The CardioClasp device decreased the left ventricular end-diastolic anterior-posterior dimension by 22.8% +/- 1.9%, decreased left ventricular wall stress from 97.3 +/- 22.8 to 67.2 +/- 7.7 g/cm(2) (P =.003), and increased the fractional area of contraction from 21.3% +/- 10.5% to 31.3% +/- 18.1% (P =.002). The clasp did not alter left ventricular end-diastolic pressure, left ventricular pressure, left ventricular dP/dt, or cardiac output. With the CardioClasp device, the slope of the end-systolic pressure-volume relationship was increased from 1.87 +/- 0.47 to 3.22 +/- 1.55 mm Hg/mL (P =.02), the slope of preload recruitable stroke work versus end-diastolic volume was increased from 28.4 +/- 11.0 to 44.1 +/- 23.5 mm Hg (P =.02), and the slope of maximum dP/dt versus end-diastolic volume was increased from 10.6 +/- 4.6 to 18.6 +/- 7.4 mm Hg x s(-1) x mL(-1) (P =.01). The CardioClasp device increased the slope of the end-systolic pressure-volume relationship by 68.0% +/- 21.7%, the slope of preload recruitable stroke work versus end-diastolic volume by 50.7% +/- 18.1%, and the slope of maximum dP/dt versus end-diastolic volume by 85.7% +/- 28.9%. CONCLUSIONS: The CardioClasp device decreased left ventricular wall stress and increased the fractional area of contraction by reshaping the left ventricle. The CardioClasp device was able to maintain cardiac output and arterial pressure. The clasp increased global left ventricular contractility by increasing the slope of the end-systolic pressure-volume relationship, the slope of preload recruitable stroke work versus end-diastolic volume, and the slope of maximum dP/dt versus end-diastolic volume. In patients with heart failure, the CardioClasp device might be effective for clinical application.

CardioClasp: a new passive device to reshape cardiac enlargement.

In dilated heart failure, geometric distortions place an extra load on the myocardial cells. If this extra burden can be eliminated, the myocardial wall stress would decrease leading to improved systolic ventricular performance. In a dilated heart failure model, we wanted to see whether the CardioClasp (which uses two indenting bars to reshape the left ventricle [LV] as two widely communicating "lobes" of reduced radius) could improve systolic performance by passively reshaping the LV and reducing the wall stress. In mongrel dogs (n = 7; 25-27 kg), rapid ventricular pacing (210 ppm 1st week to 240 ppm 4th week) induced dilated heart failure. After 4 weeks, LV performance was evaluated at baseline and with the CardioClasp by measuring LV end-diastolic and peak LV systolic pressure, LV +dP/dt, LV -dP/ dt, and cardiac output. With the Clasp on, LV wall stress was reduced to 58.6+/-3.5 from 108.3+/-8.2 g/cm2. The fractional area of contraction (FAC) with the Clasp on (28.4+/-4.4) was significantly increased (p < 0.05) from baseline (20.8+/-4.6) and consistent with improved systolic performance. Cardiac output, LV peak systolic and end-diastolic pressures, and regional myocardial blood flow were unaltered. The Clasp was able to acutely reshape the left ventricle, while preserving the contractile mass, and reduced the tension on the myocardial cells and increased the fractional area of contraction without decreasing the systolic blood pressure.