Buccal misoprostol plus laminaria for cervical preparation before dilation and evacuation at 21–23 weeks of gestation: a randomized controlled trial

Objective

To describe the effectiveness of buccal misoprostol as an adjunct to laminaria for cervical ripening before later second-trimester abortion by dilation and evacuation (D&E).

Methods

A randomized, double-blinded, placebo-controlled trial of 196 women undergoing D&E between 21 and 23 weeks of gestation. Subjects had overnight laminaria and 400 mcg buccal misoprostol or placebo 3–4 h before the abortion. We used logarithmic transformation of the primary outcome — D&E procedure duration — to achieve a normal distribution.

Results

Mean D&E duration was 1.7 min shorter with misoprostol (p=.02). The median duration was 9.7 versus 10.4 min in the misoprostol and placebo groups, respectively (p=.09). Cervical dilation was slightly greater with misoprostol (median 75 mm vs. 73 mm, p=.04); however, physicians did not find the misoprostol D&Es easier to complete. Half of subjects reported severe pain after misoprostol vs. 11% with placebo (p<.001).

Conclusion

Adjuvant buccal misoprostol results in slightly shorter D&Es at the cost of more side effects.     

A randomized trial of misoprostol versus laminaria before dilation and evacuation in South Africa

Objective

To compare complication rates, efficacy and acceptability of buccal misoprostol to laminaria for cervical preparation before dilation and evacuation (D&E) in South Africa.

Study design

We performed a randomized, single-blind trial comparing buccal misoprostol 400 mcg (1–2 doses, administered at least 3 h before D&E) to laminaria inserted the day before D&E among women at 13–19 weeks gestation. The primary outcome was expulsion of the fetus prior to surgery; secondary outcomes included other complications, need for mechanical dilation, procedure duration, side effects and satisfaction. Required sample size was 176 to detect a difference in expulsion of 20% to 5%, with a two-sided alpha of 0.05 and 80% power.

Results

Due to slow enrollment and low incidence of primary outcome, the study was stopped early. One hundred fifty-nine women were randomized, and 156 received treatment (78 in each group). Mean gestational age was 14.8 weeks (range, 13.0–18.6 weeks). Complications were rare and did not differ by group [three in each group; odds ratio (OR), 1; 95% confidence interval (CI), 0.20–5.11]; this included two expulsions in the misoprostol group (2.6%). Misoprostol participants were more likely to require mechanical dilation compared to those receiving laminaria (35% vs. 8%; OR, 6.4; 95% CI, 2.4–16.5). The proportion of women reporting each side effect was similar except for diarrhea (21.3% in misoprostol group vs. 5.2% in laminaria group, p=0.004). Procedure time and satisfaction did not differ between groups.

Conclusions

Both misoprostol and laminaria are associated with a low complication rate in this setting, although misoprostol requires more mechanical dilation and causes more diarrhea.

Implications

Cervical preparation using either laminaria or misoprostol can be safely used before D&E up to at least 19 weeks. Physicians using misoprostol must be skilled at mechanical dilation, since this is commonly required.     

Self-administered lidocaine gel for local anesthesia prior to osmotic dilator placement: a randomized trial

Objective(s)

To compare pain scores during cervical dilator placement prior to dilation and evacuation (D&E) with patient-administered vaginal lidocaine gel versus lidocaine paracervical block (PCB).

Lidocaine spray in addition to paracervical block reduces pain during first-trimester surgical abortion: a placebo-controlled clinical trial

Background

A variety of anesthetic and analgesic techniques have been used for uterine aspiration, and most clinicians use a paracervical block with or without additional analgesia. We intended to evaluate whether the addition of 10% lidocaine spray to a paracervical block decreases pain during cervical dilation and uterine aspiration.

Study Design

Seventy-seven patients were divided into two groups: paracervical blocks (PCB) (n=30) and PCB plus 10% lidocaine spray (n=47). Anticipated and overall perceived pain scores were measured with a standard Visual Analog Scale (VAS).

Results

Anticipated pain VAS scores of two groups were similar, however overall perceived pain VAS scores demonstrated a significant difference. PCB with Lidocaine only group had 6.56±1.43 cm mean VAS score, whereas lidocaine plus lidocaine spray group had 2.35±1.39 cm, the difference being statistically significant (p<.01).

Conclusion

We found that 10% lidocaine spray safely decreases perceived pain during first-trimester surgical abortion, when used in addition to PCB with lidocaine HCl.     

Higher dose cervical 2% lidocaine gel for IUD insertion: a randomized controlled trial

Objective

To determine the effectiveness of 6 mL of 2% lidocaine cervical gel for pain during intrauterine device (IUD) insertion.

Study Design

This is a randomized double-blind placebo controlled trial of 6 mL of 2% lidocaine gel for IUD insertion pain among first-time IUD users. No other analgesia other than the study intervention was provided. The study was conducted at a university-based obstetrics and gynecology clinic. The primary outcome, pain during IUD insertion on a 0 to 100-mm visual analog scale, was analyzed using the t test.

Results

Seventy-three women received placebo gel, and 72 women received 2% lidocaine gel. The groups had similar sociodemographic and clinical characteristics. Baseline pain scores with speculum insertion were no different between the two groups. The lidocaine group reported a mean pain score with tenaculum placement of 37.5 (median: 39) compared to the placebo group of 41.6 (median: 37) (p=.4). Similarly, pain with IUD insertion was no different with a mean pain score of 35.2 (median: 34) in the lidocaine group and 36.7 (median 36) in the placebo group (p=.8).

Conclusions

Two percent lidocaine gel placed on the anterior lip of the cervix and at the internal os did not reduce pain with tenaculum placement and IUD insertion compared to placebo gel.

Implications

Among first-time IUD users, including both nulliparous and multiparous women, 6 mL of 2% lidocaine gel placed on the anterior lip of the cervix and at the internal os for 3 min did not reduce pain with tenaculum placement and IUD insertion compared to placebo gel.     

Can ultrasound predict IUD expulsion after medical abortion?

Objectives

Our randomized trial compared early and delayed intrauterine device (IUD) insertion following medical abortion. In this planned substudy, we explore if endometrial thickness and initial IUD position were associated with IUD expulsion. We also describe IUD movement within the uterus during the 6 months after insertion.

Study design

We recruited women undergoing medical abortion and choosing the copper IUD for contraception (n = 156). Participants were randomly assigned to early insertion 1 week after mifepristone or delayed insertion 4–6 weeks later. We measured endometrial thickness by transvaginal sonogram 1 week after abortion and IUD distance from the fundal aspect of the endometrial cavity three times: at insertion, 6–8 weeks later and at 6 months.

Results

We analyzed endometrial thickness in 113 women, baseline IUD position in 114 women and IUD movement in 65 women. Women who expelled IUDs (n = 15) had slightly thicker endometria (p = .007) and slightly lower baseline IUD positions (p = .03) than those who retained IUDs, but no clear cutoffs emerged in the receiver operating characteristic curve analysis. Retained IUDs commonly moved up and down throughout the 6 months (from 14 mm towards the fundus to 32 mm towards the cervix). Overall, retained IUDs moved a median of 2 mm towards the cervix between insertion and exit (p < .0001).

Conclusions

After medical abortion, the risk of IUD expulsion increases with thicker endometria and lower baseline position. Since no clear cutoffs emerged in the analysis and expulsion remained uncommon even with thicker endometria, we do not recommend restricting IUD insertion based on ultrasound data.

Implication

Copper T IUDs often move within the uterus without expelling. Expulsion is uncommon, and we do not recommend restricting IUD insertion based on ultrasound data.     

Alcohol drinking patterns and health-related quality of life reported in the Spanish adult population

Objectives

To examine the association between alcohol drinking patterns and health-related quality of life (HRQL).

Methods

Population-based cross-sectional study was conducted in 2008–2010 among 12,715 adult individuals in Spain. HRQL was assessed with the SF-12 questionnaire and alcohol intake with a diet history. The threshold between average moderate drinking and average heavy drinking was ≥ 40 g/day of alcohol in men and ≥ 24 g/day in women. Binge drinking was defined as the intake of ≥ 80 g in men and ≥ 60 g in women at any drinking session during the preceding 30 days. Analyses were performed with linear regression and adjusted for the main confounders.

Results

Compared to non-drinkers, all types of average drinkers reported better scores on the SF-12 physical component: β = 1.42 (95% confidence interval 1.03 to 1.81) in moderate drinkers and β = 1.86 (1.07 to 2.64) in heavy drinkers. In contrast, average alcohol consumption was not associated with the mental component of the SF-12. The number of binge drinking episodes and most types of beverage preference showed no association with physical or mental HRQL.

Conclusions

Alcohol drinkers, including those with heavy drinking, reported better physical HRQL than non-drinkers.     

Reducing children's pain and distress towards flu vaccinations: A novel and effective application of humanoid robotics

Objective

Millions of children in North America receive an annual flu vaccination, many of whom are at risk of experiencing severe distress. Millions of children also use technologically advanced devices such as computers and cell phones. Based on this familiarity, we introduced another sophisticated device – a humanoid robot – to interact with children during their vaccination. We hypothesized that these children would experience less pain and distress than children who did not have this interaction.

Method

This was a randomized controlled study in which 57 children (30 male; age, mean ± SD: 6.87 ± 1.34 years) were randomly assigned to a vaccination session with a nurse who used standard administration procedures, or with a robot who was programmed to use cognitive-behavioral strategies with them while a nurse administered the vaccination. Measures of pain and distress were completed by children, parents, nurses, and researchers.

Results

Multivariate analyses of variance indicated that interaction with a robot during flu vaccination resulted in significantly less pain and distress in children according to parent, child, nurse, and researcher ratings with effect sizes in the moderate to high range (Cohen's d = 0.49–0.90).

Conclusion

This is the first study to examine the effectiveness of child–robot interaction for reducing children's pain and distress during a medical procedure. All measures of reduction were significant. These findings suggest that further research on robotics at the bedside is warranted to determine how they can effectively help children manage painful medical procedures.     

Muscle strength and physical activity are associated with self-rated health in an adult Danish population

Objective

To describe associations of muscle strength, physical activity and self-rated health.

Method

Isometric muscle strength by maximal handgrip strength (HGS) or muscle strength by 30 s repeated chair stand test (30 s-CS) was combined with leisure time physical activity. Using logistic regression odds ratio was calculated for good self-rated health according to the combined associations among 16,539 participants (59.7% women), mean age 51.9 (SD: 13.8) years, from a cross-sectional study in Denmark 2007–2008.

Results

Good self-rated health was positively associated with higher levels of physical activity and greater muscle strength. Regarding HGS the highest OR for good self-rated health was in the moderate/vigorous physically active participants with high HGS (OR = 6.84, 95% CI: 4.85–9.65 and OR = 7.34, 95% CI: 5.42–9.96 for men and women, respectively). Similarly the highest OR for good self-rated health was in the moderate/vigorous physically active participants with high scores in the 30 s-CS test (6.06, 95% CI: 4.32–8.50 and 13.38, 95% CI: 9.59–18.67 for men and women, respectively). The reference groups were sedentary participants with low strength (HGS or 30 s-CS).

Conclusion

The combined score for physical activity level with either HGS or 30 s-CS was strongly positively associated with self-related health.     

Barriers to D&E practice among family planning subspecialists

Objective

Over 95% of all second-trimester abortions are managed by dilation and evacuation procedures (D&E) and account for nearly 9% of all abortions in the United States annually. The Fellowship in Family Planning (FFP) offers subspecialty training in abortion and contraception to obstetrician–gynecologists and family medicine physicians. Twenty years after the FFP founding, we report on the abortion practice characteristics and specific barriers these subspecialists face.

Study Design

We surveyed obstetrician–gynecologist family planning (FP) subspecialists by email regarding second-trimester abortion training and practice barriers with a focus on D&E.

Results

Our response rate was 62% (105/169) of all fellowship-affiliated physicians. Respondents were composed primarily of young women working in academic settings in the West and Northeast regions. Nearly all FP subspecialists have been trained to 24 weeks’ gestation and currently provide D&Es, with an average of nearly 200 per year. D&E practice barriers vary by geographical location and degree of “regional restrictiveness.” FP subspecialists practicing in more abortion-restrictive regions were four times more likely to report a personal main barrier (such as concern for safety) than other types of main barriers (p=.05). Providing D&Es in a hospital operating room was associated with 2.8 times higher odds of reporting an institutional or coworker main barrier (p=.02). High-volume D&E practice was associated with three times lower odds of reporting an institutional/coworker main barrier (p=.02).

Conclusions

By identifying the barriers to D&E practice experienced by FP subspecialists, we can begin to develop a coordinated approach to eradicating modifiable barriers and, ultimately, improve access for women seeking D&E services.     

Same-day and delayed reports of pain intensity in second-trimester medical termination of pregnancy: a brief report

Objective

To assess same-day and delayed reports of pain intensity during and after second-trimester medical termination of pregnancy (MTOP).

Study Design

A prospective randomized trial (217 women) comparing 1- and 2-day mifepristone–misoprostol intervals.

Results

Women reported intense pain [median visual analogue scale (interquartile range)] related to expulsion of the fetus [6 (0–10)]. Delayed reports of maximal pain described the pain as more intense than same-day reports [8 (3–10) vs. 7 (1–10), p<.001].

Conclusions

Most women reported and readily remembered intense pain associated with fetal expulsion during second-trimester MTOP.

Implications

Adequate, properly timed pain management during second-trimester MTOP is crucial.     

HIV seroprevalence among inmates in Togo

Background

There is no data on HIV seroprevalence among prisoners in Togo.

Methods

A cross-sectional study was conducted among prisoners in Togo from November 2011 to January 2012. The study population was included by selecting the most densely populated prison in each of the six Togo regions, and by including prisoners (at least18 years of age and having been in prison for more than 30 days) on a voluntary basis. HIV prevalence was estimated with a 95% confidence interval (CI).

Results

One thousand three hundred and fourty-two prisoners were included in the study. Their median age was 28 years, (IQR 25–33 years) and 39 (2.9%) were women. The median time spent in the prison was 10 months, interquartile range [4–24 months]. HIV testing was accepted by 96.0%. HIV seroprevalence in prisons was 4.3%, 95 CI% [3.2–5.5%]. Few prisoners (2.9%) reported having had sex in prisons. The only factor associated with HIV infection was gender with an HIV seroprevalence of 14.3% for women compared to 4.0% for men (P = 0.003).

Conclusion

The prevention and the management of HIV infection should be a priority in Togolese prisons. This requires implementing healthcare facilities in prisons.     

Trends and disparity in zoster vaccine uptake in a managed care population

Objectives

Zoster vaccine is recommended for prevention of herpes zoster among adults aged 60 years and older. We examined the zoster vaccination rates during 2007–2011 and assessed association with age, sex, race/ethnicity, neighborhood income and education attainment in eligible adults at Kaiser Permanente Southern California, a managed care organization in the US.

Methods

We calculated annual zoster vaccination rate among members ≥60 years without documented contraindications. Multivariable logistic regression was performed to examine factors associated with zoster vaccine uptake in an open cohort of 819,466 adults.

Results

The zoster vaccination rates increased annually in all groups and the overall rate reached 21.7% in 2011 (P-trend < 0.001). Coverage was highest among individuals aged 65–74 years, who were female and non-Hispanic White. In the adjusted analysis, odds of vaccination decreased by age. Females (odds ratio [OR] = 1.19, 95% confidence interval [CI] = 1.17–1.20) and those who lived in neighborhoods with higher education attainment were more likely to be vaccinated (>75% vs. <50% adults with some college education: OR = 1.76, 95% CI = 1.73–1.80). Compared to Whites, non-Hispanic Blacks and Hispanics were less likely to receive the vaccine (non-Hispanic Blacks: OR = 0.56, 95% CI = 0.55–0.58; Hispanics: OR = 0.59, 95% CI = 0.58–0.60).

Conclusion

The zoster vaccine coverage is higher in this insured population than previously reported in the US general population, but it remains low. Significant racial/ethnic disparity was observed and worsened even among individuals with relatively equal access to zoster vaccination.     

Association between physical activity and major depressive disorder among current or former smokers with pulmonary disease

Objective

To examine the association between physical activity and major depressive disorder (MDD) in a nationally representative sample of current or former smokers with pulmonary impairments.

Methods

The analyzed sample from the National Health and Nutrition Examination Survey (NHANES) 2007–2010 included 536 adults who indicated that they were current or former smokers, had at least mild pulmonary impairment (FEV₁/FVC < 0.70), and provided depression and physical activity data.

Results

After controlling for asthma status, pulmonary impairment, age, poverty-to-income ratio (PIR), education, gender, marital status, body mass index (BMI), cotinine, comorbidity index, race-ethnicity, and smoking status, those who met physical activity guidelines had a 59% (odds ratio (OR) = 0.41; 95% confidence interval (CI): 0.18–0.94) lower odds of having MDD. Using multivariate linear regression with depression symptoms as the outcome variable, and after adjustments, physical activity was inversely associated with depression symptoms in a dose–response manner; lowest tertile was the referent group, middle tertile coefficient: − 1.06 (95% CI: − 1.98 to − 0.14), and highest tertile coefficient: − 1.10 (95% CI: − 1.84 to − 0.34).

Conclusions

Physical activity inversely associates with MDD in adults with pulmonary impairments, and does so in a dose–response manner. This suggests that individuals with pulmonary impairments should be encouraged to engage in enjoyable, safe forms of physical activity in a progressive manner.     

Mortality attributable to smoking in Vietnamese men in 2008

Objective

Smoking prevalence among Vietnamese men is among the highest in the world. Our aim was to provide estimates of tobacco attributable mortality to support tobacco control policies.

Method

We used the Peto–Lopez method using lung cancer mortality to derive a Smoking Impact Ratio (SIR) as a marker of cumulative exposure to smoking. SIRs were applied to relative risks from the Cancer Prevention Study, Phase II. Prevalence-based and hybrid methods, using the SIR for cancers and chronic obstructive pulmonary disease and smoking prevalence for all other outcomes, were used in sensitivity analyses.

Results

When lung cancer was used to measure cumulative smoking exposure, 28% (95% uncertainty interval 24–31%) of all adult male deaths (> 35 years) in Vietnam in 2008 were attributable to smoking. Lower estimates resulted from prevalence-based methods [24% (95% uncertainty interval 21–26%)] with the hybrid method yielding intermediate estimates [26% (95% uncertainty interval 23–28%)].

Conclusion

Despite uncertainty in these estimates of attributable mortality, tobacco smoking is already a major risk factor for death in Vietnamese men. Given the high current prevalence of smoking, this has important implications not only for preventing the uptake of tobacco but also for immediate action to adopt and enforce stronger tobacco control measures.     

Prevalence and associated factors of intention to participate in HIV voluntary counseling and testing for the first time among men who have sex with men in Hong Kong,China

Objective

We investigated the prevalence and associated factors of men who have sex with men (MSM) and had never participated in Human Immunodeficiency Virus (HIV) voluntary counseling and testing (VCT) but intended to do so in the next six months.

Method

An anonymous cross-sectional survey interviewed 577 MSM in Hong Kong, China, face-to-face or through an electronic questionnaire.

Results

We identified 245 MSM who had never participated in VCT (never-testers), among whom 12.7% intended to do so in the next six months. Factors associated positively with high behavioral intention were: 1) perceived necessity to participate in HIV test regularly (multivariate odds ratios (ORm) = 4.54, 95% confidence interval (CI): 1.30–15.83), 2) perception that > 20% of the local MSM had participated in VCT (ORm = 17.86, 95% CI: 1.89–169.08) and 3) perceived higher chance to have sex with people living with HIV (PLWH) in the next six months (ORm = 2.92, 95% CI: 1.08–7.93). Negatively associated factors were: local residency (ORm = 0.06, 95% CI: 0.01–0.34) and perceived higher chance of having unprotected anal intercourse (UAI) in the next six months (ORm = 0.27, 95% CI: 0.09–0.84). In addition, no interaction term between the independent variable and UAI status was found to be statistically significant.

Conclusion

Many sampled never-testers had low intention to take up VCT and were in the pre-contemplation stage of the Transtheoretical Model. Stage-matched promotions are warranted.     

Prevalence of metabolic syndrome and its influencing factors among the Chinese adults: The China Health and Nutrition Survey in 2009

Objective

We aimed to estimate the up-to-date prevalence of metabolic syndrome (MS) and its influencing factors among the Chinese adults.

Methods

Data were obtained from the China Health and Nutrition Survey conducted in 2009, which was a cross-sectional and partially nationally representative study including a total of 7488 Chinese adults (age ≥ 18 years).

Results

The overall age-standardized prevalence estimates of the MS were 21.3% (95%confidence interval (CI): 20.4%–22.2%), 18.2% (95%CI: 17.3%–19.1%) and 10.5% (95%CI: 9.8%–11.2%) based on definitions of revised NCEP ATPIII, IDF and CDS criteria, respectively. Individuals who were women (compared to men: odds ratio [OR] = 1.37, 95% CI = 1.16–1.61), 40 years or older (compared to less than 40 years old: OR = 2.82, 95%CI = 2.37–3.34 for 40–59 years; OR = 4.41, 95%CI = 3.68–5.29 for 60 years or older), overweight/obese (compared to normal weight: OR = 4.32, 95%CI = 3.77–4.95 for overweight; OR = 11.24, 95%CI = 9.53–13.26 for obese), and living in urban area (compared to living in rural area: OR = 1.27, 95%CI = 1.12–1.43) were more likely to have a higher prevalence estimate of MS. In addition, frequency of alcohol consumption and cigarette intake were also found to be significantly associated with probability of MS.

Conclusions

Our results suggest an urgent need to develop national strategies for the prevention, detection, treatment and control of obesity and MS in China.     

Exploring the risk factors for vaccine-associated and non-vaccine associated febrile seizures in a large pediatric cohort

Introduction

It is not known whether there are underlying physiologic or immunologic differences between febrile seizures (FS) triggered by vaccines versus other causes. Furthermore, while secular and individual-level factors have been associated with FS risk, they are rarely evaluated simultaneously.

Methods

Subjects included members of Kaiser Permanente Southern California aged 6 months to 3 years from July 1, 2003–December 31, 2011. Primary outcome was first diagnosis of FS. Vaccine-associated (VA) FS were defined as those occurring from day 0 to day 15 following any vaccine; non-vaccine associated (NVA) FS were those outside this period. We compared incidence rates of VA-FS versus NVA-FS. Poisson regression was used to assess the association between FS and secular and individual-level factors. We also evaluated interactions between vaccine exposure and each model covariate on the risk of FS.

Results

Among 265,275 children, 3348 FS were identified; 383(11%) were VA-FS, and 2965(89%) were NVA-FS. Incidence rates were 2.73 and 2.05 per 100,000 person-days for VA-FS and NVA-FS, respectively. Multivariable analyses confirmed previously reported increased risk of FS by age, low gestational age, and winter months. Increased risk was also associated with VA exposure (RR = 1.63[95% CI: 1.27–2.11]), non-White race/ethnicity vs. White (African-American RR = 1.41[1.22–1.63]; Asian RR = 1.58[1.40–1.79]; Hispanic RR = 1.60[1.47–1.75]), and maternal age 29 years or less vs. 40+ years (≤19 years RR = 1.28[1.00–1.65]; 20–29 years RR = 1.21[1.02–1.42]). Females were at lower risk of NVA-FS (RR = 0.77[0.72–0.83]), but were similar to males for VA-FS (RR = 0.97[0.79–1.19]). Children with low 1 min Apgar scores (≤3) had increased risk of VA-FS (RR = 3.40[1.86–6.22]), but no increased risk for NVA-FS (RR = 1.05[0.69–1.60]) compared to children with normal Apgar scores (≥7).

Discussion

This study suggests that there may be immunogenetic differences underlying VA-FSs compared with other FSs. However, further studies are needed. An understanding of the mechanisms behind these findings may help improve vaccine design or policies.