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  1. 201
    Peer Reviewed

    Advanced Prescription of Emergency Contraceptive Pills Among Adolescents and Young Adults.

    Santibenchakul S; Tschann M; Carlson ADP; Hurwitz EL; Salcedo J

    Southern Medical Journal. 2019 Mar; 112(3):180-184.

    OBJECTIVE: To examine healthcare providers' adherence to professional recommendations for advanced prescription of emergency contraceptive pills (ECPs). METHODS: We conducted a retrospective chart review of 432 visits by 282 unique nonpregnant women 14 to 25 years of age seen at an obstetrics and gynecology teaching clinic to determine the percentage of visits during which advanced prescriptions of ECPs were provided when indicated. A logistic regression model, which accounted for nonindependent observations through generalized estimating equations, was used to identify factors associated with the provision of ECP advanced prescriptions. RESULTS: Approximately one-fifth of eligible visits (19.9%) and eligible patients (19.1%) had documentation of an ECP advanced prescription when indicated. Healthcare providers in this clinical setting were more likely to prescribe ECPs to adolescents and women whose primary contraceptive methods were associated with higher failure rates in typical use, such as condoms. Compared with women aged 20 to 25 years, the adjusted odds ratio of receiving an advanced prescription for ECPs was 5.94 (95% confidence interval [CI] 2.85-12.41) for adolescents. Compared with users of depot medroxyprogesterone acetate, the adjusted odds ratio was 4.25 (95% CI 1.62-11.15) for condom users, and 3.90 (95% CI 1.54-9.86) for users of other short-term hormonal contraceptives. CONCLUSIONS: Despite clear professional recommendations for ECP advanced prescriptions for all women at risk for unintended pregnancy, a substantial gap exists between this standard of care and routine clinical service provision in an obstetrics and gynecology teaching clinic.
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  2. 202
    Peer Reviewed

    Segesterone acetate/Ethinyl estradiol 12-month contraceptive vaginal system safety evaluation.

    Gemzell-Danielsson K; Sitruk-Ware R; Creinin MD; Thomas M; Barnhart KT; Creasy G; Sussman H; Alami M; Burke AE; Weisberg E; Fraser I; Miranda MJ; Gilliam M; Liu J; Carr BR; Plagianos M; Roberts K; Blithe D

    Contraception. 2019 Mar 1;

    OBJECTIVES: To evaluate safety outcomes from clinical studies of a 12-month contraceptive vaginal system (CVS) releasing an average of segesterone acetate (SA) 150 mcg and ethinyl estradiol (EE) 13 mcg daily. STUDY DESIGN: We integrated clinical safety data from nine studies in which women used the CVS for 21 consecutive days and removed it for 7days of each 28-daycycle. Four studies used the final manufactured CVS, including a one-year pharmacokinetic study, two one-year phase 3 trials, and a second-year treatment extension study. We assessed safety by evaluating adverse events women reported in a daily diary. We also included data from focused safety studies evaluating endometrial biopsies, vaginal microbiology, and liver proteins from one of the phase 3 studies. RESULTS: The combined studies included 3052 women; 2308 women (mean age 26.7+/-5.1years; mean BMI 24.1+/-3.7kg/m(2)) received the final manufactured CVS of whom 999 (43.3%) completed 13cycles of use. Women using the final CVS most commonly reported adverse events of headache (n=601, 26%), nausea (n=420, 18%), vaginal discharge/vulvovaginal mycotic infection (n=242,10%), and abdominal pain (n=225, 10%). Few (<1.5%) women discontinued for these complaints. Four (0.2%) women experienced venous thromboembolism (VTE), three of whom had risk factors for thrombosis (Factor V Leiden mutation [n=1]; BMI>29kg/m(2) [n=2]). During 21,482 treatment cycles in the phase 3 studies evaluable for expulsion, women reported partial expulsions in 4259 (19.5%) cycles and complete expulsions in 1509 (7%) cycles, most frequently in the initial cycle (499/2050 [24.3%] and 190/2050 [9.3%], respectively). Safety-focused studies revealed no safety concerns. CONCLUSION: The one-year SA/EE CVS has an acceptable safety profile. Additional studies are warranted in obese women at higher risk of VTE. IMPLICATIONS: This one-year contraceptive vaginal system represents a new long-term, user-controlled, and procedure-free option with a safety profile similar to other combination hormonal contraceptives. The same precautions currently used for combination hormonal contraceptive prescriptions apply to this new contraceptive vaginal system.
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  3. 203
    Peer Reviewed

    Bleeding and spotting with the levonorgestrel 13.5mg intrauterine system: the impact of insertion timing.

    Shimoni N; Choudhury T; Goldman A; Frondelli M; Chen PH

    Contraception. 2019 Mar 1;

    OBJECTIVE: To assess the impact of early versus late menstrual cycle insertion on bleeding/spotting in the 90days following levonorgestrel (LNG) 13.5mg intrauterine system (IUS) insertion. STUDY DESIGN: In this observational study, participants received a LNG 13.5mg IUS and provided 90days of bleeding/spotting data by answering the following daily text: "Have you had no flow (0), spotting (1), or bleeding (2) today?" We dichotomized insertion timing as early (days 1-7 from LMP) and late (remainder of menstrual cycle) and compared bleeding/spotting between the two groups in the 90- and 30-day reference periods. We used multivariate regression methods to study associations between cycle day at insertion, parity, historical bleeding, recent hormonal contraceptive use and bleeding/spotting. RESULTS: In the 90-day dichotomous analysis (n=125), we found no differences in the number of days of bleeding/spotting, bleeding, or spotting between the early and late insertion groups. In the 30-day dichotomous analysis (n=131), early insertion was associated with fewer days of bleeding than late insertion (5+/-3 vs. 7+/-4days, p=.009). Recent hormonal contraceptive users experienced fewer days of bleeding than new users (5+/-4 vs. 7+/-3days, p=.002). In the 90- and 30-day regression models, earlier insertion was associated with fewer days of bleeding (p=.019, p=.018). Recent contraceptive use was associated with fewer days of bleeding/spotting (90-day, p=.026) and fewer days of bleeding (30-day, p=.002). Nulliparity was associated with spotting (30-day, p=.039). CONCLUSIONS: Early cycle insertion does not impact 90-day bleeding/spotting. Early cycle insertion and recent hormonal contraceptive use decrease 30-day bleeding. IMPLICATIONS: The LNG 13.5mg IUS may be inserted throughout the menstrual cycle with small differences in bleeding patterns in the 30 but not the 90days following insertion. Shared decision making should determine timing of insertion.
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  4. 204
    Peer Reviewed

    Predictors of condom use behavior among men who have sex with men in China using a modified information-motivation-behavioral skills (IMB) model.

    Jiang H; Chen X; Li J; Tan Z; Cheng W; Yang Y

    BMC Public Health. 2019 Mar 4; 19(1):261.

    BACKGROUND: Men who have sex with men (MSM) are at high risk for human immunodeficiency virus (HIV) infection in China. Correct and consistent condom use is one of the most effective strategies for preventing the spread of HIV. This study developed a modified Information-Motivation-Behavioral Skills (IMB) model to predict condom use behavior among Chinese MSM. METHODS: A cross-sectional study was conducted to collect data using self-administered electronic questionnaire. Participants were recruited from HIV Voluntary Counseling and Testing clinics in six district Centers for Disease Control and Prevention in Guangzhou and two community-based HIV service centers (Lingnan Partners and Zhitong Charity) from May to September 2017. Structural equation modeling was performed to develop the modified IMB model with extended multilevel factors. RESULTS: Among the 976 MSM included, 52.05% had engaged in anal intercourse with a condom every time. The final modified IMB model fitted the data more ideally than the conventional model. The final modified IMB model revealed that behavioral skills positively contributed directly to condom use (beta = 0.385, p < 0.001) and partially mediated the associations between information (beta = 0.106, p = 0.005) and motivation (beta = 0.390, p < 0.001) and condom use. Regarding the extended multilevel factors, education, income, receiving HIV prevention services, sexual partner seeking behavior, depression, intimate partner violence, and child sexual abuse had indirect impacts on condom use that were mediated by information, motivation, and/or behavioral skills (p < 0.05). All paths from the latent variable to the corresponding observed variables were statistically significant (p < 0.001). CONCLUSION: The modified IMB model with extended multilevel factors could serve as a theoretical framework for behavioral interventions for condom use among Chinese MSM. Further prospective studies are needed to examine the predictive power of the modified IMB model.
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  5. 205
    Peer Reviewed

    Contraceptive use intentions and unmet need for family planning among reproductive-aged women in the Upper East Region of Ghana.

    Bawah AA; Asuming P; Achana SF; Kanmiki EW; Awoonor-Williams JK; Phillips JF

    Reproductive Health. 2019 Mar 4; 16(1):26.

    BACKGROUND: Motivations for use of contraceptives vary across populations. While some women use contraceptives for birth spacing, others adopt contraception for stopping childbearing. As part of efforts to guide the policy framework to promote contraceptive utilization among women in Ghana, this paper examines the intentions for contraceptive use among reproductive-aged women in one of the most impoverished regions of Ghana. METHODS: This paper utilizes data collected in 2011 from seven districts in the Upper East Region of northern Ghana to examine whether women who reported the use of contraceptives did so for the purposes of stopping or spacing childbirth. A total of 5511 women were interviewed on various health and reproductive health related issues, including fertility and family planning behavior. Women were asked if they would like to have any more children (for those who already had children or those who were pregnant at the time of the survey). RESULTS: The prevalence of contraceptive use was low at 13%, while unmet need is highly pervasive and demand for family planning is predominantly for spacing future childbearing rather than for the purpose of stopping. Overall, about 31.7%of women not using contraceptives reported a need for spacing while 17.6% expressed a need for limiting. Thus, the latent demand for family planning is dominated by preferences for space rather than limiting childbearing. CONCLUSION: Results show that there is latent demand for family planning and therefore if family planning programs are appropriately implemented they can yield the desired impact.
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  6. 206

    Dyslipidemia and associated factors among women using hormonal contraceptives in Harar town, Eastern Ethiopia.

    Sufa B; Abebe G; Cheneke W

    BMC Research Notes. 2019 Mar 4; 12(1):120.

    OBJECTIVE: Dyslipidemia is abnormal amount of lipid in blood. Hormonal contraceptives affect lipid metabolism and can enhance the risk of vascular disease like atherosclerosis. In Harar, among contraceptive users, biochemical changes follow up is almost none and magnitude of dyslipidemia is not known. Therefore this study is designed to determine prevalence of dyslipidemia and its predisposing factors. Accordingly, cross-sectional study was conducted from April to June 2014 among hormonal contraceptive users from three health centers and one hospital. Socio-demographic data, anthropometric measurements, and blood biochemical tests were performed for every participant. Descriptive statistics and logistic regression analysis with 95% confidence interval using SPSS was used. RESULT: Totally 365 participants were included and the prevalence of dyslipidemia was 34.8%. The mean levels +/- standard deviation of total cholesterol, low density lipoprotein (LDL), high density lipoprotein (HDL), the total cholesterol to HDL ratio, and triglyceride were 186 +/- 27 mg/dl, 121 +/- 31 mg/dl, 45.21 +/- 7.7 mg/dl, 4.44, and 108 +/- 3.45 mg/dl, respectively. Age, fasting blood sugar, drinking coffee twice and eating no vegetables 4 times/week were identified as predictors of dyslipidemia. In conclusion, hormonal contraceptive users of Harar have high rate of dyslipidemia. This result emphasizes the urgent need for a public health strategy for prevention, early detection, and treatment of dyslipidemia.
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  7. 207
    Peer Reviewed

    Unintended Pregnancy among Pregnant Women in Ghana: Prevalence and Predictors.

    Nyarko SH

    Journal of Pregnancy. 2019; 2019:2920491.

    Background: Unintended pregnancy is seen as the key concept for better understanding the fertility and the unmet need for family planning of populations. It is seen as a major challenge among women in many developing countries including Ghana. However, there is scarcely nationally representative information on its prevalence and predictors in Ghana. Methods: In a cross-sectional study design, data for this study were extracted from the 2014 Ghana Demographic and Health Survey. The prevalence of unintended pregnancies was computed, and logit regression models were fitted to predict the factors influencing unintended pregnancies in the country. Results: The total prevalence of unintended pregnancies among pregnant women in Ghana was found to be 40%. Background characteristics such as age (OR=4.85, CI=1.48-15.84), level of education (OR=0.50, CI=0.26-1.01), marital status (OR=3.83, CI=1.67-8.75), parity (OR=0.13, CI=0.05-0.32), and region of residence (OR=0.11, CI=0.03-0.31) were the significant predictors of unintended pregnancy, net of unmet need for contraception. However, unmet need for contraception (OR=7.13, CI=1.57-8.91) serves as an independently significant predictor of unintended pregnancy regardless of the background characteristics of respondents. Conclusions: The study findings strongly underscore the need for significant improvement in the access to contraception methods and family planning information in the quest to considerably reduce unintended pregnancies in the entire country.
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  8. 208
    Peer Reviewed

    A New Year-Long Combination Hormonal Contraceptive.

    Blakely KK

    Nursing For Women's Health. 2019 Mar 2;

    The U.S. Food and Drug Administration approved a new combination hormonal contraceptive in August 2018. Sold under the brand name Annovera, it is a combination of segesterone acetate and ethinyl estradiol, and it is the first multiuse vaginal contraceptive system that prevents ovulation for up to 13 menstrual cycles in a year. Although there are several combination hormonal contraceptives on the market, this is the first single system that can be repeatedly used for an entire year and does not require placement by a health care provider. This innovation gives women control over when to stop using the contraceptive, should they so desire. Annovera is stored at room temperature when not in use, allowing women living in uncontrolled-temperature climates to use one contraceptive method for an entire year.
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  9. 209
    Peer Reviewed

    Emergency Contraception Use in School-Based Health Centers: A Qualitative Study.

    Fink GN; Dean G; Nucci-Sack A; Arden M; Lunde B

    Journal of Pediatric and Adolescent Gynecology. 2019 Apr; 32(2):175-181.

    STUDY OBJECTIVE: To understand contraceptive behaviors and decision-making in school-based health center (SBHC) female patients who have used emergency contraception (EC). DESIGN: Qualitative interviews and questionnaires. SETTING: SBHCs. PARTICIPANTS: Female adolescents, who self-reported EC use, were recruited from SBHCs. INTERVENTIONS: Interviews were conducted until thematic saturation was reached on the following themes: reasons for selecting EC, perceived EC efficacy, reasons for use, nonuse, or inconsistent use of nonemergent contraception (NEC), and beliefs surrounding pregnancy risk. MAIN OUTCOME MEASURES: The team used a modified grounded theory approach and open coding technique to identify common themes. Participants completed a questionnaire to assess demographic information and EC knowledge. RESULTS: Twenty-eight interviews were completed. Reasons for using EC include not using another contraceptive method, using another method incorrectly, or in combination with another method for added protection. Reasons for EC preference include ease of administration, ease of access, minimal side effects, perceived high efficacy, and because it can be used discreetly. Use of NEC was supported by identifying it as more effective, increased sexual experience and anticipation of sex, belief that excess EC decreases efficacy or is detrimental to health, and social interactions. Participants reported having used EC a mean of 3.5 times. Eighteen of 28 participants (65%) incorrectly believed that EC is 90%-99% effective, and 15 of 28 participants (53%) correctly identified ovulation inhibition as the mechanism of action. CONCLUSION: EC use is promoted by ease of access and administration, experiencing minimal side effects, and perceived high efficacy. Compliance issues with NEC and condoms and a desire for a discreet contraceptive method support EC use.
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  10. 210
    Peer Reviewed

    Utilization of modern contraceptives and predictors among women in Shimelba refugee camp, Northern Ethiopia.

    Seyife A; Fisseha G; Yebyo H; Gidey G; Gerensea H

    PloS One. 2019; 14(3):e0212262.

    Women living in refugee camps, in addition to the common hardships, such as drought, and famine, are also prone to another peculiar problem: an unintended pregnancy. The impact of unintended pregnancy is so severe that the rate of women who die or suffer an injury while giving birth in crisis settings is almost double the world average death rate. Thus, this study was aimed to investigate the utilization of modern contraceptive and associated factors among women in the reproductive age group in Shimelba refugee camp, Northern Ethiopia. A community-based cross-sectional study was employed and 329 study subjects were selected using simple random sampling technique with a face-to-face interview. The prevalence of using modern contraceptive was 47.7% and the study showed that being older [AOR = 0.017, 95%CI: 0.001, 0.467], being single [AOR = 0.17, 95%CI:0.031,0.914], being unemployed [AOR = 0.21, 95% CI:0.001,0.392], having no partner support [AOR = 0.006, 95% CI:0.001,0.044], and inconvenient service site AOR = 0.089,95% CI:0.013, 0.595] were factors that contributed to women not using modern contraceptive methods. Receipt of counseling on family planning utilization was more likely to helps women to use it [AOR = 3.37, 95% CI: 1.1095, 10.236]. Our study concluded that the current prevalence rate of contraceptive use is fairly good. However, much effort has to be made to improve this result. The situations in refugee can exacerbate the existing barriers to the use of contraceptives. Given its grave consequence on the livelihood of women, the contraceptive issue should be given due emphasis using several techniques including education to expand the awareness on modern contraceptive so as to augment access to family planning.
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  11. 211
    Peer Reviewed

    Empowering HIV-infected women in low-resource settings: A pilot study evaluating a patient-centered HIV prevention strategy for reproduction in Kisumu, Kenya.

    Mmeje O; Njoroge B; Wekesa P; Murage A; Ondondo RO; van der Poel S; Guze MA; Shade SB; Bukusi EA; Cohan D; Cohen CR

    PloS One. 2019; 14(3):e0212656.

    BACKGROUND: Female positive/male negative HIV-serodiscordant couples express a desire for children and may engage in condomless sex to become pregnant. Current guidelines recommend antiretroviral treatment in HIV-serodiscordant couples, yet HIV RNA viral suppression may not be routinely assessed or guaranteed and pre-exposure prophylaxis may not be readily available. Therefore, options for becoming pregnant while limiting HIV transmission should be offered and accessible to HIV-affected couples desiring children. METHODS: A prospective pilot study of female positive/male negative HIV-serodiscordant couples desiring children was conducted to evaluate the acceptability, feasibility, and effectiveness of timed vaginal insemination. Eligible women were 18-34 years with regular menses. Prior to timed vaginal insemination, couples were observed for two months, and tested and treated for sexually transmitted infections. Timed vaginal insemination was performed for up to six menstrual cycles. A fertility evaluation and HIV RNA viral load assessment was offered to couples who did not become pregnant. FINDINGS: Forty female positive/male negative HIV-serodiscordant couples were enrolled; 17 (42.5%) exited prior to timed vaginal insemination. Twenty-three couples (57.5%) were introduced to timed vaginal insemination; eight (34.8%) achieved pregnancy, and six live births resulted without a case of HIV transmission. Seven couples completed a fertility evaluation. Four women had no demonstrable tubal patency bilaterally; one male partner had decreased sperm motility. Five women had unilateral/bilateral tubal patency; and seven women had an HIV RNA viral load (>/= 400 copies/mL). CONCLUSION: Timed vaginal insemination is an acceptable, feasible, and effective method for attempting pregnancy. Given the desire for children and inadequate viral suppression, interventions to support safely becoming pregnant should be integrated into HIV prevention programs.
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  12. 212
    Peer Reviewed

    Constructing contentious and noncontentious facts: How gynecology textbooks create certainty around pharma-contraceptive safety.

    Bertotti AM; Miner SA

    Social Studies of Science. 2019 Mar 7; 306312719834676.

    Using critical discourse analysis, we examine how seven popular gynecology textbooks use sociolinguistic devices to describe the health effects of pharma-contraception (intrauterine and hormonal methods). Though previous studies have noted that textbooks generally use neutral language, we find that gynecology textbooks differentially deployed linguistic devices, framing pharma-contraceptive benefits as certain and risks as doubtful. These discursive strategies transform pharma-contraceptive safety into fact. We expand on Latour and Woolgar's concept of noncontentious facts by showing how some facts that are taken for granted by the medical community still require discursive fortification to counter potential negative accusations from outside the profession. We call these contentious facts. Our findings suggest that a pro-pharma orientation exists in gynecology textbooks, which may influence physicians' understanding of pharmaceutical safety. As such, these texts may affect medical practice by normalizing pharma-contraceptives without full considerations of their risks.
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  13. 213
    Peer Reviewed

    Concurrence and selection of sexual partners as predictors of condom use among Mexican indigenous migrant workers.

    Caballero-Hoyos JR; Monarrez-Espino J

    Revista de Salud Publica. 2018 May-Jun; 20(3):293-300.

    OBJECTIVE : To identify if the selection of mixed sexual partners and the existence of concurrent partners are predictors of condom use in indigenous migrant agricultural workers from Colima, Mexico. METHODS : Analytical cross-sectional study using an egocentric sexual network approach. Community interviewers applied a structured questionnaire to 192 indigenous migrant workers in a sugarcane agro-industrial context. Data were analyzed with binary logistic regression; odds ratios (OR) and 95% confidence intervals (CI 95%) were estimated. RESULTS : In the logistic regression model, adjusted odds (OR; 95% CI) of steady condom use were lower within partnerships of the same indigenous ethnicity compared to other partnerships (0.30; 0.17-0.53), partnerships that were concurrent to other partnerships (0.27; 0.15-0.50), and partnerships that used illegal drugs during sex to other partnerships (0.23; 0.11-0.49). Those variables were actually associated with increased risk of unprotected sex (occasionally or never using condoms), and therefore exposures were unprotected. CONCLUSION : Sexual partners of the same ethnicity, concurrent partnerships and partnerships that use illegal drugs favor the low frequency of constant condom use and, in turn, the vulnerability to STIs and HIV transmission in indigenous migrant agricultural workers.
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  14. 214
    Peer Reviewed

    Helping patients select long-acting reversible contraceptives.

    Sierra T

    JAAPA. 2019 Mar 5;

    To reduce the rate of unintended pregnancies, patients should select a contraceptive option that fits their needs and lifestyle. Long-acting reversible contraceptives (LARCs) are a relatively safe and effective option. This article outlines the characteristics of available LARCs and identifies the appropriate method for specific patient populations.
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  15. 215
    Peer Reviewed

    Association Between the Quality of Contraceptive Counseling and Method Continuation: Findings From a Prospective Cohort Study in Social Franchise Clinics in Pakistan and Uganda.

    Chakraborty NM; Chang K; Bellows B; Grepin KA; Hameed W; Kalamar A; Gul X; Atuyambe L; Montagu D

    Global Health, Science and Practice. 2019 Mar 7;

    Quality of family planning counseling is likely associated with whether or not women continue to use the same contraceptive method over time. The Method Information Index (MII) is a widely available measure of contraceptive counseling quality but little is known about its association with rates of method continuation. The index ranges from 0 to 3 based on a client's answer to whether she was told about other methods, potential side effects with her chosen method, and what to do if she experienced side effects. Using data from a prospective cohort study of 1,998 social franchise clients in Pakistan and Uganda, we investigated the relationship between reported baseline MII and the risk of method continuation over 12 months using survival analysis and Cox proportional hazard models. At baseline, about 65% of women in Pakistan and 73% of women in Uganda reported receiving information about all 3 MII aspects. In Pakistan, 59.4% of the 165 women who stopped using their modern method did so while still in need of contraception. In Uganda, of the 77 women who stopped modern method use, 64.9% discontinued while in need. Despite important differences in the demographics and method mix between the 2 countries, we found similar associations between baseline MII and discontinuation: in both countries as the MII score increased, the risk of discontinuation while in need decreased. In Pakistan, the risk of contraceptive discontinuation was 64% lower (crude hazard ratio [HRcrude]=0.36; P=.03), and 72% lower (HRcrude=0.28; P=.007), among women who were told about any 2, or any 3 aspects of MII, respectively. After adjusting for additional covariates, only the difference in the risk of contraceptive discontinuation between MII=3 and MII=0 remained statistically significant (HRadj=0.35; P=0.04). In Uganda, women who reported being informed about all aspects of MII were 80% less likely to discontinue while in need (HRadj=0.20; P<.001), women informed about any 2 aspects of MII were 90% less likely (HRadj=0.10; P<.001), and women who were informed about any 1 aspect of MII were 68% less likely (HRadj=0.32; P<.02) to discontinue contraceptive use while in need as compared to women who reported not being informed about any aspect of MII. Baseline MII scores were positively associated with method continuation rates in our sample of clients from social franchises in both Pakistan and Uganda and could potentially be used as an indicator of contraceptive counseling quality.
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  16. 216

    Electrospun Transdermal Patch for Contraceptive Hormone Delivery.

    Mofidfar M; Prausnitz MR

    Current Drug Delivery. 2019 Mar 7;

    BACKGROUND: A transdermal patch for delivery of levonorgestrel (LNG) can be used for long-acting contraception. OBJECTIVE: In this study, we designed and characterized a patch made of nonwoven electrospun microfibers comprised of polycaprolactone (PCL) encapsulating LNG for slow release in a mineral oil matrix. METHODS AND RESULTS: Scanning electron microscopy showed uniform, randomly oriented PCL fibers with large interconnected voids filled with mineral oil. Thermogravimetric analysis indicated that LNG loaded into PCL fibers had thermal stability up to ~200 degrees C. Differential scanning calorimetry suggested that LNG was dispersed in the electrospun fibers without interaction between the LNG and PCL, and without formation of drug crystals. Fourier transform infrared spectrometry and X-ray diffraction results further supported the conclusion that there was no chemical drug-polymer interaction in LNG-loaded fibers. Effective in vitro flux (i) from patches into mineral oil was 1.9 microgcm-2h-1, (ii) from mineral oil across porcine skin was 4.6 microg cm-2 h-1 and (iii) from patches across porcine skin was 1.7 microgcm-2h-1, indicating that transdermal delivery rate was controlled by a combination of the patch and the skin. CONCLUSION: The LNG-loaded patches demonstrated steady delivery of LNG across skin for up to 5 days in vitro. With additional development, LNG-loaded electrospun PCL patches could be used for long-acting contraception.
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  17. 217
    Peer Reviewed

    Acceptability of the Woman's condom in a phase III multicenter open-label study.

    Chen BA; Blithe DL; Muraguri GR; Lance AA; Carr BR; Jensen JT; Kimble TD; Murthy AS; Schreiber CA; Thomas MA; Walsh TL; Westhoff C; Burke AE

    Contraception. 2019 Mar 5;

    OBJECTIVE: To evaluate the acceptability of the Woman's Condom (WC) over 6months (183days) and>/=6 menstrual cycles in a U.S.-based multicenter open-label Phase III contraceptive efficacy trial. STUDY DESIGN: We assessed acceptability via written questionnaire at Visit 2 (after the 3rd cycle) and Visit 3 (after the 6th cycle or>183days, or upon early discontinuation). Key domains included ease of use, comfort/lubrication, sexual satisfaction, male partner satisfaction, and confidence in pregnancy and sexually transmitted infection (STI) prevention. We analyzed quantitative data using descriptive statistics. We conducted a content analysis to identify major themes from four open-ended questions. RESULTS: Most women (327/405 (81%) had limited or no previous experience with female (internal) condoms. Of 405 evaluable women, 346 women completed questionnaires at Visit 2 and 303 women at Visit 3; 282 women attended both visits. Of women attending both visits, 165/282 (59%) reported at Visit 2 that WC insertion was easy/very easy; this increased to 195/282 (69%) at Visit 3 (p=.03). Many women (166/281 (59%)) preferred the WC (105/281 (37%)) or were neutral (61/281 (22%)) while 115/281 (41%) preferred male condoms. Women attending Visit 3 felt confident that the WC could prevent pregnancy (246/303 (81%)) and STIs (217/303 (72%)). Many women expressed empowerment with having control over their contraception; some disliked the design, esthetics, and insertion process. Most women (254/299 (85%)) would recommend the WC to a friend. CONCLUSION: The WC's acceptability and ease of use is promising for wider dissemination as a female-controlled method that can protect against both pregnancy and STIs. IMPLICATIONS: The Woman's Condom's overall acceptability and ease of use is promising for a new female-controlled barrier contraceptive option that can protect against both pregnancy and sexually transmitted infections.
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  18. 218
    Peer Reviewed

    Reports of Two Broken Nexplanon(R) Rods.

    Campodonico J; Wolfrey J; Buchanan J

    Journal of the American Board of Family Medicine. 2019 Mar-Apr; 32(2):269-271.

    Damage to progestin containing contraceptive implants has been reported for Implanon(R) rods but there appear to be few reports of damage to Nexplanon(R) rods. This report describes 2 cases of Nexplanon(R) rod breakage in an 18-year-old female and a 25-year-old female. The literature regarding damaged progestin implants is reviewed. These reports often involve an alteration in menstrual bleeding pattern and patients frequently request removal of bent or broken implants. The overall incidence of rod breakage and impact of damaged implants on contraceptive efficacy is not clear. Evidence based guidelines to inform management of suspected damage to contraceptive implants would be helpful. In the meantime, a shared decision-making process offering removal and replacement of damaged implants would seem reasonable.
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  19. 219
    Peer Reviewed

    Coital frequency and condom use in age-disparate partnerships involving women aged 15 to 24: evidence from a cross-sectional study in KwaZulu-Natal, South Africa.

    George G; Maughan-Brown B; Beckett S; Evans M; Cawood C; Khanyile D; Govender K; Kharsany AB

    BMJ Open. 2019 Mar 9; 9(3):e024362.

    OBJECTIVE: This study examines the role of age-disparate partnerships on young women's HIV risk by investigating coital frequency and condom use within age-disparate partnerships involving women aged 15 to 24. DESIGN: A community-based, cross-sectional study was conducted. SETTING: Participants were randomly selected using a two-stage random sampling method in uMgungundlovu district, KwaZulu-Natal, South Africa, between June 2014 and June 2015. PARTICIPANTS: A total of 1306 15-24-year-old women in an ongoing heterosexual partnership were included in the analysis. Participants had to be a resident in the area for 12 months, and able to provide informed consent and speak one of the local languages (Zulu or English). PRIMARY AND SECONDARY OUTCOME MEASURES: Sexual frequency was assessed by asking participants how many times they had sex with each partner in the past 12 months. The degree of condomless sex within partnerships was assessed in the survey by asking participants how often they used a condom with their partners. RESULTS: Age-disparate partnerships were associated with a higher order category (once, 2-5, 6-10, 11-20, >20) of coital frequency (adjusted OR (aOR) 1.32, p<0.05, 95% CI 1.02 to 1.71) and with sex on more than 10 occasions (aOR 1.48, p<0.01, 95% CI 1.12 to 1.96) compared with age-similar partnerships. Age-disparate partnerships were also more likely to involve sex on more than 10 occasions with inconsistent condom use (aOR 1.43, p<0.05, 95% CI 1.04 to 1.96) in the previous 12 months. CONCLUSION: The finding that increased sexual activity is positively associated with age-disparate partnerships adds to the evidence that age-disparate partnerships pose greater HIV risk for young women. Our study results indicate that interventions to reduce risky sexual behaviour within age-disparate partnerships remain relevant to reducing the high HIV incidence rates among adolescent girls and young women.
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  20. 220
    Peer Reviewed

    Global burden of maternal and congenital syphilis and associated adverse birth outcomes-Estimates for 2016 and progress since 2012.

    Korenromp EL; Rowley J; Alonso M; Mello MB; Wijesooriya NS; Mahiane SG; Ishikawa N; Le LV; Newman-Owiredu M; Nagelkerke N; Newman L; Kamb M; Broutet N; Taylor MM

    PloS One. 2019; 14(2):e0211720.

    BACKGROUND: In 2007 the World Health Organization (WHO) launched the global initiative to eliminate mother-to-child transmission of syphilis (congenital syphilis, or CS). To assess progress towards the goal of <50 CS cases per 100,000 live births, we generated regional and global estimates of maternal and congenital syphilis for 2016 and updated the 2012 estimates. METHODS: Maternal syphilis estimates were generated using the Spectrum-STI model, fitted to sentinel surveys and routine testing of pregnant women during antenatal care (ANC) and other representative population data. Global and regional estimates of CS used the same approach as previous WHO estimates. RESULTS: The estimated global maternal syphilis prevalence in 2016 was 0.69% (95% confidence interval: 0.57-0.81%) resulting in a global CS rate of 473 (385-561) per 100,000 live births and 661,000 (538,000-784,000) total CS cases, including 355,000 (290,000-419,000) adverse birth outcomes (ABO) and 306,000 (249,000-363,000) non-clinical CS cases (infants without clinical signs born to un-treated mothers). The ABOs included 143,000 early fetal deaths and stillbirths, 61,000 neonatal deaths, 41,000 preterm or low-birth weight births, and 109,000 infants with clinical CS. Of these ABOs- 203,000 (57%) occurred in pregnant women attending ANC but not screened for syphilis; 74,000 (21%) in mothers not enrolled in ANC, 55,000 (16%) in mothers screened but not treated, and 23,000 (6%) in mothers enrolled, screened and treated. The revised 2012 estimates were 0.70% (95% CI: 0.63-0.77%) maternal prevalence, and 748,000 CS cases (539 per 100,000 live births) including 397,000 (361,000-432,000) ABOs. The estimated decrease in CS case rates between 2012 and 2016 reflected increased access to ANC and to syphilis screening and treatment. CONCLUSIONS: Congenital syphilis decreased worldwide between 2012 and 2016, although maternal prevalence was stable. Achieving global CS elimination, however, will require improving access to early syphilis screening and treatment in ANC, clinically monitoring all women diagnosed with syphilis and their infants, improving partner management, and reducing syphilis prevalence in the general population by expanding testing, treatment and partner referral beyond ANC.
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  21. 221

    Relationship between low maternal vitamin D status and the risk of severe preeclampsia: A case control study.

    Pashapour S; Golmohammadlou S; Behroozi-Lak T; Ghasemnejad-Berenji H; Sadeghpour S; Ghasemnejad-Berenji M

    Pregnancy Hypertension. 2019 Jan; 15:161-165.

    BACKGROUND: Low maternal vitamin D status has been associated with several adverse outcomes during pregnancy. The aim of the study was to evaluate the vitamin D levels in preeclamptic and healthy pregnant women and the role of vitamin D deficiency in the etiology of preeclampsia. METHODS: In this case-control study, 80 preeclamptic women and 80 healthy pregnant women were selected from Motahari hospital in Urmia, Iran. 2ml of venous blood sample was collected from each pregnant woman and the serum 25-OH-D level was measured by Enzyme-Linked Immunosorbent Assay (ELISA) and reported in nanograms per milliliter. levels of 25-OH-D less than 10ngmL(-1), between 10ngmL(-1) and 29ngmL(-1) and more than 30ngmL(-1), were considered as deficient, insufficient and normal 25-OH-D concentrations, respectively. Results were analyzed by independent t-test, Mann-Whitney U test, and logistic regression. RESULTS: Preeclamptic women (n=80) were noted to have decreased total 25-OH-D levels relative to healthy control women (n=80; P=0.01). This difference in total 25-OH-D remained significant after control for potential confounders [odds ratio (OR)=4.79, confidence interval (CI)=1.45-9.87, P=0.01]. CONCLUSION: These results showed that vitamin D deficiency has a statistically significant relationship with preeclampsia and support the hypothesis that vitamin D deficiency may be a risk factor for preeclampsia. Copyright (c) 2019 International Society for the Study of Hypertension in Pregnancy. Published by Elsevier B.V. All rights reserved.
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  22. 222

    Effect of maternal role training program based on Mercer theory on maternal self-confidence of primiparous women with unplanned pregnancy.

    Fasanghari M; Kordi M; Asgharipour N

    Journal of Education and Health Promotion. 2019; 8:4.

    INTRODUCTION: Maternal confidence is an extremely important factor in playing the mother's role and her identity formation. Loss of self-confidence occurs in primiparous women due to the lack of maternal skills. Obtaining the behaviors of maternal role and self-confidence, the mother provides better care for her child. Hence, the aim of this study was to examine the effect of maternal role training program based on Mercer theory on maternal self-confidence of primiparous women with unplanned pregnancy. METHODOLOGY OF THE RESEARCH: This clinical trial was performed on 67 primiparous women referring to Mashhad health centers. Individuals were randomly divided into intervention and control groups. A maternal role training program based on Mercer theory was carried out for intervention group (three sessions of group training in the 34(th), 35(th), and 36(th) weeks of pregnancy and one individual training session before discharge from the hospital and then, weekly follow-up over the phone for 4 weeks). The control group received the normal pregnancy care. The research tools were questionnaires of demographic characteristics, London, DASS 21, Edinburgh Postnatal Depression Scale, Parenting Sense of Competence, General Impressions on Infant Temperament Questionnaire, and Six Simple Questions. Maternal self-confidence was measured before training, 4 weeks after delivery, and 4 months after delivery. Data analysis was carried out using independent t-test, Chi-square test, paired t- test, Mann-Whitney test, one-way ANOVA, and Wilcoxon test. P < 0.05 was considered statistically significant. RESULTS: There was a significant difference between mean maternal self-confidence changes (before training and 4 weeks after delivery (P = 0.003) and before training and 4 months after delivery (P = 0.001) in both groups. After eliminating the effect of interventional variables, the mean scores of maternal self-confidence after training in the intervention group had a statistically significant difference with that in the control group (P = 0.001). CONCLUSIONS: Maternal role training program based on Mercer theory increases maternal self-confidence in primiparous women with unplanned pregnancy. Teaching maternal role is recommended to all health-care providers.
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  23. 223
    Peer Reviewed

    The Socioeconomic and Sexual Health Status of Young People Living in Urban Slum Areas of Kampala, Uganda.

    Kamara JK; Namugambe BM; Egessa R; Kamanga G; Renzaho AMN

    Journal of Urban Health. 2019 Feb 21;

    Slum dweller youth in Kampala, Uganda, face social economic exclusion and a plethora of health risks, and their needs are poorly understood. The aim of the current study was to analyze their needs and to suggest contextual evidence-based solutions to improve their well-being sustainably. We conducted a qualitative study involving 10 focus group discussions (FGDs; N = 113) and 20 key informant (KII) interviews. Emerging themes and sub-themes were identified, defined, reviewed, and organized and narrated following the structuration theoretical framework, which enabled the examination of the inherent capacity of slum dweller youth to make choices independently and the recurrent rules and resources that influence or limit the choices and opportunities available to them. The findings suggest that the slum dweller youth's ability to reach and fulfil their potential remains constrained by a confluence of individual and societal-level factors. The individual factors were poor quality of and dissatisfaction with life, and poor sexual and reproductive health practices. The societal-level factors were poor sexual and reproductive health services, and an extremely weak labor market. The needs of slum dweller youth in Kampala, Uganda, remain unaddressed, and leaving such a large population economically unproductive and dissatisfied with life is a recipe for political instability and insecurity. Interventions to address their needs need to adopt a whole-community approach in order to engage and empower all parts of the slum community and strengthen community structures that improve livelihoods and harness the opportunities that engender income fortification and socio-civic transformation for the youth.
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  24. 224
    Peer Reviewed

    Syphilis in during pregnancy: association of maternal and perinatal characteristics in a region of southern Brazil.

    Padovani C; Oliveira RR; Pelloso SM

    Revista Latino - Americana de Enfermagem. 2018 Aug 9; 26:e3019.

    OBJECTIVE: To analyze the prevalence of syphilis in during pregnancy and its association with socioeconomic characteristics, reproductive history, prenatal and labor care, and newborn characteristics. METHOD: A retrospective, cross-sectional study based on gestational and congenital syphilis reports. A (records) linkage was performed in the Brazilian databases: "Information System for Notifiable Diseases" (Sistema de Informacao de Agravos de Notificacao - SINAN); "Live Births Information System" (Sistema de Informacao sobre Nascidos Vivos - SINASC); and "Mortality Information System" (Sistema de Informacao sobre Mortalidade - SIM). RESULTS: The prevalence of gestational syphilis was 0.57%. The following associations of syphilis in pregnancy were found: non-white skin color/ethnicity (PR=4.6, CI=3.62-5.76); low educational level (PR=15.4; CI=12.60-18.86); and absence of prenatal care (PR=7.4, CI=3.68-14.9). The perinatal outcomes associated with gestational syphilis were prematurity (PR=1.6 CI=1.17-2.21) and low birth weight (PR=1.6; CI=1.14-2.28). Two deaths from congenital syphilis, one death from another cause and five stillbirths were reported. CONCLUSION: The results signify a long way until reaching the World Health Organization's goal of eradicating congenital syphilis.
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  25. 225
    Peer Reviewed

    Lifetime Spousal Violence Victimization and Perpetration, Physical Illness, and Health Risk Behaviours among Women in India.

    Pengpid S; Peltzer K

    International Journal of Environmental Research and Public Health. 2018 Dec 4; 15(12)

    The aim of this study was to assess the association between lifetime spousal violence victimization, spousal violence perpetration, and physical health outcomes and behaviours among women in India. In the 2015(-)2016 National Family Health Survey, a sample of ever-married women (15(-)49 years) (N = 66,013) were interviewed about spousal violence. Results indicate that 29.9% of women reported lifetime spousal physical violence victimization and 7.1% lifetime spousal sexual violence victimization (31.1% physical and/or sexual violence victimization), and 3.5% lifetime spousal physical violence perpetration. Lifetime spousal violence victimization and lifetime spousal violence perpetration were significantly positively correlated with asthma, genital discharge, genital sores or ulcers, sexually transmitted infections (STIs), tobacco use, alcohol use, and termination of pregnancy, and negatively associated with daily consumption of dark vegetables. In addition, lifetime spousal violence victimization was positively associated with being underweight, high random blood glucose levels, and anaemia, and negatively correlated with being overweight or obese. Lifetime spousal violence perpetration was marginally significantly associated with hypertension. The study found in a national sample of women in India a decrease of lifetime physical and/or sexual spousal violence victimization and an increase of lifetime spousal physical violence perpetration from 2005/5 to 2015/6. The results support other studies that found that, among women, lifetime spousal physical and/or sexual spousal violence victimization and lifetime spousal physical violence perpetration increase the odds of chronic conditions, physical illnesses, and health risk behaviours.
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