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1.
Obstet Gynecol ; 140(2): 227-233, 2022 Aug 01.
Artículo en Inglés | MEDLINE | ID: mdl-35852273

RESUMEN

OBJECTIVE: To assess the Pearl Index for risk of ectopic pregnancy in women using levonorgestrel-releasing intrauterine systems (LNG-IUS) with hormonal reservoirs of 13.5 mg, 19.5 mg, or 52 mg. METHODS: This was a retrospective cohort study. Women diagnosed with an ectopic pregnancy in Stockholm County, Sweden, between January 1, 2014, and December 31, 2019, were identified through the electronic medical record system. The final analysis included 2,252 cases of ectopic pregnancy. Information on age, reproductive and medical history, as well as current use of contraception was retrieved. The time of intrauterine device (IUD) insertion before ectopic pregnancy and the numbers of sold LNG-IUS during the study period were used to calculate the incidence rate for ectopic pregnancy during use per 100 woman-years (Pearl Index). RESULTS: Among women with an ectopic pregnancy diagnosis, 105 presented with a known type of hormonal IUD in situ, of whom 94 were included in the calculations of the Pearl Index. The estimated Pearl Index for ectopic pregnancy was 0.136 (95% CI 0.106-0.176) for the LNG-IUS 13.5-mg, 0.037 (95% CI 0.021-0.067) for the LNG-IUS 19.5-mg, and 0.009 (95% CI 0.006-0.014) for the LNG-IUS 52-mg. With the 52-mg LNG-IUS as referent, the relative risk (RR) for ectopic pregnancy was higher during the first year for LNG 13.5-mg (RR 20.59, 95% CI 12.04-35.21), and for both 13.5-mg (RR 14.49, 95% CI 9.01-23.3) and 19.5-mg (RR 4.44, 95% CI 1.64-12.00) during the total study period. CONCLUSION: The absolute risk of ectopic pregnancy during the use of LNG-IUS at any doses was low. The results show that the lower the dose of the IUD, the higher the risk of an ectopic pregnancy. Higher-dose LNG-IUS should be considered when providing contraceptive counseling to a woman with known risk factors for ectopic pregnancy who are considering a hormonal IUD.


Asunto(s)
Anticonceptivos Femeninos , Dispositivos Intrauterinos Medicados , Embarazo Ectópico , Anticonceptivos Femeninos/efectos adversos , Femenino , Humanos , Dispositivos Intrauterinos Medicados/efectos adversos , Levonorgestrel/efectos adversos , Embarazo , Embarazo Ectópico/epidemiología , Embarazo Ectópico/etiología , Estudios Retrospectivos
2.
BMJ Glob Health ; 7(7)2022 07.
Artículo en Inglés | MEDLINE | ID: mdl-35835480

RESUMEN

Subcutaneous depot medroxyprogesterone acetate (DMPA-SC) is an innovative contraceptive method aimed at meeting women's unique circumstances and needs, largely due to its ability to be self-injected. Substantial research and advocacy investments have been made to promote roll-out of DMPA-SC across sub-Saharan Africa. To date, research on the demand for DMPA-SC as a self-injectable method has been conducted largely with healthcare providers, via qualitative research, or with highly specific subsamples that are not population based. Using three recent rounds of data from Performance Monitoring for Action, we examined population-representative trends in demand, use, and preference for self-injection among current non-users in Burkina Faso, the Democratic Republic of Congo (Kinshasa and Kongo Central regions), Kenya, and Nigeria (Lagos and Kano States). We found that while over 80.0% of women had heard of injectables across settings, few women had heard of self-injection (ranging from 13.0% in Kenya to 24.8% in Burkina Faso). Despite initial increases in DMPA-SC prevalence, DMPA-SC usage began to stagnate or even decrease in all settings in the recent three years (except in Nigeria-Kano). Few (0.0%-16.7%) current DMPA-SC users were self-injecting, and the majority instead were relying on a healthcare provider for administration of DMPA-SC. Among current contraceptive non-users wishing to use an injectable in the future, only 1.5%-11.4% preferred to self-inject. Our results show that self-injection is uncommon, and demand for self-injection is very limited across six settings, calling for further qualitative and quantitative research on women's views on DMPA-SC and self-injection and, ultimately, their contraceptive preferences and needs.


Asunto(s)
Anticonceptivos Femeninos , Acetato de Medroxiprogesterona , República Democrática del Congo , Femenino , Humanos , Inyecciones Subcutáneas , Nigeria , Autoadministración
4.
BMC Public Health ; 22(1): 1291, 2022 07 05.
Artículo en Inglés | MEDLINE | ID: mdl-35788216

RESUMEN

BACKGROUND: Over time, demographic and health survey (DHS) data remain valuable to examine variables relating to nationally representative population outcomes for low- and middle-income countries. In Tanzania, there are very limited DHS-based studies on the uptake of Modern Contraceptive Use (MCU). Present studies have focused on measurements at the level of individuals, yet research has shown that MCU variations exists at other levels within populations. In this study, we use a variance component modelling approach to explore variation in MCU at primary sampling unit (PSU) and regional levels while considering survey sample weights. METHODS: Using DHS data from 2016-2017 in Tanzania, we study different variance structures and the respective variation on MCU in a sample of 5263 Women of Reproductive Age (WRA) defined as between the ages of 15-49 years. First, a single variance component was used, followed by its extension to a random coefficient model and we tracked changes in the models. RESULTS: There was an influence of random variations on MCU on the levels of populations much explained by PSU-level clustering than region. On the fixed part, age of a woman, husband education level, desire to have children, and exposure to media and wealth tertiles were important determinants for MCU. Compared to WRA in 15-19 years, the odds of MCU among middle aged women (20-29 and 30-39 years) were 1.94 (95%CI:1.244-3.024) and 2.28 (95%CI:1.372-3.803). Also, increases in media exposure and middle and rich wealth tertiles women led to higher odds for MCU. We also found the presence of random effects influence of wealth tertiles levels on MCU. CONCLUSION: This study highlighted the utility of accounting for variance structures in addressing determinants of MCU while using DHS national level data. Apart from MCU, the DHS data have been widely applied to examine other variables pertaining to public health issues. This approach could be considered a better modelling technique for the DHS studies compared to traditional survey approaches, and to guide hierarchical population-based interventions to increase MCU.


Asunto(s)
Conducta Anticonceptiva , Anticonceptivos , Encuestas Epidemiológicas , Adolescente , Adulto , Análisis de Varianza , Análisis por Conglomerados , Conducta Anticonceptiva/estadística & datos numéricos , Anticonceptivos/uso terapéutico , Anticonceptivos Femeninos/uso terapéutico , Dispositivos Anticonceptivos Femeninos/estadística & datos numéricos , Demografía , Escolaridad , Femenino , Encuestas Epidemiológicas/estadística & datos numéricos , Humanos , Persona de Mediana Edad , Modelos Estadísticos , Tanzanía/epidemiología , Adulto Joven
5.
Am J Public Health ; 112(S5): S555-S562, 2022 06.
Artículo en Inglés | MEDLINE | ID: mdl-35767786

RESUMEN

Objectives. To describe patterns of providing moderately effective versus the most effective contraception and of providing implants versus intrauterine devices in US community health centers. Methods. We conducted a historical cohort study (2017-2019). Outcomes were woman-level receipt of most effective contraception (long-acting reversible contraception; implants and intrauterine devices) or moderately effective contraception. We used logistic regression to identify patient and clinic factors associated with providing (1) most versus moderately effective methods, and (2) implants versus intrauterine devices. We calculated adjusted probabilities for both outcomes by age group. Results. We included 199 652 events of providing contraception to 114 280 women in 410 community health centers. Adjusted probabilities were similar across age groups for moderately versus most effective methods. However, the adjusted marginal means for receiving an implant compared with an intrauterine device were highest for adolescents (15-17 years: 78.2% [95% confidence interval (CI) = 75.6%, 80.6%]; 18-19 years: 69.5% [95% CI = 66.7%, 72.3%]). Women's health specialists were more likely to provide most versus moderately effective contraception. Conclusions. Community health centers are an important access point for most effective contraception for women of all ages. Adolescents are more likely to use implants than intrauterine devices. (Am J Public Health. 2022;112(S5):S555-S562. https://doi.org/10.2105/AJPH.2022.306913).


Asunto(s)
Anticonceptivos Femeninos , Dispositivos Intrauterinos , Anticoncepción Reversible de Larga Duración , Adolescente , Estudios de Cohortes , Anticoncepción/métodos , Femenino , Humanos
6.
BMC Womens Health ; 22(1): 257, 2022 06 27.
Artículo en Inglés | MEDLINE | ID: mdl-35761328

RESUMEN

BACKGROUND: It is estimated that between 12 to 25% of women who undergo an endometrial ablation for heavy menstrual bleeding (HMB) are dissatisfied after two years because of recurrent menstrual bleeding and/or cyclical pelvic pain, with around 15% of these women ultimately having a hysterectomy. The insertion of a levonorgestrel-releasing intrauterine system (LNG-IUS) immediately after endometrial ablation may inactivate residual untreated endometrium and/or inhibit the regeneration of endometrial tissue. Furthermore, the LNG-IUS may prevent agglutination of the uterine walls preventing intrauterine adhesion formation associated with endometrial ablation. In these ways, insertion of an LNG-IUS immediately after endometrial ablation might prevent subsequent hysterectomies because of persisting uterine bleeding and cyclical pelvic pain or pain that arises de novo. Hence, we evaluate if the combination of endometrial ablation and an LNG-IUS is superior to endometrial ablation alone in terms of reducing subsequent rates of hysterectomy at two years following the initial ablative procedure. METHODS/DESIGN: We perform a multicentre randomised controlled trial in 35 hospitals in the Netherlands. Women with heavy menstrual bleeding, who opt for treatment with endometrial ablation and without contraindication for an LNG-IUS are eligible. After informed consent, participants are randomly allocated to either endometrial ablation plus LNG-IUS or endometrial ablation alone. The primary outcome is the hysterectomy rate at 24 months following endometrial ablation. Secondary outcomes include women's satisfaction, reinterventions, complications, side effects, menstrual bleeding patterns, quality of life, societal costs. DISCUSSION: The results of this study will help clinicians inform women with HMB who opt for treatment with endometrial ablation about whether concomitant use of the LNG-IUS is beneficial for reducing the need for hysterectomy due to ongoing bleeding and/or pain symptoms. Trial registration Dutch Trial registration: NL7817. Registered 20 June 2019, https://www.trialregister.nl/trial/7817 .


Asunto(s)
Anticonceptivos Femeninos , Técnicas de Ablación Endometrial , Dispositivos Intrauterinos Medicados , Menorragia , Anticonceptivos Femeninos/uso terapéutico , Técnicas de Ablación Endometrial/métodos , Femenino , Humanos , Levonorgestrel/uso terapéutico , Menorragia/cirugía , Estudios Multicéntricos como Asunto , Dolor Pélvico/etiología , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto
8.
PLoS One ; 17(6): e0269317, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35657948

RESUMEN

INTRODUCTION: South Africa has the highest national burden of HIV globally. Understanding drivers of HIV acquisition in recently completed, prospective studies in which HIV was an endpoint may help inform the strategy and investments in national HIV prevention efforts and guide the design of future HIV prevention trials. We assessed HIV incidence and correlates of incidence among women enrolled in ECHO (Evidence for Contraceptive Options and HIV Outcomes), a large, open-label randomized clinical trial that compared three highly effective. reversible methods of contraception and rates of HIV acquisition. METHODS: During December 2015 to October 2018, ECHO followed sexually active, HIV-seronegative women, aged 16-35 years, seeking contraceptive services and willing to be randomized to one of three contraceptive methods (intramuscular depot medroxyprogesterone acetate, copper intrauterine device, or levonorgestrel implant) for 12-18 months at nine sites in South Africa. HIV incidence based on prospectively observed HIV seroconversion events. Cox proportional hazards regression models were used to define baseline cofactors related to incident HIV infection. RESULTS: 5768 women were enrolled and contributed 7647 woman-years of follow-up. The median age was 23 years and 62.5% were ≤24 years. A total of 345 incident HIV infections occurred, an incidence of 4.51 per 100 woman-years (95%CI 4.05-5.01). Incidence was >3 per 100 woman-years at all sites. Age ≤24 years, baseline infection with sexually transmitted infections, BMI≤30, and having new or multiple partners in the three months prior to enrollment were associated with incident HIV. CONCLUSIONS: HIV incidence was high among South African women seeking contraceptive services. Integration of diagnostic management of sexually transmitted infections alongside delivery of HIV prevention options in health facilities providing contraception services are needed to mitigate ongoing risks of HIV acquisition for this vulnerable population. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, number NCT02550067 was the main Clinical Trial from which this secondary, non-randomized / observational analysis was derived with data limited to just South African sites.


Asunto(s)
Síndrome de Inmunodeficiencia Adquirida , Anticonceptivos Femeninos , Infecciones por VIH , Enfermedades de Transmisión Sexual , Síndrome de Inmunodeficiencia Adquirida/complicaciones , Adulto , Femenino , Infecciones por VIH/epidemiología , Infecciones por VIH/etiología , Infecciones por VIH/prevención & control , Humanos , Incidencia , Estudios Prospectivos , Enfermedades de Transmisión Sexual/complicaciones , Sudáfrica/epidemiología , Adulto Joven
9.
BMC Womens Health ; 22(1): 211, 2022 06 07.
Artículo en Inglés | MEDLINE | ID: mdl-35672692

RESUMEN

BACKGROUND: In 2014, the Thai government launched a free-of-charge long-acting reversible contraception (LARC) program for Thai female adolescents. However, its acceptance had not been reported. Therefore, this study aimed to describe contraceptive use among women of reproductive age before and after the program was implemented. METHODS: This retrospective cross-sectional study was carried out from the medical records of 9000 women of reproductive age, who attended the Family Planning Clinic at Maharaj Nakorn Chiang Mai Hospital between 2009 and 2018. The Chi-square test was used to compare the contraceptive methods administered before and after the program was implemented, and binary logistic regression was used to find the factors associated with implant use after completion of the program. RESULTS: Depot medroxy progesterone acetate (DMPA) injection was the most popular contraceptive method used among 40.9% of the women. The rates of subdermal implant use were increased significantly after the program was implemented (2.3-9.3%, p < 0.001). Implant use for adolescents aged less than 20 years increased from 2.6% to 56.4%, while DMPA was the most popular method used among adult women at 36.4%. Factors associated significantly with implant use after implement of the program included age of less than 20 years (aOR = 4.17 (CI: 1.84-9.44); p = 0.001) and nulliparity (aOR = 8.55 (CI: 3.77-19.39); p < 0.001). CONCLUSION: This study showed a significant increase in contraceptive implant use after the free-LARC program for adolescents had been applied. STATEMENT OF IMPLICATIONS: Contraceptive implant is the most effective hormonal reversible contraception. Its use rate is low among all age groups, but increased clearly after the free-of-charge program was applied for adolescents.


Asunto(s)
Anticonceptivos Femeninos , Anticoncepción Reversible de Larga Duración , Adolescente , Adulto , Anticoncepción/métodos , Anticonceptivos Femeninos/uso terapéutico , Estudios Transversales , Femenino , Humanos , Estudios Retrospectivos , Tailandia
10.
BMC Womens Health ; 22(1): 178, 2022 05 15.
Artículo en Inglés | MEDLINE | ID: mdl-35570281

RESUMEN

BACKGROUND: The levonorgestrel-releasing intrauterine device (IUD)-also known as the hormonal IUD-is a highly effective contraceptive method that has not been widely available in the public sector in Zambia. Early introduction efforts can provide critical insights into the characteristics of users, reasons for method choice, and experiences getting their method. METHODS: We conducted a survey with 710 public sector clients who received a hormonal IUD, copper IUD, implant or injectable in two provinces of Zambia, and additional in-depth interviews with 29 women. We performed descriptive analyses of survey data and fitted multivariable logistic regression models to assess factors associated with hormonal IUD use. Qualitative interviews were analyzed thematically. RESULTS: Factors associated with hormonal IUD use included full-time or self-employment (relative to both implant and copper IUD use), as well as being older, wealthier, and partner not being aware of method use (relative to implant use only). Common reasons for choosing long-acting methods were duration, perception that the method was "right for my body," and convenience. In addition, a portion of hormonal IUD acceptors mentioned effectiveness, potential for discreet use, few or manageable side effects, and treatment for heavy or painful periods. Between 83 and 95% of women said that they were counseled about menstrual changes and/or non-bleeding side effects; however, more hormonal IUD acceptors recalled being counseled on the possibility of experiencing reduced bleeding (88%) than amenorrhea (43%). Qualitative interviews indicate that women seek methods with minimal or tolerable side effects. While most women reported their partner was aware of method use, men may be more consistently involved in the decision to use contraception rather than in the choice of a particular method. Qualitative results show an appreciation of the lifestyle benefits of reduced bleeding (especially lighter bleeding), although amenorrhea can be cause for concern. CONCLUSIONS: Initial efforts to introduce the hormonal IUD can provide valuable learnings that can inform broader method introduction to expand choice and better suit women's needs in Zambia and elsewhere. Scale-up plans should include emphasis on high quality counseling and demand generation. The government of Zambia is committed to increasing access to high-quality contraception and making more choices available to users. To date, the hormonal IUD, a highly effective, long-lasting contraceptive has not been widely available in the country. A study in pilot introduction settings provided insights into why women chose the methods, their characteristics, and their experiences getting their methods. The 710 women in the study received family planning services in public sector settings in two provinces in Zambia. Women in the study who received a hormonal IUD, copper IUD, implant, or injectable completed a quantitative survey; in-depth interviews were also conducted with 29 women. Results showed common reasons for choosing the long-acting methods (hormonal IUD, copper IUD or implants) were their duration, perception that the method was "right for my body," and convenience. In addition, some hormonal IUD acceptors indicated that they were attracted to the method's effectiveness, potential for discreet use, few or manageable side effects, and treatment for heavy or painful periods. Qualitative interviews with women also showed that women want contraceptive methods that lead to minimal or tolerable side effects. Male partners were typically aware of contraceptive use; however, men were less involved with decisions about the particular method women selected. Use of the hormonal IUD can lead to reduced menstrual bleeding, and in the interviews, women indicated that they liked reduced bleeding (especially lighter bleeding), although amenorrhea (paused bleeding) can be cause for concern. The results can help inform broader method introduction.


Asunto(s)
Anticonceptivos Femeninos , Dispositivos Intrauterinos , Amenorrea , Anticoncepción/métodos , Anticonceptivos Femeninos/efectos adversos , Femenino , Hemorragia , Humanos , Levonorgestrel/efectos adversos , Masculino , Sector Público , Zambia
11.
Obstet Gynecol ; 139(5): 764-770, 2022 05 01.
Artículo en Inglés | MEDLINE | ID: mdl-35576335

RESUMEN

OBJECTIVE: To estimate the incidence rates for ectopic pregnancy by contraceptive method in a cohort of women using hormonal contraception in Sweden between 2005 and 2016. METHOD: Women aged 15-49 years with a filled prescription for a hormonal contraceptive in the Swedish Prescribed Drug Register between 2005 and 2016 were included. For each woman, all exposed woman-years were allocated to treatment episodes depending on the method of contraception. Treatment time started on the day the prescription was filled and ended on the first day of the end of supply, new eligible dispensing, pregnancy-related diagnosis and its associated estimated last menstrual period, or removal procedure. Ectopic pregnancy was defined as having at least two records of International Classification of Diseases, Tenth Revision code O00-, including O00.0, O00.1, O00.2, O00.8, O00.9, within 30 days or one episode of O00- and one surgical procedure for ectopic pregnancy (NOMESCO Classification of Surgical Procedures code LBA, LBC, LBD, LBE, LBW). Incidence rates per 1,000 woman-years and 95% CIs were calculated for each method of contraception. RESULTS: The study included 1,663,242 women and 1,915 events of ectopic pregnancy. The incidence rate (95% CI) for ectopic pregnancy per method of hormonal contraception was estimated: 13.5-mg levonorgestrel (LNG) hormonal intrauterine device (IUD), 2.76 (2.26-3.35) per 1,000 woman-years; 52-mg LNG hormonal IUD, 0.30 (0.28-0.33) per 1,000 woman-years; combined oral contraception, 0.20 (0.19-0.22) per 1,000 woman-years; progestogen implants, 0.31 (0.26-0.37) per 1,000 woman-years; oral medium-dose progestogen (desogestrel 75 mg), 0.24 per 1,000 woman-years, (0.21-0.27); and oral low-dose progestogen (norethisterone 0.35 mg and lynestrenol 0.5 mg), 0.81 (0.70-0.93) per 1,000 woman-years. CONCLUSION: Hormonal contraception lowers the risk of ectopic pregnancy markedly. The incidence rate of ectopic pregnancy among women using a low-dose hormonal IUD (13.5 mg LNG) was substantially higher than that in women using other types of hormonal contraception. This study provides real-world evidence to inform best clinical practice for women-centered contraceptive counseling.


Asunto(s)
Anticonceptivos Femeninos , Embarazo Ectópico , Anticoncepción/métodos , Femenino , Anticoncepción Hormonal , Humanos , Levonorgestrel/uso terapéutico , Embarazo , Embarazo Ectópico/epidemiología , Progestinas
12.
Obstet Gynecol ; 139(5): 797-807, 2022 05 01.
Artículo en Inglés | MEDLINE | ID: mdl-35576339

RESUMEN

OBJECTIVE: Investigate the association between use of depot medroxyprogesterone acetate (DMPA) (an injectable progestin-only contraceptive) and leiomyoma development. METHODS: We conducted a cohort study in the Detroit, Michigan, area that involved four clinic visits at 20-month intervals over 5 years (2010-2018) and used a standardized ultrasonography protocol to prospectively measure leiomyomas 0.5 cm or more in diameter. Participants were 1,693 self-identified Black women aged 23-35 years with no prior leiomyoma diagnosis and no hysterectomy. For this substudy, years since last use of DMPA was ascertained from questionnaire data at every visit. Leiomyoma incidence was defined as the first visit with an observed leiomyoma among women who were leiomyoma-free at enrollment. Depot medroxyprogesterone acetate associations were examined with Cox models. Leiomyoma growth was calculated as the change in log-volume for leiomyomas matched at successive visits and was modeled using linear mixed models accounting for clustered data. Leiomyoma loss, defined as a reduction in leiomyoma number in successive visits, was modeled using Poisson regression. All models used time-varying exposure and covariates. RESULTS: Of participants with at least one follow-up visit (N=1,610), 42.9% had ever used DMPA. Participants exposed to DMPA within the previous 2 years experienced reduced leiomyoma development during the subsequent observation interval compared with never users, including lower leiomyoma incidence (5.2% vs 10.7%), adjusted hazard ratio 0.6 (95% CI 0.4-1.0), 42.0% lower leiomyoma growth (95% CI -51.4 to -30.7) and 60% greater leiomyoma loss (adjusted risk ratio 1.6, 95% CI 1.1-2.2). Excess leiomyoma loss was also seen for those who used DMPA 2-4 years before the visit compared with never users, 2.1-fold increase (95% CI 1.4-3.1). CONCLUSION: Recent use of DMPA was associated with reduced leiomyoma development and increased leiomyoma loss. Such changes in early leiomyoma development in young women could delay symptom onset and reduce the need for invasive treatment.


Asunto(s)
Anticonceptivos Femeninos , Leiomioma , Estudios de Cohortes , Anticonceptivos Femeninos/efectos adversos , Preparaciones de Acción Retardada , Femenino , Humanos , Incidencia , Leiomioma/inducido químicamente , Leiomioma/tratamiento farmacológico , Leiomioma/epidemiología , Medroxiprogesterona , Acetato de Medroxiprogesterona/efectos adversos
13.
Obstet Gynecol ; 139(4): 579-587, 2022 04 01.
Artículo en Inglés | MEDLINE | ID: mdl-35594123

RESUMEN

OBJECTIVE: To evaluate topiramate and etonogestrel pharmacokinetic interactions in contraceptive implant users. METHODS: We conducted a prospective, noninferiority study with healthy women using etonogestrel implants continuously for 12-36 months. We measured baseline serum etonogestrel concentrations and then began a 6-week titrated topiramate regimen to standard migraine (100 mg/day) and epilepsy (400 mg/day) dosages. We repeated serum etonogestrel concentrations at 3 weeks (100 mg/day), 4 weeks (200 mg/day), and 6 weeks (400 mg/day) of topiramate therapy. We measured etonogestrel using a validated liquid chromatography-tandem, mass-spectrometry assay and tested for noninferiority (less than 30% decrease) in serum etonogestrel concentrations from baseline. RESULTS: We enrolled 48 total participants; 32 completed 3 weeks, 31 completed 4 weeks, and 27 completed all follow-up visits. Participants' median age was 25.3 years (range 18.3-37.2), median body mass index (BMI) was 25.5 kg/m2 (range 18.7-42.2), and median duration of implant use was 24 months (range 12-36). Median etonogestrel concentrations were 142 pg/mL (range 76.2-771) at baseline, 126 pg/mL (range 72.4-585) at 3 weeks, 119 pg/mL (range 65.6-542) at 4 weeks, and 105 pg/mL (46.2-859) at 6 weeks. The 95% CIs for mean percent change in serum etonogestrel concentrations from baseline were [-37.3%+16.9%], [-45.4%+5.2%], and [-66.8%+24.8%] at 3 weeks, 4 weeks, and 6 weeks, respectively. Excluding one participant who had a serum etonogestrel concentration less than 90 pg/mL at baseline, 30.8% of participants (8/26, 95% CI 14.3-51.8%) had a serum etonogestrel concentration less than 90 pg/mL at 6 weeks. CONCLUSION: Though only a mild enzyme-inducing antiepileptic drug, concomitant topiramate use led to inferior serum etonogestrel concentrations among implant users, with a significant proportion reaching etonogestrel concentrations below the threshold for ovulatory suppression when taking antiepileptic dosages of topiramate. FUNDING SOURCE: This study was primarily funded through an Investigator-Initiated Study grant from Merck Sharp & Dohme Corp [MISP#57073]. This work was also supported by NIH/NCATS CTSA Grant Number UL1 TR001082 and NICHD K12 Women's Reproductive Health Research Scholar Program (grant number 5K12HD001271-18). CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03335163.


Asunto(s)
Anticonceptivos Femeninos , Adolescente , Adulto , Desogestrel , Implantes de Medicamentos , Femenino , Humanos , Estudios Prospectivos , Topiramato , Adulto Joven
14.
PLoS Pathog ; 18(5): e1010494, 2022 05.
Artículo en Inglés | MEDLINE | ID: mdl-35533147

RESUMEN

Depot medroxyprogesterone acetate (DMPA) is an injectable hormonal contraceptive used by millions of women worldwide. However, experimental studies have associated DMPA use with genital epithelial barrier disruption and mucosal influx of human immunodeficiency virus (HIV) target cells. We explored the underlying molecular mechanisms of these findings. Ectocervical biopsies and cervicovaginal lavage (CVL) specimens were collected from HIV-seronegative Kenyan sex workers using DMPA (n = 32) or regularly cycling controls (n = 64). Tissue samples were assessed by RNA-sequencing and quantitative imaging analysis, whereas protein levels were measured in CVL samples. The results suggested a DMPA-associated upregulation of genes involved in immune regulation, including genes associated with cytokine-mediated signaling and neutrophil-mediated immunity. A transcription factor analysis further revealed DMPA-associated upregulation of RELA and NFKB1 which are involved in several immune activation pathways. Several genes significantly downregulated in the DMPA versus the control group were involved in epithelial structure and function, including genes encoding keratins, small proline-rich proteins, and cell-cell adhesion proteins. Pathway analyses indicated DMPA use was associated with immune activation and suppression of epithelium development, including keratinization and cornification processes. The cervicovaginal microbiome composition (Lactobacillus dominant and non-Lactobacillus dominant) had no overall interactional impact on the DMPA associated tissue gene expression. Imaging analysis verified that DMPA use was associated with an impaired epithelial layer as illustrated by staining for the selected epithelial junction proteins E-cadherin, desmoglein-1 and claudin-1. Additional staining for CD4+ cells revealed a more superficial location of these cells in the ectocervical epithelium of DMPA users versus controls. Altered protein levels of SERPINB1 and ITIH2 were further observed in the DMPA group. Identification of specific impaired epithelial barrier structures at the gene expression level, which were verified at the functional level by tissue imaging analysis, illustrates mechanisms by which DMPA adversely may affect the integrity of the genital mucosa.


Asunto(s)
Anticonceptivos Femeninos , Infecciones por VIH , Serpinas , Cuello del Útero , Anticonceptivos Femeninos/efectos adversos , Femenino , Humanos , Kenia , Acetato de Medroxiprogesterona/efectos adversos
15.
Fertil Steril ; 118(1): 168-179, 2022 07.
Artículo en Inglés | MEDLINE | ID: mdl-35637026

RESUMEN

OBJECTIVE: To assess the awareness, knowledge, and misconceptions of young people regarding long-acting reversible contraceptives (LARCs). DESIGN: We conducted a systematic review in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines of MEDLINE-Ovid, Embase, and Cumulative Index to Nursing and Allied Health Literature. A random-effects meta-analysis was performed with formal tests for heterogeneity and publication bias. Additional outcomes were summarized using thematic analysis. SETTING: Not applicable. PATIENT(S): Adolescents and young adults (aged 12-25 years) with a uterus. INTERVENTION(S): Not applicable. MAIN OUTCOME MEASURE(S): Patient-reported outcomes related to awareness, knowledge, and misconceptions of LARCs (including intrauterine devices, subdermal implants, and injections) were analyzed. RESULT(S): Of the 4,077 database citations, we included 40 studies encompassing 10,470 adolescents and young people. Twenty studies were eligible for meta-analysis. The pooled prevalence described that only 65.0% (95% confidence interval [CI], 51-78) of participants were aware of at least 1 type of LARC (I2 = 100). The meta-regression noted that the region, risk of bias, gravidity, sexual history, previous LARC experience, and postsecondary education were not associated with awareness. There were numerous misconceptions regarding eligibility, safety, and usage. Notably, 62% (95% CI, 20-91) did not understand that LARCs could be used in nulliparous individuals, and 37% (95% CI, 21-56) believed that LARCs could cause infertility. CONCLUSION(S): There are notable knowledge gaps among adolescents and young people regarding LARCs, such as eligibility criteria, the reversibility of long-acting options, and misconceptions regarding infertility. Clinicians should specifically counsel regarding the suitability for LARCs in nulliparous populations and that LARCs do not cause infertility.


Asunto(s)
Anticonceptivos Femeninos , Infertilidad , Dispositivos Intrauterinos , Adolescente , Anticonceptivos Femeninos/efectos adversos , Femenino , Humanos , Dispositivos Intrauterinos/efectos adversos , Adulto Joven
17.
AAPS J ; 24(3): 63, 2022 05 02.
Artículo en Inglés | MEDLINE | ID: mdl-35501412

RESUMEN

An intrauterine system (IUS) can be implanted in the uterus and deliver drug directly at the site of pharmacological action. Mirena was the first FDA-approved levonorgestrel (LNG) releasing IUS without an approved generic form. Its 5-year application duration presents challenges for bioequivalence (BE) assessment using the conventional in vivo studies with pharmacokinetic and/or comparative clinical endpoints. Conventionally, along with other conditions, BE could be established if the 90% confidence interval (CI) of the ratio of geometric means of residual LNG at the end of 5 years is within the BE limits of 80.00% and 125.00%. Modeling and simulation were conducted to identify a shortened BE study duration and its corresponding BE acceptance limit that can be used as a surrogate for the conventional limit for a 5-year study. Simulation results suggest that having the 90% CI of the residual LNG 12 months post insertion within 95.00-105.26% would ensure that residual LNG amount at 5 years to be within 80.00-125.00%. This modeling and simulation practice leads to the current BE recommendation: if a test IUS is made of the same material in the same concentration and has the same physical dimensions as the Mirena, its BE could be established by showing (1) comparative physicochemical and mechanical properties; (2) comparative in vitro drug release behavior for 5 years; and (3) performance in a comparative short-term in vivo study and BE based on 90% confidence interval of test and reference ratio of residual LNG to be within 95.00-105.26% at month 12.


Asunto(s)
Anticonceptivos Femeninos , Dispositivos Intrauterinos Medicados , Anticonceptivos Femeninos/farmacocinética , Femenino , Humanos , Levonorgestrel/farmacocinética , Equivalencia Terapéutica , Factores de Tiempo
19.
Contraception ; 112: 11-13, 2022 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-35378085

RESUMEN

Depot medroxyprogesterone acetate (DMPA) is a highly-effective, injectable contraceptive method that requires injections every 12 to 15 weeks. The need for return visits to a healthcare provider may present barriers to access, use, and continuation of DMPA. Studies demonstrate that self-administration of subcutaneous DMPA (DMPA-SC) outside clinical settings is safe, effective, feasible, acceptable, and can improve continuation. Based on existing evidence and potential to improve contraceptive access and autonomy, the Society of Family Planning recommends that DMPA-SC self-administration be made widely available as an additional option for patients. Provider-administered DMPA must also remain available to meet patients' individual needs and preferences.


Asunto(s)
Anticonceptivos Femeninos , Acetato de Medroxiprogesterona , Compuestos de Anilina , Consenso , Servicios de Planificación Familiar , Femenino , Humanos , Inyecciones Subcutáneas
20.
Am J Reprod Immunol ; 88(2): e13542, 2022 08.
Artículo en Inglés | MEDLINE | ID: mdl-35394678

RESUMEN

PROBLEM: Data on the effects of contraceptives on female genital tract (FGT) immune mediators are inconsistent, possibly in part due to pre-existing conditions that influence immune mediator changes in response to contraceptive initiation. METHODS: This study included 161 South African women randomised to injectable depot medroxyprogesterone acetate (DMPA-IM), copper intrauterine device (IUD), or levonorgestrel (LNG) implant in the Evidence for Contraceptive Options and HIV Outcomes (ECHO) trial. We measured thirteen cytokines and antimicrobial peptides previously associated with HIV acquisition in vaginal swabs using Luminex and ELISA, before, and at 1 and 3 months after contraceptive initiation. Women were grouped according to an overall baseline inflammatory profile. We evaluated modification of the relationships between contraceptives and immune mediators by baseline inflammation, demographic, and clinical factors. RESULTS: Overall, LNG implant and copper IUD initiation were associated with increases in inflammatory cytokines, while no changes were observed following DMPA-IM initiation. However, when stratifying by baseline inflammatory profile, women with low baseline inflammation in all groups experienced significant increases in inflammatory cytokines, while those with a high baseline inflammatory profile experienced no change or decreases in inflammatory cytokines. CONCLUSION: We conclude that pre-contraceptive initiation immune profile modifies the effect of contraceptives on the FGT innate immune response.


Asunto(s)
Anticonceptivos Femeninos , Infecciones por VIH , Anticonceptivos Femeninos/efectos adversos , Anticonceptivos Femeninos/farmacología , Citocinas , Femenino , Genitales , Infecciones por VIH/epidemiología , Humanos , Inmunidad Innata , Inflamación , Dispositivos Intrauterinos de Cobre/efectos adversos , Levonorgestrel/efectos adversos , Levonorgestrel/farmacología , Acetato de Medroxiprogesterona/efectos adversos , Acetato de Medroxiprogesterona/farmacología
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