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1.
BMC Health Serv Res ; 24(1): 697, 2024 Jun 03.
Article in English | MEDLINE | ID: mdl-38825705

ABSTRACT

BACKGROUND: The etonogestrel contraceptive implant is currently approved by the United States Food and Drug Administration (FDA) for the prevention of pregnancy up to 3 years. However, studies that suggest efficacy up to 5 years. There is little information on the prevalence of extended use and the factors that influence clinicians in offering extended use. We investigated clinician perspectives on the barriers and facilitators to offering extended use of the contraceptive implant. METHODS: Using the Consolidated Framework for Implementation Research (CFIR), we conducted semi-structured qualitative interviews. Participants were recruited from a nationwide survey study of reproductive health clinicians on their knowledge and perspective of extended use of the contraceptive implant. To optimize the diversity of perspectives, we purposefully sampled participants from this study. We used content analysis and consensual qualitative research methods to inform our coding and data analysis. Themes arose deductively and inductively. RESULTS: We interviewed 20 clinicians including advance practice clinicians, family medicine physicians, obstetrician/gynecologist and complex family planning sub-specialists. Themes regarding barriers and facilitators to extended use of the contraceptive implant emerged. Barriers included the FDA approval for 3 years and clinician concern about liability in the context of off-label use of the contraceptive implant. Educational materials and a champion of extended use were facilitators. CONCLUSIONS: There is opportunity to expand access to extended use of the contraceptive implant by developing educational materials for clinicians and patients, identifying a champion of extended use, and providing information on extended use prior to replacement appointments at 3 years.


Subject(s)
Desogestrel , Implementation Science , Qualitative Research , Humans , Female , Desogestrel/administration & dosage , Adult , Contraceptive Agents, Female/administration & dosage , Contraceptive Agents, Female/therapeutic use , United States , Interviews as Topic , Drug Implants , Male , Attitude of Health Personnel , Middle Aged , Practice Patterns, Physicians'/statistics & numerical data , Time Factors
2.
Sci Rep ; 14(1): 11062, 2024 05 14.
Article in English | MEDLINE | ID: mdl-38745005

ABSTRACT

To evaluate gene expression associated with unfavorable vaginal bleeding in users of the Etonogestrel (ENG) contraceptive implant. Prospective study involving 100 women who intended to use the ENG implant. Exclusion criteria included abnormal uterine bleeding, inability to attend a 1-year follow-up, and implant removal for reasons unrelated to vaginal bleeding or loss of follow-up. We obtained endometrial biopsies before implant placement and assessed the expression of 20 selected genes. Users maintained a uterine bleeding diary for 12 months post-implant placement. For statistical analysis, we categorized women into those with or without favorable vaginal bleeding at 3 and 12 months. Women with lower CXCL1 expression had a 6.8-fold increased risk of unfavorable vaginal bleeding at 3 months (OR 6.8, 95% CI 2.21-20.79, p < 0.001), while those with higher BCL6 and BMP6 expression had 6- and 5.1-fold increased risks, respectively. By the 12-month follow-up, women with lower CXCL1 expression had a 5.37-fold increased risk of unfavorable vaginal bleeding (OR 5.37, 95% CI 1.63-17.73, p = 0.006). Women with CXCL1 expression < 0.0675, BCL6 > 0.65, and BMP6 > 3.4 had a higher likelihood of experiencing unfavorable vaginal bleeding at 3 months, and CXCL1 < 0.158 at 12 months. Users of ENG contraceptive implants with elevated BCL6 and BMP6 expression exhibited a higher risk of breakthrough bleeding at the 3-month follow-up. Conversely, reduced CXCL1 expression was associated with an elevated risk of bleeding at both the 3 and 12-month follow-ups.


Subject(s)
Contraceptive Agents, Female , Desogestrel , Uterine Hemorrhage , Humans , Female , Desogestrel/administration & dosage , Desogestrel/adverse effects , Adult , Prospective Studies , Uterine Hemorrhage/genetics , Contraceptive Agents, Female/adverse effects , Contraceptive Agents, Female/administration & dosage , Endometrium/metabolism , Endometrium/drug effects , Endometrium/pathology , Drug Implants , Chemokine CXCL1/genetics , Chemokine CXCL1/metabolism , Young Adult
3.
Eur J Contracept Reprod Health Care ; 29(3): 115-130, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38712717

ABSTRACT

INTRODUCTION: Migration is a rare but serious complication of the etonogestrel contraceptive implant, and little is known about its extent. PURPOSE: To document and characterise cases of etonogestrel contraceptive implant migration in the scientific literature. METHODS: A systematic review of Medline, Embase and Global Health databases was carried out between January 2000 and January 2023 to identify articles presenting implant migrations. Narrative reviews, conference abstracts and articles not written in English or French were excluded. RESULTS: Forty-five articles, mostly published since 2016, were identified (eight case series and 37 case reports), for a total of 148 independent cases of migration: in pulmonary blood vessels (n = 74), in non-pulmonary blood vessels (n = 16) and extravascular (n = 58). Many patients are asymptomatic and migration is often an incidental finding. A non-palpable implant and symptoms related to implant location (intra- or extra-vascular) may be indicative of migration. Inadequate insertion and normal or underweight appear to increase the risk of migration. Scientific societies and authors offer practical strategies to deal with implant migration. CONCLUSION: Professionals who insert and remove contraceptive implants must be adequately trained. They need to be on the lookout for implant migration, and promptly refer patients to appropriate care if migration is suspected.


This systematic review documents and characterises 148 cases of vascular and extravascular etonogestrel contraceptive implant migration. Healthcare professionals must be aware of this rare but serious complication and be adequately trained to insert and remove contraceptive implants.


Subject(s)
Contraceptive Agents, Female , Desogestrel , Drug Implants , Foreign-Body Migration , Humans , Desogestrel/administration & dosage , Desogestrel/adverse effects , Female , Drug Implants/adverse effects , Contraceptive Agents, Female/administration & dosage , Contraceptive Agents, Female/adverse effects , Device Removal , Contraceptive Agents, Hormonal/adverse effects , Contraceptive Agents, Hormonal/administration & dosage
4.
J Med Case Rep ; 18(1): 234, 2024 May 02.
Article in English | MEDLINE | ID: mdl-38698425

ABSTRACT

BACKGROUND: Nexplanon implants are a common hormonal contraceptive modality. Though rare, these devices can embolize into the injured wall of the basilic vein, through the right heart, and finally wedge itself into a pulmonary artery. With adherence to the arterial wall over time, it becomes less amenable to endovascular retrieval. Patients may present with symptoms mimicking a pulmonary embolism, or without any symptoms at all. In asymptomatic cases, endovascular retrieval and/or surgery is required when patients wish to begin having children prior to biological inactivity. The current literature showed as little as nine case reports detailing lung tissue removal in the aim of reversing a patient's implanted contraceptive device. CASE PRESENTATION: A 22-year-old asymptomatic active-duty Caucasian female presented for elective outpatient Nexplanon removal. The suspicion of possible implant migration arose when it was discovered to be non-palpable in her left arm. After plain film x-rays failed to localize the implant, a chest x-ray and follow-up Computed Tomography (CT) scan revealed that the Nexplanon had migrated to a distal branch of the left pulmonary artery. Due to the patient's strong desires to begin having children, the decision was made for removal. Initial endovascular retrieval failed due to Nexplanon encapsulation within the arterial wall. Ultimately, the patient underwent a left video-assisted thoracoscopic surgery (VATS) for exploration and left lower lobe basilar S7-9 segmentectomy, which successfully removed the Nexplanon. CONCLUSIONS: Implanted contraceptive devices can rarely result in migration to the pulmonary vasculature. These radiopaque devices are detectable on imaging studies if patients and clinicians are unable to palpate them. An endovascular approach should be considered first to spare lung tissue and avoid chest-wall incisions, but can be complicated by encapsulation and adherence to adjacent tissue. A VATS procedure with single-lung ventilation via a double-lumen endotracheal tube allows surgeons to safely operate on an immobilized lung while anesthesiologists facilitate single-lung ventilation. This patient's case details the uncommon phenomenon of Nexplanon migration, and the exceedingly rare treatment resolution of lung resection to remove an embolized device.


Subject(s)
Desogestrel , Device Removal , Foreign-Body Migration , Humans , Female , Device Removal/methods , Desogestrel/administration & dosage , Foreign-Body Migration/surgery , Foreign-Body Migration/diagnostic imaging , Young Adult , Contraceptive Agents, Female/administration & dosage , Drug Implants , Pulmonary Artery/surgery , Pulmonary Artery/diagnostic imaging , Tomography, X-Ray Computed , Pulmonary Embolism/etiology , Treatment Outcome , Pneumonectomy
5.
PLoS One ; 19(5): e0299802, 2024.
Article in English | MEDLINE | ID: mdl-38722832

ABSTRACT

BACKGROUND: Contraceptive use has complex effects on sexual behaviour and mood, including those related to reduced concerns about unintended pregnancy, direct hormonal effects and effects on endogenous sex hormones. We set out to obtain robust evidence on the relative effects of three contraceptive methods on sex behaviours, which is important for guiding contraceptive choice and future contraceptive developments. METHODS: This is a secondary analysis of data from the Evidence for Contraceptive Options and HIV Outcomes (ECHO) randomized trial in which 7,829 HIV-uninfected women from 12 sites in Eswatini, Kenya, South Africa and Zambia seeking contraception were randomly assigned to intramuscular depot-medroxyprogesterone acetate (DMPA-IM), the copper intrauterine device (Cu-IUD) or the levonorgestrel (LNG) implant. Data collected for 12 to 18 months using 3-monthly behavioural questionnaires that relied on recall from the preceding 3 months, were used to estimate relative risk of post-baseline sex behaviours, as well as sexual desire and menstrual bleeding between randomized groups using modified Poisson regression. RESULTS: We observed small but generally consistent effects wherein DMPA-IM users reported lower prevalence of specified high risk sexual behaviours than implant users than Cu-IUD users (the '>' and '<' symbols indicate statistically significant differences): multiple sex partners 3.6% < 4.8% < 6.2% respectively; new sex partner 3.0% < 4.0% <5.3%; coital acts 16.45, 16.65, 17.12 (DMPA-IM < Cu-IUD); unprotected sex 65% < 68%, 70%; unprotected sex past 7 days 33% <36%, 37%; sex during vaginal bleeding 7.1%, 7.1% < 8.9%; no sex acts 4.1%, 3.8%, 3.4% (DMPA-IM > Cu-IUD); partner has sex with others 10% < 11%, 11%. The one exception was having any sex partner 96.5%, 96.9% < 97.4% (DMPA-IM < Cu-IUD). Decrease in sexual desire was reported by 1.6% > 1.1% >0.5%; amenorrhoea by 49% > 41% >12% and regular menstrual pattern by 26% <35% < 87% respectively. CONCLUSIONS: These findings suggest that women assigned to DMPA-IM may have a modest decrease in libido and sexual activity relative to the implant, and the implant relative to the Cu-IUD. We found more menstrual disturbance with DMPA-IM than with the implant (and as expected, both more than the Cu-IUD). These findings are important for informing the contraceptive choices of women and policymakers and highlight the need for robust comparison of the effects of other contraceptive methods as well.


Subject(s)
Intrauterine Devices, Copper , Levonorgestrel , Medroxyprogesterone Acetate , Sexual Behavior , Humans , Female , Levonorgestrel/administration & dosage , Medroxyprogesterone Acetate/administration & dosage , Medroxyprogesterone Acetate/adverse effects , Intrauterine Devices, Copper/adverse effects , Sexual Behavior/drug effects , Adult , Young Adult , Contraceptive Agents, Female/administration & dosage , Adolescent , Injections, Intramuscular , Contraception/methods , Drug Implants
6.
Contraception ; 135: 110450, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38614274

ABSTRACT

OBJECTIVES: Inherited bleeding disorders may cause heavy menstrual bleeding in women, impacting quality of life and impairing daily and social activities. The levonorgestrel-releasing intrauterine system is a potential treatment for these women, which might reduce menstrual blood loss. STUDY DESIGN: We performed a systematic review and single-arm meta-analysis to examine the levonorgestrel-releasing intrauterine system in women with inherited bleeding disorders and heavy menstrual bleeding. RESULTS: A systematic search on PubMed, Embase and Cochrane yielded 583 results, of which six observational studies (n = 156) met inclusion criteria. Levonorgestrel-releasing intrauterine system use in patients with inherited bleeding disorders and heavy menstrual bleeding was associated with amenorrhea in 60% of patients and a significant increase of 1.40 g/dL in hemoglobin and of 19.75 ng/mL in ferritin levels when comparing post- and pre-treatment levels. The post-treatment mean hemoglobin was 13.32 g/dL and the mean ferritin was 43.22 ng/dL. The rate of intrauterine device expulsion or removal due to mal position was low (13%), as was the need for intrauterine device removal due to lack of efficacy (14%). CONCLUSION: The levonorgestrel-releasing intrauterine system may improve bleeding patterns and quality of life in patients with inherited bleeding disorders and heavy menstrual bleeding. IMPLICATIONS: Women with inherited bleeding disorders could benefit from levonorgestrel-releasing intrauterine system, so its use should be an option for this women.


Subject(s)
Intrauterine Devices, Medicated , Levonorgestrel , Menorrhagia , Female , Humans , Amenorrhea , Blood Coagulation Disorders, Inherited/complications , Contraceptive Agents, Female/administration & dosage , Contraceptive Agents, Hormonal/administration & dosage , Ferritins/blood , Hemoglobins/analysis , Intrauterine Device Expulsion , Intrauterine Devices, Medicated/adverse effects , Levonorgestrel/administration & dosage , Menorrhagia/drug therapy , Quality of Life
7.
Contraception ; 134: 110418, 2024 06.
Article in English | MEDLINE | ID: mdl-38452921

ABSTRACT

OBJECTIVES: To measure plasma concentrations of medroxyprogesterone acetate (MPA) in users with epilepsy treated with antiseizure medications and compare these to MPA concentrations in those without epilepsy. STUDY DESIGN: For this multisite cross-sectional study, we obtained a single blood sample from those with epilepsy treated with various antiseizure medications (n = 18) within the week before their next depot medroxyprogesterone injection. Among the participants without epilepsy (n = 20), 10 similarly were scheduled within the week prior to the next injection, and 10 were scheduled at earlier intervals to attempt to balance the time intervals between groups. MPA concentrations were determined by a validated assay. RESULTS: MPA concentrations were similar among those with epilepsy and controls and between groups with and without the use of enzyme-inducing medications. The lowest MPA concentrations, under 0.07 ng/mL, were observed among two of eight using enzyme-inducing antiseizure medications, one of 10 using noninducing medications, and one of 19 controls had concentrations below 0.2 ng/mL. CONCLUSIONS: In this exploratory study, lower MPA concentrations in some participants using enzyme-inducing antiseizure medications suggest a potential interaction that could reduce depot medroxyprogesterone efficacy.


Subject(s)
Anticonvulsants , Epilepsy , Medroxyprogesterone Acetate , Humans , Medroxyprogesterone Acetate/administration & dosage , Medroxyprogesterone Acetate/pharmacokinetics , Medroxyprogesterone Acetate/blood , Female , Anticonvulsants/administration & dosage , Anticonvulsants/blood , Anticonvulsants/pharmacokinetics , Cross-Sectional Studies , Adult , Epilepsy/drug therapy , Epilepsy/blood , Young Adult , Delayed-Action Preparations , Adolescent , Contraceptive Agents, Hormonal/administration & dosage , Contraceptive Agents, Hormonal/pharmacokinetics , Middle Aged , Contraceptive Agents, Female/administration & dosage , Contraceptive Agents, Female/pharmacokinetics , Contraceptive Agents, Female/blood
8.
Contraception ; 135: 110440, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38552818

ABSTRACT

OBJECTIVES: Evaluate the safety of Ovaprene, an investigational nonhormonal vaginal contraceptive designed for monthly use. STUDY DESIGN: Open-label, multicenter study enrolling heterosexually-active women with previous permanent contraception who underwent assessments during five menstrual cycles: baseline postcoital test cycle, diaphragm postcoital test cycle, Ovaprene safety cycle, and two Ovaprene postcoital test cycles. Safety outcomes included treatment-emergent adverse events, systemic laboratory findings, pelvic examinations, colposcopies, Nugent scores, determination of community state types of vaginal microbiota, and anti-Escherichia coli activity and inflammatory markers in cervicovaginal fluids. RESULTS: We enrolled 38 participants. Of these, 33 used Ovaprene and completed 77 Ovaprene cycles. The most common product-related urogenital treatment-emergent adverse events were bacterial vaginosis and vaginal odor. The frequency of transitioning from Lactobacillus-dominated community state type to community state type IV (not Lactobacillus-dominated) was similar before Ovaprene use and afterwards. Mean Nugent scores were <4 at each visit without a discernible upward trend. Inflammatory markers showed wide variation but no upward trend, and E. coli inhibitory activity of cervical secretions did not change. We found no Staphylococcus aureus, the causative agent in toxic shock syndrome, on used Ovaprenes or in vaginal samples. No clinically important changes in systemic laboratory findings, pelvic examinations, or colposcopies occurred during Ovaprene use. CONCLUSIONS: Ovaprene use did not result in cervicovaginal irritation or adverse effects on resident vaginal microbiota and did not impact transitions from a Lactobacillus-dominated community state type to community state type IV. IMPLICATIONS: The finding that the use of Ovaprene, an investigational monthly user-controlled nonhormonal vaginal contraceptive, does not appear to result in adverse changes in vaginal health during short-term use supports further evaluation of the contraceptive potential of the device.


Subject(s)
Vagina , Humans , Female , Adult , Vagina/microbiology , Vagina/drug effects , Contraceptive Agents, Female/adverse effects , Contraceptive Agents, Female/administration & dosage , Young Adult , Vaginosis, Bacterial , Escherichia coli/drug effects , Contraceptive Devices, Female , Odorants/analysis , Microbiota/drug effects , Administration, Intravaginal
9.
Contraception ; 135: 110442, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38552822

ABSTRACT

OBJECTIVES: To assess the pharmacokinetics and pharmacodynamics of the etonogestrel (ENG) contraceptive implant when inserted at an alternative scapular site. STUDY DESIGN: We conducted a pilot study of healthy, reproductive-age females who underwent subdermal insertion of an ENG implant over the inferior edge of the nondominant scapula (scapular insertion). We measured serum ENG levels over 1 year at nine time points. Participants completed questionnaires on insertion site and bleeding side effects. We collected photographs and video recordings of insertion and removal techniques. RESULTS: We enrolled five participants (as prespecified), their median age was 26.0 years (range: 19.6-30.3), and median body mass index was 25.0 kg/m2 (range: 22.0-28.0). All serum ENG concentrations remained >90 pg/mL and were within the range of published data for arm insertion of ENG implant at all time points. The mean serum ENG level was 511.7 pg/mL (±168.2) at 1 week and 136.6 pg/mL (±21.8) at 12 months. During the first week after insertion, four of five participants noted insertion site pain with a median pain score of 2 (range 1-3), but all noted resolution by week two. Participants reported variable bleeding patterns consistent with standard ENG implant placement. At the end of the study, all participants reported satisfaction with the implant and would recommend scapular insertion to a friend. CONCLUSIONS: Scapular insertion of the ENG contraceptive implant has similar pharmacokinetics to arm insertion over 1 year of use. This novel, alternative site was well tolerated and demonstrated similar bleeding side effects to standard arm insertion. IMPLICATIONS: Subdermal scapular insertion of the etonogestrel contraceptive implant demonstrated similar pharmacokinetics to arm insertion over 1 year of use. Our pilot data support scapular insertion as an alternative site for ENG contraceptive implants, which could be beneficial for certain patient populations.


Subject(s)
Contraceptive Agents, Female , Desogestrel , Drug Implants , Scapula , Humans , Female , Desogestrel/administration & dosage , Desogestrel/pharmacokinetics , Pilot Projects , Adult , Contraceptive Agents, Female/pharmacokinetics , Contraceptive Agents, Female/administration & dosage , Young Adult , Contraceptive Agents, Hormonal/administration & dosage , Contraceptive Agents, Hormonal/pharmacokinetics
10.
J Gynecol Obstet Hum Reprod ; 53(6): 102777, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38531476

ABSTRACT

PURPOSE: The purpose of this study was to analyse the impact of embedment of side arms of the levonorgestrel 52 mg intrauterine device (LNG-IUD) in the myometrium (assessed by three-dimensional transvaginal ultrasound (3D-TVUS)) on uterine bleeding and pain. MATERIALS AND METHODS: We performed a prospective cohort study in a large Dutch teaching hospital between February 2015 and December 2016. Participants over 18 years of age who selected a LNG-IUD for contraception or because of heavy menstrual bleeding were eligible for inclusion. Six weeks after insertion, a 3D-TVUS was performed to diagnose embedment of the side arms. At that moment participants filled in questionnaires about their bleeding pattern and pelvic pain. Menstruation patterns 'no bleeding', 'regular menstruation', 'sometimes a day of spotting (maximum once a week)' were classified as favourable bleeding pattern. Menstruation patterns 'heavy menstrual bleeding', 'several days a week bleeding days', 'several days a week spotting days', 'continuously spotting', and 'completely irregular cycle' were classified as unfavourable bleeding pattern. Univariate and multivariate logistic regression analysis was used to calculate odds ratios (OR) and 95 %-confidence intervals (CI). The multivariate analysis included endometrial thickness, reason for insertion and parity. The analysis of pelvic pain additionally included previous insertion. RESULTS: A total of 220 participants were evaluated for the study of whom 176 returned the questionnaires. Embedment of the side arms was observed in 43 of the 176 responding participants (24.4 %). Favourable bleeding pattern was reported by 25/43 (58.1 %) participants with embedment and 53/133 (39.8 %) participants without embedment (ORadj 1.8, 95 % CI 0.9-3.9). Pelvic pain was reported by 4/43 (9.3 %) participants with embedment and 24/133 (18.1 %) participants without embedment (ORadj 0.3; CI 0.1-1.2). CONCLUSIONS: The present study suggests that embedment of the side arms of the LNG-IUD in the myometrium assessed by 3D-TVUS is not associated with a unfavourable bleeding pattern nor pelvic pain six weeks after insertion. From this point of view, we do not recommend to perform standard 3D-TVUS for the purpose of excluding or demonstrating embedment.


Subject(s)
Intrauterine Devices, Medicated , Levonorgestrel , Pelvic Pain , Humans , Female , Levonorgestrel/administration & dosage , Levonorgestrel/adverse effects , Prospective Studies , Adult , Intrauterine Devices, Medicated/adverse effects , Pelvic Pain/etiology , Myometrium , Ultrasonography/methods , Uterine Hemorrhage/etiology , Cohort Studies , Contraceptive Agents, Female/administration & dosage , Contraceptive Agents, Female/adverse effects , Menorrhagia , Middle Aged , Imaging, Three-Dimensional/methods , Young Adult
11.
Int J Gynaecol Obstet ; 165(3): 1199-1209, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38299835

ABSTRACT

OBJECTIVE: To evaluate gene expression associated with vaginal bleeding in the 52-mg hormonal intrauterine device (IUD) users. MATERIALS AND METHODS: We conducted a prospective study involving 100 women seeking to use the 52-mg hormonal IUD for contraception. We excluded women with a history or current condition of abnormal uterine bleeding and who were unable to attend a 1-year follow up. Women who expelled the device, removed it for reasons unrelated to vaginal bleeding, or were lost to follow up were discontinued. We collected endometrial biopsies immediately before IUD placement and assessed 20 selected genes using reverse transcription quantitative polymerase chain reaction. Users maintained a uterine bleeding diary for 12 months following IUD insertion. For statistical analysis, participants were categorized into groups with or without vaginal bleeding at 3 and 12 months. RESULTS: Women with elevated CXCL9 expression had an 8.15-fold higher likelihood of experiencing vaginal bleeding at 3 months (odds ratio [OR] 8.15, 95% confidence interval [CI] 2.24-29.61, P = 0.001). At 12 months of follow up, women with increased TIMP1 expression had a 2.74-fold higher chance of experiencing vaginal bleeding (OR 2.74, 95% CI 1.08-6.95, P = 0.033). CXCL9 ≥ 1.5 and IL17A ≥ 0.68 were associated with a higher probability of vaginal bleeding at 3 months, while TIMP1 levels ≥0.943 were linked to an increased risk of bleeding at 12 months. CONCLUSION: Users of the 52-mg hormonal IUD with elevated relative CXCL9 expression face an increased risk of vaginal bleeding at 3-month follow up, whereas those with heightened TIMP1 expression are more likely to experience vaginal bleeding at 12 months.


Subject(s)
Intrauterine Devices, Medicated , Levonorgestrel , Uterine Hemorrhage , Humans , Female , Prospective Studies , Levonorgestrel/administration & dosage , Levonorgestrel/adverse effects , Adult , Uterine Hemorrhage/genetics , Intrauterine Devices, Medicated/adverse effects , Endometrium , Contraceptive Agents, Female/administration & dosage , Contraceptive Agents, Female/adverse effects , Gene Expression , Young Adult , Middle Aged
14.
Pediatrics ; 149(1)2022 01 01.
Article in English | MEDLINE | ID: mdl-34972227

ABSTRACT

OBJECTIVES: Provision of reproductive health preventive services to adolescents is critical given their high rates of sexually transmitted infections and unintended pregnancies. Pediatricians are well positioned to provide these services but often face barriers. With this project, we aimed to build quality improvement (QI) capacity within pediatric practices to improve adherence to national guidelines for adolescent reproductive health preventive services. METHODS: In 2016, an accountable care organization overseeing health care delivery for low-income children in the Midwestern United States used practice facilitation, a proven approach to improve health care quality, to support pediatric practices in implementing reproductive health QI projects. Interested practices pursued projects aimed at providing (1) sexual risk reduction and contraceptive counseling (reproductive health assessments [RHAs]) or (2) etonogestrel implants. QI specialists helped practices build key driver diagrams and implement interventions. Outcome measures included the proportion of well-care visits with RHAs completed and number of etonogestrel insertions performed monthly. RESULTS: Between November 1, 2016, and December 31, 2019, 6 practices serving >7000 adolescents pursued QI projects. Among practices focused on RHAs, the proportion of well-care visits with completed RHAs per month increased from 0% to 65.8% (P < .001) within 18 months. Among practices focused on etonogestrel implant insertions, overall insertions per month increased from 0 to 8.5 (P < .001). CONCLUSIONS: Practice facilitation is an effective way to increase adherence to national guidelines for adolescent reproductive health preventive services within primary care practices. Success was driven by practice-specific customization of interventions and ongoing, hands-on support.


Subject(s)
Adolescent Health Services/organization & administration , Adolescent Health Services/standards , Quality Improvement , Reproductive Health Services/organization & administration , Reproductive Health Services/standards , Adolescent , Child , Contraception Behavior , Contraceptive Agents, Female/administration & dosage , Desogestrel/administration & dosage , Drug Implants , Female , Guideline Adherence , Humans , Midwestern United States , Pregnancy , Pregnancy, Unwanted , Sex Counseling , Sexually Transmitted Diseases/prevention & control , Unsafe Sex/prevention & control , Young Adult
15.
Gynecol Endocrinol ; 38(1): 68-72, 2022 Jan.
Article in English | MEDLINE | ID: mdl-34672861

ABSTRACT

OBJECTIVE: This study aims to assess sexual function (SF) and quality of life (QoL) among women using copper intrauterine devices (Cu-IUD), levonorgestrel-releasing intrauterine system (LNG-IUS) or etonogestrel(ENG)-releasing subdermal implant. METHODS: This is a cross-sectional study involving 213 women who are sexually active, using Cu-IUD, LNG-IUS or ENG implant for at least one year. SF assessment was carried out through the Female Sexual Function Index (FSFI) and QoL was made through The Short Form Health Research. RESULTS: Frequency of sexual dysfunction score in Cu-IUD users was 33.8%; 47.2% in LNG-IUS users and 47.8% in ENG-implant users, without difference between groups. Desire domain had higher score in Cu-IUD users (Cu-IUD:4.20 ± 1.15 × LNG-IUS:3.76 ± 1.17 × ENG-implant:3.63 ± 1.15; p = .009). Between Cu-IUD and LNG-IUS users there was no difference in FSFI score. Total FSFI score was higher in Cu-IUD group when compared only to ENG-implant (Cu-IUD:27.48 ± 6.14 × Implant:25.07 ± 6.89; p = .029). Regarding the QoL score, difference was found only in general health domain (Cu-IUD:65.22 ± 14.91 × LNG-IUS:62.61 ± 19.04 × Implant:58.33 ± 16.46; p = .034), with lower score for implant group. CONCLUSION: There was no difference in the SF total score between the users of Cu-IUD, LNG-IUS and ENG implant. However, the score of the FSFI desire domain and general health status were higher among users of the Cu-IUD.


Subject(s)
Desogestrel/adverse effects , Intrauterine Devices, Copper/adverse effects , Intrauterine Devices, Medicated/adverse effects , Levonorgestrel/adverse effects , Quality of Life , Sexual Dysfunction, Physiological/epidemiology , Adult , Contraceptive Agents, Female/administration & dosage , Cross-Sectional Studies , Desogestrel/administration & dosage , Female , Humans , Levonorgestrel/administration & dosage
16.
Gynecol Endocrinol ; 38(1): 90-93, 2022 Jan.
Article in English | MEDLINE | ID: mdl-34486922

ABSTRACT

INTRODUCTION: Thalidomide is an immunomodulatory drug and first choice in the treatment of erythema nodosum leprosum. Given its teratogenic potential, it is essential that an effective contraceptive method is used, especially a long-acting reversible contraceptive (LARC) method. The subdermal etonogestrel (ENG)-releasing implant is an adequate method due to the high effectiveness and long-term use. However, interaction between thalidomide and ENG has not been well documented. Concern arises because thalidomide interacts with cytochrome P450 (CYP450) enzymes that metabolize sexual steroids. AIM: We aimed to study the effectiveness and safety of the ENG-implant in a thalidomide user. METHODS: Case report of a sexually active 21-year-old patient with both Hansen's disease and leprosy reaction type 2 treated with thalidomide requiring effective contraception. Follow-up was up to 36 months after implant placement. RESULTS: Contraception with ENG-implant was effective and safe, based on clinical parameters (reduction of menstrual flow and cervical mucus thickening) and laboratory parameters (gonadotropins and sexual steroids). CONCLUSION: To the best of our knowledge, this is the first case reported which presents a patient in simultaneous use of thalidomide and ENG-implant. Although this case report preliminary supports effectiveness and safety of ENG-implant as a contraceptive option in women using thalidomide, rigorous drug-drug interaction research is needed to better characterize the interaction between thalidomide and the ENG-implant.


Subject(s)
Contraceptive Agents, Female/administration & dosage , Desogestrel/administration & dosage , Erythema Nodosum/drug therapy , Leprosy, Lepromatous/drug therapy , Teratogens , Thalidomide/therapeutic use , Adult , Desogestrel/adverse effects , Drug Implants , Drug Interactions , Female , Humans , Thalidomide/adverse effects , Young Adult
17.
Evid. actual. práct. ambul ; 25(2): e006994, 2022. tab
Article in Spanish | LILACS, UNISALUD, BINACIS | ID: biblio-1380545

ABSTRACT

El spottingo sangrado irregular no menstrual es uno de los principales efectos secundarios de los implantes anticonceptivos, situación que se recomienda discutir con la usuaria previo a la colocación, para evitar falsas expectativas o temores que lleven a la extracción temprana del dispositivo. A propósito de una paciente sin antecedentes relevantes que consultó al centro de salud por spotting desde la colocación del implante cuatro meses antes, decidimos revisar la evidencia sobre la efectividad de los distintos esquemas farmacológicos disponibles para el manejo de este evento adverso. Luego de realizar una búsqueda bibliográfica concluimos que, si bien existe sustento para indicar algunos de los esquemas farmacológicos, este es aún débil y son necesarios estudios clínicos adicionales que brinden evidencia sólida sobre qué esquema en particular utilizar, evaluando sus riesgos y beneficios. (AU)


Spotting or irregular non-menstrual bleeding is one of the main side effects of contraceptive implants, a situation that health professionals must discuss with the user prior to its placement in order to avoid false expectations or fears that lead to early removal of the implant. Regarding a patient with no relevant history who consulted the health center due to spotting four months after implant placement, we decided to review the evidence onthe effectiveness on different pharmacological schemes available for the management of this adverse event. After performing a literature search, we concluded that, although there is support for indicating some of the pharmacological schemes, this is still weak, and further clinical studies are needed to provide solid evidence on which particular scheme touse, assessing its risks and benefits. (AU)


Subject(s)
Humans , Female , Adult , Young Adult , Ibuprofen/administration & dosage , Contraceptive Agents, Female/adverse effects , Contraceptives, Oral/administration & dosage , Contraceptives, Oral/therapeutic use , Drug Implants , Metrorrhagia/drug therapy , Randomized Controlled Trials as Topic , Desogestrel/adverse effects , Doxycycline/administration & dosage , Contraceptive Agents, Female/administration & dosage , Systematic Reviews as Topic
18.
PLoS One ; 16(12): e0258844, 2021.
Article in English | MEDLINE | ID: mdl-34879066

ABSTRACT

BACKGROUND: Evidence suggests that in countries with high fertility and fecundity rates, such as Nigeria, the promotion of modern contraceptive use prevents approximately 32% and 10% of maternal and child mortality, respectively. Therefore, this study aimed to assess the spatial distribution of modern contraceptive use and its predictors among women of reproductive age in Nigeria. METHODS: The study employed a cross-sectional analysis of population-based data involving 24,281 women of reproductive age in Nigeria. The study adopted both multilevel and spatial analyses to identify the predictors of modern contraceptive use and its spatial clustering among women in Nigeria. RESULTS: Modern contraceptive use among the study population in Nigeria ranged from 0% to 75%, with regional variations. The spatial analysis showed that areas with a low proportion of modern contraceptive use were Sokoto, Yobe, Borno, Katsina, Zamfara, Kebbi, Niger, Taraba and Delta. Areas with a high proportion of modern contraceptive use were Lagos, Oyo, Osun, Ekiti, Federal capital territory, Plateau, Adamawa, Imo, and Bayelsa. The multilevel analysis revealed that at the individual level, women with secondary/higher education, women from the Yoruba ethnic group, those who had four children and above, and those exposed to mass media had higher odds of using modern contraceptives. On the other hand, women who were 35 years and above, those who were married, and women who were practicing Islam were less likely to use modern contraceptives. At the household/community level, women from the richest households, those residing in communities with medium knowledge of modern contraceptive methods, and women residing in communities with a high literacy level were more likely to use modern contraceptives. CONCLUSION: There were major variations in the use of modern contraception across various regions in Nigeria. As a result, areas with low contraceptive rates should be given the most deserving attention by promoting contraceptive education and use as well as considering significant factors at the individual and household/community levels.


Subject(s)
Contraception Behavior , Contraceptive Agents, Female/administration & dosage , Health Knowledge, Attitudes, Practice , Adolescent , Adult , Cross-Sectional Studies , Educational Status , Family Planning Services , Female , Humans , Middle Aged , Nigeria
19.
Front Immunol ; 12: 760504, 2021.
Article in English | MEDLINE | ID: mdl-34956191

ABSTRACT

Background: Cervicovaginal inflammation, bacterial microbiota and hormonal contraceptives all influence sexual and reproductive health. To date, the effects of intramuscular depo-medroxyprogesterone acetate (DMPA-IM) versus injectable norethisterone enanthate (NET-EN) on vaginal microbiota or cytokines have not been compared back-to-back, although in-vitro data suggest that DMPA-IM and NET-EN have different pharmacokinetic and biologic activities. This study aimed at comparing the effects of DMPA-IM versus NET-EN initiation on cervicovaginal cytokines and microbiota in women at high risk for sexually transmitted infections (STIs) assigned to the respective contraceptives. Methods: We collected socio-demographic characteristics and vaginal samples from women initiating DMPA-IM (ECHO Trial; n = 53) and NET-EN (UChoose Trial; n = 44) at baseline and after two consecutive injections to assess cytokine concentrations by Luminex, vaginal microbiota by 16S rRNA gene sequencing, STIs, bacterial vaginosis (BV) and candidiasis. Results: Cytokine concentrations did not change significantly after initiating DMPA-IM or NET-EN, although NET-EN versus DMPA-IM-associated profiles were distinct. While the abundance of bacterial taxa associated with optimal and non-optimal microbiota fluctuated with DMPA-IM use, overall community composition did not significantly change with either contraceptive. HSV-2 serology, chlamydial infection, gonorrhoea and candidiasis did not influence the associations between contraceptive type and cervicovaginal cytokines or microbiota. Conclusions: Both DMPA-IM and NET-EN use did not lead to broad inflammatory or microbiota changes in the female genital tract of sub-Saharan African women. This suggests that NET-EN is likely a viable option for contraception in African women at high risk of BV and STIs.


Subject(s)
Contraceptive Agents, Female/administration & dosage , Contraceptive Agents, Hormonal/administration & dosage , Cytokines/immunology , Genitalia, Female/drug effects , Medroxyprogesterone Acetate/administration & dosage , Microbiota/drug effects , Norethindrone/analogs & derivatives , Adolescent , Adult , Africa South of the Sahara , Cross-Over Studies , Female , Genitalia, Female/immunology , Genitalia, Female/microbiology , Humans , Injections, Intramuscular , Microbiota/genetics , Norethindrone/administration & dosage , Prospective Studies , RNA, Ribosomal, 16S , Sexually Transmitted Diseases/diagnosis , Sexually Transmitted Diseases/immunology , Sexually Transmitted Diseases/microbiology , Vaginosis, Bacterial/diagnosis , Vaginosis, Bacterial/immunology , Vaginosis, Bacterial/microbiology , Young Adult
20.
Obstet Gynecol ; 138(4): 574-577, 2021 10 01.
Article in English | MEDLINE | ID: mdl-34623069

ABSTRACT

Since the beginning of the coronavirus disease 2019 (COVID-19) pandemic, health care professionals have made swift accommodations to provide consistent and safe care, including emphasizing remote access to allow physical distancing. Depot medroxyprogesterone acetate intramuscular injection (DMPA-IM) prescription is typically administered by a health care professional, whereas DMPA-subcutaneous has the potential to be safely self-injected by patients, avoiding contact with a health care professional. However, DMPA-subcutaneous is rarely prescribed despite its U.S. Food and Drug Administration approval in 2004 and widespread coverage by both state Medicaid providers and many private insurers. Depot medroxyprogesterone acetate users are disproportionately non-White, and thus the restriction in DMPA-subcutaneous prescribing may both stem from and contribute to systemic racial health disparities. We review evidence on acceptability, safety, and continuation rates of DMPA-subcutaneous, consider sources of implicit bias that may impede prescription of this contraceptive method, and provide recommendations for implementing DMPA-subcutaneous prescribing.


Subject(s)
COVID-19 , Contraceptive Agents, Female/administration & dosage , Family Planning Services/statistics & numerical data , Medroxyprogesterone Acetate/administration & dosage , Patient Acceptance of Health Care/statistics & numerical data , Contraception/statistics & numerical data , Drug Prescriptions/statistics & numerical data , Family Planning Services/methods , Female , Health Services Accessibility/statistics & numerical data , Healthcare Disparities/statistics & numerical data , Humans , Injections, Subcutaneous , SARS-CoV-2 , Self Administration , United States
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