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Clinical Immunology (Orlando, Fla.) Oct 2023Although effective contraceptives are crucial for preventing unintended pregnancies, evidence suggests that their use may perturb the female genital tract (FGT). A... (Randomized Controlled Trial)
Randomized Controlled Trial
Although effective contraceptives are crucial for preventing unintended pregnancies, evidence suggests that their use may perturb the female genital tract (FGT). A comparative analysis of the effects of the most common contraceptives on the FGT have not been evaluated in a randomized clinical trial setting. Here, we evaluated the effect of three long-acting contraceptive methods: depot medroxyprogesterone acetate(DMPA-IM), levonorgestrel(LNG) implant, and a copper intrauterine device (Cu-IUD), on the endocervical host transcriptome in 188 women from the Evidence for Contraceptive Options and HIV Outcomes Trial (ECHO) trial. Cu-IUD usage showed the most extensive transcriptomic changes, and was associated with inflammatory and anti-viral host responses. DMPA-IM usage was enriched for pathways associated with T cell responses. LNG implant had the mildest effect on endocervical gene expression, and was associated with growth factor signaling. These data provide a mechanistic basis for the diverse influence that varying contraceptives have on the FGT.
Topics: Pregnancy; Female; Humans; Copper; Levonorgestrel; Intrauterine Devices, Copper; Contraceptive Agents; Systems Analysis
PubMed: 37660744
DOI: 10.1016/j.clim.2023.109750 -
Frontiers in Global Women's Health 2023To determine the epidemiological profile of women who inserted copper intrauterine device (Cu-IUD), subdermal etonogestrel implant (ENG), tubal ligation (TL), depot...
PURPOSE
To determine the epidemiological profile of women who inserted copper intrauterine device (Cu-IUD), subdermal etonogestrel implant (ENG), tubal ligation (TL), depot medroxyprogesterone acetate (DMPA) or did not choose a contraceptive method (NCM) in the immediate postpartum period and compare the contraceptive effectiveness of Cu-IUD and DPMA with non-MAC.
METHODS
We analyzed the epidemiological profile of women who inserted copper intrauterine device (Cu-IUD), subdermal etonogestrel implant (ENG), tubal ligation (TL), depot medroxyprogesterone acetate (DMPA) or did not choose a contraceptive method (NCM) in the immediate postpartum. The data was collected by electronic medical records of postpartum women assisted at the University Hospital of São Bernardo do Campo (HMU-SBC) from January 2016 to December 2020. Also, we compared the contraceptive effectiveness of Cu-IUD and DPMA with non-MAC by identifying women who returned for second delivery during the study period and analyzing the contraceptive method chosen in the first hospitalization. Then the pregnancies interval and the sociodemographic characteristics were analyzed according to contraceptive method type.
RESULTS
Data from 20,896 women were collected, of which 8,183 (39%) opted for Cu-IUD, 559 (2.5%) DPMA, and 10,989 (52.5%) chose not to use contraception at the time of hospital discharge. When comparing these groups, women in the DPMA were younger (26.5 ± 7.3, < 0.05), and NCM showed women with a lower number of pregnancies (2.2 ± 1.3, < 0.05). Subjects in the TL group (4.6%) had the higher number of pregnancies (3.8 ± 1.2, < 0.05), and ENG group, the highest number of miscarriages (1.6 ± 1.3, < 0.05). Of those women who returned pregnant, 5.5% belonged to the DPMA group, 6% to the NCM group, and 2.3% to the Cu-IUD.
CONCLUSIONS
Women who opted for Cu-IUD insertion were younger, had more pregnancies and vaginal delivery when compared to those who did not choose a method. Of those women who returned, the minority opted for Cu-IUD compared to those that opted for DPMA or no method.
PubMed: 37637759
DOI: 10.3389/fgwh.2023.1052224 -
World Journal of Clinical Cases Aug 2023Endometrial cancer is one of the most commonly diagnosed gynecological cancers worldwide, and early-stage high-risk endometrial cancer has a poor prognosis. Adjuvant...
BACKGROUND
Endometrial cancer is one of the most commonly diagnosed gynecological cancers worldwide, and early-stage high-risk endometrial cancer has a poor prognosis. Adjuvant treatments after surgery, such as chemotherapy and radiotherapy, have been widely used in clinical practice to improve patient survival. Medroxyprogesterone acetate is a synthetic progestogen that has been reported to have potential anticancer effects in endometrial cancer. However, its efficacy, safety, and long-term prognostic benefits as an adjuvant treatment for endometrial cancer remain controversial. Therefore, this study aimed to observe the efficacy and prognostic impact of adjuvant medroxyprogesterone acetate treatment in patients with early-stage high-risk endometrial cancer and evaluate its safety.
AIM
To observe the efficacy and prognosis of adjuvant treatment of endometrial cancer with medroxyprogesterone acetate and to evaluate its safety.
METHODS
We collected the clinical data of 200 patients with early-stage high-risk endometrial cancer who were admitted to the Department of Obstetrics and Gynecology of our hospital from January 2018 to December 2022. The control group (100 patients) underwent conventional surgical treatment, and the study group (100 patients) was administered adjuvant medroxyprogesterone acetate tablets on top of the control group. The Kaplan-Meier curve analysis and log-rank test were performed to determine the possible factors influencing the 5-year cumulative survival rate in the patients. The Cox regression analysis was performed to identify the factors influencing the survival prognosis of endometrial cancer.
RESULTS
According to the Cox regression analysis, age [hazard ratio (HR) = 4.636, 95% confidence interval (95%CI): 1.411-15.237], pathological type (HR = 6.943, 95%CI: 2.299-20.977), molecular typing (HR = 5.789, 95%CI: 3.305-10.141), and myometrial infiltration (HR = 5.768, 95%CI: 1.898-17.520) were factors influencing the prognosis of patients with early-stage high-risk endometrial cancer.
CONCLUSION
Age, pathological type, molecular typing, and myometrial infiltration were all relevant factors affecting the prognosis of early-stage high-risk endometrial cancer. The potential long-term prognostic benefit of adjuvant postoperative radiotherapy in patients with early-stage high-risk endometrial cancer is worthy of clinical consideration.
PubMed: 37637703
DOI: 10.12998/wjcc.v11.i23.5447 -
JMIR Research Protocols Aug 2023The introduction of self-administered injectable contraception presents an opportunity to address the unmet need for family planning. As ministries of health scale up...
Enhancing the Introduction and Scale Up of Self-Administered Injectable Contraception (DMPA-SC) in Health Systems (the EASIER Project): Protocol for Embedded Implementation Research.
BACKGROUND
The introduction of self-administered injectable contraception presents an opportunity to address the unmet need for family planning. As ministries of health scale up self-administered injectable contraception, there is a scarcity of knowledge on the implementation practices and contextual conditions that help and hinder these efforts. The World Health Organization has launched the "enhancing self-administered family planning through embedded research project" (EASIER) to address this challenge.
OBJECTIVE
EASIER's objectives are to: (1) assess the coverage of self-injectable contraception, and the readiness of health systems to integrate it into the contraceptive method mix; (2) document strategies used to introduce and scale up self-injectable contraception and understand practices that have led to success and challenges; (3) identify the contextual factors that affect the adoption and implementation of self-injectable contraception throughout health systems; (4) understand whether implementation addresses users' preferences and needs; (5) strengthen collaboration between decision makers, researchers, and implementers; support and build capacity to use evidence.
METHODS
EASIER developed a global protocol that implementation research (IR) teams in Burkina Faso, Ghana, and Kenya adapted into country-level embedded IR projects. In all countries (1) at the national level, IR teams evaluate the policy environment for scaling up by conducting a desk review and in-depth interviews; (2) at the local level, IR teams implement quantitative questionnaires on structural and organizational readiness to integrate self-injection into the method mix; (3) in "case study" localities, IR teams conduct in-depth interviews and focus group discussions with implementers, method users, and community members; and (4) IR teams use participatory action research to elicit stakeholder participation and translate findings into programmatic decisions.
RESULTS
EASIER has been launched in all 3 countries. Preliminary findings are available from Burkina Faso and Kenya. In Burkina Faso, IR teams identified the need to strengthen health worker training approaches to ensure that family planning providers at primary health care facilities are adequately oriented to depo-medroxyprogesterone acetate subcutaneous (DMPA-SC) and self-injection and capacitated to initiate women to the method. In addition, they report the need for service communication strategies that reach potential users of the method with knowledge about self-injection and how to initiate the practice. In Kenya, the findings illuminate the need for practice guidelines that county health teams can use to coordinate the rollout of self-administered DMPA-SC. In addition, Kenya's findings underscore the importance of addressing logistical bottlenecks to help avoid stock-outs.
CONCLUSIONS
EASIER presents a strategy to embed IR in contraceptive method introduction and scale-up, address local knowledge needs, devise ways to maximize the impact of new technologies in health systems, and build capacity for using evidence in programmatic decisions. Adaptation and implementation of country-level IR studies will advance the use of IR to strengthen family planning programs.
TRIAL REGISTRATION
Australia New Zealand Clinical Trials Registry ACTRN12622001228774; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384534&isReview=true.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/44222.
PubMed: 37610819
DOI: 10.2196/44222 -
PloS One 2023Hormonal contraceptives are artificial preparations that contain artificial progestins and Ethinylestradiol; these preparations are utilized by women of reproductive age...
Assessment of liver function tests of women taking hormonal contraceptives at University of Gondar comprehensive specialized hospital and Family Guidance Association of Gondar (FGAE), 2022; a comparative cross-sectional study.
INTRODUCTION
Hormonal contraceptives are artificial preparations that contain artificial progestins and Ethinylestradiol; these preparations are utilized by women of reproductive age to prevent pregnancy. Roughly a billion women in the world use some form of contraceptive worldwide. Despite the utility of these preparations, they are linked with several adverse effects, including disturbances of liver functionality and integrity. However, previous studies conducted to assess the association between hormonal contraceptive utilization and liver function tests reported conflicting results, and the effects remained a matter of concern.
METHODS
The study enrolled a total of 264 participants, who were allocated into two groups. One group of hormonal contraceptive users who use the medication for a minimum of six months: Depot medroxyprogesterone acetate (DMPA), combined oral contraceptives (COC), Norplant, and Implant users and another age-matched non-user control group in a ratio of 1:1. A semi-structured questionnaire was used to collect socio-demographic, behavioral, and clinical data. Five ml serum blood sample was collected for liver function test analysis on a Beckman Coulter Clinical Chemistry analyzer (DXC 700 AU). Independent t-test was used to compare liver function tests of hormonal contraceptive users and non-user controls, whereas ANOVA followed by a Bonferroni post hoc test was used for intra- (between classes of contraceptives) and inter-group (between each class of contraceptives and controls) comparisons and to identify factors associated.
RESULTS
Hormonal contraceptive users were observed to have a statistically significant higher mean value of liver enzymes assessed compared to non-user control groups: aspartate aminotransferase (AST) (47.07±14.79 versus 25.92±7.37; p <0.001), alanine aminotransferase (ALT) (35.83±13.76 versus 16.56 ± 5.03; p <0.001), alkaline phosphatase (ALP) (63.34±14.74 versus 45.41±14.34, p <0.001) and for γ-glutamyl transferase (GGT) (47.37±24.32 versus 19.45 ± 6.86 p <0.001). Similarly, the mean value of total and direct bilirubin (mg/dL) among HC users showed a statistically significant elevation (0.68 ± 0.22 against 0.32 ± 0.13, p <0.001) for total bilirubin and (0.14 ± 0.06 against 0.06 ± 0.03, p <0.001) for direct bilirubin respectively. However, no statistically significant result was observed in the mean values of total protein and albumin. For total protein (6.7 ± 0.89 versus 6.5 ± 1.15, p 0.07) and for albumin (5.4 ± 0.92 versus 5.3 ± 1.08; p 0.30). The current study also indicates the level of hepatic function test alteration is related to the type of hormonal contraceptives, duration of usage, and level of adherence to a specific class of contraceptives.
CONCLUSION AND RECOMMENDATION
Hormonal contraceptive use was observed to affect hepatic function. Based on this finding, we strongly recommend to closely monitor liver function tests in women using hormonal contraceptives.
Topics: Pregnancy; Humans; Female; Liver Function Tests; Cross-Sectional Studies; Bilirubin; Albumins; Contraceptives, Oral, Combined; Hospitals
PubMed: 37590278
DOI: 10.1371/journal.pone.0289746 -
Blood Advances Oct 2023Patients with sickle cell disease (SCD) are at a risk of thromboembolism (TE), and use of hormonal contraception can further increase that risk. This study aims to...
Patients with sickle cell disease (SCD) are at a risk of thromboembolism (TE), and use of hormonal contraception can further increase that risk. This study aims to assess patterns of hormonal contraceptive use and compare risk of contraception-related TE between combined hormonal contraceptives (CHCs) and progestin-only contraceptives (POCs). Patients with SCD aged between 12 and 44 years with a new prescription of a hormonal contraceptive in the Centers for Medicare and Medicaid Services Medicaid Analytic eXtract database (2006-2018) were followed up to 1 year. We identified 7173 new users: 44.6% initiated CHC and 55.4% initiated POC. Combined oral contraceptive pills (OCPs; 36.5%) and progestin-only depot medroxyprogesterone acetate (33.9%) were the most frequently prescribed agents. A total of 1.8% of contraception users had a new diagnosis of TE within 1 year of the first identified contraception prescription. There were no significant differences in TE event rates between CHC and POC users (17.2 and 24.7 events per 1000 person-years, respectively). In patients prescribed OCP, there were no differences in TE event rates based on estrogen dose or progestin generation. Transdermal patch had a 2.4-fold increased risk of TE as compared with that of OCP. Although limited by the retrospective study design and use of administrative claims data, this study found no significant differences in TE rates between new users of CHC and POC in patients with SCD. Careful evaluation of underlying TE risk factors should be considered for each patient with SCD before initiation of hormonal contraception.
Topics: United States; Female; Humans; Aged; Child; Adolescent; Young Adult; Adult; Progestins; Hormonal Contraception; Contraceptives, Oral, Hormonal; Retrospective Studies; Medicare; Thromboembolism; Anemia, Sickle Cell
PubMed: 37585480
DOI: 10.1182/bloodadvances.2023010204 -
Contraception Dec 2023This study aimed to evaluate the feasibility and effectiveness of providing bedside family planning services to women with chronic medical conditions in the inpatient... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVES
This study aimed to evaluate the feasibility and effectiveness of providing bedside family planning services to women with chronic medical conditions in the inpatient setting.
STUDY DESIGN
We initiated a parallel randomized controlled trial of patients listed as female aged 18 to 44 years who were admitted to the hospital from February 2018 to May 2021 with at least one chronic medical condition associated with lower rates of contraception usage and no documentation of contraception. Patients who confirmed they were not using contraception were enrolled and randomized to one of the three arms. They received bedside family planning counseling and an offer of contraception prior to discharge (oral contraceptive pills, etonogestrel implant, or medroxyprogesterone injection), received a flyer recommending they talk with their outpatient physician about contraception, or received standard care. The primary outcomes were contraception use at 3 months and 12 months after discharge.
RESULTS
Altogether 76 subjects were enrolled and randomized with 22 in the counseling arm and 27 each in the other arms. In the counseling arm, five (23%; 95% CI: 8.0%-45%) elected to receive contraception prior to discharge. Inferential statistics at follow-up were not able to be calculated due to high attrition.
CONCLUSIONS
Providing counseling and offering immediate contraception initiation in the inpatient setting may be a feasible approach to improving contraception access for this population. Additional investigation into the acceptability, efficacy, and generalizability of this approach is warranted.
IMPLICATIONS
Utilizing the inpatient setting may be a feasible approach for delivering contraception counseling to women with chronic medical conditions. This approach merits further study for effectiveness and acceptability. This study highlights the need for contraceptive counseling and initiation to become a standard part of hospital care for pregnancy-capable individuals.
Topics: Pregnancy; Female; Humans; Family Planning Services; Inpatients; Feasibility Studies; Contraception; Counseling
PubMed: 37549724
DOI: 10.1016/j.contraception.2023.110133 -
Acta Bio-medica : Atenei Parmensis Aug 2023Hypogonadism and abnormalities of glucose homeostasis, resulting from iron-induced pituitary and pancreatic β-cell dysfunction respectively, are the most frequently...
Retrospective study on long-term effects of hormone replacement therapy (HRT) and iron chelation therapy on glucose homeostasis and insulin secretion in female ß- thalassemia major (β-TM) patients with acquired hypogonadotropic- hypogonadism (AHH).
BACKGROUND AND AIM
Hypogonadism and abnormalities of glucose homeostasis, resulting from iron-induced pituitary and pancreatic β-cell dysfunction respectively, are the most frequently reported endocrine abnormalities in patients with ß-thalassemia major (β-TM), also identified as transfusion-dependent thalassemia (TDT).
STUDY DESIGN AND PATIENTS
The aim of the present retrospective study was to evaluate the long-term effects of hormone replacement therapy (HRT) on glucose metabolism and insulin secretion/sensitivity during 3-h oral glucose tolerance test (OGTT) in adolescent and young β-TM women with acquired hypogonadototropic -hypogonadism (AHH).Twelve hypogonadal β-TM females with AHH on HRT were followed for 8.26 ± 1.49 years.
RESULTS
At baseline, 10 patients (83.3%) had normal OGTT, 1 patient presented with impaired glucose tolerance (IGT) and 1 patient had an isolated PG level of 165 mg/dL at 1-h during OGTT (H-NGT). At last evaluation, 7 patients (58.4 %) had normal OGTT, while 5 patients (41.6%) had abnormal OGTT. Reduced insulin sensitivity and impaired first-phase insulin secretion were also documented. Three of 4 β-TM patients on treatment with estradiol hemihydrate MX 50 patches plus oral medroxyprogesterone acetate (MPA), associated with a very effective iron chelation therapy, maintained normal glucose tolerance from baseline to last evaluation. Significant adverse events due to HRT or additional endocrine complications were not documented in any cases during the follow-up.
CONCLUSION
Deterioration of glycemia (dysglycemia) occurred in 45.4% (5/11) of thalassemic females on long-term HRT. Additional studies are needed to elucidate the validity of our preliminary observations.
Topics: Adolescent; Female; Humans; beta-Thalassemia; Blood Glucose; Chelation Therapy; Endocrine System Diseases; Glucose; Glucose Intolerance; Homeostasis; Hormone Replacement Therapy; Hypogonadism; Insulin Resistance; Insulin Secretion; Iron; Retrospective Studies; Young Adult
PubMed: 37539597
DOI: 10.23750/abm.v94i4.14631 -
PloS One 2023Women who use hormonal contraception face delayed return of fertility upon discontinuation. There was limited evidence of fertility return after hormonal contraceptive...
Fertility return after hormonal contraceptive discontinuation and associated factors among women attended Family Guidance Association of Ethiopia Dessie model clinic, Northeast Ethiopia: A cross-sectional study.
BACKGROUND
Women who use hormonal contraception face delayed return of fertility upon discontinuation. There was limited evidence of fertility return after hormonal contraceptive discontinuation in the study area. Hence this study assessed fertility return after hormonal contraceptive discontinuation and associated factors among pregnant women attending Family Guidance Association Ethiopia (FGAE) Dessie model clinic, Northeast Ethiopia, 2019.
METHODS
A cross-sectional study was conducted on 423 samples selected by using systematic random sampling. Data were collected by face-to-face interview using a pretested and structured questionnaire and reviewing client records. Data were entered using Epi Data version 3.1 and analyzed using SPSS version 23. Both bi-variable and multivariable binary logistic regressions were used to identify predictors of delayed fertility return. Adjusted odds ratio (AOR) along with a 95% Confidence Interval (CI) was used to measure the strength and the direction of the association and statistical significance was declared at a P-value less than 0.05.
RESULT
The proportion of fertility return among currently pregnant women after discontinuation of any hormonal contraceptive methods was 88.6% (95% CI; (85.6%-92%)). The proportion of fertility return among Depo-Provera, implant, Intrauterine Contraceptive Device (IUCD), and Oral Contraceptive Pill (OCP) users was 75%, 99.1%, 100%, and 97.8% respectively. Age, (AOR = 5.37, (95% CI; (1.48, 13.6)) and using Depo-Provera (AOR = 4.82, 95% CI; (1.89, 14.2)) had a significant association with delayed fertility return.
CONCLUSIONS
The proportion of fertility return among women after discontinuation of any hormonal contraceptive methods was high. Age and using Depo-Provera had a positive association with delayed fertility return. This study recommends a contraceptive counseling approach that addresses concerns about delay in the return of fertility after hormonal contraceptive discontinuation to avoid confusion among family planning users.
Topics: Pregnancy; Female; Humans; Cross-Sectional Studies; Ethiopia; Medroxyprogesterone Acetate; Fertility; Contraceptives, Oral; Intrauterine Devices
PubMed: 37432916
DOI: 10.1371/journal.pone.0287440