High Continuation Rates Research Articles

Long-term outcomes of vedolizumab in inflammatory bowel disease: the Swedish prospective multicentre SVEAH extension study.

Real-world data on long-term outcomes of vedolizumab (VDZ) are scarce. To assess long-term outcomes (up to 3 years) of VDZ in treating inflammatory bowel disease (IBD). A nationwide, prospective multicentre extension of a Swedish observational study on VDZ assessing Effectiveness And Healthcare resource utilization in patients with IBD (SVEAH). After re-consent, data of patients with Crohn's disease (CD) (n = 68) and ulcerative colitis (UC) (n = 46) treated with VDZ were prospectively recorded using an electronic case report form integrated with the Swedish IBD Register (SWIBREG). The primary outcome was clinical remission (defined as Harvey-Bradshaw Index ⩽4 in CD and partial Mayo score ⩽2 in UC) at 104 and 156 weeks in patients with a response and/or remission 12 weeks after starting VDZ. Secondary outcomes included health-related quality of life (HRQoL) and biochemical outcomes. VDZ continuation rates were high at weeks 104 and 156, 88% and 84%, respectively, for CD and 87% and 78%, respectively, for UC. Of the 53 CD patients with a response/remission at 12 weeks, 40 (75%) patients were in remission at 104 weeks and 42 (79%) patients at 156 weeks. For UC, these numbers were 25/31 (81%) and 22/31 (71%), respectively. Improvements were seen in the Short Health Scale (p < 0.01 for each dimension; CD, n = 51; UC, n = 33) and the EuroQol 5-Dimensions, 5-levels index value (p < 0.01; CD, n = 39; UC, n = 30). Median plasma-C-reactive protein concentrations (mg/L) decreased from 5 at baseline to 4 in CD (p = 0.01, n = 53) and from 5 to 4 in UC (p = 0.03, n = 34) at 156 weeks. Correspondingly, median faecal-calprotectin (µg/g) decreased from 641 to 114 in CD patients (p < 0.01, n = 26) and from 387 to 37 in UC patients (p = 0.02, n = 17). VDZ demonstrated high continuation rates and was associated with improvements in clinical outcomes, HRQoL measures and inflammatory markers at 2 and 3 years after treatment initiation in this prospective national SVEAH extension study. ENCePP registration number: EUPAS22735.

Switching and discontinuation of participant-masked randomization to a copper or levonorgestrel intrauterine device when presenting for emergency contraception

ObjectivesExamine intrauterine device (IUD) switching or discontinuation up to 6 months after participant-masked randomization to different IUDs. Study designParticipants were randomized 1:1 to the copper T380A or levonorgestrel 52 mg IUD for emergency contraception and informed they could switch IUD type without cost at any time. ResultsOf the 327 subjects allocated to the levonorgestrel IUD, 7 (2.1%) switched their IUD type by 6 months versus 18 (5.5%) of the 328 copper IUD users (RR: 0.4 [95% CI: 0.2, 0.9], p = 0.03). Six-month IUD discontinuation occurred in 34 (10.4%) levonorgestrel and 35 (10.7%) copper IUD users. ConclusionIndividuals randomly assigned to IUD type at presentation for emergency contraception continue their assigned IUDs at high rates over 6 months. ImplicationsWhile many recruited individuals declined enrollment, those who accepted randomization had high continuation rates; the high continuation and low cross-over supports using IUD randomization as a tool for future investigation. Participants’ similar rates of and reasons for switching and discontinuation by IUD type over the study period may impact clinical counseling.

What Have We Learned? Implementation of a Shared Learning Agenda and Access Strategy for the Hormonal Intrauterine Device.

In 2015, a global learning agenda for the hormonal intrauterine device (IUD) was developed with priority research questions regarding use of the method in low- and middle-income countries. In addition, members of the Hormonal IUD Access Group aligned on a strategy to expand access in the context of volunteerism and contraceptive method choice. This article synthesizes evidence generated since then and describes steps taken to address demand- and supply-side barriers to access. Findings demonstrated high continuation rates and satisfaction among hormonal IUD users that are comparable to other long-acting reversible contraceptives (LARCs). Across studies, a sizable number of users reported they would have chosen a short-acting method or no method at all if the hormonal IUD were not an option, which suggests that women did not see the hormonal IUD as interchangeable with other LARC options and thus it may fill an important niche in the market. With several countries now poised to scale up the method, resource mobilization will be key. On the demand side, investments in implementation research will be critical to understanding how best to launch and scale the method, while ensuring the sustainability of multiple quality-assured suppliers with affordable public-sector pricing will be necessary on the supply side.

Clinical Outcomes of Post Placental Intrauterine Contraceptive Device Insertion in Women Delivering by Cesarean Section

Background: Short pregnancy interval after caesarean section increases the risks of morbidity, mortality and surgical interventions. This can be easily avoided by post placental insertion of IUCD during caesarean section. Immediate post placental IUCD insertion is defined as insertion of IUCD within 10 minutes of delivery of the placenta. It is a very promising an appealing approach as patient does not have to come for a separate postpartum visit. Objectives: To determine the outcome (safety, complications, failure and continuation rate) of post placental IUCD insertion during caesarean section. Materials and Methods: Our study was a prospective cross-sectional study, carried out in the Department of Obstetrics and gynecology at Qazi Hussain Ahmad Medical Complex, Nowshera. All the pregnant women willing for post placental intrauterine contraceptive device were included in the study. Women who had postpartum hemorrhage, chorioamnionitis, structurally malformed uterus and fibroid uterus were excluded from the study. Follow up visits were scheduled at one month, 3 months and 6 months. Results: 156 women were included in this study. Majority(35.2%) belonged to 31- 35 years age group. 46.7% of them were illiterate and 30.7% have just primary education. 40.38% of women belonged to low socio-economic group. 26.2% of women were para 4. 26.9% had previous 3 caesarean section. The most common adverse events during follow up of 6months were vaginal discharge, menstrual irregularities and pelvic pain. At the end of 6 months there were 9expulsions, 12 removals and 2 pregnancies with the gross cumulative expulsions, removal, failure and continuation rate of 5.7%, 7.6%, 1.28% and 85.2% respectively. The incidence of undescended strings at the end of 6 months was high (32.4%). Conclusion: Post placental intra uterine Copper T 380 A insertion is a safe, effective and easy reversible method of contraception with low expulsion and high continuation rates. Keywords: Intrauterine device,Intra-cesarean section, Post placental insertion

Thirty-day Treatment Continuation After Audio-only Buprenorphine Telehealth Initiation.

Before the coronavirus disease 2019 pandemic, federal law required in-person evaluation before buprenorphine initiation. Regulatory changes during the pandemic allow for buprenorphine initiation by audio-only or audiovisual telehealth. Little is known about treatment engagement after buprenorphine initiation conducted via audio-only telehealth. A retrospective cohort study of 94 individuals who received initial treatment through an audio-only encounter between April 2020 and February 2021 was performed. Participant demographics, substance use history, withdrawal symptoms, 30-day treatment engagement, and adverse outcomes were determined by an electronic chart and REDcap database review. Subsequent buprenorphine prescriptions filled within 30 days of the initial encounter were tracked through the Rhode Island Prescription Drug Monitoring Program. Buprenorphine was prescribed for 94 individuals. Most (92 of 94 [97.9%]) filled their prescription within 30 days. Most had previously taken buprenorphine, including prescribed (42 of 92 [45.7%]) and nonprescribed (58 of 92 [63.0%]). Two thirds were in opioid withdrawal at the time of the call (61 of 92 [66.3%]) with a mean Subjective Opioid Withdrawal Scale of 26.8 (range, 4-57). Four individuals experienced precipitated withdrawal (4 of 94 [4.3%]), and 2 reported persistent withdrawal at their follow-up visit (2 of 94 [2.1%]). More than 70% filled a subsequent prescription for buprenorphine within 30 days of the end of their hotline prescription (65 of 92 [70.7%]), on average of 5.88 days (range, 0-28) after completion of their telehealth prescription. Expanding telehealth-delivered buprenorphine care has the potential to address treatment gaps and facilitate delivery of on-demand services during peak motivation. This evaluation of audio-only buprenorphine initiation found high rates of unobserved buprenorphine initiation and treatment continuation with low rates of complications.

Use of 52-mg Levonorgestrel-Releasing Intrauterine System in Adolescents and Young Adult Women: 3-Year Follow-Up

Study ObjectiveTo evaluate continuance rates, bleeding patterns, and patient satisfaction with 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) use in adolescents and young adult women during the first 3 years of use DesignWe conducted an observational prospective study. SettingFamily Planning Service of a tertiary hospital in Brazil ParticipantsOne hundred adolescents and young women aged 16-24 years. InterventionInsertion of 52-mg LNG-IUS for the main purpose of contraception. Follow-up visits were conducted at 12, 24, and 36 months after insertion. Main Outcome MeasuresContinuance rates, reasons for discontinuation of the method, and women's satisfaction and bleeding patterns ResultsAmong those who were not lost to follow-up, LNG-IUS continuance rates were 89.1% (82/92), 82.9% (72/87), and 75.3% (64/85) in the first, second, and third years of use, respectively. The main reason for discontinuation was acne, followed by expulsion of/malpositioned LNG-IUS. Other reasons for discontinuation were irregular uterine bleeding, dysmenorrhea, and abdominal pain. The amenorrhea rates were 50%, 54.1%, and 39% at 12, 24, and 36 months, respectively. Spotting rates increased during the first 3 years of use (20.8%, 16.7%, and 26.6%, respectively). Adolescents and young women using the LNG-IUS showed high rates of satisfaction, with 93.9%, 100%, and 96.8% of women being very satisfied/satisfied in the first 3 years of use. Only 2 participants who continued using the LNG-IUS reported being very dissatisfied/dissatisfied in the third year of follow-up. ConclusionThe LNG-IUS showed high rates of continuation and satisfaction in the first 3 years of use in Brazilian adolescents and young adults. Most women reported a favorable bleeding pattern.

Increasing access to immediate postpartum contraceptive implants: a prospective clinical trial among patients with opioid use disorder

Objective To evaluate the effects of increased access to immediate postpartum contraceptive implants (IPI) on repeat pregnancy and contraceptive use rates among patients with opioid use disorder (OUD). Materials and Methods Between 2016 and 2018, 194 postpartum patients with OUD were offered the option of IPI placement at an institution with limited immediate postpartum long-acting reversible contraception availability and followed for one-year postpartum. Differences in pregnancy rates between participants who did and did not choose IPI were examined using logistic regression with inverse probability of treatment weighting from propensity scores accounting for differences between the two groups. Results Among 194 participants, 96 (49.5%) chose an IPI and 98 (50.5%) chose an alternative method or no contraception (non-IPI). Among IPI participants, 76 (80.9%) continued to use their implant at one-year postpartum. Overall, 19 participants had a repeat pregnancy and 11 (57.9%) were unintended. In multivariable analyses, repeat pregnancy was more likely among those who did not choose IPI (OR 9.90; 95% CI 3.58–27.03) than those who did. Participants with OUD and who used alcohol (11.66; 1.38, 98.20) or cocaine (2.72; 1.23, 5.99) during pregnancy were more likely to choose IPI. Participants who were married (0.28; 0.09, 0.89), engaged in OUD treatment prior to pregnancy (0.48; 0.25, 0.93), and happier when they found out about their pregnancy (0.87; 0.77, 0.98) were less likely to choose IPI. Conclusion Offering patients with OUD the option of IPI is associated with high utilisation and continuation rates, and low rates of repeat pregnancy within one-year postpartum.

Call to action: The pharmacist’s role in improving contraceptive knowledge and access

Pharmacists have the knowledge and training to participate in contraceptive education and management and should feel empowered to do so. Advocating for legislation to expand the pharmacist’s role in this setting can improve patient access to hormonal contraceptives. As the nation digests the Supreme Court’s decision to overturn Roe vs. Wade, many health care providers have stopped to think about what our role will be in this uncertain future. Approximately, 20 states/jurisdictions have legislation in place that allows pharmacists to prescribe or dispense oral contraceptives without a prescription; broadening the scope of practice for pharmacists increases patients’ access to care, and may improve overall adherence. When compared to clinician-initiated contraception, pharmacists were more likely to prescribe contraception to eligible women and had a higher rate of continuation at 12 months. In addition, pharmacists providing education to both patients and prescribers can help debunk misinformation on hormonal contraceptives which may impact access and adherence. With the recently changing federal—and in many instances state—legislation, pharmacists will need to seek out more opportunities to facilitate access to hormonal contraceptives and increase knowledge surrounding emergency contraceptive options and other medications used for reproductive health. Pharmacists have the knowledge and accessibility to assist in contraceptive care. Now, more than ever, pharmacists’ involvement in hormonal contraceptive care will be a necessary step to ensure that our patients receive the appropriate care they deserve.

Continuation rates of two different-sized copper intrauterine devices among nulliparous women: Interim 12-month results of a single-blind, randomised, multicentre trial.

SummaryBackgroundThe most widely used copper intrauterine device (IUD) in the world (the TCu380A), and the only product available in many countries, causes side effects and early removals for many users. These problems are exacerbated in nulliparous women, who have smaller uterine cavities compared to parous women. We compared first-year continuation rates and reasons/probabilities for early removal of the TCu380A versus a smaller Belgian copper IUD among nulliparous users.MethodsThis 12-month interim report is derived from a pre-planned interim analysis of a sub population and focused on key secondary comparative endpoints. In this participant-blinded trial at 16 centres in the USA, we randomised participants aged 17–40 in a 4:1 ratio to the NT380-Mini or the TCu380A. In the first year, participants had follow-up visits at 6-weeks and 3, 6, and 12-months, and a phone contact at 9 months; we documented continued use, expulsions, and reasons for removal. Among participants with successful IUD placement, we compared probabilities of IUD continuation and specific reasons for discontinuation using log-rank tests. This trial is registered with ClinicalTrials.gov number NCT03124160 and is closed to recruitment.FindingsBetween June 1, 2017, and February 25, 2019, we assigned 927 nulliparous women to either the NT380-Mini (n = 744) or the TCu380A (n = 183); the analysis population was 732 (NT380-Mini) and 176 (TCu380A). Participants using the NT380-Mini, compared to the TCu380A, had higher 12-month continuation rates (78·7% [95% CI: 72·9–84·5%] vs. 70·2% [95% CI: 59·7–80·7], p = 0·014), lower rates of removal for bleeding and/or pain (8·1% vs. 16·2%, p = 0·003) and lower IUD expulsion rates (4·8% vs. 8·9%, p = 0·023), respectively.InterpretationThe NT380-Mini offers important benefits for a nulliparous population compared to the TCu380A in the first twelve months, when pivotal experiences typically occur. Higher continuation rates with the NT380-Mini may avert disruptions in contraceptive use and help users avoid unintended pregnancy.FundingBill & Melinda Gates Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development, and Mona Lisa, N.V. (Belgium).

Uterine volume, menstrual patterns, and contraceptive outcomes in users of the levonorgestrel-releasing intrauterine system: A cohort study with a five-year follow-up

ObjectiveThe aim of our study was to evaluate the effects of the LNG-IUS on uterine volume, bleeding patterns, and LNG-IUS-related outcomes among women using the device to treat abnormal uterine bleeding caused by fibroids, adenomyosis, HMB (without structural cause), or contraception. Study designThis was a 5-year cohort study with LNG-IUS users. We selected 147 women, who were allocated to four groups: a) control (contraception indication); b) fibroids; c) adenomyosis; d) HMB. The visits for clinical and ultrasound evaluations were made at baseline and at 3, 6, 12, 24, 36, 48, and 60 months postinsertion. All data are expressed as mean and standard deviation (SD) or absolute and relative (%) frequency. Differences among groups were established by using the χ2 (chi-square) test and Fisher's exact tests for categorical outcomes, as well as the Mann-Whitney and the Kruskal-Wallis tests and Friedman’s ANOVA for continuous variables. We used the 5% significance level as an indication of statistical significance. Logistic regression analyses were performed to study the association between predictors and outcomes. Results are expressed as odds ratios (ORs) with a 95% confidence interval (CI 95%). Results: Although all groups had real rates of bleeding patterns, troublesome bleeding appeared to be more frequent in the fibroid group (∼15%). Also, along the 60 months of follow-up, uterine volume slightly decreased in the groups of HMB, adenomyosis, and fibroids, but not in the contraception group. However, the isolated volume of fibroids remained unchanged. In this cohort, we observed high continuation rates among LNG-IUS users. The uterine volume ≥200 cm3 was the main predictor of hysterectomy or IUS expulsion in the adenomyosis and fibroid groups. ConclusionThe LNG-IUS may control uterine menstrual bleeding as well as uterine volume in adenomyosis, fibroids, and HMB. An initial uterine volume smaller than 200 cm3 is an important predictor of adherence to treatment and better outcomes.

To evaluate the efficacy and complications of post placental IUCD insertion in vaginal and post cesarean deliveries

Introduction: PPIUCD is an emerging contraceptive method for women which is easily available, safe, efficient, long acting, reversible and available just after birth of baby. Aims and Objectives To study the efficacy of postplacental IUCD insertion in vaginal and cesarean delivaries. Comparative evaluation of postplacental IUCD in vaginal and cesarean insertion in terms of counseling and complications. Material and Method: This study was conducted at Department of Obsterics S&amp; Gynecology ,SMS Medical College,Jaipur .Total 150 Vaginal and Cesarean Deliveries were included in this study.Women counseled for PPIUCD during antepartum, intrapartum or during preparation of cesarean section for post placental IUCD insertion in cesarean delivery or vaginal delivery and followed for any complication. Observation: In our study it was observed that the proportion of parturient accepting post placental IUCD on counseling was 27.98% in vaginal delivery and 36.95% in cesarean delivery. Excessive bleeding through os was seen in 6 to 8% of cases, missing tail was seen in 38.7% of cases in group B and 8.7% of cases in group A had expulsion of IUCD. There was higher acceptance of post placental IUCD with better follow up, with no expulsion and higher continuation rate in cesarean delivery in comparison to vaginal delivery. Conclusion: To conclude post placental IUCD is an effective, reversible method of contraception.specially in area where the situation is of limited access to post-partum care and inability of women to return back for contraceptive measures.

Continuation of Gender-affirming Hormones Among Transgender Adolescents and Adults.

Concerns about future regret and treatment discontinuation have led to restricted access to gender-affirming medical treatment for transgender and gender-diverse (TGD) minors in some jurisdictions. However, these concerns are merely speculative because few studies have examined gender-affirming hormone continuation rates among TGD individuals. We performed a secondary analysis of 2009 to 2018 medical and pharmacy records from the US Military Healthcare System. We identified TGD patients who were children and spouses of active-duty, retired, or deceased military members using International Classification of Diseases-9/10 codes. We assessed initiation and continuation of gender-affirming hormones using pharmacy records. Kaplan-Meier and Cox proportional hazard analyses estimated continuation rates. The study sample included 627 transmasculine and 325 transfeminine individuals with an average age of 19.2 ± 5.3 years. The 4-year gender-affirming hormone continuation rate was 70.2% (95% CI, 63.9-76.5). Transfeminine individuals had a higher continuation rate than transmasculine individuals 81.0% (72.0%-90.0%) vs 64.4% (56.0%-72.8%). People who started hormones as minors had higher continuation rate than people who started as adults 74.4% (66.0%-82.8%) vs 64.4% (56.0%-72.8%). Continuation was not associated with household income or family member type. In Cox regression, both transmasculine gender identity (hazard ratio, 2.40; 95% CI, 1.50-3.86) and starting hormones as an adult (hazard ratio, 1.69; 95% CI, 1.14-2.52) were independently associated with increased discontinuation rates. Our results suggest that >70% of TGD individuals who start gender-affirming hormones will continue use beyond 4 years, with higher continuation rates in transfeminine individuals. Patients who start hormones, with their parents' assistance, before age 18 years have higher continuation rates than adults.

Effect of Treatment of Subclinical Thyroid Dysfunction on Pregnancy Outcome in Patients with 1st Trimester Recurrent Miscarriages

Introduction: Thyroid dysfunction and thyroid autoimmunity are prevalent among women of reproductive age and are associated with adverse outcomes including miscarriage and preterm delivery. Preconception or early pregnancy screening for thyroid dysfunction has been proposed but is not widely accepted Objective: To determine the effect of treatment of subclinical thyroid dysfunction on pregnancy outcome(pregnancy going beyond 24 weeks ;period of viability in developing world/ miscarriage in first trimester) in patients with recurrent 1st trimester miscarriages. Material and Mathod: Study Design: Randomized controlled trial Settings: Department of Obstetric and Gynaecology, Lady Wallingdon Hospital, Lahore Duration: One year after submission of synopsis. Data Collection: The data was collected from the patients admitted in gynae unit 2 through outpatient department with history, examination and investigation which was included according to the inclusion criteria mentioned above. All the patients were assessed with thyroid hormone level. TSH and free T4 was sent to in pathology lab, the result was interpreted by the pathologist to evaluate for the presence of subclinical thyroid dysfunction according to operational definitions. The women with subclinical thyroid dysfunction was categorized as subclinical hypothyroidism and subclinical hyperthyroidism according to results. These women were further evaluated by endocrinologist to allocate them between treatment and control groups. The data collection procedure will be explained to each patient and informed written consent was taken . Each woman was ensured that confidentiality of each subject is kept. It is the matter of controversary in subject of gynecology whether to treat the subclinical thyroid dysfunction or not during pregnancy on the basis of which control group was selected. However if during research study convincing evidence comes in favour of giving treatment to control group then treatment was offered to those patient as well. Single blinding was maintained in control group by giving placebo therapy. Eligible women were allocated in 1:1 in treatment and control groups. The thyroxin (dose 0.5mg/kg body weight) was given to women with subclinical hypothyroidism in treatment group and propylthiouracil (0.3mg/kg body weight) was given to women with subclinical hyperthyroidism in treatment group to maintain TSH (0.45 to4.5IU) and the free t4 level between (14-20umol/l).woman thyroid function test was carried out on biweekly basis in follow up and dose adjustment accordingly. In non-treatment group no treatment given for subclinical thyroid dysfunction and outcomes was assessed and compared in both groups in current pregnancy in respect of miscarriage in first trimester or continuation of pregnancy beyond period of viability. Results: Frequency of miscarriage in treatment group and in control group was 60.2% and 78.5%. However frequency of miscarriage was significantly higher in control group as that of treatment group. There were 37(39.85) women in treatment group and 20(21.5%) women in control group in which continuation of pregnancy was seen beyond 24 weeks. However women in treatment group had high pregnancy continuation rate as that of control group. i.e. p-value=0.007 Conclusion: Results of this study showed that treatment of subclinical thyroid dysfunction during pregnancy in women with 1st trimester recurrent miscarriages has better pregnancy outcomes. Treatment of thyroid insufficiency during pregnancy is important in avoiding hostile not only maternal as well as fetal outcome Keywords: Treatment, Subclinical thyroid dysfunction, Pregnancy outcome, Recurrent, 1st trimester miscarriages

Effectiveness, safety and overall satisfaction of early postpartum placement of hormonal IUD compared with standard procedure: An open-label, randomized, multicenter study.

In this open-label, randomized controlled, non-inferiority, multicenter study we aimed to study the risk of termination of pregnancy within 1year postpartum, the safety profile and patient acceptability after early postpartum insertion of a hormonal intrauterine device (LNG-IUS, Mirena®) compared with standard placement 6-8weeks postpartum. April 2018 to January 2020 women with uncomplicated vaginal delivery at four urban birth centers in Sweden, were randomized to either early placement within 48h after delivery (early group) or standard placement 6-8weeks postpartum (standard group) of a hormonal intrauterine device. The main outcome measure was the proportion of terminations of pregnancies in each group during the first year after placement of the intrauterine device. Registration EudraCT database no. 2017-001945-29. The study was prematurely stopped according to the protocol due to an expulsion rate >20% in the early group. No pregnancies occurred. Fifty-two women were randomized to early and 49 women to standard insertion. In the early group, 23/52 (44.2%) of the intrauterine devices were expelled. After expulsion, 10 women chose to have another hormonal intrauterine device placed but still significantly fewer women (39/52, 75%, p=0.22) in the early group used the hormonal intrauterine device method at study completion. No expulsions occurred in the standard group, but 5/49 (10.2%) requested removal and 41/49 (83.7%, p=0.22) had used the hormonal intrauterine device method continuously for 1year. Early hormonal intrauterine device insertion after vaginal delivery is associated with high expulsion rates. Despite this, a high continuation rate of the hormonal intrauterine device method is seen among women once choosing the method. In the light of high continuation rates, the advantages of early insertion could balance the risk of expulsion for well-informed women.

Daily Oral Pre-exposure Prophylaxis (PrEP) Continuation Among Women from Durban, South Africa, Who Initiated PrEP as Standard of Care for HIV Prevention in a Clinical Trial

HIV incidence among women in Eastern and Southern Africa remains unacceptably high, highlighting the need for effective HIV prevention options, including pre-exposure prophylaxis (PrEP). The Evidence for Contraceptive Options and HIV Outcomes trial offered daily oral PrEP to participants during the latter part of the clinical trial as an additional HIV prevention choice. We explored daily oral PrEP continuation at trial exit among women enrolled from Durban, South Africa who initiated oral PrEP at the trial site. Of the 132 women initiating oral PrEP, 87% reported continuation of oral PrEP at month 1, 80% at month 3, and 75% continued using oral PrEP at their final trial visit and were referred to off-site facilities for ongoing oral PrEP access. The median duration of oral PrEP use in trial participants who used oral PrEP was 91 days (IQR 87 to 142 days). Women who disclosed their oral PrEP use to someone had increased odds of continuing oral PrEP at trial exit. Women who reported > 1 sex partner and those who felt they would probably or definitely get infected with HIV had reduced odds of continuing oral PrEP at trial exit. Of those discontinuing oral PrEP (n = 32), > 50% discontinued within the first month, and the most common reason for discontinuation was reporting side effects. The high rates of oral PrEP continuation in our study are encouraging and our findings can be utilized by other clinical trials providing oral PrEP as standard of care for HIV prevention and by oral PrEP implementation programmes.

Introducing the hormonal Intrauterine Device in Madagascar, Nigeria, and Zambia: results from a pilot study

BackgroundThe hormonal Intrauterine Device (IUD) is a highly effective contraceptive option growing in popularity and availability in many countries. The hormonal IUD has been shown to have high rates of satisfaction and continuation among users in high-income countries. The study aims to understand the profiles of clients who choose the hormonal IUD in low- and middle-income countries (LMICs) and describe their continuation and satisfaction with the method after 12 months of use.MethodsA prospective longitudinal study of hormonal IUD acceptors was conducted across three countries—Madagascar, Nigeria, and Zambia—where the hormonal IUD had been introduced in a pilot setting within the of a broad mix of available methods. Women were interviewed at baseline immediately following their voluntary hormonal IUD insertion, and again 3 and 12 months following provision of the method. A descriptive analysis of user characteristics and satisfaction with the method was conducted on an analytic sample of women who completed baseline, 3-month, and 12-month follow-up questionnaires. Kaplan–Meier time-to-event models were used to estimate the cumulative probability of method continuation rates up to 12 months post-insertion.ResultsEach country had a unique demographic profile of hormonal IUD users with different method-use histories. Across all three countries, women reported high rates of satisfaction with the hormonal IUD (67–100%) and high rates of continuation at the 12-month mark (82–90%).ConclusionsRates of satisfaction and continuation among hormonal IUD users in the study suggest that expanding method choice with the hormonal IUD would provide a highly effective, long-acting method desirable to many different population segments, including those with high unmet need.

Evaluation of Expulsion and Continuation Rate of Immediate Postpartum Intrauterine Contraceptive Devices: A Prospective Hospital-based Study

Introduction: Family planning can avert nearly one-third of maternal deaths and 10% of child mortality when couples space their pregnancies more than two years apart. With increased institutional deliveries, Postpartum Intrauterine Contraceptive Devices (PPIUCD) can play an important role in addressing the unmet needs of spacing methods in India. Moreover, in this digital age, generalised awareness of the female population about contraception has increased considerably, so the acceptance and continuation rate might be high. Aim: To evaluate expulsion and continuation rate of immediate PPIUCDs at a tertiary care hospital in Haryana, India. Materials and Methods: The prospective, hospital-based study was conducted from October 2020 to September 2021 in the Department of Obstetrics and Gynaecology at Kalpana Chawla Government Medical College, Karnal, Haryana, India. Ninety women who underwent IUCD insertion within 10 minutes of delivery of the placenta were enrolled, irrespective of the mode of delivery. Patients were followed-up at six weeks, three months, and six months. The expulsion and continuation rate of immediate PPIUCD and reasons for removal were studied. Descriptive variables were expressed in percentages. The Chi-square test was used to determine the continuation rate and expulsion/ removal rates in vaginal versus cesarean deliveries and a p-value less than 0.05 was taken as statistically significant. Results: A continuation rate of 84.4% was observed at six months. A statistically significant difference was observed in the continuation rate of participants of vaginal delivery versus caesarean section (82.67% vs 93.33%, p-value &lt;0.01). Overall, the expulsion rate was 6.66%. Conclusion: Immediate PPIUCD insertion has high continuation rates and can play an important role in family planning.

Study of the client experience and continuation rate of postpartum intrauterine Copper-T device in semi-urban population in India

Background: Postpartum intrauterine copper device (PPIUCD) is a reliable and efficient method of contraception for women. In spite of its ease of administration, its acceptance is very low owing to a number of factors. The current study was undertaken to analyze the continuation rates and problems among women accepting PPIUCD as contraceptive method. Methods: The present study was undertaken in the family planning department of a teaching hospital in New Delhi. It was an ambispective, observational study in which 880 beneficiaries of PPIUCD were telephonically contacted and interviewed. A pro forma containing demographic profile, obstetric history of the women, date and timing of insertion of PPIUCD, source of information about PPIUCD, side effects encountered, willingness to continue, and reasons of discontinuation, if applicable, was filled and the data, collected thus, were analyzed. Results: Most of the women enrolled in the study had a mean age of 26.5 (±4.1) years; the average parity was two. The timing of insertion of PPIUCD was postplacental in majority of women (91.7%). Most of the women received information about PPIUCD from health-care workers (90.1%). It was found that 86.7% of women were using PPIUCD at the time of interview and 73.3% were satisfied with it and willing to continue further. The predominant side effect observed was pain abdomen (15%), followed by menstrual irregularity. Conclusion: The present study revealed a high continuation rate of PPIUCD. Health-care professionals were the foremost source of information for PPIUCD. It is a highly effective method which needs to be popularized among the masses by the active participation of media and other agencies as it has the potential to bridge the gaps in existing family planning services.

Experimental investigation of dynamic mass transfer during droplet formation using micro-LIF in a coaxial microchannel

The mass transfer of Rhodamine 6G from the droplet to the continuous phase in a coaxial micro-channel is studied using micro-LIF (Laser-Induced Fluorescence). The mass distribution inside droplet is measured and visualized. The experimental results affirm that there exists the internal circulation inside the droplet and it could enhance the convective mass transfer. The stagnant center of vortices is also observed. The extraction fraction could reach 40%−80%. In order to establish the mass transfer model, different flow rates of the dispersed and continuous phase are adopted. The high continuous phase flow rate and low dispersed phase flow rate are both beneficial to enhance mass transfer by expediting the internal circulation. A modified mass transfer model is found to calculate the extraction fraction. A good agreement between the model and experiment in various conditions demonstrates that the mass transfer model in this work is reliable and feasible.

The use of different doses levonorgestrel-releasing intrauterine system (LNG-IUS): real-world data from a multicenter Italian study

Purpose Current research fails to adequately inform about the differential use of available levonorgestrel-releasing intrauterine systems (LNG-IUSs) in real life. Aim of our study was to compare the characteristics, satisfaction, continuation rates, and adverse effects between users of the high-dose LNG-IUS (52 mg) and of the low dose LNG-IUS (13.5 mg and 19.5 mg). Materials and Methods A prospective cohort study was performed in two Services for Family Planning in normal menstruating women with the inclusion of all new prescriptions of LNG-IUS for contraception. Women were followed for a mean of 9.1 ± 2.6 months after placement. Results 109 women (mean age of 39.8 ± 8.7 years old) were included, 69.7% using a high dose LNG-IUS and 30.3% using a low dose LNG-IUS. Women with a low dose LNG-IUS were significantly younger, thinner, more nulliparous, with fewer vaginal deliveries and C-sections, with a lower menstrual flow length and with more previous use of short-acting reversible contraceptives (p < 0.05). LNG-IUS continuation was similar and very high at the last follow-up: 100 vs. 94.7% in the low and high dose LNG-IUS groups, respectively (p = 0.18). Satisfaction with treatment at the end of the study was similar between different LNG-IUS doses (p = 0.85), with 78.9% being satisfied/very satisfied. Bleeding patterns were significantly different between the two LNG-IUS doses (p < 0.0001). Diagnosis of dysfunctional cysts was more frequent in women with high dose compared to low dose LNG-IUS (22.2 vs. 12.1%), albeit not significantly. Conclusions We have shown a clear differential use of available LNG-IUS in clinical practice, both as baseline characteristics and as different outcomes, primarily for bleeding patterns. However, all these systems were associated with a very high rate of satisfaction and continuation.