Pearl Index Research Articles

The probability of pregnancy in 100 episodes of sexual intercourse: A measure of male contraceptive performance.

Accurately judging the efficacy of contraceptives is vital for preventing unintended pregnancy. The Pearl index and life table analysis describe female contraceptive performance. However, they are not ideal for quantifying male contraceptive efficacy given differences between male and female methods. In particular, male contraceptives like condoms are used "on demand" rather than long-term like female contraceptives. Additionally, the number of episodes of sexual intercourse, a key determinant of risk, is not considered. Lastly, men can father concurrent pregnancies in more than one woman. For these reasons, a male-specific measure may provide a more accurate measure of male contraceptive efficacy. As each episode of heterosexual intercourse within a fertile couple is associated with an approximately 3% risk of pregnancy, the chance of an unintended pregnancy with a given number of episodes of sexual intercourse can be modeled with and without contraceptives of various effectiveness. Such modeling demonstrates that unintended pregnancy is strongly associated with both the number of episodes of sexual intercourse and the efficacy of the method. Based on these models, I propose a novel metric for male contraceptive efficacy called the Probability of Pregnancy100, defined as the percent chance of an unintended pregnancy occurring with 100 episodes of intercourse. Probability of Pregnancy100 should be easy for men to understand and is applicable to men with multiple sexual partners or men using "on-demand" contraceptives. The prevention of unintended pregnancy by a male contraceptive is strongly influenced by both method efficacy and sexual frequency. Probability of Pregnancy100 may offer a better measure of male contraceptive efficacy compared to the Pearl index and life table analysis as it takes sexual frequency into account; however, Probability of Pregnancy100 will need to be tested prospectively in male contraceptive studies alongside the Pearl index and life table analysis to determine its utility compared to these existing measures of contraceptive efficacy.

Exploring the Feasibility of a Bracketing Approach Utilizing Modeling for Development of Long-Acting Injectables for Regulatory Approval-A Case Study Using Levonorgestrel.

The development of long-acting products of a characterized drug substance is of great interest. It is possible to support the development of these products with available clinical data by matching the exposure to a predefined bracket of a minimal concentration for efficacy and a maximal concentration for safety. This bracketing approach would cut down on the time and cost of new long-acting contraceptive products progressing to market. The current study describes the assessment of the data available to support a bracketing approach to conclude comparable levels of efficacy and safety for a postulated novel long-acting reversible contraceptive (LARC) product of levonorgestrel. Literature evidence of levonorgestrel efficacy, as quantified by the Pearl Index, was utilized and modeled by incorporating three LARC products for the estimation of a minimal concentration required for efficacy. Further literature was reviewed to quantify the maximal concentration required to ensure product safety. Additionally, a review of the regulatory precedence for the approach was conducted using European and UK databases. There was a reasonable definition of the minimal concentrations for efficacy where the target concentrations of levonorgestrel were in the range of 200-400 pg/mL. Maximum concentrations for safety were less well defined. Although regulatory guidance supports the bracketing approach, there is little precedence for licensing new products based on pharmacokinetic data only, despite much reduced clinical and non-clinical packages being evidenced. Understanding of the exposure response is not currently considered sufficient to support a bracketing approach for a new levonorgestrel product. If additional safety data are established, current regulations may allow for a reduced application package. Additional work is needed to support the approach, and this could utilize the wealth of information in real-world datasets combined with systems models.

Three-year efficacy, safety, and tolerability outcomes from a phase 3 study of a low-dose copper intrauterine device

ObjectivesTo assess 3-year efficacy, safety, and tolerability of the Cu 175mm2 copper intrauterine device (IUD). Study DesignThis single-arm trial recruited participants at risk of pregnancy aged 17-45 years at 42 U.S. centers to receive a Cu 175mm2 IUD with a flexible nitinol frame. We assessed efficacy in participants ≤35 years old at enrollment and assessed all other outcomes in the entire population. We calculated the Pearl Index (pregnancies/100 person-years) through 3 years as the primary efficacy outcome. Secondary outcomes included pregnancy percentages by life-table analysis, placement success, safety (adverse events), and tolerability. ResultsOf 1620 enrollees, 1601 (98.8%) had successful IUD placement, with 1397 ≤35 years at enrollment. We observed a 1-year Pearl Index of 0.94 (95%CI 0.43-1.78) and 1-year and cumulative 3-year life-table pregnancy rates of 1.26% (95%CI 0.57%-1.95%) and 2.47% (95%CI 1.34%-3.60%), respectively. The most common adverse events included bleeding and pain. Over 3 years, 15.4% of participants discontinued due to bleeding or pain. Device expulsions occurred in 36 (2.2%) and 63 (3.9%) participants over 1 and 3 years, respectively. Eight related serious adverse events occurred, including five ectopic pregnancies and one each of uterine perforation, anemia, and uterine hemorrhage. One- and three-year continuation rates were 78.9% and 49.6%, respectively. ConclusionThese data support efficacy, safety, and tolerability of the Cu 175mm2 IUD during the first 3 years of use. Clinical TrialNCT03633799

The sexual behaviors of young Polish women and their knowledge about contraception

Introduction. With the increasing trend of early sexual activity among adolescents, contraception has become a crucial topic. Poland ranks last in the Contraceptive Atlas, as the country with the poorest access to contraception methods and information. This results in a low level of contraceptive knowledge among young people, leading to unintended pregnancies and sexually transmitted infections. Adequate sexual education is a key element in promoting sexual health, enabling informed contraceptive choices based on medical knowledge. The responsibility for sexual education lies not only with parents but also with educators, pedagogues, doctors, and governmental bodies. Aim. To assess knowledge about contraception and investigate the sexual behaviors of women aged 15-25, comparing the results with available literature and indicating possible preventive actions in the studied area. Material and methods. An anonymous electronic survey was conducted among women aged 15-25 from across Poland. The survey was distributed on various internet groups, primarily comprising students. It included closed-ended questions verifying knowledge of the topic under study and a demographic section. Statistical analysis of the data was performed using Statistica and Microsoft Excel. Results. The average age of sexual initiation among respondents was 17.84±1.96 years, with one-third of them yet to engage in sexual activity. The majority of respondents (58%) had 1 to 3 sexual partners, and with increasing age and education level, the percentage of those with a higher number of sexual partners increased. The most popular contraceptive methods among respondents were barrier methods, combined oral contraceptive pills, and a combination of barrier and hormonal methods. The main sources of contraceptive information for the respondents were the internet, gynecologists, and scientific literature. Almost all respondents were aware of the definition of contraception, but only half were aware of the Pearl Index. Less than half of the respondents could identify the most effective contraceptive method, while almost all correctly identified the least effective method. The knowledge of the majority of respondents was assessed as moderate, good, or very good. Conclusions. Despite the generally good knowledge of contraception among the majority of respondents, there are still gaps that need to be filled. Due to the progressively decreasing age of sexual initiation, education on contraception is a priority that will help reduce the number of unintended pregnancies and sexually transmitted diseases in the future.

Effectiveness of the etonogestrel subdermal implant in users with overweight and obesity: a systematic literature review

BackgroundThe etonogestrel (ENG) subdermal implant is considered a well-tolerated and effective contraception option to avoid unintended pregnancies. However, it is unclear whether being affected by overweight or obesity diminishes the...

Analyzing and Comparing Global Sustainability Standards: LEED, BREEAM, and PBRS in Green Building arch article topic

Since the year 2000, a heightened environmental awareness has led to the emergence of global trends in forefront countries, prompting the need for standardized practices in the environmental building industry. This paper explores various experiments on buildings, demonstrating trends through examinations and tests conducted by governmental or private organizations. Notable among these trends are the standards set by global evaluation systems such as BREEAM, LEED, PBRS, and SSBS. The paper highlights the recent adoptaion of Arab standards in Abu Dhabi, positioning the emirate as a pioneer in sustainable development. The research focuses on the city of Kirkuk, where building regulations lack consideration for environmental standards. The study aims to identify applicable international standards, emphasizing the importance of residential standards in comparison to other criteria. The World Green Building Council's universal standards for existing buildings are discussed, with the recognition that these standards may need customization to align with the local environment and architectural characteristics of Kirkuk. The paper delves into the methodology used, employing a theoretical framework, analytical methodology, and a deductive approach to formulate recommendations tailored to meet local standards. The Abu Dhabi experience with the Pearl Rating System is explored, outlining its three evaluation stages and the specific criteria for building assessment. A comparison between sustainability standards reveals disparities in evaluation criteria, emphasizing the challenge in establishing global standards. The study calls for a transparent and globally applicable evaluation basis, considering discrepancies among diverse countries and their respective tools. The paper concludes by underlining the importance of establishing local standards, serving as a benchmark for quality and operational efficiency within the real estate market. It also emphasizes the crucial role of existing residential buildings in proposed solutions for sustainable development, highlighting their significance in local markets.

Risk factors for and outcomes of ring expulsions with a 1-year contraceptive vaginal system

The US Food and Drug Administration-approved segesterone acetate and ethinyl estradiol ring-shaped contraceptive vaginal system, known as Annovera (Sever Pharma Solutions/QPharma, Malmö, Sweden), was inserted and removed under a woman's control for a 21 day in and 7 day out regimen for up to 13 cycles of use. We aimed to describe the patterns of ring expulsion over time, to identify potential predictors of expulsion, and to evaluate the impact of expulsions on method discontinuation and pregnancy risk. Using data from 2064 participants who were enrolled in 2 multinational phase 3 clinical trials on the use of this contraceptive vaginal system, we examined data from participants' daily diaries for documentation of complete ring expulsion. We modeled the odds of reported expulsions over time with adjustment for background and demographic characteristics using mixed-effects logistic regression models with random intercepts. We compared the probability of continuation between those who did and those who did not report expulsions in the first cycle of use using survival analysis and hazards modeling. To determine if expulsions during the first cycle of use affected the risk for pregnancy, we calculated Pearl Indices. Most participants (75%) never experienced any expulsions during any cycle of use, and 91% to 97% did not experience an expulsion during any 1 cycle. The incidence of expulsion was highest in cycle 1 (9%). The odds of experiencing expulsions decreased by half in cycles 2 to 8 when compared with cycle 1 (0.48; 95% confidence interval, 0.40-0.58), and in cycles 9 to 13, expulsions were about a third of that in cycle 1 (0.32; 95% confidence interval, 0.26-0.41). Of those who did experience expulsions, most (62%-84%) experienced ≤2 expulsions per cycle. Participants from study sites in Latin America vs those in the United States had higher odds of not experiencing an expulsion (odds ratio, 1.95; 95% confidence interval, 1.45-2.63). Women with a higher education level had higher odds of experiencing an expulsion. Notably, parity, age, and body mass index were not associated with expulsion. Participants who experienced any expulsions in cycle 1 were more likely to discontinue use early (hazard ratio, 1.28; 95% confidence interval, 1.14-1.43) than participants who did not have an expulsion. The Pearl Index for participants who had expulsions during cycle 1 was 3.99 (95% confidence interval, 1.29-9.31), which was higher than that among participants who reported no expulsions (Pearl Index, 2.39; 95% confidence interval, 1.61-3.41), but the overlapping confidence intervals indicate that there is not sufficient evidence to demonstrate an association between expulsions and pregnancy risk. Expulsions were infrequent overall, decreased with subsequent cycles of use, and were not associated with body mass index or parity. Early discontinuation of product use was higher among participants who experienced an expulsion during cycle 1. Although it is unclear whether pregnancy risk was associated with expulsions, early recognition of expulsions among users may identify those at higher risk for discontinuation and may highlight when enhanced anticipatory counselling and guidance may be advantageous.

Comparison of Combined Parenteral and Oral Hormonal Contraceptives: A Systematic Review and Meta-Analysis of Randomized Trials.

Delivering contraceptive hormones through a transdermal patch or a vaginal ring might have advantages over the traditional oral route. To compare the effectiveness, compliance, and side effect profile of oral and parenteral drug administration methods. We performed a systematic literature search in four medical databases-MEDLINE (via PubMed), Cochrane Library (CENTRAL), Embase, and Scopus-from inception to 20 November 2022. Randomized controlled trials assessing the efficacy, compliance, and adverse event profile of combined parenteral and oral hormonal contraceptives were included. Our systematic search provided 3952 records; after duplicate removal, we screened 2707 duplicate-free records. A total of 13 eligible studies were identified after title, abstract, and full-text selection. We observed no significant difference in contraceptive efficacy (Pearl Index) between oral and parenteral drug administration (MD = -0.06, CI: -0.66-0.53; I2 = 0%). We found significant subgroup differences between parenteral methods in terms of compliance (χ2 = 4.32, p =0.038, I2 = 80%) and certain adverse events: breast discomfort (χ2 = 19.04, p =0.001, I2 = 80%), nausea (χ2 = 8.04, p =0.005, I2 = 75%), and vomiting (χ2 = 9.30, p =0.002; I2 = 72%). Both parenteral and oral contraceptives can be used as an effective contraceptive method, and the route of administration should be tailored to patient needs and adverse event occurrence.

Analytical Comparison of Leading Sustainability Systems in the Iraqi Environment

Over the last two decades, several sustainability assessment methods have developed as key accelerators for the development and improvement of sustainable industrial buildings. Some of these systems, like as LEED or BREEAM, are considered international, whereas others, such as Pearl Rating Systems (PRS), are local. Although they all share similar goals, they can lead to the construction of green buildings or the improvement of the efficiency of existing conventional buildings. Each technique has its structure, certification process, and weighting norms. The inequalities have prompted various questions about whether global assessment systems appropriately consider the country’s national settings. This study aims to compare the Pearl System, the Gulf region’s most popular Pearl, to the Iraqi High-rise Buildings Sustainability System, as well as the two most prominent international systems, LEED and BREEAM. The goal is to evaluate the possibility of applying codes to the performance of newly constructed buildings in Iraq using the sustainability approach, as well as to identify the benefits and drawbacks of this sophisticated system. The study included a multi-method approach, including a survey of the literature and open and closed interviews with local and worldwide experts on sustainable buildings. These techniques provided a full overview of the individual evaluation plans, allowing for required comparisons. The results revealed that the independent system combines the majority of the others while also differing from them in terms of sustainability techniques, resulting in an appealing impact on building design, performance, occupants of classified structures, and the environment.

Role of Artistic Copper-T Shiksha Model to sensitize women for the use of Copper–T as a safe contraceptive

The contraceptives are integral part of healthy sexual life. The choice of contraceptives depends on family planning and will of couple specially woman. Copper-T, an intrauterine device (IUD) is one of the most effective, cheapest and reversible contraceptive methods. It can be used for both spacing and birth control and it has minimum side effects as compared to other contraceptives. But it is highly neglected contraceptive though Copper- T has High pearl index and has less failure rate than other temporary contraceptive methods. As most of women are unaware of its potential significance & refuse it after misconception of perforation of uterus and expulsion. Copper-T Shiksha Model is innovative way of contraceptive counselling by artistic presentation to female and her family even in presence of children. It is based on the Arts Integration Approach and Neuro-linguistic programming. Copper-T is promoted as ornament of uterus instead of sharp object and displayed beautifully with a framed painting with significant meaning of contraception by famous artist Rahul Bhandare. Woman is also warned of side effects of Copper-T and conditions like excessive bleeding. It boosts up faith and confidence in contraceptive method. Both hand cards and clinic model is used in awareness. 400 women were selected randomly in group meets, door to door survey and individual counselling.

Is the multinational, surveillance PRO-E2 study informative for all countries? The Italian data on VTE and contraceptive effectiveness

Purpose To evaluate whether the thromboembolic risk and contraceptive effectiveness of NOMAC-E2 observed in the PRO-E2 study can be extended to each participating country, as lifestyle, cardiovascular risk factors and prescribing habits may differ geographically. This analysis was performed on the PRO-E2 Italian subpopulation, where smoking habit and women over 35 years were more prevalent compared with the overall study population. Materials and methods Data from NOMAC-E2 or levonorgestrel-containing COCs (COCLNG) new users were descriptively analysed. Incidence rates of thrombosis (events/10,000 women-years [WY]) and the Pearl Index (pregnancies/100 WY) were calculated. Results Overall, 11,179 NOMAC-E2 and 8,504 COCLNG users were followed up to 2 years (34,869 WY). The NOMAC-E2 cohort included more women over 35 vs. COCLNG (37.7% vs. 31.8%; p = 0.001). A comparable low risk of combined deep venous thrombosis of lower extremities (DVT) and pulmonary embolism (PE) was observed in NOMAC-E2 (1.7/10,000 WY; 95% CI: 0.21–6.2) and COCLNG users (6.6/10,000 WY; 95% CI: 2.4–14.4). Similar results were obtained by considering all thromboembolic events (VTE). Unintended pregnancies did not differ between NOMAC-E2 (0.12/100 WY; 95% CI: 0.06–0.21) and COCLNG (0.15/100 WY; 95% CI: 0.08–0.26) cohorts. Conclusion Despite the higher age and tobacco use, findings from the Italian subpopulation were broadly consistent with overall PRO-E2 results, confirming a similar low thromboembolic risk and high contraceptive effectiveness of NOMAC-E2 and COCLNG. Short condensation This subgroup analysis of the PRO-E2 study provides comprehensive epidemiological data on the use of combined oral contraceptives in a large Italian cohort, with a higher prevalence of women over 35 years and smokers. The study confirms the low thromboembolic risk and high contraceptive effectiveness of NOMAC-E2 pill.

Opill: The Over-the-Counter Contraceptive Pill.

The U.S. Food and Drug Administration has approved the first oral contraceptive pill (OCP) for over-the-counter status. This progestin-only pill contains norgestrel 0.075 mg taken daily, with a Pearl Index estimated at 4.4 (95% CI, 1.9-8.8). This formulation has an excellent safety profile, with current breast cancer as the only absolute contraindication and few relative contraindications. Ultimately, this approval has great potential to improve the accessibility of effective contraception for many pregnancy-capable Americans, especially those who have poor access to the health care system for prescription-required contraception, most notably people who hold marginalized identities. The pill's overall success in reducing rates of unintended pregnancy will rely on its availability, particularly in rural communities that may rely on one pharmacy, and affordability, especially for uninsured or underinsured individuals. However, given the need for improved contraceptive provision, particularly in abortion-restrictive settings, the over-the-counter approval of this daily OCP is a major advancement in the nation's contraceptive ecosystem.

The benefits of estetrol addition to drospirenone for contraception

Ethinylestradiol and drospirenone combined oral contraceptive formulations have been marketed for >20 years. Drospirenone has antimineralocorticoid and anti-androgenic effects that may offer several health benefits. Recently, 2 new drospirenone-containing oral contraceptives entered the market, 1 as a progestin-only pill containing 4 mg drospirenone and the other as a combined oral contraceptive containing 15 mg estetrol and 3 mg drospirenone. Estetrol has a unique differential effect on nuclear and membrane estrogen α-receptors when compared with other estrogens, leading to low impact on the liver, breast, and hemostasis parameters and a beneficial effect on the endometrium, vagina, cardiovascular system, bone, and brain. Phase 3 clinical studies demonstrated that the Pearl Index (pregnancies per 100-woman-years) for drospirenone alone is 4.0 in the United States and 0.93 in the European Union and for the estetrol-drospirenone combination it is 2.65 and 0.44, respectively. Drospirenone alone demonstrates high rates of unscheduled bleeding and low rates of scheduled bleeding, whereas the estetrol-drospirenone combination demonstrates a predictable and regular bleeding profile for most users with a high stable rate of scheduled bleeding and a low rate of unscheduled bleeding, reported primarily as spotting only. The adverse event profiles and discontinuation rates owing to adverse events are comparable, and no clinically significant effects were observed on metabolic parameters with either product. Hemostatic assays for drospirenone do not fully evaluate all parameters although the testing that is available suggests negligible effects, whereas validated hemostatic assays demonstrate that the estetrol-drospirenone combination has limited impact on hemostasis. The introduction of 4 mg drospirenone and 15 mg estetrol with 3 mg drospirenone are valuable additions to the contraceptive market. Adding estetrol to 3 mg drospirenone provides advantages of contraceptive efficacy and a regular, predictable bleeding profile with minimal impact on hemostasis parameters.

EFFICACY, SAFETY AND ACCEPTABILITY OF A BENZALKONIUM CHLORIDE SPERMICIDE CREAM IN WOMEN AGED 40 YEARS AND OVER NEEDING CONTRACEPTION: A PROSPECTIVE MULTICENTRE STUDY.

This multicenter prospective study (BZK40+) aims to determine the efficacy and tolerance of a benzalkonium chloride-containing spermicide as contraceptive among women aged 40 and over. Fertile women enrolled in this open single-arm study were instructed to systematically use the benzalkonium chloride spermicide before each intercourse. At the end of a 6-month mandatory period, participants were given the option of continuing the study for a further 6 months. The primary endpoint for contraceptive efficacy was the Pearl Index (PI) up to 12months of typical use. A total of 151 women (mean age: 45.9 years) were enrolled, 144 (95.4%) completed the initial 6-month period and 63 (41.7%) completed the optional 6-month period. The median number of intercourses ranged from 3 to 5 per month. The spermicide was applied before 96.3% of the 5,895sexual intercourses. The PI up to 12 months of typical use was 0 pregnancies (95% confidence interval: 0-2.88). The cumulative treatment exposure was 1249.7 women-months. This first study in women aged 40 years and over shows that benzalkonium chloride spermicide (Pharmatex®) is effective, well tolerated and well accepted in this population. Although very interesting, these results with a PI equal to zero are surprising and not in accordance with the low efficacy of spermicides in the overall population according to the WHO. So, our results should be interpreted with caution and confirmed by future research. Clinical trial registration number (EudraCT): 2016-004188-38.

The efficacy, safety, and tolerability of an estrogen-free oral contraceptive drospirenone 4 mg (24/4-day regimen) in obese users

ObjectivesThis study aimed to compare contraceptive efficacy and safety of drospirenone 4 mg in a 24/4-day regimen in nonobese and obese users and describe pharmacokinetics according to bodyweight. Study designWe analyzed data from three drospirenone 4 mg trials (2 European and 1 United States) to report outcomes in nonobese (body mass index <30 kg/m2) and obese (body mass index ≥30 kg/m2) users. We used data from the US trial to calculate the Pearl Index (pregnancies per 100 woman-years) in nonbreastfeeding participants aged ≤35 years at enrollment for confirmed pregnancies. We assessed safety outcomes from all trials based on reported treatment-emergent adverse events. We evaluated pharmacokinetics by bodyweight in the US trial. ResultsThe three trials combined comprised 2152 nonobese and 425 obese participants, including 590 nonobese and 325 obese participants in the US trial. Eight nonobese and four obese participants had confirmed pregnancies in the US trial, resulting in Pearl Indices of 3.0 (95% CI: 1.3–5.8) and 2.9 (95% CI: 0.8–7.3), respectively. Two-hundred forty-four (11.3%) nonobese and 39 (9.2%) obese participants discontinued due to a treatment-emergent adverse event. The pharmacokinetic analysis included 814 participants with a median weight of 73 (interquartile range 61–89) kg and median plasma drospirenone exposure (AUC0–24ss) of 661.3 (interquartile range 522–828) ng∙h/mL. Changing bodyweight from the median to the fifth percentile (51 kg) or 95th percentile (118 kg) changed drospirenone exposure (AUC0–24,ss) by 22.2% and –23.6%, respectively. ConclusionsDrospirenone 4 mg demonstrated similar contraceptive efficacy for both nonobese and obese users despite a difference in exposure based on bodyweight. ImplicationsOur limited comparison between obese and nonobese users of drospirenone-only oral contraception demonstrated no evidence that efficacy or discontinuation for adverse events differs between groups. Serum drospirenone levels vary by bodyweight and may correlate with bleeding outcomes.

Innovate and Stockpile: Respiratory Protection for Essential Workers in a Catastrophic Pandemic.

Innovate and Stockpile: Respiratory Protection for Essential Workers in a Catastrophic Pandemic.

Sustainability of Credit Union: A Systematic Review of Measurement and Determinants

ABSTRACT Credit union is considered as an alternative solution for global poverty and financial inclusiveness for social development. However, to achieve this goal, first and foremost a credit union must be sustainable. The purpose of this paper is to provide a systematic literature review on the key determinants of sustainability of credit unions and its measurements through comprehensive literature search and assessment based on the PRISMA-P guidelines. The findings reveal standard quantitative measures such as operations of self-sufficiency ratio, financial sustainability score, return on assets and pearl index (two studies qualitatively assessed governance structure and membership rate as measures). Additionally, key factors such as efficiency, loan management factors, deposit mobilization, portfolio at risk, credit risk, regulatory environment, and asset factors are significant determinants of sustainability of credit unions. The findings suggest a great need for complementarity of role and responsible conduct of the key stakeholders (members), staff, management and enabling regulatory environment for sustainable credit union.

Effectiveness, safety, and acceptability of postplacental insertion of GyneFix postpartum intrauterine device among women undergoing cesarean section: A multicenter prospective cohort study in China

ObjectivesTo assess the effectiveness, safety, and acceptability of postplacental insertion of GyneFix postpartum intrauterine device (PPIUD) in women undergoing cesarean section (C-section). Study designWe conducted a prospective cohort study at 14 hospitals in four eastern coastal provinces of China between September 2017 and November 2020. A total of 470 women who underwent C-section and consented to the postplacental insertion of GyneFix PPIUD were enrolled, and 400 completed the 12-month follow-up. Participants were interviewed in the wards after delivery and followed up at 42 days, and months 3, 6, and 12 after delivery. We used Pearl Index (PI) to measure the rate of contraceptive failure, life-table method to measure the rate of PPIUD discontinuation, including IUD expulsion, and Cox regression model to explore the risk factors associated with discontinuation of the device. ResultsNine pregnancies were detected during the first year after GyneFix PPIUD insertion: seven were due to device expulsion and two occurred with PPIUD in situ. The PIs for overall 1-year pregnancy rate and pregnancies with IUD in situ were 2.3 (95% CI: 1.1–4.4) and 0.5 (95% CI: 0.1–1.9), respectively. The 6- and 12-month cumulative expulsion rates for PPIUD expulsion were 6.3% and 7.6%, respectively. The overall 1-year continuation rate was 86.6% (95% CI: 83.3–89.8). We did not identify any patient with insertion failure, uterine perforation, pelvic infection, or excess bleeding due to GyneFix PPIUD insertion. Women's age, education, occupation, previous history of C-section, parity, and breastfeeding were not associated with removal of GyneFix PPIUD in the first year of use. ConclusionsPostplacental insertion of GyneFix PPIUD is effective, safe, and acceptable for women undergoing C-section. Expulsion is the most common reason for GyneFix PPIUD discontinuation and pregnancy. The expulsion rate for GyneFix PPIUD is lower than that for framed IUDs, but more evidence is needed for a firm verdict.

NOMAC-E2 compares to LNG combined oral contraceptives in women over forty: real-world PRO-E2 study

Objective To investigate safety and effectiveness of NOMAC-E2 and levonorgestrel-containing COCs (COCLNG) in users over 40. Methods In this large, observational study, new users 1 of NOMAC-E2 and COCLNG were recruited in Europe, Australia, and Latin America and followed-up via questionnaires. Incidence of venous thromboembolism (VTE) was expressed as incidence rate (IR; events/104 women-years [WY]). Unintended pregnancy was expressed by the Pearl Index (PI; contraceptive failures/100 WY). Mood and weight changes were defined as mean changes in mood score and percentage of body weight. Results Overall, 7,762 NOMAC-E2 and 6,059 COCLNG users over 40 were followed-up. NOMAC-E2 showed no increased VTE risk compared to COCLNG; confirmed events: 5 NOMAC-E2 (IR 5.9; 95% CI, 1.9–13.7) vs 4 COCLNG (IR 5.9; 95% CI, 1.6–15.1). Unintended pregnancy did not differ substantially between cohorts; confirmed events: 4 NOMAC-E2 (PI 0.05; 95% CI, 0.01–0.13) vs 5 COCLNG (PI 0.08; 95% CI, 0.03–0.18). No differential effect on mood and weight was observed between cohorts. Conclusions NOMAC-E2 can be considered a valid alternative to COCLNG in perimenopausal women.

NOMAC-E2 shows a better contraceptive effectiveness than LNG combined oral contraceptives in women under 25: real-world PRO-E2 study

Objective: To investigate unintended pregnancy and changes in mood, acne, and weight in NOMAC-E2 vs levonorgestrel-containing COC (COCLNG) users under 25 years. Methods: In this large, observational study, new users (first-ever users of an eligible COC or restarting with the same or a new eligible COC after a break of at least 2 months) of NOMAC-E2 and COCLNG were recruited in 12 countries in Europe, Australia, and Latin America and followed up via questionnaires for up to 2 years. Unintended pregnancy was expressed by the Pearl Index (PI; contraceptive failures/100 women-years). Crude (HRcrude) and adjusted hazard ratios (HRadj) were calculated. Mood and acne changes were defined as change of score from baseline. Weight change was defined as percent change of body weight. Results: Overall, 12,829 NOMAC-E2 users and 17,095 COCLNG users under 25 were followed-up. The risk of unintended pregnancy was statistically significantly lower in the NOMAC-E2 cohort; confirmed events: 30 NOMAC-E2 (PI 0.24; 95% CI, 0.16–0.35) vs 94 COCLNG (PI 0.51; 95% CI, 0.41–0.62). The HRcrude for unintended pregnancy comparing NOMAC-E2 to COCLNG was 0.47 (95% CI, 0.31–0.71) and the HRadj was 0.52 (95% CI, 0.34–0.78). No differential effect on acne, mood, and weight was observed between cohorts. Conclusions: NOMAC-E2 shows a significantly better contraceptive effectiveness in young women and has no differential effect on acne, mood, and weight compared to COCLNG.