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DRCOG OSCE for Circuit C Answers
Published in Una F. Coales, DRCOG: Practice MCQs and OSCEs: How to Pass First Time three Complete MCQ Practice Exams (180 MCQs) Three Complete OSCE Practice Papers (60 Questions) Detailed Answers and Tips, 2020
to standardize the results to reflect the experience of 100 woman-years with each woman contributing 13 cycles per year. Simply put, the Pearl Index is the failure rate per 100 woman-years of any given contraceptive method.
Adolescent contraception
Published in Joseph S. Sanfilippo, Eduardo Lara-Torre, Veronica Gomez-Lobo, Sanfilippo's Textbook of Pediatric and Adolescent GynecologySecond Edition, 2019
Hanna Goldberg, Jasmine Multani, Sari Kives
The implantable contraceptive is a single 4 mm by 2 mm rod, 68 mg etonorgestrel implant, which is placed discretely under the skin on the inner upper arm during a small procedure in the physician's office and releases 40 μg of etonorgestrel daily. The implant can be used for up to 3 years. The pearl index is 0.05 pregnancies per 100 woman-years provided that insertion is on days 1–5 of the menstrual cycle.53 The primary mechanism of action is inhibition of ovulation as well as thickening of cervical mucus and thinning of the endometrial lining.33 The invisible nature of the implant and reduced requirement for adherence make it a particularly good choice for adolescents who are seeking long-term contraception.33 Contraindications and side effects are very similar to other progestin methods of contraception, with the exception of bone density, as the implant does not impact unfavorably on bone density.33 Menstrual irregularities are the most common side effect seen with the implant and other progestin methods of contraception. Headache, emotional lability, acne, breast pain, abdominal pain, and weight gain have also been described.54–56 Studies have also indicated a 1% rate of complications associated with the site of implant insertion, such as erythema, swelling, hematoma, pain, and difficult insertion.54,57 Removal complications were only 1.7% and included problems of fibrosis, broken implant, and difficulty finding the implant.58
Lactic acid, citric acid, and potassium bitartrate non-hormonal prescription vaginal pH modulator (VPM) gel for the prevention of pregnancy
Published in Expert Review of Clinical Pharmacology, 2022
Benzalkonium chloride is both a spermicide and bactericidal agent that has been in use since 1935, however it is not approved by the U.S. FDA for contraception [27]. In concentrations above 0.007% it has the ability to immobilize sperm [27]. Clinical studies assessing the efficacy of benzalkonium chloride as a contraceptive have resulted in 17 pregnancies in 1998 cases (Pearl Index 1.1) [27]. A further multicenter phase III trial assessing contraceptive efficacy, tolerance and acceptability showed out of 653 women who were using the product, 23 became pregnant (Pearl Index 1.4) [27]. Benzalkonium chloride is generally well tolerated with one or more side effects reported in 22.6% of women – resulting in a discontinuation rate of only 2.4% [27]. A recent phase IV study involving 151 women age 40 and above in France and Russia was completed but has not released results [28]. However, as benzalkonium chloride immobilizes sperm by rupturing the integrity of the plasma membrane, similar to other spermicides, its safety has been debated, with a rising amount of evidence suggesting these products can increase susceptibility to STIs [29]. This occurs due to the harmful effects spermicides can have on the lining of vaginal epithelium triggering inflammatory responses as well as disrupting the balance of vaginal microbiota [29].
A technology evaluation of Annovera: a segesterone acetate and ethinyl estradiol vaginal ring used to prevent pregnancy for up to one year
Published in Expert Opinion on Drug Delivery, 2020
Elizabeth A. Micks, Jeffrey T. Jensen
As with other Phase III contraceptive trials, the primary efficacy endpoint was the Pearl Index for women under 35 years old, which indicates the pregnancy incidence per 100 woman-years. The efficacy analysis included 2,265 participants (1,130 in the U.S. study and 1,135 in the international study [14]. Forty pregnancies occurred in this group, leading to a calculated Pearl Index of 2.98 (95% CI 2.13–4.06) per 100 woman-years. Based on these data, efficacy is comparable to that of other methods of combined hormonal contraception. Of interest, the Pearl index was 2.10 among women who did not report any unscheduled ring removals greater than 2 hours. The Pearl Index was significantly lower among the European participants (0.47, 95% CI 0.03–2.07). Compared to the other study sites, and also varied by participant age.
Comprehensive overview of the recently FDA-approved contraceptive vaginal ring releasing segesterone acetate and ethinylestradiol: A new year-long, patient controlled, reversible birth control method
Published in Expert Review of Clinical Pharmacology, 2019
All pregnancies that occurred when women were using the ring or were within 7 days of their final CVR use were included. Cycles were excluded if another method was used but were not excluded for no sexual activity. Pregnancy rates were reported using Pearl Index (PI) (pregnancies per 100 woman-years) and by an intent-to-treat Kaplan-Meier (KM) life table analysis that represented cumulative probability of not becoming pregnant by cycle. Secondary analyses were performed for Pearl Index for correct ring use, age, race, ethnicity, geographic region, and parity. Post hoc analysis of pregnancy rates also was done based on patient’s desire for post-study pregnancy, adjusted for each of those other variables. User surveys provided insights into factors that influenced patient satisfaction [10].