Search

STUDY QUESTION: What is the effect on ovarian activity of a preceding intake of ulipristal acetate (UPA) when starting a combined oral contraceptive (COC) in the mid- to late-follicular phase of the cycle? SUMMARY ANSWER: This study shows that UPA does not affect the ability of the COC to induce ovarian quiescence. WHAT IS KNOWN ALREADY: UPA is a progesterone receptor modulator that is available for emergency contraception (EC). In theory, UPA could alter the effectiveness of hormonal contraception started immediately following it and vice versa. Current guidelines regarding quick starting a COC following UPA are based on expert opinion only. STUDY DESIGN, SIZE, DURATION: A double-blind, randomized, placebo-controlled trial was conducted at three separate sites, Edinburgh (Scotland), Stockholm (Sweden) and Groningen (the Netherlands), over a 5-month period in 2012. Healthy female volunteers were randomized to take either UPA or an identically packaged placebo, at mid-cycle (once a lead ovarian follicle was determined to be > 13 mm on transvaginal ultrasound imaging). Participants were randomized by a computer-generated randomization schedule, allocated by sequential, sealed envelopes. All women then started 21 days of the same COC the following day. The study was designed to show non-inferiority of UPA compared with placebo in terms of the proportion of women attaining ovarian quiescence, as measured by the Hoogland scoring system, while taking COC. PARTICIPANTS/MATERIALS, SETTING, METHODS: A total of 76 women were recruited over the three sites, Edinburgh (n = 18), Stockholm (n = 13), Groningen (n = 45) and received either UPA (n = 39) or placebo (n = 37). MAIN results and the role of chance: There were no significant differences in demographic characteristics of women in the UPA and placebo groups. Among the 76 participants treated, 47 (61.8%) reached quiescence and 25 (32.9%) ovulated. There were no significant differences between the groups in the odds ratio (OR) of reaching ovarian quiescence or not; OR 0.97 (95% CI: 0.39-2.46). All women who reached quiescence had done so after taking COCs for 14 days. LIMITATIONS, REASONS FOR CAUTION: The main limitations of the study were that measurements of follicle size and blood tests were performed every 2-3 days and so it was not possible to determine the actual day that follicle rupture occurred for the women who ovulated. Furthermore, the ultrasonography was conducted by a number of investigators at the sites which may introduce error in the form of inter-observer variability in measurements of follicle growth. Finally, the findings of the study cannot be extrapolated to other combined hormonal methods of contraception such as the patch or ring, nor to progestogen- only methods of contraception. WIDER IMPLICATIONS OF THE FINDINGS: This study provides evidence to suggest that UPA does not affect the ability of the COC to induce ovarian quiescence. However, this study design cannot determine whether the COC affects the ability of UPA to delay ovulation. STUDY FUNDING/COMPETING INTEREST(S): Funding was provided by HRA Pharma Paris, France. C.K., S.T.C. and K.G.D. have received funds for conducting research studies and lectures for HRA Pharma. C.K. is director of a contract research organization (Dinox). The remaining authors declare no conflicts of interests. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov: NCT015691 13. [ABSTRACT FROM AUTHOR]

The levonorgestrel intrauterine system (LNG-IUS), originally designed for long-term contraceptive use, has been on the Scandinavian market for approximately 20 years. Novel clinical indications for the LNG-IUS, derived mainly from investigator-initiated studies, are emerging. These include heavy menstrual bleeding associated with uterine fibroids, endometriosis, adenomyosis, as well as endometrial hyperplasia. In both cohort and randomized studies, the LNG-IUS is effective in decreasing heavy menstrual bleeding, also in women diagnosed with uterine fibroids. In randomized studies the LNG-IUS has shown comparable clinical efficacy to GnRH analogues or progestins for the symptomatic treatment of endometriosis. Experience with LNG-IUS in adenomyosis is based on prospective cohort studies. Dysmenorrhea has been reported to decrease in all women, and uterine volume was seen to diminish in some of these studies. In the treatment of endometrial hyperplasias, including atypical hyperplasia, the LNG-IUS is equal or superior to treatment with systemic progestins. Further studies are needed to examine the full potential of the LNG-IUS in such common clinical situations. [ABSTRACT FROM AUTHOR]

BACKGROUND Endometriosis is a common benign gynaecological disease. Epidemiological studies have demonstrated associations between endometriosis and ovarian cancer. Recent genome-wide association studies of ovarian cancer have identified several single nucleotide polymorphisms (SNPs) in the Basonuclin 2 (BNC2) gene. In this study, we investigated these polymorphism in women with endometriosis. METHODS Six SNPs in and upstream of the BNC2 gene (rs3814113, rs4445329, rs10962656, rs12379183, rs10756819 and rs1339552) were investigated using TaqMan allelic discrimination analysis in a Caucasian population (cases: 798, controls: 351). Allelic frequencies were used as main outcome measure. RESULTS No associations were observed between the analysed SNPs and endometriosis. CONCLUSIONS Our results suggest that the analysed polymorphisms in the BNC2 gene are unlikely to contribute to the previously reported risk of ovarian cancer in women with endometriosis. [ABSTRACT FROM PUBLISHER]

Copyright of Der Gynäkologe is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

BACKGROUND Despite increasing contraceptive availability, unintended pregnancy remains a global problem, representing as many as 30% of all known pregnancies. Various strategies have been proposed to reverse this disturbing trend, especially increased use of long-acting reversible contraceptive (LARC) methods. In this review we aim to discuss the role of LARC methods and importance of contraceptive counseling in reducing unintended pregnancy rates. METHODS References/resources cited were identified based on searches of medical literature (MEDLINE, 1990–2009), bibliographies of relevant publications and the Internet. RESULTS AND CONCLUSIONS LARC methods—copper intrauterine devices (IUDs), progestogen-releasing intrauterine system and injectable and implantable contraceptives—are safe and effective contraceptive options (unintended pregnancy rates with typical versus perfect use: 0.05–3.0 versus 0.05–0.6%) that are appropriate for a wide range of women seeking to limit or space childbearing. Despite their safety and efficacy records, these methods remain underutilized; injectable and implantable methods are used by an estimated 3.4% and intrauterine methods by 15.5% of women worldwide. LARC methods require no daily or coital adherence and avoid the adverse events and health risks of estrogen-containing contraceptives. The copper IUD and progestin-only injections and implants have been shown to be more cost-effective than more commonly used methods, such as condoms and the pill (5-year savings: $13 373–$14 122, LARC; $12 239, condoms; $12 879, pill). Women who are considering use of LARC methods should receive comprehensive contraceptive counseling, as women who receive counseling before use demonstrate higher rates of after-use method satisfaction, continuation and acceptance than those who do not. [ABSTRACT FROM AUTHOR]

Please cite this paper as: von Hertzen H, Huong N, Piaggio G, Bayalag M, Cabezas E, Fang A, Gemzell-Danielsson K, Hinh N, Mittal S, Ng E, Chaturachinda K, Pinter B, Puscasiu L, Savardekar L, Shenoy S, Khomassuridge A, Tuyet H, Velasco A, Peregoudov A, for the WHO Research Group on Postovulatory Methods of Fertility Regulation. Misoprostol dose and route after mifepristone for early medical abortion: a randomised controlled noninferiority trial. BJOG 2010;117:1186–1196. Objective To compare 400 and 800 μg sublingual or vaginal misoprostol 24 hours after 200 mg mifepristone for noninferiority regarding efficacy in achieving complete abortion for pregnancy termination up to 63 days of gestation. Design Placebo-controlled, randomised, noninferiority factorial trial, stratified by centre and length of gestation. Misoprostol 400 or 800 μg, administered either sublingually or vaginally, with follow up after 2 and 6 weeks. Setting Fifteen obstetrics/gynaecology departments in ten countries. Population Pregnant women ( n = 3005) up to 63 days of gestation requesting medical abortion. Methods Two-sided 95% CI for differences in failure of complete abortion and continuing pregnancy, with a 3% noninferiority margin, were calculated. Proportions of women with adverse effects were recorded. Outcome measures Complete abortion without surgical intervention (main); continuing live pregnancies, induction-to-abortion interval, adverse effects, women’s perceptions (secondary). Results Efficacy outcomes analysed for 2962 women (98.6%): 90.5% had complete abortion after 400 μg misoprostol, 94.2% after 800 μg. Noninferiority of 400 μg misoprostol was not demonstrated for failure of complete abortion (difference: 3.7%; 95% CI 1.8–5.6%). The 400-μg dose showed higher risk of incomplete abortion ( P < 0.01) and continuing pregnancy ( P < 0.01) than 800 μg. Vaginal and sublingual routes had similar risks of failure to achieve complete abortion ( P = 0.47, difference in sublingual minus vaginal −0.7%, 95% CI −2.6–1.2%). A similar pattern was observed for continuing pregnancies ( P = 0.21). Fewer women reported adverse effects with vaginal than sublingual administration and with the 400-μg dose than the 800-μg dose. Of the women, 94% were satisfied or highly satisfied with the regimens, 53% preferred the sublingual route and 47% preferred the vaginal route. Conclusions A 400-μg dose of misoprostol should not replace the 800-μg dose when administered 24 hours after 200 mg mifepristone for inducing abortion in pregnancies up to 63 days. Sublingual and vaginal misoprostol have similar efficacy, but vaginal administration is associated with a lower frequency of adverse effects. [ABSTRACT FROM AUTHOR]

BACKGROUND: Consecutive use of the levonorgestrel-releasing intrauterine system (LNG-IUS) is increasing. However, little is known about factors that predict the bleeding during consecutive use. The objective of this study was to analyse the possible factors which may predict the bleeding pattern during the first year of use of a second LNG-IUS. [ABSTRACT FROM PUBLISHER]

BACKGROUND: Home use of misoprostol for termination of pregnancy is still controversial in many countries. Acceptability of home use of misoprostol has been investigated in pregnancies below 49 days gestation. In this study, we aimed to assess efficacy, feasibility and acceptability of home use of vaginal misoprostol for medical termination of pregnancy at 50–63 days compared with gestation of below 50 days among women who chose to administer misoprostol at home. [ABSTRACT FROM PUBLISHER]

BACKGROUND: The standard regimen of the levonorgestrel-only pill (1.5 mg either in a single dose or in a dose of 0.75 mg twice, 12 h apart) administered orally for emergency contraception (EC) has been shown to have no effect on endometrial development and markers of endometrial receptivity. We aimed to explore whether repeated oral and single vaginal administration of levonorgestrel affect the endometrium and thus potentially increase the EC efficacy, compared with the standard regimen. [ABSTRACT FROM PUBLISHER]

BACKGROUND: The LNG-IUS has increasingly been used for contraception, treatment of menorrhagia and endometrial protection during hormone replacement therapy since mid-1990s. Thus, many women use the LNG-IUS consecutively. However, published data on the bleeding pattern regarding consecutive use of the LNG-IUS is scarce. [ABSTRACT FROM PUBLISHER]

Whereas in high-income countries potential users of Emergency Contraception (EC) have information and access to emergency contraceptive pills (ECPs), it has remained secretive in low-income countries like Uganda. Although several studies have been conducted in relation to EC, few have addressed users' perceptions. The objective of our study was to explore perceptions of EC by university students in Kampala, Uganda. Seven focus group discussions and four key informant interviews were conducted at Makerere University, Kampala. The transcribed data was analyzed for content and recurrent themes. Participants expressed ambivalence about ECPs. The method was generally recommended but only to the 'right people', in this context being those aged eighteen years and more. There were reservations surrounding provision of ECPs like similarity with abortion and fear of side effects. Users' and potential-users' perceptions are crucial in the accessibility and utilization of ECPs. [ABSTRACT FROM AUTHOR]

Women on Web is a service that uses telemedicine to help women access mifepristone and misoprostol in countries with no safe care for termination of pregnancy (TOP). This study reviews the telemedicine service. After an online consultation, women with an unwanted pregnancy of up to 9 weeks are referred to a doctor. If there are no contraindications, a medical TOP is conducted by mail. After maximising the follow up from 54.8 to 77.6%, 12.6% decided not to do the TOP and 6.8% of the women who did the medical TOP at home needed a vacuum aspiration. Telemedicine can provide an alternative to unsafe TOP. Outcomes of care are in the same range as TOP provided in outpatient settings. [ABSTRACT FROM AUTHOR]

The methods used for abortion in the second trimester have changed considerably in recent years. The surgical procedure dilatation and evacuation (D&E) has replaced hysterotomy. Instead of injecting different compounds, such as hypertonic saline, prostaglandin analogues are administered by non-invasive routes. The most effective medical method is combining a prostaglandin analogue with mifepristone. The consequence of these developments is that abortion in the second trimester can be be performed significantly more effectively and that the currently recommended methods being used are associated with fewer side effects and complications. [ABSTRACT FROM AUTHOR]

Second trimester abortions constitute 10-15% of all induced abortions worldwide but are responsible for two-thirds of major abortion-related complications. During the last decade, medical methods for second trimester induced abortion have been considerably improved and become safe and more accessible. Today, in most cases, safe and efficient medical abortion services can be offered or improved by minor changes in existing health care facilities. Second trimester medical abortion can be provided by a nurse-midwife with the back-up of a gynaecologist. Because of the potential for heavy vaginal bleeding and serious complications, it is advisable that second trimester terminations take place in a health care facility where blood transfusion and emergency surgery (including laparotomy) are available. This article provides basic information on regimens recommended for second trimester medical abortion. The combination of mifepristone and misoprostol is now an established and highly effective method for second trimester abortion. Where mifepristone is not available or affordable, misoprostol alone has also been shown to be effective, although a higher total dose is needed and efficacy is lower than for the combined regimen. Therefore, whenever possible, the combined regimen should be used. Efforts should be made to reduce unnecessary surgical evacuation of the uterus after expulsion of the fetus. Future studies should focus on improving pain management, the treatment of women with failed medical abortion after 24 hours, and the safety of medical abortion regimens in women with a previous caesarean section or uterine scar. [ABSTRACT FROM AUTHOR]

Abstract: Missed abortion in the first trimester is characterized by the arrest of embryonic or fetal development. The cervix is closed and there is no or only slight bleeding. Ultrasound examination shows an empty gestational sac or an embryo/fetus without cardiac activity. Based on a review of the published literature a single dose of 800 μg vaginal misoprostol may be offered as an effective, safe, and acceptable alternative to the traditional surgical treatment for this indication. Alternatively, 600 μg misoprostol can be administered sublingually. After administration of misoprostol, hospitalization is not necessary and the time to expulsion varies considerably. Bleeding may last for more than 14 days with additional days of light bleeding or spotting. The woman should be advised to contact a provider in case of heavy bleeding or signs of infection. A follow-up is recommended after 1 to 2 weeks. [Copyright &y& Elsevier]

Abstract: Misoprostol, a synthetic prostaglandin E1 analogue, is commonly used for medical abortion, cervical priming, the management of miscarriage, induction of labor and the management of postpartum hemorrhage. It can be given orally, vaginally, sublingually, buccally or rectally. Studies of misoprostol''s pharmacokinetics and effects on uterine activity have demonstrated the properties of the drug after various routes of administration. These studies can help to discover the optimal dose and route of administration of misoprostol for individual clinical applications. Misoprostol is a safe drug but serious complications and teratogenicity can occur with unsupervised use. [Copyright &y& Elsevier]

Abstract: A combination of mifepristone and misoprostol is the regimen of choice for termination of pregnancy between 13 to 26 weeks. In many countries, mifepristone is still not available, and misoprostol has to be used alone. Many misoprostol-alone regimens have been reported in the literature with apparently good results. Most of the trials were conducted in pregnancies between 13 and 22 weeks. For this gestational period, we recommend the regimen of 400 μg of vaginal misoprostol every 3 h up to 5 doses, as it appears to be effective without excessive side effects or complications. There is inadequate data to recommend a regimen for the gestational period of 23 to 26 weeks but it is advisable to reduce the dose and frequency of administration of misoprostol. Common side effects of misoprostol-induced termination of pregnancy include gastrointestinal side effects, abdominal cramps, bleeding, fever and chills. Complications may include infection or rarely rupture of uterus. [Copyright &y& Elsevier]

Background: The safety and efficacy of the anti-progestogen Org 31710 in improving cycle control in healthy women using the desogestrel progestogen-only pill was investigated in this randomized, double-blind, placebo-controlled study.Methods: A total of 103 women using the 75 micro g desogestrel progestogen-only pill daily also received either 150 mg Org 31710 or placebo once every 28 days, starting on day 1, for a duration of 4-7 treatment cycles.Results: The percentage of women with bleeding or spotting (B/S) every day in the placebo group was on average 30% during the whole treatment period and no days without reported B/S occurred. In contrast, a cyclic pattern was observed for the Org 31710 group; a peak incidence of B/S was observed on day 3 or 4 of each cycle, followed by a sharp decrease on cycle days 9-15. Compared with controls, less subjects in the Org 31710 group reported irregular, frequent or prolonged bleeding. These differences were clearly observed in the initial cycles, but were somewhat less pronounced during the later cycles of the treatment period. A relatively high incidence of B/S episodes starting in the second section of the cycle was also observed.Conclusion: The addition of Org 31710 once a month improved cycle control in women using daily treatment with 75 micro g desogestrel. [ABSTRACT FROM AUTHOR]