https://digitalcommons.wustl.edu/cgi/viewcontent.cgi?article=5632&context=open_access_pubs

Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system

Pictorial blood loss assessment charts (PBACs) represent the most widely used method to assess menstrual blood loss (MBL) in clinical trials. The aims of this review were to: (1) determine the diagnostic accuracy of PBACs that have been validated against the reference alkaline hematin technique; (2) categorize the pitfalls of using obsolete and nonvalidated charts; (3) provide guidelines for development of a new PBAC or use of an existing chart to measure MBL in clinical trials; and (4) consider the feasibility of using pictorial charts in primary care. A literature review was conducted using Embase and MEDLINE databases. The review identified reports of women with self-perceived or actual heavy menstrual bleeding (HMB), bleeding disorders, abnormal uterine bleeding, leiomyomata (uterine fibroids) or endometriosis, and women undergoing treatment for HMB, as well as those with normal menstrual periods. Data were reviewed from studies that focused on the development and validation of PBACs and from those that used derivative noncertified charts to assess HMB. Nine studies reported validation of PBAC scoring systems against the alkaline hematin technique. Across these studies, the sensitivity was 58–97%, the specificity was 7.5–95.5%, the positive and negative likelihood ratios were 1.1–13.8 and 0.14–0.56, respectively, and the diagnostic odds ratio was 2.6–52.4. The cut-off score above which the diagnosis of HMB was made ranged from 50 to 185. Several modifications of these PBACs were used in other studies; however, objective confirmation of their validity was not reported. Overall, there was widespread inconsistency of chart design, scoring systems, diagnostic cut-off limits and post-treatment outcome measures. PBACs are best suited to the controlled and specific environment of clinical studies, where clinical outcome parameters are defined. The current lack of standardization precludes widespread use of the PBAC in primary care. PROSPERO international prospective register of systematic reviews: CRD42016030083.

/pdf/pictorial-methods-to-assess-heavy-menstrual-bleeding-in-1gjzhrwswi.pdf

Pictorial methods to assess heavy menstrual bleeding in research and clinical practice: a systematic literature review

IMPORTANCE: Heavy menstrual bleeding (HMB) is a common complaint among reproductive-aged women which negatively affects their health as well as their social professional and family lives. Modern medical management usually provides effective control of HMB irrespective of the underlying cause. Surgical interventions should be reserved for women with significant pelvic pathology and those unresponsive to medical therapy. OBJECTIVE: The aim of this review was to provide a comprehensive summary of the efficacy and safety of available medical treatments of HMB. EVIDENCE ACQUISITION: A comprehensive MEDLINE and EMBASE literature search was undertaken using selected terms associated with HMB to identify clinical studies published before March 20 2013 that reported changes in menstrual blood loss in women receiving medical intervention. RESULTS: The effectiveness of treatments to reduce HMB due to endometrial dysfunction in descending order was as follows: (1) the levonorgestrel-releasing intrauterine system (LNG-IUS) (initial release rate of 20 mug of LNG per 24 hours) (2) combined hormonal contraceptives (oral or transvaginal) (3) tranexamic acid and (4) long-course oral progestogens (>/=3 weeks per cycle). The LNG-IUS was found to reduce HMB due to some structural causes (leiomyomas and adenomyosis). The reduction in menstrual blood loss achieved with nonsteroidal anti-inflammatory drugs and short-course oral progestogens (</=14 days per cycle) is less impressive but may be sufficient for women who have marginally increased blood loss. CONCLUSIONS AND RELEVANCE: For women not seeking pregnancy the LNG-IUS is the first-line medical therapy for HMB with combined hormonal contraceptives as second choice. For other women fewer effective options exist.

Medical management of heavy menstrual bleeding: A comprehensive review of the literature

This paper presents a comparison of 2 management strategies for idiopathic menorrhagiathe levonorgestrel intrauterine system (LNG IUS) and the more commonly used oral mefenamic acid. The LNG IUS is a progesterone-impregnated intrauterine device that has been shown to reduce menstrual blood loss (MBL). Study subjects were chosen from 391 women who presented to The Luton and Dunstable Hospital NHS Trust in South Bedfordshire, U.K., between May 1996 and December 1998 with the complaint of heavy menstrual bleeding. Enrollment was offered to healthy women age 18 to 47 with menorrhagia, defined as menstrual blood loss of 80 mL or more in one cycle confirmed by the modified alkaline-hematin technique. Each subject maintained a menstrual diary and completed a pictorial blood loss assessment chart (PBAC) within 4 months of starting the trial. In addition, study subjects participated in an objective assessment of total menstrual fluid loss (TMFL), which involved measuring the increase in weight of all tampons and sanitary napkins used in one menstrual cycle. Fifty-one women met all inclusion criteria and were randomized to receive 500 mg oral mefenamic acid 3 times daily on days 1 to 4 of the menstrual cycle (n = 26) or to have insertion of an LNG IUS containing 52 mg levonorgestrel released at 20 μg per 24 hours (n = 25). The study period for each treatment method was 6 cycles. Overall, MBL, TMFL, and PBAC scores improved significantly for both treatment groups. However, compared with those in the mefenamic acid group, women in the LNG IUS group had significantly lower blood loss on all 3 measurements at each evaluation point of the study period (P >.001 for all). Improvements in scores for MBL, TMFL, and PBAC were significantly correlated over the study period (P <.001 for the correlation between MBL and TMFL, P =.0007 for correlation of MBL and PBAC, and P = 0002 for correlation of TMFL and PBAC). Overall, women with the LNG IUS experienced more adverse events, 2 of which were serious, over the course of the study than did women in the mefenamic acid group (158 vs 84). In one patient who developed severe hypertension, the LNG IUS was discovered in the endocervical canal and removed after 55 days. In a second woman, the LNG IUS was expelled after successful treatment for chlamydial endometritis.

Randomised Comparative Trial of the Levonorgestrel Intrauterine System and Mefenamic Acid for the Treatment of Idiopathic Menorrhagia: A Multiple Analysis Using Total Menstrual Fluid Loss, Menstrual Blood Loss, and Pictorial Blood Loss Assessment Charts

Many more women in the US today rely upon intrauterine devices (IUDs) than in the past. This increased utilization may have substantially contributed to the decline in the percentage of unintended pregnancies in the US. Evidence-based practices have increased the number of women who are medically eligible for IUDs and have enabled more rapid access to the methods. Many women enjoy freedom to use IUDs without cost, but for many the impact of the Affordable Care Act has yet to be realized. Currently, there are three hormonal IUDs and one copper IUD available in the US. Each IUD is extremely effective, convenient, and safe. The newer IUDs have been tested in populations not usually included in clinical trials and provide reassuring answers to older concerns about IUD use in these women, including information about expulsion, infection, and discontinuation. On the other hand, larger surveillance studies have provided new estimates about the risks of complications such as perforation, especially in postpartum and breastfeeding women. This article summarizes significant features of each IUD and provides a summary of the differences to aid clinicians in the US and other countries in advising women about IUD choices.

/pdf/new-developments-in-intrauterine-device-use-focus-on-the-us-2r1x5uuwcf.pdf

New developments in intrauterine device use: focus on the US.

CONTROLLED OVARIAN HYPERSTIMULATION AND IVF PREGNANCY PROGNOSIS (Abstract): IVF (in vitro fertilization) often represents the ultimate step in our attempt to treat infertility. Nowadays this method is more and more used, couple's expectations are higher and higher, so that optimizing the chance that one IVF pregnancy became a healthy newborn child is becoming an important issue. In this study we analyzed the controlled ovarian hyperstimul a- tion impact on IVF pregnancy prognosis. We studied 307 patients who had IVF fresh proce- dures in "Panait Sirbu" Clinical Hospital of Obstetrics and Gynecology - Department of Assist- ed Human Reproduction between 01.01.2008 - 31.12.2010 and obtained pregnancy; pregnancy rate according to our statistics is 34%. For statistic analysis we used the odd Student test. Our data proved better results (defined as a better birth/ abortion ratio) for the patients where r e- combinant FSH was used towards patients where highly purified urinary gonadotropin or the combination of the two drugs was used. Our statistical data also proved that none of the varia- bles: age, BMI (body mass index), endometrium thickness, number of oocytes, number of em- bryos or number of days of stimulation is a favorable variable for this better result, but t he number of units of gonadotropin is a favorable variable for a better birth/ abortion ratio. We consider that our data gives an interesting perspective upon the connection between controlled ovarian hyperstimulation and pregnancy outcome, especially these days when tendencies are to obtain as many oocytes in one procedure as we can, which often means to use high doses of gonadotropin. Keywords: IN VITRO FERTILIZATION, CONTROLLED OVARIAN HYPER STIMULATION, PREGNANCY, PROGNOSIS. Nearly 13-15% of reproductive aged couples are infertile (1). Infertility is a real health problem; it is always associated with emotional stress and affects couple's social life and work. This means a long term im- pact on society because it affects family stability on one hand, and on the other hand treatment is often expensive and consump- tive. In vitro fertilization (IVF) often repre- sents the ultimate step in our attempt to treat infertility. Nowadays this method is more and more used; couple's expecta-

Controlled ovarian hyperstimulation and IVF pregnancy prognosis.

Objective To evaluate a new levonorgestrel-releasing intrauterine system (LNG-IUS) called Levosert® for the treatment of heavy menstrual bleeding (HMB) in comparison to the reference product Mirena®.Methods A multicentre, randomised, controlled trial, in non-menopausal women diagnosed with functional HMB (defined as menstrual blood loss [MBL] ≥ 80 mL) randomised to either Levosert® or Mirena® and followed for up to one year. MBL was evaluated using a validated modified version of the Wyatt pictogram.Results A total of 280 women were randomised (141 to Levosert® and 139 to Mirena®). During the one-year treatment period, both Levosert® and Mirena® dramatically decreased MBL and increased haemoglobin and ferritin levels. There were no statistically significant differences between Levosert® and Mirena® regarding any of the parameters evaluated during the study. Similar bleeding patterns were observed in both groups. Levosert® was inserted with the same ease as Mirena®. Both treatments were associated ...

Impact of a new levonorgestrel intrauterine system, Levosert®, on heavy menstrual bleeding: results of a one-year randomised controlled trial

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Controlled ovarian hyperstimulation and IVF pregnancy prognosis.

Impact of a new levonorgestrel intrauterine system, Levosert®, on heavy menstrual bleeding: results of a one-year randomised controlled trial