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Utility of a screening tool for haemostatic defects in a multicentre cohort of adolescents with heavy menstrual bleeding.

ABSTRACT: INTRODUCTION:Heavy menstrual bleeding (HMB) may be expected for many adolescents after menarche. Accurate assessment of HMB, a key component in the diagnosis of a haemostatic defect (HD), is a well-recognized challenge. AIM:Our objective was to determine the diagnostic accuracy of an HMB-specific screening tool for HDs in adolescents with HMB, presenting to a secondary care setting. METHODS:Adolescents with HMB were evaluated for a HD at 4 US centres. A screening tool, the Philipp Tool, developed and validated in adult women with HMB, was administered. We modified the tool by assigning a score based on the number of affirmative responses. Sensitivity, specificity and likelihood ratios (LRs) of a positive tool, modified tool, with a pictorial blood assessment chart (PBAC) score >185, and with serum ferritin ?20 ng/mL were calculated for HDs. RESULTS:Among 248 adolescents with HMB, 29% were diagnosed with HDs. Sensitivity, specificity and LR of a positive screening tool for HDs were 95% (range 88-99), 14% (9-21) and 1.1 (1-1.2), respectively. A score of ?2, addition of a PBAC score >185 and ferritin ?20 ng/mL changed the sensitivity, specificity and LR of the tool to 72% (61-81), 94% (83-99), 76% (65-85); 60% (53-68), 24% (16-34) and 39% (31-47) and 1.8 (1.4-2.2), 1.2 (1.1-1.4) and 1.2 (1-1.4), respectively. CONCLUSION:Although sensitive, the discriminative ability of the tool to identify adolescents with HDs from those without, who presented with HMB, was low. Further research is needed to optimize or develop an adolescent-specific HMB tool for secondary care settings.

SUBMITTER: Zia A

PROVIDER: S-EPMC6261667 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Utility of a screening tool for haemostatic defects in a multicentre cohort of adolescents with heavy menstrual bleeding.

Zia Ayesha A Stanek Joseph J Christian-Rancy Myra M Ahuja Sanjay P SP Savelli Stephanie S O'Brien Sarah H SH

Haemophilia : the official journal of the World Federation of Hemophilia 20180912 6

<h4>Introduction</h4>Heavy menstrual bleeding (HMB) may be expected for many adolescents after menarche. Accurate assessment of HMB, a key component in the diagnosis of a haemostatic defect (HD), is a well-recognized challenge.<h4>Aim</h4>Our objective was to determine the diagnostic accuracy of an HMB-specific screening tool for HDs in adolescents with HMB, presenting to a secondary care setting.<h4>Methods</h4>Adolescents with HMB were evaluated for a HD at 4 US centres. A screening tool, the ...[more]

PMID: 30207633

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Project description:BackgroundHeavy menstrual bleeding (HMB) is an important cause of ill health in premenopausal women. Although surgery is often used as a treatment, a range of medical therapies are also available. Non-steroidal anti-inflammatory drugs (NSAIDs) reduce prostaglandin levels, which are elevated in women with excessive menstrual bleeding and also may have a beneficial effect on dysmenorrhoea.ObjectivesTo determine the effectiveness, safety and tolerability of NSAIDs in achieving a reduction in menstrual blood loss (MBL) in women of reproductive years with HMB.Search methodsWe searched, in April 2019, the Cochrane Gynaecology and Fertility specialised register, Cochrane Central Register of Studies Online (CENTRAL CRSO), MEDLINE, Embase, PsycINFO, the clinical trial registries and reference lists of articles.Selection criteriaThe inclusion criteria were randomised comparisons of individual NSAIDs or combined with other medical therapy with each other, placebo or other medical treatments in women with regular heavy periods measured either objectively or subjectively and with no pathological or iatrogenic (treatment-induced) causes for their HMB.Data collection and analysisWe identified 19 randomised controlled trials (RCTs) (759 women) that fulfilled the inclusion criteria for this review and two review authors independently extracted data. We estimated odds ratios (ORs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes from the data of nine trials. We described in data tables the results of the remaining seven cross-over trials with data unsuitable for pooling, one trial with skewed data, and one trial with missing variances. One trial had no data available for analysis.Main resultsAs a group, NSAIDs were more effective than placebo at reducing HMB but less effective than tranexamic acid, danazol or the levonorgestrel-releasing intrauterine system (LNG IUS). Treatment with danazol caused a shorter duration of menstruation and more adverse events than NSAIDs, but this did not appear to affect the acceptability of treatment, based on trials from 1980 to 1990. However, currently danazol is not a usual or recommended treatment for HMB. There was no clear evidence of difference between NSAIDs and the other treatments (oral luteal progestogen, ethamsylate, an older progesterone-releasing intrauterine system and the oral contraceptive pill (OCP), but most studies were underpowered. There was no evidence of a difference between the individual NSAIDs (naproxen and mefenamic acid) in reducing HMB. The evidence quality ranged from low to moderate, the main limitations being risk of bias and imprecision.Authors' conclusionsNSAIDs reduce HMB when compared with placebo, but are less effective than tranexamic acid, danazol or LNG IUS. However, adverse events are more severe with danazol therapy. In the limited number of small studies suitable for evaluation, there was no clear evidence of a difference in efficacy between NSAIDs and other medical treatments such as oral luteal progestogen, ethamsylate, OCP or the older progesterone-releasing intrauterine system.

Project description:ObjectiveTo evaluate heavy menstrual bleeding treatment outcomes with levonorgestrel 52-mg intrauterine device (IUD) use in participants without body mass index (BMI) or parity restrictions.MethodsInvestigators included participants aged 18-50 years with no pelvic or systemic pathology causing heavy menstrual bleeding at 29 U.S. centers in a prospective trial. Participants had up to three screening cycles with menstrual product collection for alkaline hematin blood-loss measurements. Investigators enrolled those with two menses with blood loss of 80 mL or more (values averaged for baseline blood loss), placed the IUD, and followed participants for up to six 28-day cycles. Participants collected any menstrual products used during cycles 3 and 6 for blood-loss measurement. We evaluated outcomes in participants with at least one follow-up assessment for the primary outcome of median absolute blood-loss change and, secondarily, treatment success , defined as the proportion with a final measured blood loss less than 80 mL and at least 50% reduction from baseline. We evaluated exploratory outcomes of differences in blood-loss changes by BMI and parity using Wilcoxon rank sum test.ResultsOf 105 enrolled participants, 47 (44.8%) had obesity (BMI 30.0 or higher) and 29 (27.6%) were nulliparous. Baseline mean blood loss ranged from 73 to 520 mL (median 143 mL, interquartile range 112-196 mL). Eighty-nine (84.8%) had at least one evaluable follow-up evaluation. Participants had median (interquartile range) absolute blood-loss decreases at cycles 3 (n=86) and 6 (n=81) of 93.3% (86.1-97.7%) and 97.6% (90.4-100%), respectively. At cycle 6, participants without obesity (n=43) and with obesity (n=38) had similar median [interquartile range] decreases (97.6% [91.8-100%] and 97.5% [90.3-100%], respectively; P =.89), with comparable findings for nulliparous (n=25) and parous (n=56) participants (97.0% [91.7-99.1%] and 98.1% [89.9-100%], respectively; P =.43). Treatment success occurred in 81.8% (95% CI 74.2-89.4%) of 99 participants, excluding those with no outcomes due to lost to follow-up or consent withdrawal, and did not vary by BMI or parity. The most common adverse events leading to discontinuation were bleeding or cramping (n=6 [5.7%]) and expulsion (n=5 [4.8%]).ConclusionThis levonorgestrel 52-mg IUD reduces blood loss by more than 90% over 6 months compared with baseline for most users with heavy menstrual bleeding.Funding sourceMedicines360.Clinical trial registrationClinicalTrials.gov , NCT03642210.

Dataset Information

Utility of a screening tool for haemostatic defects in a multicentre cohort of adolescents with heavy menstrual bleeding.

Publications

Utility of a screening tool for haemostatic defects in a multicentre cohort of adolescents with heavy menstrual bleeding.

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