Guideline:
Bibliographic Source(s)
- Kaiser Permanente Southern California. Acute uterine bleeding unrelated to pregnancy. Pasadena (CA): Kaiser Permanente Southern California; 2006 Aug. 27 p. [70 references]
Guideline Status
This is the current release of the guideline.
Guideline Category
Diagnosis
Evaluation
Management
Treatment
Intended Users
Emergency Medical Technicians/Paramedics
Physicians
Guideline Objective(s)
To provide clinical guidelines for the investigation and management of acute abnormal uterine bleeding (AUB) based upon the best available evidence
Target Population
Women and adolescent girls with acute abnormal uterine bleeding (AUB)
Interventions and Practices Considered
Diagnosis/Evaluation
- Medical history including family history
- Physical exam including bimanual examination of the pelvis
- Laboratory investigations including a complete blood count urinary (or serum) assay to rule out pregnancy and other tests as indicated
- Uterine assessment including:
- Histological assessment with endometrial biopsy
- Ultrasonographic techniques (transvaginal ultrasound and saline infusion sonography [SIS])
- Hysteroscopy
- Myometrial evaluation if indicated
Management/Treatment
- Stabilization (blood transfusion) if needed
- Medical management
- Intravenous conjugated equine estrogens
- Combination oral contraceptives
- Progestin-only preparation
- Antifibrinolytics
- Gonadotropin-releasing hormone (GnRH) agonists
- Procedural management
- Intracavitory tamponade with Foley catheters
- Dilation and Curettage (D&C) with hysteroscopy
- Endometrial ablation
- Uterine artery occlusion/embolization
- Hysterectomy
- Reevaluation for causes of bleeding and appropriate preventive management
Major Outcomes Considered
- Accuracy and sensitivity of diagnostic tests
- Efficacy of medical and surgical treatment
- Incidence of disorders of hemostasis in women with acute uterine bleeding
Methods Used to Collect/Select Evidence
Searches of Electronic Databases
Description of Methods used to Collect/Select the Evidence
Literature searches were performed in MEDLINE and MEDLINE Randomized Trials (1966 to December 2004) and the Cochrane Database of Systematic Reviews and the Cochrane Controlled Trials Registry (2004 Issue 4). Combination(s) of the following terms were used: "uterine" "acute" "menorrhagia" "treatment" "management" "heavy" von Willebrand's. Also searched were the Web sites of the American College of Obstetricians and Gynecologists the Society of Obstetricians and Gynecologists of Canada the New Zealand Guidelines Group the Royal College of Obstetricians and Gynecologists and the Geneva Foundation for Medical Education and Research (http://www.gfmer.ch/000_Homepage_En.htm) each a repository of web-published guidelines. The date of the last search of these sources was December 31 2004.
Number of Source Documents
One randomized clinical trial (RCT) evaluating acute abnormal uterine bleeding and 6 additional relevant publications were identified.
Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence
Hierarchy of Evidence*
- Randomized controlled trials
- Non-randomized but internally controlled trials. Controls are considered to be "internal" if they are included in the original design of the study. Post hoc or historical comparisons are not considered internal controls. Comparisons of otherwise uncontrolled clinical series are not considered internal controls
- Case control studies
- Cohort studies
- Clinical series without internal comparison
- Expert opinion without available clinical studies**
*Kaiser Permanente National Guideline Directors Group Edition 3 September 1 2004
**Level of evidence added by the Abnormal Uterine Bleeding Work Group (AUBWG).
Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence
Evidence was originally classified using a system developed by the Kaiser Permanente National Guideline Directors Group (GDG). The Abnormal Uterine Bleeding Work Group (AUBWG) added a "Class 6" to allow for the inclusion of evidence generated from expert opinion including that from guidelines or other consensus documents from national or international organizations or from the collective opinion of the members of the AUBWG itself. The recommendations were created and classified according to the strength of the evidence system developed by the GDG.
Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations
The guideline was developed using the best available evidence and where such evidence was insufficient or absent a consensus process.
Rating Scheme for the Strength of the Recommendations
Support for Recommendations*
Recommendation: A
Language: The Guideline Development Team (GDT) strongly recommends that clinicians routinely provide the intervention to eligible patients.
Evidence: The intervention improves important health outcomes based on good evidence and the GDT concludes that benefits substantially outweigh harms and costs.
Recommendation: B
Language: The GDT recommends that clinicians routinely provide the intervention to eligible patients.
Evidence: The intervention improves important health outcomes based on 1) good evidence that benefits outweigh harms and costs; or 2) fair evidence that benefits substantially outweigh harms and costs.
Recommendation: C
Language: The GDT makes no recommendation for or against routine provision of the intervention. At the discretion of the GDT the recommendation may use the language "option" but must list all the equivalent options.
Evidence: Evidence is sufficient to determine the benefits harms and costs of an intervention and there is at least fair evidence that the intervention improves important health outcomes. But the GDT concludes that the balance of the benefits harms and costs is too close to justify a general recommendation.
Recommendation: D
Language: The GDT recommends against routinely providing the intervention to eligible patients.
Evidence: The GDT found at least fair evidence that the intervention is ineffective or that harms or costs outweigh benefits.
Recommendation: I
Language: The GDT concludes that the evidence is insufficient to recommend for or against routinely providing the intervention. At the discretion of the GDT the recommendation may use the language "option" but must list all the equivalent options.
Evidence: Evidence that the intervention is effective is lacking of poor quality or conflicting and the balance of benefits harms and costs cannot be determined.
*Kaiser Permanente National Guideline Directors Group Edition 3 September 1 2004
Cost Analysis
A formal cost analysis was not performed and published cost analyses were not reviewed.
Method of Guideline Validation
Not stated
Description of Method of Guideline Validation
Not applicable
Major Recommendations
Hierarchy (classes) of evidence (1– 6) and support for recommendation (A –D and I) definitions are given at the end of the "Major Recommendations" field.
Summary of Recommendations
Recommendations are evidence based (E) unless sufficient evidence is not available where consensus-based recommendations are provided (C).
| Method* | Strength** | Recommendation | |
|---|---|---|---|
| 1 | C | N/A | It is important to exclude pregnancy in all patients with acute abnormal uterine bleeding (AUB) in the reproductive years. |
| 2 | E | A | Perimenarcheal patients with acute AUB may be at increased risk for an inherited coagulopathy and should be screened accordingly with a structured history. (See Appendix III in the original guideline document). |
| 3 | C | N/A | Hemodynamically stable patients may be offered either oral multidose progestins or oral multidose monophasic combination oral contraceptives. (See Appendix IV in the original guideline document). |
| 4 | E | C | There is fair evidence supporting the efficacy of intravenous conjugated equine estrogens for hemodynamically-stable patients. |
| 5 | C | N/A | Dilation and curettage (D&C) should be reserved for patients who in the opinion of the clinician are inappropriate for unresponsive to or contraindicated from the use of medical therapy. |
| 6 | E | A | When performed D&C should be accompanied by hysteroscopy. |
| 7 | C | N/A | Parenteral antifibrinolytic agents such as epsilon aminocaproic acid may have a role in the management of patients with recalcitrant acute AUB who otherwise would be candidates for more invasive surgical procedures including those that remove fertility such as hysterectomy. |
| 8 | C | N/A | Patients with acute uterine bleeding may be offered surgical alternatives to D&C that may preserve fertility including intrauterine Foley balloon and uterine artery occlusion/embolization. |
| 9 | C | N/A | In some instances it will be necessary to offer patients options that will remove future fertility by removing or destroying the endometrium. These include endometrial ablation and hysterectomy. |
| 10 | E | A | Many patients with acute uterine bleeding have an underlying chronic disorder that requires systematic evaluation and in many instances chronic therapy following the arrest of the acute phase of the process. |
*E = Evidence-based; C = Consensus-based
**See Definitions below; Strength of evidence is not applicable (N/A) to consensus-based recommendations.
Definitions:
Hierarchy of Evidence*
- Randomized controlled trials
- Non-randomized but internally controlled trials. Controls are considered to be "internal" if they are included in the original design of the study. Post hoc or historical comparisons are not considered internal controls. Comparisons of otherwise uncontrolled clinical series are not considered internal controls
- Case control studies
- Cohort studies
- Clinical series without internal comparison
- Expert opinion without available clinical studies**
Support for Recommendations*
Recommendation: A
Language: The Guideline Development Team (GDT) strongly recommends that clinicians routinely provide the intervention to eligible patients.
Evidence: The intervention improves important health outcomes based on good evidence and the GDT concludes that benefits substantially outweigh harms and costs.
Recommendation: B
Language: The GDT recommends that clinicians routinely provide the intervention to eligible patients.
Evidence: The intervention improves important health outcomes based on 1) good evidence that benefits outweigh harms and costs; or 2) fair evidence that benefits substantially outweigh harms and costs.
Recommendation: C
Language: The GDT makes no recommendation for or against routine provision of the intervention. At the discretion of the GDT the recommendation may use the language "option" but must list all the equivalent options.
Evidence: Evidence is sufficient to determine the benefits harms and costs of an intervention and there is at least fair evidence that the intervention improves important health outcomes. But the GDT concludes that the balance of the benefits harms and costs is too close to justify a general recommendation.
Recommendation: D
Language: The GDT recommends against routinely providing the intervention to eligible patients.
Evidence: The GDT found at least fair evidence that the intervention is ineffective or that harms or costs outweigh benefits.
Recommendation: I
Language: The GDT concludes that the evidence is insufficient to recommend for or against routinely providing the intervention. At the discretion of the GDT the recommendation may use the language "option" but must list all the equivalent options.
Evidence: Evidence that the intervention is effective is lacking of poor quality or conflicting and the balance of benefits harms and costs cannot be determined.
*Kaiser Permanente National Guideline Directors Group Edition 3 September 1 2004
**Level of evidence added by the Abnormal Uterine Bleeding Work Group (AUBWG).
Clinical Algorithm(s)
A clinical algorithm is provided in the original guideline document for acute uterine bleeding.
Type of Evidence supporting the Recommendations
The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").
Potential Benefits
Appropriate evaluation and management of acute abnormal uterine bleeding (AUB)
Potential Harms
- Estradiol "flare" that follows induction of gonadotropin-releasing hormone (GnRH) agonists lasts from about day 5 to day 14 and it is often accompanied by uterine bleeding which may be heavy. Consequently if GnRH agonists are used they should be accompanied by three weeks of medroxyprogesterone acetate (MPA) or a combination oral contraceptive daily for the same period of time.
- Estrogen-containing products should be used with caution in women with previous breast cancer as well as in those with increased risk of arterial thromboembolic disease including heavy smokers over the age of 35 and those with previous thrombotic stroke.
- Nineteen carbon atom (C-19) progestins such as norethindrone and norethindrone acetate may undergo conversion to ethinyl estradiol both in the liver and peripherally. C-19 progestins should be used with caution in women in whom exogenous estrogens are contraindicated.
Qualifying Statements
The recommendations in this guideline are for information purposes only. They are not intended or designed as a substitute for the reasonable exercise of independent clinical judgment by practitioners considering each patient's needs on an individual basis. Guideline recommendations apply to populations of patients. Clinical judgment is necessary to design treatment plans for individual patients.
Description of Implementation Strategy
An implementation strategy was not provided.
Implementation Tools
Clinical Algorithm
For information about availability see the "Availability of Companion Documents" and "Patient Resources" fields below.
IOM Care Need
Getting Better
IOM Domain
Effectiveness
Bibliographic Source(s)
- Kaiser Permanente Southern California. Acute uterine bleeding unrelated to pregnancy. Pasadena (CA): Kaiser Permanente Southern California; 2006 Aug. 27 p. [70 references]
Adaptation
Not applicable: The guideline was not adapted from another source.
Source(s) of Funding
Kaiser Permanente Southern California
Guideline Committee
Southern California Permanente Medical Group Abnormal Uterine Bleeding Working Group
Composition of Group that Authored the Guideline
Clinical Lead: Malcolm Munro MD (Chair)
Kaiser Permanente Southern California Abnormal Uterine Bleeding Working Group Members: Michael Amann MD; Hector Anguiano MD; Rosalie Bauman MD; Mon-Lai Chung MD; Selena Harris MD; Murali Kamath MD; John Kennedy MD; Seth Kivnick MD; Aaron Lim MD; Malcolm Munro MD (Chair); Saad Solh MD
Financial Disclosures/Conflicts of Interest
Not stated
Guideline Status
This is the current release of the guideline.
Guideline Availability
Electronic copies: Available from Marguerite Koster Practice Leader Technology Assessment and Guidelines Unit Kaiser Permanente Southern California; Email: Marguerite.A.Koster@kp.org
Print copies: Available from Malcolm G. Munro MD FRCS(c) FACOG Department of Obstetrics and Gynecology Kaiser Permanente Southern California Professor Department of Obstetrics & Gynecology David Geffen School of Medicine at UCLA; Email: M.G.Munro@kp.org
Availability of Companion Documents
None available
Patient Resources
None available
NGC STATUS
This NGC summary was completed by ECRI on September 20 2006. The information was verified by the guideline developer on December 6 2006.
COPYRIGHT STATEMENT
This NGC summary is based on the original guideline which is subject to Kaiser Permanente Southern California's copyright restrictions.
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