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Guideline Summary
Guideline Title
Management of unscheduled bleeding in women using hormonal contraception.
Bibliographic Source(s)
Clinical Effectiveness Unit. Management of unscheduled bleeding in women using hormonal contraception. London (UK): Faculty of Sexual and Reproductive Healthcare (FSRH); 2009 May. 19 p. [64 references]
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Unscheduled bleeding in women using hormonal contraception

Note: The term 'unscheduled bleeding' in this guidance refers to breakthrough bleeding, spotting, prolonged, or frequent bleeding.

Guideline Category
Counseling
Evaluation
Management
Risk Assessment
Treatment
Clinical Specialty
Family Practice
Internal Medicine
Obstetrics and Gynecology
Intended Users
Advanced Practice Nurses
Nurses
Patients
Pharmacists
Physician Assistants
Physicians
Guideline Objective(s)

To provide evidence-based recommendations and good practice points for clinicians on the management of unscheduled bleeding in women using hormonal contraception

Target Population

Women who have unscheduled bleeding while using hormonal contraception

Interventions and Practices Considered

Counseling

Counseling about the expected bleeding patterns with use of hormonal contraception

Assessment

  1. Clinical history
  2. Clinical testing, as indicated
    • Chlamydia trachomatis testing
    • Neisseria gonorrhoeae testing
    • Cervical screening
    • Pregnancy test
    • Speculum examination
    • Bimanual examination
    • Endometrial biopsy
    • Transvaginal ultrasound
    • Hysteroscopy

Management/Treatment

  1. Continuation of the hormonal contraceptive without change
  2. Increased dose of ethinylestradiol (EE) in women using a combined oral contraceptive (COC)
  3. Changing the type and dose of progestogen-only pills in some individuals
  4. Use of a combined oral contraceptive pill in women with unscheduled bleeding using a progestogen-only injectable, implant, or intrauterine system (IUS)
  5. Use of mefenamic acid in women using a progestogen-only injectable contraceptive
Major Outcomes Considered
  • Patient concerns about bleeding patterns
  • Continued use of the contraceptive method
  • Changes in bleeding patterns

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

Evidence is identified using a systematic literature review and electronic searches are performed for: MEDLINE (CD Ovid version) (1996–2008); EMBASE (1996–2008); PubMed (1996–2008); The Cochrane Library (to 2008) and the National Guideline Clearinghouse (NGC). The searches are performed using relevant medical subject headings (MeSH), terms and text words. The Cochrane Library is searched for systematic reviews, meta-analyses, and controlled trials relevant to unscheduled bleeding. Previously existing guidelines from the Faculty of Sexual and Reproductive Healthcare (FSRH; formerly the Faculty of Family Planning and Reproductive Health Care), the Royal College of Obstetricians and Gynaecologists (RCOG), the World Health Organization (WHO), and the British Association for Sexual Health and HIV (BASHH), and reference lists of identified publications are also searched.

Number of Source Documents

Not stated

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

Level of Evidence

Ia Evidence obtained from meta-analysis of randomised trials

Ib Evidence obtained from at least one randomised controlled trial (RCT)

IIa Evidence obtained from at least one well-designed controlled study, without randomisation

IIb Evidence obtained from at least one other type of well-designed quasi-experimental study

III Evidence obtained from well-designed non-experimental descriptive studies, correlation studies, and case studies

IV Evidence obtained from expert committee reports or opinions and/or clinical experience of respected authorities

Methods Used to Analyze the Evidence
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence

Selected key publications are appraised using standard methodological checklists similar to those used by the National Institute for Health and Clinical Excellence (NICE). All papers are graded according to the Grades of Recommendations Assessment, Development, and Evaluation (GRADE) system. Recommendations are graded using a scheme similar to that adopted by the Royal College of Obstetricians and Gynaecologists (RCOG) and other guideline development organisations. The clinical recommendations within this Guidance are based on evidence whenever possible. Summary evidence tables are available on request from the Clinical Effectiveness Unit (CEU).

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

The Draft One Guidance document is written, providing recommendations and good practice points based on the literature review. The Clinical Effectiveness Unit (CEU) has overall responsibility for writing the Guidance document. The Multidisciplinary Group and other peer reviewers should highlight inconsistencies and errors or where the text is incomprehensible. A Multidisciplinary Group Meeting is held, comprising stakeholders and including service user representation, representation from the Faculty of Sexual and Reproductive Healthcare (FSRH) Education Committee, and, where possible, representation from the FSRH Clinical Effectiveness Committee (CEC) and FSRH Council. A one-day meeting is held with the Multidisciplinary Group to discuss the Draft One Guidance document.

Rating Scheme for the Strength of the Recommendations

Grades of Recommendations

A: Evidence based on randomised controlled trials (RCTs)

B: Evidence based on other robust experimental or observational studies

C: Evidence is limited but the advice relies on expert opinion and has the endorsement of respected authorities

Good Practice Point: Where no evidence exists but where best practice is based on the clinical experience of the multidisciplinary group

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation

The Draft Two Guidance document is peer reviewed by the Multidisciplinary Group and the Faculty of Sexual and Reproductive Healthcare (FSRH) Clinical Effectiveness Council (CEC). All written feedback on the Draft Two Guidance document is tabulated and the Clinical Effectiveness Unit (CEU) response to these comments is outlined. The Draft Three Guidance document is prepared based on written feedback and is sent to the Multidisciplinary Group and the FSRH CEC. In addition, two independent reviewers are identified by the CEC to provide feedback at this stage. Only minor comments can be accepted at this stage. The Final Guidance document is published by the FSRH. Proofreading of the Guidance is then performed by three members of the CEU team independently and comments collated and sent back by the Unit Director. A Portable Document Format (PDF) version of the Guidance is made available on the FSRH Web site.

This guideline was approved by the Standards Board of the Royal College of Obstetricians and Gynaecologists (RCOG).

Recommendations

Major Recommendations

The recommendation grades (A to C, Good Practice Point) are defined at the end of the "Major Recommendations" field.

Bleeding Pattern Expected with Hormonal Contraceptives

Before starting hormonal contraception, women should be advised about the expected bleeding patterns, both initially and in the longer term. (Good Practice Point)

Management of Women with Unscheduled Bleeding

A clinical history should be taken from women using hormonal contraception with unscheduled bleeding to identify the possibility of an underlying cause. (Grade C)

Hormonal contraceptive users with unscheduled bleeding who are at risk of sexually transmitted infections (STIs) (i.e., those aged <25 years old, or who have a new sexual partner, or more than one partner in the last year) should be tested for Chlamydia trachomatis as a minimum. Testing for Neisseria gonorrhoeae will depend on sexual risk and local prevalence. (Good Practice Point)

Women using hormonal contraception who have unscheduled bleeding who are not participating in a National Cervical Screening Programme should have a cervical screen. (Good Practice Point)

A pregnancy test is indicated for women using hormonal contraception with unscheduled bleeding if the clinical history identifies the possibility of incorrect method use, drug interactions, or illness, which may lead to malabsorption of oral hormones. (Good Practice Point)

When May Examination NOT Be Required?

In general, in women attending with unscheduled bleeding using hormonal contraception, examination may not be required if after taking a clinical history there are no risk factors for STIs, no concurrent symptoms suggestive of underlying causes, and the woman is participating in a National Cervical Screening Programme. (Good Practice Point)

When Is Examination Required?

Providing there has been consistent and correct use of hormonal contraception, a speculum examination should be performed for women using hormonal contraception with unscheduled bleeding if they have: persistent bleeding or a change in bleeding after at least 3 months use; failed medical treatment; if they have not participated in a National Cervical Screening Programme. (Good Practice Point)

Providing there has been consistent and correct use of hormonal contraception in addition to a speculum examination, a bimanual examination should be performed for women using hormonal contraception with unscheduled bleeding if they have other symptoms (such as pain, dyspareunia, or heavy bleeding). (Good Practice Point)

When Is Further Investigation (Endometrial Biopsy, Ultrasound Scan, or Hysteroscopy) Required?

In general, an endometrial biopsy should be considered in women aged ≥45 years (or in women aged <45 years with risk factors for endometrial cancer [e.g., obesity or polycystic ovarian syndrome]) who have persistent unscheduled bleeding after the first 3 months of starting a method or who present with a change in bleeding pattern. (Good Practice Point)

The role of uterine polyps, fibroids, or ovarian cysts as a cause of unscheduled bleeding is limited. Nevertheless, for all women using hormonal contraception with unscheduled bleeding, if such a structural abnormality is suspected a transvaginal ultrasound scan and/or hysteroscopy may be indicated. (Good Practice Point)

Treatment Options for Women with Unscheduled Bleeding Using Hormonal Contraception

Treatment Options for Women Using Combined Hormonal Contraception

It is not generally recommended that a combined oral contraceptive pill (COC) is changed within the first 3 months of use as bleeding disturbances often settle in this time. (Good Practice Point)

For women using a combined oral contraceptive pill, the lowest dose of ethinylestradiol (EE) to provide good cycle control should be used. However, the dose of ethinylestradiol can be increased to a maximum of 35 micrograms to provide good cycle control. (Good Practice Point)

Treatment Options for Women Using Progestogen-Only Contraception

Bleeding is common in the initial months of progestogen-only method use and may settle without treatment. If treatment may encourage women to continue with the method, it may be considered. (Good Practice Point)

There is no evidence that changing the type and dose of progestogen-only pills will improve bleeding, but this may help some individuals. (Good Practice Point)

For women with unscheduled bleeding using a progestogen-only injectable, implant, or intrauterine system (IUS) who wish to continue with the method and are medically eligible, a combined oral contraceptive pill may be used for up to 3 months (this can be in the usual cyclic manner or continuously without a pill-free interval). (Good Practice Point)

For women using a progestogen-only injectable contraceptive with unscheduled bleeding, mefenamic acid 500 mg twice daily (or as licensed up to three times daily) for 5 days can reduce the length of a bleeding episode but has little effect on bleeding in the longer term. (Grade B)

Definitions:

Grades of Recommendations

A: Evidence based on randomised controlled trials (RCTs)

B: Evidence based on other robust experimental or observational studies

C: Evidence is limited but the advice relies on expert opinion and has the endorsement of respected authorities

Good Practice Point: Where no evidence exists but where best practice is based on the clinical experience of the Multidisciplinary Group

Clinical Algorithm(s)

The following clinical algorithms are provided in the original guideline document:

  • Management plan for a woman using hormonal contraception with unscheduled bleeding
  • Medical therapy options for women using hormonal contraception with unscheduled bleeding

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see the "Major Recommendations" field).

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Appropriate management of unscheduled bleeding in women using hormonal contraception

Potential Harms

Not stated

Qualifying Statements

Qualifying Statements

This Guidance is not intended to serve alone as a standard of medical care, as this should be determined individually based on available clinical information.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Clinical Algorithm
Staff Training/Competency Material
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
IOM Domain
Effectiveness
Patient-centeredness

Identifying Information and Availability

Bibliographic Source(s)
Clinical Effectiveness Unit. Management of unscheduled bleeding in women using hormonal contraception. London (UK): Faculty of Sexual and Reproductive Healthcare (FSRH); 2009 May. 19 p. [64 references]
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2009 May
Guideline Developer(s)
Faculty of Sexual and Reproductive Healthcare - Professional Association
Royal College of Obstetricians and Gynaecologists - Medical Specialty Society
Source(s) of Funding

Faculty of Sexual and Reproductive Health Care

Guideline Committee

Clinical Effectiveness Unit

Composition of Group That Authored the Guideline

Clinical Effectiveness Unit (CEU): Dr Susan Brechin (Unit Director); Dr Madhuri Thakur (Research Assistants); Ms Lisa Allerton (Research Assistant); Dr Sharon Cameron (Consultant Gynaecologist, Dean Terrace Centre and Royal Infirmary of Edinburgh); Professor Hilary Critchley (Professor of Reproductive Medicine, University of Edinburgh); Dr Mehmet Gazvani (Consultant Gynaecologist and Subspecialist in Reproductive Medicine and Surgery, Liverpool Women's Hospital/RCOG Guideline and Audit Committee Representative); Dr Ailsa Gebbie (Consultant in Community Gynaecology, Edinburgh/Vice-President of the FSRH and FSRH Council Representative); Dr Anna Graham (GP, Horfield Health Centre, Bristol/Member of the FSRH Clinical Effectiveness Committee [CEC]); Dr Kay McAllister (Consultant in Sexual and Reproductive Health, The Sandyford Initiative, Glasgow); Dr Karen Piegsa (Consultant in Reproductive Health, Forth Park Hospital, Kirkcaldy); Dr Mark Shapley (GP/Research Fellow, ARC National Primary Care Centre, Keele University)

Financial Disclosures/Conflicts of Interest

No competing interests were noted by members of the multidisciplinary group.

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) from the Faculty of Sexual and Reproductive Health Care Web site External Web Site Policy.

Print copies: Available from the Faculty of Sexual and Reproductive Health Care, 27 Sussex Place, Regent's Park, London NW1 4RG

Availability of Companion Documents

Discussion points and questions for management of unscheduled bleeding in women using hormonal contraception developed by the Faculty for Sexual & Reproductive Healthcare Education Committee are available at the end of the original guideline document External Web Site Policy.

Patient Resources

None available

NGC Status

This summary was completed by ECRI Institute on December 6, 2010.

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

Disclaimer

NGC Disclaimer

The National Guideline Clearinghouseâ„¢ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

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