The management of unscheduled bleeding in women using hormonal contraception

1. The management of unscheduled bleeding in women using hormonal contraception Dr Susan Brechin MRCOG, MFSRH, MD, ILTM, MIPM Consultant in Sexual Health NHS Grampian

2. Evidence-based Guidance Multidisciplinary Expert Group Best evidence and expert opinion The management of unscheduled bleeding in women using hormonal contraception www.fsrh.org.uk

3. Grades of Recommendations A At least RCTs addressing the specific question B Well-controlled studies without randomisation C Absence of directly applicable clinical studies of good quality Good Practice Points Based on the opinion of the current Expert Group where no evidence exists Of the 15 recommendations all but one is a good practice point

4. Management is challenging • Due to method itself and will settle with time • Exclude underlying causes – infection, missed pills, etc • Management will vary depending on duration of use and concurrent symptoms • Management plan individualised

5. Aetiology of unscheduled bleeding • Sequential exposure to estrogen and progesterone leads to histological changes in the endometrium • Withdrawal of sex steroids triggers menstruation • Hormonal contraception influences endometrial histology in different ways depending on the • dose • concentration • mode of delivery • duration of contraceptive use • Mechanism of bleeding is unclear • vessel fragility • More research required

6. Expected bleeding patterns

7. Management–clinical history • Her own concerns • Current method use and duration of use • Concurrent medications or illness • Bleeding patterns • Other symptoms – pain, dyspareunia, postcoital bleeding • Possibility of pregnancy • Cervical screening history • Risk for sexually transmitted infection

8. Management – Check cervical screen • If not up to date with cervical screening programme offer a smear • NO evidence to perform cervical cytology if she is • out with the age for the screening programme • has had a negative smear in last 3 years • NOTE: Most cases of cervical cancer are microinvasive disease and identified at colposcopy. An speculum examination will however identify the rare case which may present with abnormal vaginal bleeding.

9. Management – Exclude STI RISK FACTORS • Age < 25 years • New partner in last 6 months • More than one partner in last 12 months TEST FOR • Chlamydia as a minimum • Gonorrhoea depending on local prevalence

10. When may an examination NOT be required? • Within initial months of use (3 and up to 6 months) • No other symptoms associated with the bleeding • Excluded risk for STI or offered a self taken LVS • Up to date with cervical screening

11. When is an examination required? • If consistent and correct use a speculum examination to visualise the cervix should be considered if: • bleeding persists beyond the initial months of use (3+months) • bleeding patterns changes or bleeding starts • not participating in a cervical screening programme • requested by the women • other symptoms such as pain, dyspareunia, abnormal vaginal discharge, postcoital bleeding (BIMANUAL also indicated)

12. When is further investigation required? Endometrial biopsy (EB) • Excludes endometrial cancer but this is rare in women: • < 45 years • using hormonal contraception • Consider an EB in women: • aged ≥ 45 years if bleeding persists or if there is a change in bleeding pattern after the initial months of use • OR as above if aged < 45 years with risk factors – PCOS, unopposed estrogen therapy, tamoxifen

13. When is further investigation required? Ultrasound scan may be considered if: • a structural abnormality (such as a submucous fibroid, intrauterine polyp or ovarian cyst) is a possible cause NOTE: these structural lesions may NOT be the cause of bleeding Hysteroscopy • May be considered with EB

14. Are there effective treatment options? • Unfortunately NO • Indirect evidence and very limited direct evidence • Some treatment options for short term management of bleeding • No long term treatments identified • Expert group suggested the following

15. Combined hormonal contraceptive users • Continue same COC for 3 months at least • Start with a second generation COC with lowest dose of ethinyl estradiol (EE) to give good cycle control – 30 micrograms • May increase EE dose to 35 micrograms • May try another COC but no evidence as to which one • No evidence changing the type of dose of progestogen is effective • Patch , ring and pill have similar bleeding patterns

16. Progestogen-only pill users • Continue same POP for at least 3 months • May try another POP but no evidence as to which one • NO evidence that the desogestrel-only pill is better than any other in terms of bleeding • No evidence increasing to two POPs per day is effective in improving bleeding

17. Progestogen-only injections, implant and intrauterine system • Try a COC for 3 months if no contraindication • Licensed regimen or tricycling (unlicensed) • NO evidence reducing the injection interval effective but can try if bleeding at end of injection time. • DMPA can be given up to 2 weeks early • Mefenamic acid 500 milligrams twice or three times daily for short term improvement

18. Questions • Key points • Management plan • Care pathway may include referral to Square 13