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  4. Post-menopausal bleeding (in development) - option 2

Post-menopausal bleeding - option with no pathway diagrams

Gynaecology

Background

There has been a significant increase in referrals for post-menopausal bleeding (PMB) in recent years, this is due to the increased use of Hormone Replacement Therapy (HRT). 

PMB is referred through the urgent suspicion of cancer pathway as there is a 10% risk of endometrial cancer associated with true PMB.

Use of HRT can cause unscheduled bleeding. The risk of cancer in people with HRT-associated PMB is significantly lower, as evidenced in literature and shown by audit data from various NHS Health Boards.

Unscheduled bleeding in patients using HRT is no longer listed as a reason for urgent suspicion of cancer referral in the Scottish Referral Guidelines for Suspected Cancer, except where the patient has risk factors for endometrial cancer.

We propose two distinct pathways:

  1. Patients with PMB not associated with HRT (with intact uterus) should receive a USC ultrasound.
  2. Patients with PMB who are on HRT, should be managed according to Red, Amber, Green risk stratifications as laid out in pathway below.

 

Pathway recommendations: Post-menopausal bleeding - Urgent suspected cancer (USC) pathway (For patients not on hormone replacement therapy (HRT), with intact uterus)

Initial presentation

Postmenopausal bleeding (Not on HRT)

  • No periods for 1 year or more
  • Not on hormonal contraception
  • People with intact uterus or cervix

 

Initial assessment

Clinical history and examination, including:

  • Bleeding pattern
  • Abdominal and pelvic examination (speculum and vaginal); visualise cervix to exclude local causes
  • Investigations where relevant, including cervical screening and lower genital tract swabs
  • If current or past history of tamoxifen, refer straight to secondary care as Urgent Suspected Cancer (USC)

For unscheduled bleeding on HRT, go to Pathway recommendations: Management of unscheduled bleeding on HRT in women with intact uterus (includes peri- and post-menopausal women).

 

Initial investigations and referral

USC transvaginal ultrasound scan to assess endometrial thickness (ET)

  • May be organised by primary or secondary care depending on service availability

If endometrium is ≤ 4 mm and speculum examination is normal:

  • Reassure
  • Identify and treat vaginal atrophy

If endometrium is > 4 mm or not measurable:

  • Refer to secondary care for endometrial assessment as USC

 

Management

Endometrium > 4 mm

  • Endometrial biopsy

If USS suggestive of polyp, complex features in endometrium / current or past history of tamoxifen:

  • Offer hysteroscopy along with endometrial biopsy

Further treatment depending on biopsy results

  • For management of endometrial hyperplasia, refer to RCOG guidance

 

Pathway recommendations: Management of unscheduled bleeding on HRT in women with intact uterus (includes peri- and post-menopausal women)

Initial assessment

Clinical history, including:

  • Bleeding pattern
  • HRT preparation, duration of use, and compliance
  • Offer abdominal and pelvic examination (speculum and vaginal), visualize cervix to exclude local causes
  • Check BMI
  • Investigations where relevant, including cervical screening and lower genital tract swabs

Assess risk factors for cancer

Minor risk factors for endometrial cancer

  • BMI 30–39
  • Unopposed estrogen >3 months but <6 months
  • Tricycling HRT (quarterly progestogen) for >6 but <12 months
  • >6 but <12 months  of using norethisterone or medroxyprogesterone acetate for <10 days/month or, micronized progesterone for <12 days/month, as part of a sequential regimen
  • Where the progestogen dose is not in proportion to estrogen dose for >12 months (including expired 52 mg LNG-IUD)
  • Anovulatory cycles, such as in polycystic ovary syndrome
  • Diabetes

Major risk factors for endometrial cancer

  • BMI ≥40
  • Genetic predisposition (Lynch / Cowden syndrome)
  • Estrogen-only HRT for >6 months in women with a uterus
  • Tricycling HRT (quarterly progestogen) for >12 months
  • Prolonged sHRT regimen: use for more than 5 years when started in women aged ≥45
  • 12 months or more of using norethisterone or medroxyprogesterone acetate for <10 days/month or, micronized progesterone for <12 days/month  as part of a sequential regiman

 

No risk factors or one minor risk factor

Initial management

  • If bleeding occurs within 6 months of starting HRT or persisting 3 months after changing HRT:
    • Offer adjustment in the estrogen and progestogen dose of HRT for 6 months
    • See Further management section, below
  • If the first presentation of bleeding occurs 6 months after starting HRT or 3 months after changing the HRT preparation:
    • See Investigations section, below

 

Two minor risk factors or if bleeding is prolonged or heavy, irrespective of interval since starting or changing HRT

  • See Investigations section, below

 

One major or three minor risk factors

  • Refer to secondary care, USC Pathway

 

Further management

If bleeding persists 6 months after adjusting progestogens:

  • urgent ultrasound within 6 weeks, or
  • weaning off HRT (choose one option)

If bleeding settles after stopping HRT at 4 weeks:

  • no further investigations needed
  • if patient elects to restart HRT offer adjustment to HRT for 6 months

If bleeding persists 6 months after restarting HRT:

  • See Investigations section, below

 

Investigations

Urgent transvaginal ultrasound within 6 weeks

 

If thickened endometrium ≥4 mm on CCHRT or ≥7 mm for sequential HRT (sHRT):

  • Refer to secondary care, USC Pathway

If endometrium regular and ≤4 mm on CCHRT and ≤7 mm on sHRT:

  • reassure that risk of cancer is low
  • offer HRT adjustment for 6 months

If bleeding increases OR persists after 6 months:

  • Refer to secondary care, USC Pathway

 

Adjusting HRT to reduce unscheduled bleeding episodes

  • Check the patient understands how to, and is using, their prescribed HRT properly, including dose and duration of progestogen. Consider whether a combined patch or pill would reduce administration errors when compared to a separate estrogen and progestogen component.
  • Offer all women a 52mg Levonorgestrel Intrauterine Device (LNG-IUD), which has been shown to reduce unscheduled bleeding more effectively than other treatments.
  • Oral preparations provide higher rates of amenorrhoea (abnormal absence of periods) than transdermal (through the skin) preparations. If there are no risk factors for thrombosis, these may be offered:
    1. as a first-line therapy, or
    2. to women who experience recurrent unscheduled bleeding while using transdermal preparations
  • Offer vaginal estrogens if atrophic findings are identified during examination.

 

Prescribed estrogen dose for ultra-low, low, standard, moderate and high dose regimens*

  Ultra-low dose Low dose Standard dose Moderate dose High dose
Osetrogel 1/2 pump 1 pump 2 pumps 3 pumps 4 pumps
Sandrena 0.25mg 0.5mg 1mg 1.5-2mg 3mg†
Lenzetto spray 1 spray 2 sprays 3 sprays 4-5 sprays† 6 sprays†
Patch 12.5µg 25µg 50µg 75µg 100µg
Oral estradiol 0.5mg 1mg 2mg 3mg∧ 4mg∧

* Management of unscheduled bleeding on hormone replacement therapy - British Menopause Society

† Off-license use,

∧ Off-license use - rarely required to achieve symptom control, 

mg = milligrams,

µg = micrograms

 

Progestogen dose per licensed estrogen dose in the baseline population*

Estrogen dose Micronised progesterone Medroxy progesterone Norethisterone LNG-IUD
  continuous sequential continuous sequential continuous sequential  
Ultra-low 100mg 200mg 2.5mg 10mg 5mg† 5mg† One - for up to 5 years of use
Standard 100mg 200mg 2.5-5mg 10mg 5mg† 5mg†
Moderate 100mg 200mg 5mg 10mg 5mg 5mg
High 200mg 300mg 10mg∧ 20mg∧ 5mg 5mg

* Management of unscheduled bleeding on hormone replacement therapy - British Menopause Society

† 1mg provides endometrial protection for ultra-low to standard dose estrogen but the lowest stand-alone dose currently available in the UK is 5mg (off-license use of three noriday POP i.e. 1.05mg, could be considered if 5mg is not tolerated).

∧ There is limited evidence in relation to optimal MPA dose with high dose estrogen; the advised dose is based on studies reporting 10mg providing protection with up to moderate dose estrogen.

 

Glossary

PMB – Post Menopausal Bleeding

HRT – Hormone Replacement Therapy

sHRT – Sequential Hormone Replacement Therapy

CCHRT – Continuous Combined Hormone Replacement Therapy

USC – Urgent Suspicion of Cancer

ET – Endometrial Thickness

USS – Ultrasound Scan

BMI – Body Mass Index

LNG-IUD – Levonorgestrel Intrauterine Device

 

References

Management of unscheduled bleeding on hormone replacement therapy - British Menopause Society

Management of endometrial hyperplasia - Royal College of Obstetricians and Gynaecologists (RCOG)  guidance - www.rcog.org.uk/guidance/browse-all-guidance/green-top-guidelines/management-of-endometrial-hyperplasia-green-top-guideline-no-67

 

 

   gjnh.cfsdpmo@gjnh.scot.nhs.uk

  www.nhscfsd.co.uk

@NHSScotCfSD

Centre for Sustainable Delivery

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