Ectopic Pregnancy and Miscarriage – Diagnosis and initial management in early pregnancy of ectopic pregnancy and miscarriage. NICE clinical guideline 154 December 2012
The National Institute for Health and Clinical Excellence (NICE) was set up in 1999 to reduce variation in the availability and quality of NHS treatments and care – the so called ‘postcode lottery’. NICE guidelines aim to help resolve uncertainty about which treatments represent the best quality care and the best value for money for the NHS.
NICE acknowledge that loss in early pregnancy accounts for over 50,000 hospital admissions in the UK annually and that the rate of ectopic pregnancy is 11 per 1000 pregnancies. Maternal mortality is 0.2 per 1000 estimated ectopic pregnancies. About two thirds of these maternal deaths are associated with substandard care.
NICE highlighted the following key areas for improvement:
- Support and information giving
- Early pregnancy assessment services
- Symptoms and signs of ectopic pregnancy and initial assessment
- Diagnosis of viable intrauterine pregnancy and of ectopic pregnancy
- Management of miscarriage – (not summarised in this document)
- Management of ectopic pregnancy
- Anti-D rhesus prophylaxis
Support and Information Giving
Women are advised to seek help if their symptoms worsen. A 24-hour contact telephone number should be provided in case of emergency. Women should know what to expect when they get home e.g. potential extent of pain and/or bleeding, and possible side effects of any treatments they are offered.
Information should be provided about post-operative care e.g. when to resume sexual activity, when to try and conceive again and what to do in a future pregnancy. Access to support and counselling services i.e. leaflets, web addresses and helpline numbers for support organisations should be provided routinely. Communication skills training should be available to all staff interacting with patients e.g. receptionists.
Early pregnancy assessment services
Symptoms and signs of ectopic pregnancy can resemble symptoms of other conditions e.g. gastrointestinal conditions and urinary tract infection. Healthcare professionals involved in the care of women of reproductive age should have access to pregnancy tests and acute services should be available 7 days a week. Consultation with a doctor/nurse should become available within 24 hours of referral.
Symptoms and signs of ectopic pregnancy
Signs/symptoms of ectopic pregnancy include abdominal or pelvic pain, amenorrhoea or missed period, vaginal bleeding with or without clots, breast tenderness, gastrointestinal symptoms, dizziness, fainting or syncope, shoulder tip pain, urinary symptoms, passage of tissue and rectal pressure or pain on defecation.
On examination, patients with pelvic tenderness, adnexal tenderness, abdominal tenderness, cervical motion tenderness (cervical excitation) rebound tenderness or peritoneal signs, pallor, abdominal distension, enlarged uterus, tachycardia (more than 100 beats per minute) or hypotension (less than 100/60 mmHg), shock or collapse or orthostatic hypotension should be referred immediately.
Diagnosis of viable intrauterine pregnancy and ectopic pregnancy
Women who attend an early pregnancy assessment service should be offered a trans-vaginal ultrasound scan to identify the location of the pregnancy and confirm presence of a heartbeat / fetal pole. Ultrasound scans should be performed and reviewed by someone with the appropriate training and experience.
Care should be taken when diagnosing a ‘complete miscarriage’ when there has not been a previously confirmed intrauterine pregnancy, as there is always a possibility of missing an ectopic pregnancy. Women should return for further review if symptoms persist.
Be aware that women with a pregnancy of unknown location could have an ectopic pregnancy until the location is determined. Serial hCG measurements (usually 48 hours apart) may prove helpful in determining the management of a pregnancy of unknown location, but the hCG measurements alone should not be used to make an actual diagnosis. Clinical symptoms are more important than hCG results.
Women with a pregnancy of unknown location should be given written information about what to do if they experience new or worsening symptoms and should return to hospital if new symptoms develop or if symptoms worsen. A rise in serum hCG concentration greater than 63% over 48 hours is likely to suggest a developing intrauterine pregnancy. A transvaginal ultrasound scan 7-14 days later should determine location of the pregnancy. Consider an earlier scan for women with a serum hCG level greater than 1500 IU/litre.
A fall in serum hCG concentration greater than 50% over 48 hours suggests the pregnancy is unlikely to continue. Oral and written information about counselling services should be provided, with a repeat urine pregnancy test after 14 days. If the test is negative, no further action is necessary. If the test is positive patients should return to the early pregnancy assessment service for clinical review within 24 hours.
Woman with a change in serum hCG concentration between a 50% decline and 63% rise, should attend for clinical review to an early pregnancy assessment service within 24 hours. Serum progesterone measurements should only be used to aid management and not used to make a primary diagnosis.
Management of Ectopic (Medical v Surgical Options)
Women who have suffered a previous ectopic pregnancy should be reminded that they can self-refer to an early pregnancy assessment service in any future pregnancies if they have any concerns.
Offer systemic methotrexate as a first-line treatment to women with an ectopic pregnancy provided they are suitable and able to return for follow-up and who have:
- No significant pain
- Unruptured ectopic pregnancy with an adnexal mass smaller than 35 mm
- No visible heartbeat
- Serum hCG level less than 1500 IU/litre
- No intrauterine pregnancy as confirmed on an ultrasound scan
Offer Surgery to woman with ectopic pregnancy who are unable to return for follow-up after methotrexate treatment and who have:
- Significant pain
- Adnexal mass of 35 mm or larger
- Fetal heartbeat visible on an ultrasound scan
- Serum hCG level of 5000 IU/litre or more.
Offer the choice of either methotrexate or surgical management to women with ectopic pregnancy who are able to return for follow-up and who have:
- Serum hCG level greater than 1500 IU/litre but less than 5000 IU/litre
- No significant pain,
- An unruptured ectopic pregnancy with an adnexal mass smaller than 35 mm
- No visible heartbeat
Women who choose methotrexate should be advised that the chance of needing further intervention is increased and they may need to be urgently admitted if their condition deteriorates. Women who have received methotrexate are advised to undergo 2 serum hCG measurements in the first week (days 4 and 7) after treatment and then 1 serum hCG measurement per week until a negative result is obtained. If hCG levels plateau or rise, reassess the condition for further treatment.
When surgical treatment is indicated for women with an ectopic pregnancy, it should be performed laparoscopically whenever possible, taking into account the condition of the woman and the complexity of the surgical procedure. Surgeons providing care to women with ectopic pregnancy should be competent to perform laparoscopic surgery.
Commissioners and managers should ensure that equipment for laparoscopic surgery is available.
Salpingectomy and Salpingotomy: Offer a salpingectomy to women undergoing surgery for an ectopic pregnancy unless they have other risk factors for infertility. Consider salpingotomy as an alternative to salpingectomy for women with risk factors for infertility such as contralateral tube damage. Inform women having a salpingotomy that up to 1 in 5 women may need further treatment. This treatment may include methotrexate and/or a salpingectomy. For women who have had a salpingotomy, take 1 serum hCG measurement at 7 days after surgery, then 1 serum hCG measurement per week until a negative result is obtained. Advise women who have had a salpingectomy that they should take a urine pregnancy test after 3 weeks. Advise women to return for further assessment if the test is positive.
Indications for Anti-D rhesus prophylaxis 250 IU
Anti-D rhesus prophylaxis at a dose of 250 IU (50 micrograms) should be offered to all rhesus negative women who have a surgical procedure to manage an ectopic pregnancy or a miscarriage.
Anti-D rhesus prophylaxis is not required for:
- Women who have received solely medical management for ectopic/miscarriage
- Threatened miscarriage
- Complete miscarriage
- Pregnancy of unknown location.
Kleihauer tests should not be used for quantifying feto–maternal haemorrhage.