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Early Pregnancy Assessment Unit
that provides efficient
management, counselling and access to appropriate information.
At all times women will be
supported in making informed choices
about their care
and
management.
The Association of Early Pregnancy Units Executive
Committee have
set out a 10 point Charter for service provision and these include:
1. Referral Guidelines and
Operational Policy that are clear to patient.
2. Recognition of Patient
choice in management.
3. Dedicated area with quiet
room for breaking bad news.
4. Availability of facility and
opening hours.
5. Competence at Scanning
6. Same day Serum HCG Service.
7. Written information leaflets
for patient care
8. Acknowledgement of patient
privacy and dignity
9. Bereavement counselling
availability
10.
Free pregnancy testing
Contents
I Guidelines for Service Organisation
˛ Site, Access, Facilities and Staffing 5
˛
Referral Guidelines 6
II Clinical Guidelines
˛ General Patient management 8
˛
Guidelines for Rhesus prophylaxis 9
˛ Record Keeping and Data Collection 10
˛ Ultrasound scanning: RCOG Criteria 11
Ultrasound features of early
pregnancy 12
Ultrasound features of early
pregnancy and management 13
˛ Viable Intra-uterine Pregnancy 15
˛ Non Viable Pregnancy 16
Incomplete miscarriage
Missed miscarriage
Conservative management 17
Medical management 19
Surgical management 20
˛
ß-HCG Assay 22
˛
Management of Pregnancy of Unknown Location (PUL) 23
˛
Ectopic Pregnancy 25
Expectant Management
Medical Management
Surgical Management
˛ Management of Recurrent Miscarriage
34
˛
Management of Gestational Trophoblastic disease 38
III Supportive Guidelines
˛
Support and follow-up after a miscarriage 39
˛
Disposal of fetal remains (< 24 weeks) and funeral services 41
I Guidelines for Service Organisation
Site
˛ It should be located in a dedicated area.
˛ The surroundings should be pleasant and comfortable with
toilets near at hand.
Access
˛ The gold standard is to have a unit open seven days a week
from 8.00am until 5.00 pm
˛
The minimum requirement would be to have a unit open for five days,
mornings only from Monday to Friday.
˛
Patient access to AEPU Website (earlypregnacy.org.uk) will give details
of nearest EPU to patient within UK and contact number.
Facilities
˛ Good quality ultrasound equipment
˛ A simple system of sensitive urine pregnancy testing should
be available in the unit
˛ There should be access to ß-hCG assay with results within 24
hours
˛ Rhesus grouping and Anti-D should be considered if gestation
is >12 weeks
˛ It is important to bear in mind that some patients may
require other gynaecological procedures
such as infection screen.
Staffing
˛ Varies between the units.
Minimum requirement would be:
a receptionist/secretary
a midwife/nurse
a gynaecologist and a sonographer
˛ Attitude of the staff involved should be caring and
sympathetic
˛ Clear and consistent verbal and written information
˛ Initial support and informal counselling should be provided
by all health professionals involved
˛ There should be access to formal counselling sessions where
necessary (this may be needed occasinally)
Referral Guidelines
Who
may be referred:
·
Women in first trimester who have had a positive pregnancy test
and a) abdominal pain
b)
vaginal bleeding
c) previous ectopic
d)
previous tubal surgery
e)
two or more previous miscarriages
f)
intrauterine contraceptive device in-situ
·
Women with a non-viable pregnancy diagnosed in ante-natal booking
clinic.
·
Women between 13-20 weeks, with pain and/or bleeding, either restricted
access to only inpatients or open to all outpatient referrals depending on the
resources of a unit
·
Post evacuation/termination with persistent bleeding.
Sources of Referral
·
Primary Care Doctors
·
Accident & Emergency Departments
·
Wards
·
Nurse Led Primary Care Drop In Centres
·
Self referral
Referral Procedure
Referral
booking is via Co-ordinator between 9 am and 5 pm and via the Gynae SHO/Senior
Gynae nurse at night.
·
The appointment book or Electronic Diary should be available on gynae
ward after 5.00pm. to enter referrals
·
Details of patient’s name, address, date of birth, name of GP and
reason for referral should be noted and a n appointment time given
·
GPs to be advised to tell the patients that :
a) a
transvaginal scan is likely
b)
as it is an emergency clinic the appointment time cannot be guaranteed
and
delays are likely
·
GPs to be encouraged to send a letter either with the patient or by fax
A
patient information leaflet on what to expect should be available in the
waiting area.
Caution
Women
referred to the unit are, by definition, stable and can be given an appointment
for the next working day.
Women
who are unwell, bleeding heavily or in whom an ectopic pregnancy is suspected
should be admitted through the usual channels and not asked to wait for an
appointment on the unit. There will also
be a proportion of women who are frightened by the loss or who are socially and
geographically isolated and prefer admission.
II Clinical Guidelines
Guidelines for
General Patient Management
·
A brief history is taken on the standardised proforma in accordance
with RCOG/RCG guidelines including:
i) Previous
obstetric history, LMP, pregnancy test in this pregnancy
ii) Pain
- description
iii) Bleeding
- amount
iv)
Passage of POC
·
Clinical examination should be considered if appropriate
·
Transvaginal scan (TVU) is performed if less than 7-8 weeks and also in
some circumstances at more than 8 weeks, with patient option to see what is
seen on the screen
·
Patient’s wishes should be respected if strongly declines a TVS
·
A clear explanation should be given by the Gynaecologist/Sonographer
performing the scan as to the possible or likely diagnosis/diagnoses.
·
Appropriate pictures are taken for the patient’s records. Pictures are not usually given to patients in
EPAU except when asked by a patient.
·
All items on the proforma should be checked
·
A plan of management should be formulated based on the guidelines
·
A pregnancy test should be performed if a pregnancy is not clearly
visible
·
Consideration for a ß-hCG assay should be given if a pregnancy test is
positive
·
Support should be given where the pregnancy is non-viable and a second,
independent observer must confirm the diagnosis. A quiet room should be
available
·
Follow up should be arranged before the woman leaves the clinic
·
Appropriate written advice and telephone numbers for contact should be
given
RCOG Guidelines for Rh
Prophylaxis
Confirmed miscariage: Anti-D immunoglobulin should be given to all
non-sensitised Rh negative women who miscarry after 12 weeks, whether complete
or incomplete and to those who miscarry below 12 weeks when the uterus is
evacuated (either surgically or medically).
Threatened miscarriage: Anti-D should be given to
all non-sensitised Rh negative women with threatened miscarriage after 12
weeks. Routine administration of anti-D is not required below 12 weeks when the
fetus is viable, unless the bleeding is heavy or associated with abdominal
pain.
Ectopic
pregnancy:
All Rh negative women with ectopic pregnancies whether managed surgically or
medically should be given anti-D. The recommended dose before 20 weeks of pregnancy is
250IU.
Documentation from
the EPAU should clearly state whether or not anti-D was given in the
Clinic.
Reference:
Use of anti-D immunoglobulin for Rh prophylaxis. RCOG ‘Green –top’ Guideline no. 22,
1999.
Guidelines on Record keeping
and Data Collection
Until
such time as computer based records are developed in the early pregnancy
assessment units, data should be maintained in hand-written registers.
Accurate
record keeping is needed to ensure that pregnancy outcome is recorded with
sufficient detail and that feedback is comprehensive.
The
training of appropriate support staff to maintain high standards of
record-keeping should be encouraged.
----------------------------------------------------------------------------------------------------------------
Guidance on maintaining
Registers
The
monitoring of the management protocols in terms of acceptance and outcome can
only be achieved through maintaining accurate registers. The following issues are important to
establish the diagnosis and its management.
1. All first visit scans should be given a diagnosis and grouped
under respective diagnostic groups,
such as:
Viable pregnancy or Threatened miscarriage if
associated with bleeding,
Complete
Miscarriage,
Incomplete
Miscarriage,
Missed
Miscarriage,
Ectopic
Pregnancy,
2. Those scans that do not fit into any of
the above diagnostic categories because a gestation
sac is either too small or not visible, should be grouped under:
EGS (early gestational sac)
with/without YS (yolk sac), when no embryo is visible and
Pregnancy
of Unknown Location (PUL) if an intrauterine or
extrauterine pregnancy can not be demonstrated on scan.
3. Pregnancy of unknown location (PUL): At a subsequent scan when a diagnosis becomes
possible they are placed under the respective groups as mentioned above. A pregnancy, which does not fit
into any of the above diagnostic groups, is still classified as Pregnancy of unknown location (PUL).
4.
Scans that are performed after a diagnosis has been allocated to an
individual patient so as to avoid counting the same patient twice in a
diagnostic category.
5. All Incomplete/Missed miscarriages should be further grouped according to the method of treatment and their outcome recorded.
6. All ectopic pregnancies should be grouped according to the method of treatment and their outcome recorded.
7. Monthly statistics should be entered on a Data sheet.
Guidelines for Scanning
RCOG Criteria
If
the gestation sac has a mean diameter greater than 20mm, with no evidence of an
embryo or yolk sac, this is highly suggestive of a silent miscarriage.
If
the embryo has a crown rump length greater than 6mm, with no evidence of heart
pulsations, this is highly suggestive of a silent miscarriage.
When
the mean gestation sac is less than 20mm or the crown rump length is less than
6mm a repeat examination should be performed at least one week later both to
assess growth of the gestation sac and embryo and to establish whether heart
activity exists.
If
the gestation sac is smaller than expected for gestational age the possibility
of incorrect dates should always be considered, especially in the absence of
clinical features suggestive of a threatened miscarriage.
In
all of the above instances a repeat scan should be undertaken in 7 days. This is necessary to confirm the diagnosis. A
second independent observer needs to confirm the findings of pregnancy loss if
fetal death is apparent.
All scans should be
performed by experienced personnel.
The
following individuals are suitably trained to perform ultrasound:
Radiographers/midwives
with the Diploma in Medical Ultrasound (DMU)/PGDip
Radiologists
with ultrasound training and experience as recommended by the Royal College of
Radiologists.
Obstetricians
and Radiologists who have completed the joint obstetric ultrasound training
scheme of the Royal College of Obstetricians and Gynaecologists and The Royal
College of Radiologists, or alternatively who have appropriate experience and
training in obstetric ultrasound.
All
personnel should have appropriate peer review of their ultrasound practice.
Information should be
recorded including:
i)
number of sacs and mean gestation sac diameter
ii)
regularity of the outline of sac and its location
ii) presence
of haematoma
iii) presence
of a yolk sac
iv) presence
of a fetal pole
v) CRL
measurement (mm)
vi)
presence of fetal heart pulsation
vii)
extra uterine observations – ovaries, adnexal mass, fluid in the Pouch
of Douglas (P.O.D.)
Guidelines
for Ultrasound Features of Early Pregnancy
|
Gestational age |
Anatomical landmarks |
Comments |
|
4
weeks 2 days |
Eccentrically
placed Gestational
sac GSD
2-3mm |
May
represent pseudosac 10-20%
of ectopic pregnancies have an intrauterine pseudo GS |
|
5th
week |
DDS |
Results
from approximation of d. capsularis
and d. vera. May be present in one third ectopics. |
|
5th
week |
GSD
5mm Yolk
sac (YS) Size
varies from 3-8mm (average 5mm) |
Confirms
IUP Large
YS > 10mm – poor prognosis. |
|
6th
week |
GSD
10mm Embryo
2-3mm Cardiac
activity (CA) |
Confirms
IUP Confirms
viability (97%
of embryos with CA have a normal outcome). |
|
7th
week |
GSD
20mm Head
and trunk distinguishable |
GS
> 20mm, if no YS – poor prognosis |
|
8th
week |
GSD
25mm Head
size = YS Limb
buds Midgut
herniation Rhombencephalon |
GS
> 25mm, if no embryo – poor prognosis |
|
9th
week |
Choroid
plexus, spine, limbs |
|
|
10
weeks |
Cardiac
chambers, Stomach,
bladder, Skeletal
ossification |
|
|
11
weeks |
Gut
returning Most
structures identified |
|
GSD
Gestational sac diameter
DDS Double decidual sign
IUP
Intrauterine pregnancy
Guidelines for Ultrasound Features of Early Pregnancy and Management
|
Ultrasound
appearance |
Diagnosis |
Plan
of management |
|
Intrauterine gestation sac (GS) and fetal pole
with cardiac activity (CA) seen |
Viable pregnancy |
Back
to GP or referral to ANC |
|
If
actively bleeding |
|
Admit
for reassurance |
|
If
haematoma |
|
Reassure
and rescan at later date depending on scan availability (See References) |
|
If
> 12 weeks |
|
Check
the need for Anti-D |
|
Gestational Sac GS
<20mm – no fetal pole |
Possible early pregnancy |
Rescan
1 week later |
|
GS
>20mm – no fetal pole |
Possible missed miscarriage |
Rescan
1 week later If
no change on second scan discuss management (see under management of
non-viable pregnancy) |
|
Crown Rump Length (CRL) <6mm Fetal
Heart Activity (FH) not demonstrated |
Possible viable |
Rescan
1 week later |
|
CRL
>6mm FH
not demonstrated |
Missed miscarriage |
Rescan
1 week later If
no change on second scan discuss management (see under management of
non-viable pregnancy) |
|
Empty uterus No
adnexal abnormality |
ß-hCG negative (<5) compelte miscarriage or never pregnant ß-hCG positive possible early pregnancy possible ectopic pregnancy possible complete
miscarriage |
No
follow-up Repeat
ß-hCG 48 hours later Rescan
if necessary (see
guidelines for ß-hCG) Warn
of possibility of ectopic pregnancy. Give
contact numbers if any pain. |
|
Empty uterus Adnexal mass Fluid in POD Pain |
Ruptured ectopic
pregnancy/ Tubal abortion |
Admit
for laparoscopy/ laparotomy |
|
Empty uterus Adnexal
mass <3cm No
other findings/symptoms |
Unruptured ectopic
pregnancy |
Conservative/medical
management Follow
up with serial ß-hCG (see
guidelines for ß-hCG assay) |
|
Endometrium/tissue
diameter <15mm |
Complete miscarriage |
Advice
follow-up 2 weeks later, if
bleeding persists |
|
Endometrium/tissue
diameter >15mm |
Incomplete miscarriage |
Discuss
management (see guidelines on management of incomplete miscarriage) |
|
Homogeneous
mass within The
uterus |
Suspect
trophoblastic disease ß-hCG assay |
Surgical
evacuation (see guidelines
for trophoblastic disease) |
|
Pregnancy of Unknown
Location (PUL) |
Diagnosis
uncertain |
See
guidelines ‘inconclusive scan’ |
|
Adequate
time should be allowed for women to make decisions. It is imperative to know
that patients will vary in their response to information at the time. If not
receptive rescan should be arranged for one week. If the patient displays
clear understanding and wishes to know about further management appropriate
choices to be given Embryos
with: CRL smaller than expected or no growth noticed after one week, tend to
be chromosomally abnormal. |
||
References:
1. Guidance on ultrasound procedures in Early Pregnancy. Standing joint committee on obstetric ultrasound of RCR/RCOG. 1995.
2. Philipp T, Philipp K, Reiner A, Beer F, Kalousek DK. Embryosopic and cytogenetic analysis of 233 missed abortions: factors involved in the pathogenesis of developmental defects of early pregnancies. Human Reproduction, 2003, 18, 1724-32.
3. Johns J, Hyett J, Jauniaux E. Obstetric outcome after threatened miscarriage with or without a haematoma on ultrasound. Obstetrics and Gynaecology, 2003, 102, 483-7.
Guidelines for Viable Intra-Uterine Pregnancy
A
normally sited gestation sac with clearly identified cardiac activity
Over
90% of women in whom fetal heart activity is detected at 8 weeks will not
miscarry (Brigham et al, 1999)
At
least 25% of all pregnancies threaten to miscarry.
A threatened
miscarriage is one in which:
-
the women bleeds a little from the vagina
-
cervical os is closed
-
there is little abdominal pain and
-
pregnancy is still viable.
All women attending EPAU receive a contact number
Women
will go back to GP for referral to ANC via the usual method
Follow
up appointment may be required in the following situations
1. significant
vaginal bleeding and patient refusing to be admitted
2. a
haematoma is noted
3.
liquor volume is reduced
4.
Fetal bradycardia
5. for
reassurance at patient’s request because of previous miscarriages
6. after
IUCD removal in the EPAU
The Embryonic heart rate:
Theoretically, cardiac activity should always be evident when the embryo is over 2mm. However, in around 5-10% of embryos between 2 and 4 mm, it can not be demonstrated. Perform a follow up scan within one week.
At 6 weeks 60-150 bpm (mean 125 bpm)
6-9 weeks 175 bpm
Thereafter heart rate gradually decreases.
14 weeks 160 bpm (approximately)
Bradycardia has been found in pregnancies that subsequently aborted. However, a single observation of slow heart rate does not necessarily predict subsequent death and in later pregnancy can be associated with maternal autoimmine disease (RO positive) and congenital heart block. Follow-up is therefore essential.
Reference: Brigham S,
Conlon C, Farquharson RG. A longitudinal of pregnancy outcome following
idiopathic recurring miscarriage. Human Reproduction, 1999, 14, 2868-71.
Guidelines for
Management of Non-viable Pregnancy
1. Incomplete Miscarriage
|
Endometrial
thickness <15mm in longitudinal
section |
diagnosed
as “Complete miscarriage” ref ą. Advise to report if bleeding persists
longer than 2/52 |
|
Intrauterine
tissue diameter 15 - 50mm |
Conservative method should be offered as an
option provided the bleeding is not heavy. Rescan 1- 2 weeks later. Alternatively,
medical management may be
offered if patient is not willing to wait. Or,
surgical evacuation is
arranged if a patient has a strong preference for it. |
|
Intrauterine
tissue diameter >50mm |
Surgical evacuation |
|
If
infected tissue is present in the uterine cavity |
Surgical
evacuation under antibiotic cover. |
2. Missed Miscarriage (early embryonic / fetal demise)
˛
Always offer choices of conservative, medical and surgical methods of
management
˛ If
patient chooses Conservative
management, rescan 1-2 weeks later, if necessary follow up with further rescans
at 1-2 week intervals.
˛ Give patient a contact number
˛ Alternatively, medical
management should be offered if patient is not willing to wait.
˛ Surgical
method should be reserved for those who:
1. make a specific request for it
2. change their mind during the course of conservative
management
3.
have heavy bleeding
4.
have infected tissue
Studies
suggest that, 10% women who miscarry fall into categories with unstable vital
signs or infected tissue2 . Since the introduction of TVS, ‘missed
miscarriage’ and ‘anembryonic pregnancy’(absent fetal echo) are felt to reflect
different aspects or stages of the same clinical process.
References:
1. Rulin MC et al. The reliability of ultrasonography in the management of spontaneous abortion, clinically thought to be complete: a prospective study. Am J Obstet Gynaecol 1993; 168 (1): 12-5
2. Ballagh SA et al. Is curettage needed for uncomplicated incomplete spontaneous abortion? Am J Obstet Gynecol 1998; 179 (5) 1279-82.
3. MIST Trial, 2004
Guidelines for Conservative
Management of Non-viable Pregnancy
Conservative
management may be continued as long as the patient is willing, provided there are
no signs of infection such as:
- vaginal discharge
- excessive bleeding
- pyrexia
- abdominal pain
Success
rates are higher with prolonged follow-up. However if patient requests a
surgical or medical method at any stage it should be arranged.
Give
patient a contact number to ring if there are any problems.
If
necessary, arrange further rescans 1-2 weeks later until a diagnosis of
complete miscarriage is made. The
duration may be as long as 6-8 weeks sometimes.
Most
women prefer a conservative approach. Women need to be given a thorough
explanation and all their questions and doubts should be satisfactorily
answered before they leave the clinic. Reassurance that the infection rate is
low at approximately 3% (MIST Trial, 2004). Go through the information leaflet and explain what to expect and how to deal with
it.
Conservative
management requires:
- Motivation and
preparation
- Thorough explanation
- Satisfactory answers to
their questions
- Reassurance with
regards to infection that it is less in comparison with surgical ERPC
- Follow up appointment
two weeks later
- ‘Patient information leaflet’
Guidelines for Medical Management of
Non-viable Pregnancy
The drugs used for medical management of induced abortion include an antiprogresterone, mifepristone (200mg) with a prostaglandin such as gemeprost or Misoprostol.
The
conventional prostaglandin E1 analogue used for abortion procedures
is gemeprost, and is effective in 95% of cases in combination with mifepristone
at <63 days of amenorrheoa. The
alternative E1 analgue, misoprostol may be given orally or vaginally
and is most effective if administered vaginally (95% versus 87%
respectively)(ElRefaey et al, 1995). The
main advantages over gemeprost are that it does not require refrigeration, it
is cheaper and can be administered orally or vaginally.
The
medical approach has implications for patients safety as it avoids the need for
an anaesthetic and surgical instrumentation.
The
morbidity in those treated medically was lower than in those requiring surgery
(1.7% verses 6.6%)(Hinshaw, 1997).
Contraindications
to medical management
Absolute: adrenal
insufficiency
long
term glucocorticoid therapy
haemoglobinopathies
or anticoagulant therapy
anaemia
(haemoglobin < 10 g/dl)
porphyria
mitral
stenosis
glaucoma
non
steroidal anti-inflammatory drug ingestion in previous 48 hours
Relative: hypertension
severe
asthma
Varying
rates of efficacy have been quoted with medical management in non-viable
pregnancies. The efficacy is greatest
for those pregnancies of less than 10 weeks or with a sac diameter of less than
24mm (92 – 94%) (DeJonge et al, 1995).
References:
- El-Refaey et al. Induction of abortion with mifeprestone (RU 486) and oral or vaginal misoprostol. N Engl J Med 1995; 332: 983-7.
- Hinshaw HKS. Medical management of miscarriage. In Grudzinkas TG, O’Brien PMS, editors. Problems in early pregnancy: advances in diagnosis and management. London: RCOG press, 1997; 284-95.
- De Jonge EJM et al. Randomised clinical trial of medical evacuation and surgical curettage for incomplete miscarriage. BMJ 1995; 311: 662.
Prostaglandin regimens – Incomplete miscarriage
Different
prostaglandin regimens for use in incomplete miscarriage include the following:
·
Gemeprost 1mg vaginally
·
Gemeprost 0.5mg vaginally
·
Misoprostol 800ug (4 x 200 ug tabs) vaginally
Prostaglandin regimens - Missed miscarriage
·
Mifepristone 200mg orally followed 36 – 48 hours later by cevagem 1mg
vaginally
·
Mifepristone 200mg orally followed 36 – 48 hours later by misoprostol
800ug (4 x 200ug tabs) vaginally
·
Since progesterone levels are low
in non-viable pregnancy mifepristone may be avoided and prostaglandin
only administered
Procedure
˛ Arrange with gynae ward
˛ Check FBC and blood group
˛ Take consent for mifepristone and PG +/- surgical evacuation
˛
Prescribe and give mifepristone
200mg orally. Advice the patient to inform the hospital if she vomits
shortly after administration of the mifepristone.
˛
In the case of a pregnancy occurring with an IUCD in-situ, the device
should be removed before administration of mifepristone.
˛
Arrange admission 48 hours
later.
˛
Inform the patient regarding the length of stay on the ward. Observe
for three- six hours after administration of prostaglandin and discharge if
clinically well.
˛
Women with gestation:
< 9 weeks on scan get only one insertion of
prostaglandin
> 9 weeks on scan get 3 hourly PG X 5
˛
Prescribe PG (Misoprostol 800ug tabs/Cervagem 1mg) vaginally and
Metronidazole 1G PR in the Drug chart.
˛
Prescribe Doxycycline 100mg bd for 10 days with co-dydramol 2 tabs qds
for one week to take home after the procedure (antichlamydial prophylaxis).
˛
Inform that in case of heavy bleeding ERPC may be required and
therefore to be prepared to stay
overnight if necessary
˛
Women may or may not pass POC while on the ward. They should be advised
of what to expect when they go home and not referred to EPAU for a scan before
their follow up appointment.
˛
Any products that are obtained should be sent for histological
examination
˛ Give patient information on - admission to gynae ward
- medical management of non-viable
pregnancy
˛
Arrange follow-up in EPAU 3 weeks later
˛ Give contact telephone numbers for EPAU/Gynae ward
Guidelines for
Surgical Evacuation of Non-viable Pregnancy
Surgical
evacuation should be preferably managed on a day case basis unless there is
heavy bleeding. Alternatively,
if the patient needs to be admitted to Gynae ward arrange with the ward.
Have a unit protocol for admission system with a clear patient pathway description.
Give the patient information on admission procedure including appropriate patient information leaflet(s).
Explain
the surgical procedure and obtain written consent with Doctor familiar with
procedure. Mention rare anaesthetic and
uncommon surgical risks involved such as uterine perforation (1%), cervical
tears, intra-abdominal trauma (0.1%), intrauterine adhesions, haemorrhage and
infection.
Arrange
for a FBC and blood grouping. Anti-D
immunoglobulin should be given to all non- sensitised Rh negative women undergoing
surgical evacuation.
All
at risk women (usually women under the age of 25 years) undergoing surgical
evacuation for miscarriage should be screened for Chlamydia trachomatis.ą
Alternatively
prescribe prophylactic doxycycline 100 mg bd for 10 days and Metronidazole 1G
PR to women undergoing surgical evacuation.
Ensure
that products of conception are seen at evacuation.
The
RCOG study group˛ recommended that all tissue obtained at a surgical
evacuation for miscarriage should be sent for histology examination. The reasons are:
1. to
diagnose molar pregnancy
2. to
exclude ectopic if chorionic tissue is found on histology
A
follow-up appointment is usually not required after a surgical evacuation.
Give
patient information on “What you may need
to know after a miscarriage”.
References:
1. Royal college of Obstetricians and Gynaecologists. The Management of Early Pregnancy Loss. Green Top Guideline No. 25. London: RCOG Press; 2000 and 2003
2. Recommendations from the 33rd RCOG Study Group. In Grudzinkas TG, O’Brien PMS, editors. Problems in early pregnancy: advances in diagnosis and management. London: RCOG press, 1997. 327-31
Guidelines for beta-hCG Measurements
Urine Measurements
The urine test is simple and reliable enough to be used routinely to establish whether or not a woman is pregnant. A rapid and simple test is available in the unit.
Serum
measurements
Measurement
of hCG in serum permits more accurate quantification which may be useful in the
following:
1. Screening in women at high risk
of ectopic pregnancy
2. Determining the appropriate
treatment for women with suspected ectopic pregnancy
3. Monitoring during expectant
management or medical management of women with ectopic pregnancy
4. Evaluation of conservative
surgical treatment of ectopic pregnancy (ref:
1)
Serum
hCG levels double approximately every two
days in early (<8 weeks) normal intrauterine pregnancy; a lesser
increase (<66% over 48 hours) is associated with ectopic pregnancy and
miscarriage.2
To
find out whether or not a pregnancy is normal or pathological, the two useful
clinical concepts of hCG measurement are the hCG doubling time and the
discriminatory
hCG level.
HCG doubling time
It refers to the time
taken for the hCG level to double its original value. A beta-hCG value of
<5 IU/L is considered
to be the non pregnant value.
The
doubling time is particularly useful in early pregnancy i.e. before 5.5 weeks
or when the plasma hCG level is <5000IU/L.
As pregnancy progresses the doubling time also lengthens.
However
15% of normal pregnancies will have abnormal doubling time and 13% of ectopic
pregnancies will have a normal doubling time 3.
Caution
1. In multiple pregnancy the
hCG level would be a little higher, requiring an extra two or three days for a
sac to become visible.
2. The possibility of a
heterotopic pregnancy should be kept in mind (1 in 3000 cases of spontaneous
conceptions and between 1% to 3% of assisted conceptions).
Discriminatory
hCG level
It refers to a defined
level of hCG above which the gestational sac of an intrauterine pregnancy
should be visible on ultrasound. In
women with an hCG result above the discriminatory level, but absence of an
intrauterine gestational sac on ultrasound, ectopic pregnancy is a distinct
possibility.
With
the use of high resolution transvaginal ultrasound the discriminatory level has
been reported to be around 1000IU/L IRP 4. However the American Fertility Society
suggested that in practice the level ought to be around 2400IU/L.
The
discriminatory level may vary in different units and depends on three factors:
i)
hCG assay
ii)
quality of ultrasound
iii)
the experience of the person performing the ultrasound
It
usually lies between 1000 – 2400IU/L.
A
diagnosis of ectopic pregnancy is more likely whenever intrauterine pregnancy
is not detected by ultrasound at serum hCG concentration above 2400IU/L.
References
1. Recommendations for clinical practice arising from 33rd RCOG Study Group. Problems of Early Pregnancy – Advances in Diagnosis and Management, 1997.
2. Kader et al. (1981) Discriminating hCG zone: Its use in the Sonographic evaluation for ectopic pregnancy, Obstet Gynecol 58, 156-61
3. Ling and Stovall (1994) Update on the diagnosis and management of ectopic pregnancy, Advances in Obstetrics and Gynaecology, 1, pp 55-83. Chicago:Mosby Year Book, Inc
4. Caeciatore et al. (1990) Diagnosis of Ectopic Pregnancy by Vaginal Ultrasonography in Combination with a discriminatory serum hCG levl of 1000IU/L (IRP). BJOG 97, 904-8.
Management
of Pregnancy of Unknown Location (PUL)
Definition
No evidence of intrauterine or extrauterine pregnancy in women with a positive pregnancy test.
Initial assessment
·
Clincal history:
the presence of risk factors
for ectopic pregnancy
(See under ectopic
pregnancy)
·
Clinical signs
·
TVS
·
Serum beta hCG
Give
appropriate information to patient.
Explain the need for further follow up
Follow up
§
Close surveillance with Serum hCG measurements every 2-3 days
§
See guidelines for beta hCG
§
Repeat TVS when beta hCG 1,000 IU/L or one week later
§
Provide support
§
Follow up until:
Intrauterine pregnancy identified
or
Miscarriage confirmed
or
Active intervention required
or
beta hCG falls to < 5 IU/L
§
Likely diagnosis
With bleeding: Miscarriage
Ectopic
pregnancy
Pregnancy
of unknown location (PUL) – Perhaps
resolving
No
bleeding: Normal
intrauterine pregnancy
Management of
PUL Scan result following TVS
hCG IU/L
|
Ultrasound
|
Pattern of change of hCG
level after 48 hours |
Management |
|
<1000 |
No
intrauterine sac No
Adnexal mass No
fluid in POD No
symptoms |
hCG
rise > 66% or doubled |
If
hCG > 1000 repeat ultrasound Or
If
hCG < 1000 repeat hCG 48 hours later |
|
>
1000 |
No
intrauterine sac |
|
|
|
|
1.
No adnexal mass No fluid POD No symptoms |
|
Repeat hCG and repeat ultrasound 2 days later |
|
|
|
A. Falling hCG |
Serial
hCG levels until hCG <5 |
|
|
|
B. Rising hCG x 3 |
Laparoscopy
Or Methotrexate |
|
|
2. Suspicious ad. Mass <3cm No fluid POD Asymptomatic |
|
Repeat hCG and repeat ultrasound 2 days later |
|
|
|
A.
Falling hCG |
Serial
hCG levels until hCG <5 |
|
|
|
B. Rising/plateuing hCG x 2 or 3 |
Laparoscopy
Or Methotrexate |
|
|
3. Ad. Mass >3cm Or
Fluid POD
Or
Symptomatic
|
|
Laparoscopy |
|
>
2400 |
No intrauterine sac
Adnexal
findings + or
- Asymptomatic |
Fluctuating
x3 Diagnosis:
Ectopic |
Laparoscopy Radical
Surgery |
Falling
hCG: Diagnosis Early miscarriage Or
Pregnancy of unknown
location – resolving
Guidelines on the Management of Ectopic Pregnancy (Liverpool Women’s Hospital in conjunction with Dr Joanne Topping).
Recommended best Practice.
Evidence:
Ectopic
pregnancy affects 1:80 pregnancies. Evidence suggests that the incidence of
ectopic pregnancies has been rising. While this increase is for the most part
real, early diagnosis also plays a role by identifying ectopic pregnancies that
would have resolved. In the U.K the incidence has doubled from 4.9 to 11.1 per
1000 pregnancies from 1973 - 1999, while mortality has decreased from 16.4 per
10,000 cases. During the last triennium (1997 -1999) ectopic pregnancies
accounted for 12.2% of all direct maternal deaths and remained the leading
cause of death in the first trimester.
The availability of sensitive and specific
radio-immunoassays of β-human chorionic gonadotrophin (β-hCG) and
high resolution transvaginal ultrasound (TVS) allow early detection of ectopic
pregnancies. Studies on β-hCG dynamics provide evidence that 85% of viable
intra-uterine will show a 66% rise in β-hCG levels in every 48 hr period
in the first 40 days of gestation. Conversely only 13% of ectopic pregnancies
will show a 66% rise. A rise of < 50% is almost always associated with a
non-viable pregnancy. An intra-uterine
pregnancy sac should be seen on abdominal scan with a β-hCG level of 6500
IU/ml or on TVS at 1000 -2000 IU/ml. Based on audit data LWH uses 1500 IU/ml as
the level we expect to see an intra-uterine gestation sac on TV scan.
The
classical surgical approach for an ectopic pregnancy is by open laparotomy.
Four randomly controlled trials (RCT) have reported the results of comparisons
between this traditional approach and laparoscopic tubal surgery. The
laparoscopic approach was associated with significantly less blood loss, lower
analgesia requirements, shorter hospital stay and quicker postoperative
recovery time. The subsequent intrauterine pregnancy rate (IUP) was 70% after
laparoscopic surgery compared to 55% after laparotomy. The recurrent ectopic
rate was also lower 5% compared to 16.6%, but this incidence of persistent
trophoblastic tissue was increased.
A
laparoscopic approach is superior to a laparotomy in terms of recovery from
surgery,
Subsequent intra-uterine pregnancy
rate and recurrent ectopic rate but is associated with a higher risk of
persistent trophoblast. (This is a
Grade A recommendation)
The wider use of laparoscopic
surgery must be tempered by its use only in appropriate situations by
appropriately trained staff.
In cases of haemorrhagic shock or
where the surgeon has inadequate experience at operative laparoscopy,
traditional rapid laparotomy is preferred. (This is a grade A recommendation)
In a meta-analysis of 40 studies
the IUP rate after tubal conservation was 46% compared to 44%
After tubal excision. The repeat
ectopic rate was respectively 15% and 10%. Similarly in an important
meta-analysis of nine good quality comparative studies Yao and Tulandi reported
no significant difference in the IUP between salpingostomy and salpingectomy.
Failure to completely remove the ectopic occurred in 4.8% - 11% of
salpingostomy cases. In contrast almost no cases of persistence followed salpingectomy.
Salpingectomy is to be preferred to
salpingostomy when the contralateral tube is healthy as it is associated with
lower rates of persistent trophoblast and subsequent repeat ectopic whilst
having similar IUP rates. (This is a grade B recommendation).
Non-surgical management is now
available for certain cases of ectopic pregnancy.
Not all ectopic pregnancies
progress and pose a risk to the mother. Spontaneous resolution is well
documented. However the risk of rupture in a woman with an ectopic pregnancy
exists until the β-hCG level has fallen to < 10iu/l. Expectant
management requires frequent hospitalisation and/or follow-up and with poor
efficacy is NOT RECOMMENDED
practice at this hospital
In selected cases methotrexate is
an effective alternative to surgery.
Methotrexate is a folic
acid-antagonist (anti-metabolite) which prevents the growth of rapidly dividing
cells by interfering with DNA synthesis. It can be administered systematically
(IV, IM or orally).
Three trials have reported the use
of Methotrexate in a single dose of 50mg/m˛ body surface area IM and these
reported a resorption rate of 92% and subsequent IUP rate of 58% with a
recurrent ectopic rate of 9%.
The incidence of side- effects
after methotrexate is related to both the dose and mode of administration.
Side effects encountered include
stomatitis, alopecia, haematosalpinx and impairment of tubal mucosa.
Methotrexate pneumonitis and
neutropenia have also been described.
Failure of Methotrexate therapy is
more likely to occur with high hCG levels (32% if initial level > 10,000iu.)
with large tubal diameters and with fetal cardiac activity. These restrictions
limit the general use of Methotrexate.
Diagnosis.
It is important to have a high index of suspicion for ectopic pregnancy, because the
patient may not be symptomatic until rupture occurs, or on the other hand the
patient may experience vague and mild symptoms early in the course of the
disease. In addition the clinical presentation and natural course of an ectopic
pregnancy are unpredictable.
Risk Factors. Are present in
25 - 50% of patients with an ectopic pregnancy. They include history of
§
Previous pelvic inflammatory disease.
§
Previous tubal surgery.
§
Previous ectopic pregnancy.
§
Assisted reproduction.
§
Conceiving with IUCD or on the progesterone only pill.
Symptoms.
§
Amenorrhoea(not universal )
§
Vaginal bleeding.
§
Lower abdominal pain.
§
Faintness / dizziness.
§
Shoulder tip pain
§
GIT symptoms -
diarrhoea or pain on defecation
Signs
1.
Lower abdominal tenderness
2.
Adnexal tenderness
3.
Adnexal mass with cervical excitation tenderness
4.
Shock/Collapse
The classic
symptoms and signs such as severe abdominal pain and hypotension are associated
with advanced or ruptured ectopic pregnancy.
Laparotomy with appropriate
resuscitation is the treatment of choice for haemodynamically-compromised
patients with ruptured ectopic pregnancy
Investigations
1. Pregnancy tests.
All
patients with a history of suspected ectopic should have a pregnancy test. If
the check mate is negative an ICON should be performed as local evidence
suggests this test is more sensitive. A NEGATIVE pregnancy test essentially
excludes a pregnancy in more than 99% of cases (although a chronic ectopic
pregnancy may be present). Therefore, if
clinical suspicion of ectopic pregnancy persists in the presence of a negative
pregnancy test and the ultrasound examination is not helpful, then serum
β-hCG should be measured serially to establish diagnosis. (See inconclusive ultrasound findings)
2. Ultrasound examination :-
Should be
arranged as soon as possible. If the patient is in significant discomfort she
should be admitted to await scan the following day. If she is clinically stable
with no discomfort she may be allowed home to await scan. Direct contact number
for the emergency room should be given and the patient asked to attend at any
time if her condition deteriorates.
: - Ultrasound
features suggestive of an ectopic
pregnancy are.
§
An empty uterus – with or without thickened
endometrium.
§
An intrauterine pseudosac.
§
A tubal ring ( doughnut sign)
§
An ectopic sac with or without heart beat.
§
Fluid in the pouch of Douglas.
(Don’t
forget ectopics at other sites such as cervix or ovary.)
Utility of
serum β-hCG in patients with non-specific ultrasound findings.
If the
ultrasound findings are non-specific. Follow diagnostic algorithm for ectopic
pregnancy.
However Arrange laparoscopy if clinical features
worsen at any stage.
Laparoscopy
remains the gold standard for the diagnosis of ectopic pregnancy, although this
approach has a false negative rate of 3-4% and a false positive rate of 5%.
Management
Management of ruptured ectopic with collapse.
§
ABC of resuscitation ( see resuscitation guidelines.)
§
Get help; call SPR 1 –3, SPR 4 –5 on call and
anaesthetist.
§
Site two IV lines ( at least 16g), commence Iv fluids
(crystalloid) give facial oxygen and insert indwelling catheter.
§
Send blood for FBC Clotting screen and cross-match at
least 4 units of blood.
§
Arrange admission and laparotomy.
§
Continue fluid resuscitation and ensure intensive
monitoring of haemodynamic state whilst awaiting transfer to theatre.
§
Do not wait for BP and pulse to normalise prior to
transfer.
§
Pfannensteil incision , locate tube directly and
clamp.
§
Salpingectomy and wash out abdomen.
§
Assess bloods consider CVP / HDU discuss with
anaesthetist.
§
Record operative findings pay close attention to the
state of the remaining tube.
§
Anti –D to be given to Rhesus negative women.
Surgical management of non-acute ectopic.
- Take blood for group and save FBC.
- Inform SPR 1-3 of admission and following
consultation arrange laparoscopy.
- If possible a doctor with appropriate skills for
laparoscopic salpingectomy should perform the surgery.
- Assess the condition of the other tube.
- Perform salpingectomy or salpingostomy.
§
Record operative findings pay close attention to the
state of remaining tube.
§
Anti -D for Rhesus negative women
§
If salpingostomy performed follow up with weekly
β-hCG until measurements return to normal
Persistent trophoblast
While trophoblast remains in the
tube it has the capacity to rupture. We recommend weekly β-hCG. If not
falling a single dose of Methotrexate 50mg/m2 can be given or repeat surgery.
Guidelines for the Medical treatment of Ectopic Pregnancy.
Patient selection.
Inclusion criteria.
§
The patient should be haemodynamically stable.
§
Serum β-hCG
< 6500 IU/ml
§
No Fetal Heart activity demonstrated.
§
Ectopic < 3.5cm.
§
Patient fully understands and will be compliant with
regular follow-up until Bhcg returns to normal.
§
Patient is aware of potential side-effects.
§
Case reviewed by SpR 4/5 or consultant
§
Agrees to avoid pregnancy for 4 months post treatment.
Exclusion Criteria.
§
Pre-existing severe medical condition or disorder.
§
Any abnormality on LFT U&E or FBC.
§
Any known renal or hepatic abnormality.
§
Any known contra-indication to methotrexate.
§
Patient is taking NSAID, Diuretics tetracycline group
drugs and is unwilling or unable to stop medication.
§
Patient not willing to return for follow-up.
§
Patient unwilling to wait 4 months before trying to
conceive again.
§
Presence of co-existing intra-uterine pregnancy.
Treatment Schedule.
§
Pre-treatment bloods for β-hCG U&E LFT and
FBC.
§
Patient’s weight and height.
§
Prescribe Methotrexate 50mg/m as once only dose.
§
Order methotrexate from pharmacy (get back from RLH
same day if ordered before 12.
§
Methotrexate to be IM into the gluteal region by a
doctor.
Patient follow-up and monitoring.
§
Day 4 before
11 00hrs Routine observations.
Β-hCG
§
Day 7 before 11 00hrs Routine observations. FBC β-hCG LFT,s
§
Day 14 before 11 00hrs Routine observations. FBC β-hCG
§
Day 21,28,35
until β-hCG is <10 i.u/l
If between day 4 and Day 7 the
β-hCG does not fall by 15% the dose of Methorexate should be repeated.
(50mg/m).The injection should be given into the opposite Gluteal after
confirming normal LFT on Day 7.
Day 4 and Day 7 tests should be
repeated on Day 11 and 14 if a second dose of Methotrexate is given.
The β-hCG can take several
weeks to fall to normal.
If β-hCG continues to rise of
levels become static despite two doses of methorexate. Laparoscopy should be
undertaken.
The patient should be advised.
§
She may experience some pain in the abdomen as the
pregnancy resolves.
§
She may take simple analgesia for this pain
Paracetamol / cocodamol. If this not sufficient to contact hospital.
§
To stay in the area till follow-up complete.
§
To avoid intercourse till follow-up complete.
§
To avoid alcohol for 7 days.
§
Patient should be given 24 hour contact number for the
emergency room.
Patients
who have had medical or surgical management of an ectopic pregnancy should be
offered a follow-up appointment. In future pregnancies a scan can be performed
in the Early Pregnancy Assessment Unit at 6 weeks to confirm the site of the
pregnancy.
Heterotrophic pregnancy.
This is a very rare occurrence,
however with the increased use of assisted reproduction the incidence has
increased.
- There is no role for medical management.
- Β-hCG is not useful.
- Laparoscopic salpingectomy is the treatment of
choice.
Guidelines
revised and updated by Dr Joanne Topping and Mr John Kirwan July 2003
References.
- Department of Health. Report on Confidential Enquiries into maternal Deaths in the United kingdom 1997 -1999 HMSO, London 2001
- Stovall TG, Ling FW. Ectopic pregnancy: Diagnostic
and therapeutics algorithms minimising
surgical intervention.
J Reprod Med 1993; 38: 807-812.
- Yao M, Tulandi T.
Current status of surgical and non-surgical management of ectopic
pregnancy. Fertil Steril 1997; 67: 421-433
- Royal College of Obstetricians and Gynaecologists. Guideline on the management of tubal pregnancies. RCOG London. Links to www.rcog.org.uk
- Glock JL, et al Efficacy and safety of single-dose methotrexate in the treatment of ectopic pregnancy. Fertil Steril 1994; 62: 716 – 721.
