In addition to these evidence-based recommendations, the guideline development group also identifies points of best clinical practice in the original guideline document.
Levels of evidence (Ia-IV) and grading of recommendations (A-C) are defined at the end of the "Major Recommendations" field.
Appropriate Terminology
C - The recommended medical term for pregnancy loss under 24 weeks is "miscarriage." The word "miscarriage" should be used in clinical practice and its use should be strongly encouraged in textbooks and scientific journals.
When talking to women, the inadvertent use of inappropriate terms such as "pregnancy failure" or "incompetent cervix" can contribute to negative self-perceptions and worsen any sense of failure, shame, guilt, and insecurity. (Evidence level IV).
The terms in the table below are recommended.
| Previous Term |
Recommended Term |
| Spontaneous abortion |
Miscarriage |
| Threatened abortion |
Threatened miscarriage |
| Inevitable abortion |
Inevitable miscarriage |
| Incomplete abortion |
Incomplete miscarriage |
| Complete abortion |
Complete miscarriage |
| Missed abortion/anembryonic pregnancy/blighted ovum (these reflect different stages in the same process) |
Missed miscarriage
Early fetal demise
Delayed miscarriage
Silent miscarriage
|
| Septic abortion |
Miscarriage with infection (sepsis) |
| Recurrent abortion |
Recurrent miscarriage |
The European Society for Human Reproduction Special Interest Group for Early Pregnancy has published revised nomenclature for use in early pregnancy loss in order to improve clarity and consistency. The following are some of the pertinent recommendations (Evidence level IV):
| Term |
Definition |
| Biochemical pregnancy loss |
Pregnancy not located on scan |
| Empty sac |
Sac with absent or minimal structures |
| Fetal loss |
Previous CRL measurement with subsequent loss of fetal heart activity (FHA) |
| Early pregnancy loss |
Confirmed empty sac or sac with fetus but no FHA <12 weeks |
| Delayed miscarriage |
As "early pregnancy loss" |
| Late pregnancy loss |
Loss of FHA >12 weeks |
| Pregnancy of unknown location |
No identifiable pregnancy on scan with positive hCG |
CRL = crown-rump length
hCG = human chorionic gonadotrophin
Service Provision
What Is the Ideal Setting for Assessment of Women with a Potential Diagnosis of Early Pregnancy Loss?
C - All units should provide a dedicated outpatient early pregnancy assessment service. There are clinical and economic benefits associated with this type of service.
What Are the Requirements for Running an Effective Early Pregnancy Assessment Unit Service?
C - The early pregnancy assessment units (EPAU) service should be comprehensive and ideally sited in a dedicated area with appropriate staffing. There should be direct access for general practitioners (GPs) and selected patient groups.
To be effective, an EPAU requires an efficient appointments system, an appropriate setting, ultrasound equipment (including transvaginal probes), and easy access to laboratory facilities for rhesus antibody testing and selective serum human chorionic gonadotrophin (hCG) and progesterone estimation. The service should be available on a daily basis during the normal working week, although many units offer an additional limited service at weekends. Standardised information leaflets, referral and discharge letters should be available and regularly reviewed. Certain patient groups, such as women who have had a previous ectopic pregnancy and those with repeated or recurrent miscarriage, can be offered future access to the service by direct self-referral via the appointments system. (Evidence level IV)
Diagnosis and Investigation
What Is the Role of Transvaginal Ultrasound in the EPAU Setting?
C - EPAUs should have access to transvaginal ultrasound (TVS) with staff appropriately trained in its use.
How Should Cases of Suspected Early Pregnancy Loss Be Managed in the EPAU?
C - EPAUs should use and develop diagnostic and therapeutic algorithms of care. In particular, these should be available for the management of suspected ectopic pregnancy, intrauterine pregnancy of uncertain viability, and for pregnancy of unknown location.
"Indeterminate" is a term used in clinical practice that has led to confusion. Some practitioners have used the term to mean "pregnancy of indeterminate site" while others mean "pregnancy of indeterminate viability." This present revision recommends that "indeterminate" should no longer be used but should be replaced with the two separate terms below. Both terms should only be used after assessment by TVS. (Evidence level IV)
- Pregnancy of unknown location: No signs of either intra- or extrauterine pregnancy or retained products of conception in a woman with a positive pregnancy test.
- Pregnancy of "uncertain viability": Intrauterine sac (<20 mm mean diameter) with) no obvious yolk sac or fetus
or
Fetal echo <6 mm crown–rump length with no obvious fetal heart activity. In order to confirm or refute viability, a repeat scan at a minimal interval of 1 week is necessary.
A basic diagnostic algorithm has been appended in the original guideline document guideline (see Appendix 1 in the original guideline document) that includes the terminology described above, with the aim of encouraging a consistent approach across EPAUs. TVS is only one part of the diagnostic process in the assessment of potential early pregnancy loss. Women should be managed within a unit-specific guideline that includes use of serum hCG assay. (Evidence level IV)
What Is the Role of Serial hCG Assessment in Predicting Pregnancy Outcome?
B - Serial serum hCG assay is particularly useful in the diagnosis of asymptomatic ectopic pregnancy.
Early ectopic pregnancy can be difficult to diagnose and the RCOG Study Group concluded that access to serial serum hCG estimation is essential, with results available within 24 hours. Staff must be familiar with what is an acceptable normal rise in 48 hours. Although a doubling of hCG titre is often expected, this can vary depending on gestation.
Serum hCG levels need caution in interpretation. In cases of twin pregnancy or heterotopic pregnancy, a suboptimal rise may be misleading.
Women with miscarriage or ectopic pregnancy who are managed expectantly may also require serial serum hCG monitoring.
Does Serum Progesterone Assay Have a Role in Predicting Pregnancy Outcome?
B - Serum progesterone can be a useful adjunct when ultrasound suggests pregnancy of unknown location. TVS, serial serum hCG levels, and progesterone may all be required in order to establish a definite diagnosis.
Should All Women with Early Pregnancy Loss Receive Anti-D Immunoglobulin?
B - Non-sensitised rhesus (Rh) negative women should receive anti-D immunoglobulin in the following situations: ectopic pregnancy, all miscarriages over 12 weeks of gestation (including threatened), and all miscarriages where the uterus is evacuated (whether medically or surgically).
C - Anti-D immunoglobulin should only be given for threatened miscarriage under 12 weeks gestation when bleeding is heavy or associated with pain. It is not required for cases of complete miscarriage under 12 weeks of gestation when there has been no formal intervention to evacuate the uterus.
Treatment
Which Women Should Be Screened for Genital Tract Infection?
C - Screening for infection, including Chlamydia trachomatis, should be considered in women undergoing surgical uterine evacuation.
Should Prophylactic Antibiotics Be Given Prior to Surgical Evacuation?
A - There is insufficient evidence to recommend routine antibiotic prophylaxis prior to surgical uterine evacuation.
When Should Surgical Uterine Evacuation Be Used?
C - Surgical uterine evacuation should be offered to women who prefer that option. Clinical indications for offering surgical evacuation include persistent excessive bleeding, haemodynamic instability, evidence of infected retained tissue, and suspected gestational trophoblastic disease.
How Should Surgical Uterine Evacuation Be Performed?
A - Surgical uterine evacuation for miscarriage should be performed using suction curettage.
C - Consideration should be given to offering surgical evacuation techniques under local anaesthesia or sedation for those women who prefer that approach.
What Are the Alternatives to Surgical Uterine Evacuation for Miscarriage?
A - Medical methods are an effective alternative in the management of confirmed first-trimester miscarriage.
The published literature on a wide range of therapeutic regimens is summarised in Appendix 2 in the original guideline document.
A - Expectant management is another effective method to use in selected cases of confirmed first-trimester miscarriage.
Expectant management is an effective and acceptable method to offer women who miscarry. Patient counselling is particularly important for those women with an intact sac who wish to adopt an expectant approach. They should be aware that complete resolution may take several weeks and that overall efficacy rates are lower. They may wish to consider a medical approach or to commence expectant management with the option of surgical evacuation at a later date if required. Expectant management for incomplete miscarriage is highly effective. (Evidence level Ib)
Expectant management is often followed by minimal bleeding, as any retained tissue will usually undergo resorption. Occasionally, the passage of tissue may be associated with heavy bleeding. In cases of missed miscarriage, managed using antiprogesterone/prostaglandin combinations, one-third of women will bleed or miscarry in the priming phase after antiprogesterone. It is important that all women undergoing medical or conservative management have direct telephone access to ward staff for advice and support. Emergency beds must be available should they require admission. (Evidence level IV)
What Are the Advantages of Arranging Histological Examination of Tissue Passed at the Time of Miscarriage?
C - Tissue obtained at the time of miscarriage should be examined histologically to confirm pregnancy and to exclude ectopic pregnancy or unsuspected gestational trophoblastic disease.
Women who miscarry at home and are admitted to hospital should be advised to take with them any tissue passed so that histological examination can be arranged. Alternatively, the attending practitioner should arrange for the appropriate examination.
Psychological Aspects of Early Pregnancy Loss
Is There Potential Benefit from Support and Follow-up after Pregnancy Loss?
A - All professionals should be aware of the psychological sequelae associated with pregnancy loss and should provide support, follow-up, and access to formal counselling when necessary. Appropriate support can result in significant positive psychological gain.
Should Care Providers Encourage Patient Choice in Deciding Which Intervention to Use to Achieve Uterine Evacuation?
A - In terms of therapeutic intervention, patient choice should be encouraged, as it is associated with positive quality-of-life outcomes.
Definitions:
Grading of Recommendations
Grade A - Requires at least one randomised controlled trial as part of a body of literature of overall good quality and consistency addressing the specific recommendation. (Evidence levels Ia, Ib)
Grade B - Requires the availability of well controlled clinical studies but no randomised clinical trials on the topic of recommendations. (Evidence levels IIa, IIb, III)
Grade C - Requires evidence obtained from expert committee reports or opinions and/or clinical experiences of respected authorities. Indicates an absence of directly applicable clinical studies of good quality. (Evidence level IV)
Levels of Evidence
Ia: Evidence obtained from meta-analyses of randomised controlled trials
Ib: Evidence obtained from at least one randomised controlled trial
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, such as comparative studies, correlation studies, and case studies
IV: Evidence obtained from expert committee reports or opinions and/or clinical experience of respected authorities
