Definition, Purpose and Scope
The term early pregnancy loss describes the loss of pregnancy within the first 12 completed gestational weeks. It primarily refers to the management of spontaneous miscarriage, but it is also relevant to women affected by ectopic pregnancy and gestational trophoblastic disease.
Spontaneous miscarriage is the most common complication of pregnancy. It occurs in up to 20% of clinically recognized pregnancies. In Ireland, approximately 14,000 miscarriages occur each year [Poulose et al., 2006].
Historically, the majority of women who experienced miscarriage underwent routine surgical uterine evacuation, known as evacuation of retained products of conception (ERPC). Over the last decade, standard management has changed significantly due to the development of more refined diagnostic techniques and therapeutic interventions. These advances have enabled a greater proportion of treatment to be delivered in an outpatient setting.
Service Provision in Early Pregnancy Assessment Units (EPAU)
All maternity units should provide a dedicated Early Pregnancy Assessment Unit (EPAU) for the evaluation of women presenting with early pregnancy complications.
All women attending an EPAU should receive a diagnosis and be classified into one of the following diagnostic categories:
Diagnostic Groups
- Viable pregnancy
- Pregnancy of uncertain viability
- Early pregnancy loss
- Incomplete miscarriage
- Complete miscarriage
- Pregnancy of unknown location (PUL)
- Ectopic pregnancy
- Hydatidiform mole
Ultrasound Criteria for Early Pregnancy Loss
According to the Royal Institute of Obstetricians, the College of Physicians of Ireland, and the Directorate of Strategy and Clinical Programmes of the Health Service Executive, early pregnancy loss is diagnosed when one or more of the following criteria are met:
Transvaginal Ultrasound (TVS) Criteria
- Mean gestational sac diameter (MGSD) > 20 mm with no fetal pole
- Fetal pole > 7 mm with no fetal cardiac activity
Transabdominal Ultrasound (TAS) Criteria
- MGSD > 25 mm with no fetal pole
- Fetal pole > 8 mm with no fetal cardiac activity
Criteria Based on Repeat Ultrasound Examination
- MGSD ≤ 20 mm with no fetal pole, or fetal pole ≤ 7 mm with no cardiac activity on TVS, with minimal or no growth after at least 7 days
- MGSD ≤ 25 mm with no fetal pole, or fetal pole ≤ 8 mm with no cardiac activity on TAS, with minimal or no growth after at least 7 days
It is important to recognize that interobserver and intraobserver variability in MGSD and fetal pole measurements can reach ±18% [Pexsters et al., 2011]. Therefore, repeated ultrasound examinations are strongly recommended, particularly when measurements are close to diagnostic thresholds.
Other Diagnostic Categories pregnancy loss
Viable Intrauterine Pregnancy
A viable pregnancy is defined by the presence of a normally located gestational sac with a fetal pole and clearly identifiable cardiac activity. Detection of fetal heart activity is associated with a successful pregnancy rate of 85–97%, depending on gestational age [Johns et al., 2003].
Follow-up may be required in cases of:
- Significant vaginal bleeding
- Subchorionic haematoma
- Fetal bradycardia
- Patient reassurance following previous miscarriages
- Recent removal of an intrauterine contraceptive device
Pregnancy of Uncertain Viability
This diagnosis is made when:
- A normally located gestational sac with MGSD ≤ 20 mm and no fetal pole is observed, or
- A fetal pole ≤ 7 mm is present without cardiac activity on TVS [Clinical Practice Guideline, 2011].
A repeat scan should be performed at least 7 days later to assess embryonic development and cardiac activity.
Incomplete Miscarriage
An incomplete miscarriage is diagnosed when the intrauterine tissue diameter is ≥ 15 mm on ultrasound.
Complete Miscarriage
A complete miscarriage is diagnosed when endometrial thickness is < 15 mm and there is previous evidence of an intrauterine gestational sac or retained products of conception.
Pregnancy of Unknown Location (PUL)
PUL is diagnosed when no evidence of intrauterine or extrauterine pregnancy is detected in a woman with a positive pregnancy test.
Possible explanations include:
- Very early intrauterine pregnancy
- Complete miscarriage
- Early ectopic pregnancy
Even with expert ultrasound assessment, the location of pregnancy cannot be determined in 8–31% of cases at the initial visit [Condus et al., 2003].
Silent Miscarriage
Wilcox et al. (1988) demonstrated that 31% of pregnancies were lost after implantation. Using sensitive hCG assays, two-thirds of these losses were clinically silent.
Aetiology of Early Pregnancy Loss
Fetal Factors
Chromosomal abnormalities are the most common cause of early miscarriage. Their incidence increases with maternal age, particularly after 35 years. Approximately 95% of chromosomal abnormalities originate from maternal gametogenesis, while 5% originate from paternal factors. Autosomal trisomy is the most frequently identified chromosomal anomaly.
Paternal Factors
- Balanced chromosomal translocations
- Aging sperm
Maternal Factors
- Endocrine disorders (hypothyroidism, diabetes mellitus)
- Chronic debilitating diseases (tuberculosis, malignancy)
- Nutritional deficiencies
- Immunological disorders
- Inherited thrombophilias
- Drug use and environmental factors (tobacco, alcohol, radiation)
- Uterine anomalies and submucosal fibroids
- Infections (Chlamydia, Mycoplasma)
According to the American College of Obstetricians and Gynecologists (2001), infections are an uncommon cause of early miscarriage. Oakeshott et al. (2002) reported an association between bacterial vaginosis and second-trimester miscarriage.
Clinical Assessment in the EPAU
A brief history should include:
- Previous obstetric history
- Last menstrual period (LMP)
- Urine pregnancy test result
- Presence and characteristics of pain
- Presence and severity of bleeding
- Passage of products of conception
Clinical examination should be performed when indicated.
In the absence of clinical symptoms, ultrasound examination before 8 weeks of gestation should be discouraged, as early scanning may increase anxiety rather than reassurance.
Diagnostic Investigations
Ultrasound Examination
TVS is required in most women attending an EPAU.
Indications for Repeat Ultrasound
- Initial scan performed before 8 weeks
- Scan performed by an untrained operator
- Doubts about scan reliability
- Long or irregular menstrual cycle
- Patient request
Serial Serum hCG Measurement
Serial hCG testing is particularly useful in diagnosing ectopic pregnancy and PUL. Levels above 1500 IU/L usually allow visualization of ectopic pregnancy on TVS.
Serum Progesterone
Serum progesterone levels below 25 nmol/L are associated with non-viable pregnancies, while levels above 60 nmol/L strongly correlate with ongoing pregnancies.
Conservative Management of Miscarriage
Conservative management is appropriate when there are no signs of infection, excessive bleeding, fever, or abdominal pain. Women should be counselled regarding expected symptoms and analgesia.
Medical Management of Miscarriage
Misoprostol is an effective prostaglandin analogue used orally or vaginally. Women should be informed about potential side effects and the possibility of surgical intervention if heavy bleeding occurs.
Surgical Management of Miscarriage
ERPC should be offered based on clinical indications or patient preference. Vacuum aspiration is preferred over sharp curettage due to lower blood loss and shorter procedure duration.
Rhesus Anti-D Prophylaxis
Anti-D immunoglobulin should be administered to non-sensitized Rh-negative women in specific clinical scenarios, including ectopic pregnancy and miscarriages beyond 12 weeks of gestation.

Doctor Svetoslav Manev, OB/GYN
/Obstetrician-Gynecologist/
