Stable Vaginal Bleeding in Pregnancy

Case 1: Threatened Miscarriage

Patient Profile: Tracey, a 30-year-old female, presents at 7+5 weeks gestation with mild cramping and bleeding. She is changing her pad every 4 hours. Her B-HCG level is 52,000, and she appears well with stable vital signs.

Remember the key points to elicit on history:

• Last normal menstrual period
• Previous US imaging in this pregnancy
• Vaginal bleeding (amount and characteristics)
  • Side note: How much bleeding is too much? Here’s a good general approach:
    • A good rule of thumb is that bleeding that is lighter than the patient’s usual menstrual period is reassuring
    • Bleeding heavier than menses should make you pause, consider US imaging, and definitely consider a pelvic exam (see below)
    • And true heavy bleeding is when the patient soaks through a maxi-pad per hour for more than 2 hours – this is concerning bleeding requiring a pelvic exam, imaging, intervention, and usually OB/Gyne consultation
  • Other vaginal symptoms (including abnormal discharge or symptoms of infection)
  • Pain or cramping (including severity and location)
  • Symptoms of hemodynamic compromise (like dizziness, orthostasis, and syncope)
  • Past obstetric, medical, and surgical histories, including history of previous pregnancy loss, ectopic pregnancy, and use of assisted reproductive technology

And the key points on your physical exam:

• Vital signs
• Abdominal exam
  • Red flags = unilateral tenderness, palpable adnexal mass, peritonitis
• Pelvic exam – do we need to do it?
  • Answer: Sometimes, with insufficient evidence in the literature either way, and shared decision-making being key
  • See Dr. O’Connell’s 2022 EM Ottawa Blog Post on Pelvic Exams in the ED here, where she provided us with a low-risk checklist for patients that may safely forgo the ED pelvic exam (1), including those who have:
    • A confirmed 1^st trimester IUP
    • Only light bleeding with stable VS
    • Minimal pain controlled with OTC analgesia
    • No suspicion for alternate etiology (eg. trauma)
    • Completed a urine STI screen (given that bleeding can be caused by cervicitis)
    • Access to reliable, timely follow-up
  • For all other patients, the pelvic remains mandatory
• PoCUS
  • This is an important step – remember that Point of Care Ultrasound (PoCUS) is considered the standard of care by Canadian EM physicians in identifying IUP vs NDIUP and screening for intra-abdominal free fluid, per the CAEP consensus guideline. (2)

Now, back to Tracey’s case: On further history, her answers are all reassuring. She does not meet the high-risk criteria for a mandatory pelvic exam, and through shared decision-making you forego this today. You confirm a +ve IUP with +FHR on your bedside PoCUS.

• You agree there is no role for radiology-performed US today, given the patient has an IUP, and she is stable with minimal symptoms
• And so ultimately this patient is diagnosed by you with a threatened miscarriage, which means there is clinical evidence of bleeding or cramping but US evidence of fetal viability. You discharge her from the ED with a plan to follow up in the Early Pregnancy Evaluation Clinic (EPEC).
• What is an EPEC, you ask? Available in most major cities in Canada, EPEC’s have been implemented and considered the gold-standard of care in the UK since the 1990s.
  • They provide a centralized, multidisciplinary service for patients experiencing early pregnancy complications.
  • They can arrange for expedited outpatient follow-up, including serial assessments, B-HCG checks, and pelvic ultrasounds when needed.
  • With an initial goal of diverting these patients away from the ED and reducing unnecessary hospital admissions, EPECs have subsequently been found to also provide more cost-effective care, more timely management, and improved patient satisfaction.
• Unfortunately, in 2019, 54% of Ontario EDs did NOT have access to early pregnancy assessment services (3), highlighting further the need for ED physicians to be comfortable and competent in managing early pregnancy complications.
  • In patients with threatened miscarriage, it is usually reasonable to refer the patient back to their family physician or own obstetrician, if they have one
  • If you do not have rapid access to an EPEC, follow-up within 1-2 weeks is reasonable in the low-risk patient
  • However, given that the uncertainty of a pregnancy’s viability is often distressing for patients, returning to the ED for serial B-HCG every 48-72 hours may also be reasonable within the culture of your department
  • In any case, good patient education will be key when discharging these patients home:
    • If the bleeding stops, she should continue routine antenatal care (with the assumption being here that the pregnancy remains viable)
    • In terms of lifestyle management:
      • Bedrest is NOT helpful or recommended
      • Pelvic rest is often recommended (avoiding intercourse, tampons, intensive exercise), although this is not based on evidence
    • Patients should be instructed to return to the ED if they experience:
      • Heavy bleeding (recall: soaking a pad an hour for 2+ hours)
      • Persistent bleeding beyond 2 weeks (suggestive of miscarriage with retained products of conception [RPOC])
      • Fever (suggests infected RPOC)

Case 2: Preventing Rh-D Alloimmunization

Patient Profile: Rhenata, a 30-year-old female presenting at 7+5 weeks with bleeding and cramping. Her case is very similar to Case 1, except this patient is Rh-negative, with blood type A-. Her history, exam, and PoCUS are all otherwise reassuring.

We know that the risk of Rh-D alloimmunization, which can lead to hemolytic disease of the newborn in future pregnancies, is significantly reduced with timely administration of Rh Immunoglobulin or RhIG (eg. WinRho, Rhogam), within 72 hours of a sensitizing event.

However, when it comes to prevention of Rh alloimmunization in early pregnancy, the leading international organizations in obstetrical care have been divided on this topic for some time (4). Specifically, there has been much debate about whether or not there is a large enough volume of feto-maternal hemorrhage to result in sensitization during bleeding events in the 1^st trimester (5,6).

And in 2024, after conducting a systematic review and GRADE analysis on the topic, the Society of Obstetricians and Gynecologists of Canada (SOGC) updated their Clinical Practice Guidelines to reflect the evolution of the evidence, stating (7,8):

• Regardless of the type of exposure, RhIG is not recommended < 8 weeks gestation
• Checking the patient’s Rh status < 8 weeks gestation is unnecessary
• RhIG is not necessary < 12 weeks gestation, but can be considered between 8 and 12 weeks in patients who are more risk-averse

Of note, they continue to recommend RhIG to 12 weeks and above in all cases.

But why debate this anyway? Why don’t we just give it to all Rh-negative moms, is there any harm? Not much on the surface, it seems. Specifically, at the doses used for prophylaxis in pregnancy, there is very little risk. At much larger doses used for the management of ITP (eg. 3500 mcg), there have been cases of acute hemolytic reaction, DIC, and renal failure, but this has not been seen in pregnancy dosing (9). Like most blood products, there is a risk of anaphylaxis and infection, but there have been no reported cases of viral transmission by the current WinRho product used in Canada (8,9).

One true risk that I think we should all be aware of is the potential for falsely elevated glucose readings with some home monitors in our diabetic patients, with case reports of fatal home over-administration of insulin as a result (10).

But from an ED perspective, it is important to consider any potentially unnecessary intervention that may result in longer ED stays and increased costs, and so that might be an important argument here. And recently, there has been a noted shortage of RhIG across North America, with calls to conserve our supply where possible.

Yet, on the contrary – some groups say there is greater benefit than risk overall, and universal use is still recommended in 1^st trimester by some – including the Society for Maternal-Fetal Medicine, and the BC Emergency Medicine Network (11,12). In recent months, the American College of Obstetricians and Gynecologists aligned their guideline with that of the SOGC (13).

So, with all of that said – you are safe to not offer RhIG to your patients < 12 weeks in the context of our leading Canadian guidelines, however, particularly in the late 1^st trimester, shared decision making seems to be the most reasonable way forward while this controversy remains.

How do I order WinRho, anyway? This can be a point of confusion, so I’ll summarize here:

• Route: IV or IM (equivalent dosing)
• Dose:
  • < 12 weeks (if choosing to give) = 120-300 mcg
    • We only have 300 mcg vials at our local centre and this dose is safe if giving under 12 weeks
  • 12-20 weeks = 300 mcg
  • > 20 weeks = 300 mcg plus, depending on your local institution/lab, you will then either order the screening Rosette test or the definitive Kleihauer-Betke test to determine if more is required
    • The Rosette test is a sensitive, qualitative screening test for feto-maternal hemorrhage. This test will be negative if the amount of fetomaternal hemorrhage is small, indicating that a single standard dose of 300 mcg x1 will be safe. However, a positive Rosette test will then prompt our lab to proceed with the quantitative Kleihauer-Betke test, which will determine the total volume of F-M hemorrhage, and our lab will tell us exactly how much RhIG to administer.

Back to Rhenata’s case: This patient is also diagnosed with a threatened miscarriage, and so her management plan is the same as in Case 1 and will include education around pelvic rest, what to watch for at home, and when to RTED.

You recall the most recent SOGC guideline and do not offer her a dose of WinRho. She leaves the ED promptly with planned follow-up within 1-2 weeks, as we previously discussed.

Case 3: Early Pregnancy Loss

Patient Profile: Missy is a 30-year-old female pregnant at 12+2 weeks (per recent dating ultrasound), presenting with cramping and bleeding. She is Rh -ve. On your assessment, she is stable with a reassuring history and exam, but your PoCUS indicates no fetal heart rate, suggesting early pregnancy loss.

Definitively diagnosing Early Pregnancy Loss (EPL) can be challenging in the ED, as it requires radiology-performed transvaginal ultrasound and/or serial B-HCG measurements. Often, we feel more comfortable diagnosing Threatened Miscarriage (see cases above), and making a plan for patient follow-up and definitive diagnosis.

However, if a patient does undergo a radiology performed transvaginal US in your ED, or presents to the ED with a community US report, we actually have very clear diagnostic ultrasound criteria for early pregnancy loss. According to the Society of Radiologists in Ultrasound (SRU), the diagnostic criteria for pregnancy failure are as follows:

These criteria can be used in the first trimester (under 13 weeks), are more stringent than previous criteria, and have been found to have a specificity and positive predictive value of 100 percent, meaning it would be extremely unlikely to mis-diagnose an EPL when there is actually a viable pregnancy (14). They are accepted across the North American obstetrical societies.

So what can we do with this information in the ED? First, the literature shows that patients with EPL often experience a delay to diagnosis, and so, at the very least, sharing your high suspicion for EPL today will prepare them for the likely next steps, which may include passage of POC at home, and confirmation of pregnancy loss on their follow-up appointment.

However, we can also offer these patients definitive treatment today.

There are 3 management options in EPL:

1. Expectant Management: Suitable for < 13 weeks gestation with an 80% success rate for complete expulsion (with greatest success in patients with actively symptomatic miscarriage). Completion may take up to 8 weeks, and the timing of tissue expulsion is unpredictable, which may be unacceptable to some patients.
2. Medical Management: Using a combination of Mifepristone and Misoprostol (known together as “Mifegymiso”), this approach offers more patient control over timing with a higher complete expulsion rate of 90%.
   • I urge ED physicians to consider this option, even if they plan to refer a patient onto a rapid follow-up Early Pregnancy Evaluation Clinic (EPEC), as initiating this in the ED will jump-start definitive management, and it may be possible to confirm completion of the miscarriage by the time of follow-up, limiting delays in patient care.
3. Surgical Management: Indicated for > 13 weeks gestation, infection/septic abortion, unstable hemorrhage, patients with severe anemia or bleeding disorders, and in cases when more conservative management has failed. It offers immediate termination of a pregnancy, which some patients may prefer.

Except for in cases meeting clear indications for surgical management, there are no differences in major outcomes between the options, and so the choice comes down to patient preference (15). It is important to counsel patients, however, that the time to completion of the pregnancy evacuation does differ, and expectant and medical approaches run a higher risk of treatment failure resulting in retained POC. Discharge education should also emphasize the following:

• What to expect
  • Moderate to severe cramping
  • Moderate to heavy bleeding
  • Analgesia is important
    • Acetaminophen + NSAID +/- opioid
  • When to RTED
    • Excess bleeding (eg. 2 maxi-pads per hour x 2 hrs)
    • No bleeding or passage of tissue
    • S&S of infection
    • Note: Transient fever lasting < 24 hrs is expected after misoprostol

And finally, a safe follow-up plan should be made. The SOGC guideline on abortion states all patients require follow-up within 1-2 weeks, but the method of determining if the pregnancy evacuation is complete can vary by provider (16). Here are the key points to know:

• Repeat US is not usually required
• If there is a clear history of expulsion at home, and the bleeding is resolved or resolving, then no further confirmation is required
• An 80% reduction in B-HCG after 7 days is also confirmatory

If none of these criteria are met, the patient will require work-up for retained POC.

Be sure to check out Dr. King’s 2024 EM Ottawa Blog Post on Abortion Care in the ED here for a much deeper dive on this topic.

Let’s return to Missy’s case: It turns out she underwent transvaginal dating US in the community earlier that day, and after a review of the report and confirming the diagnostic criteria listed above, you break the news to her that she has suffered an Early Pregnancy Loss, and you discuss her options. She opts for medical management with Mifegymiso. You counsel her on what to expect and when to RTED. You provide her with multi-modal analgesia, give her a dose of WinRho 300 mcg x1 because she is over 12 weeks gestation, and you refer her to the EPEC for follow-up.

Case 4: Pregnancy of Unknown Location (PUL)

Patient Profile: Pula, a 30-year-old female presenting at 6+1 weeks gestation with stable bleeding and a low-risk history and exam. She has not had any previous imaging in this pregnancy. Her B-HCG level is 1200 today, which you recall is below the “discriminatory zone” for transvaginal ultrasound. Unsurprisingly, your PoCUS today is non-diagnostic for intra-uterine pregnancy (NDIUP), and there is no intra-abdominal free fluid on FAST.

This is a case of Pregnancy of Unknown Location (PUL). A PUL is defined as “a temporary state of pregnancy where the B-HCG is positive but the location of the pregnancy is unknown – until a final diagnosis can be made by means of serial ultrasounds and B-HCG levels” (17).

The possible ultimate outcomes of a PUL include 3 key categories:

• An intrauterine pregnancy, which may be:
  • Developing and viable, or
  • Non-viable
• Miscarriage
• Ectopic pregnancy

And of course, our greatest concern here should always be for an ectopic. The SOGC reminds us that “until a location is confirmed, a pregnancy of unknown location should always be considered potentially ectopic”. And here’s why: Although ectopic pregnancy occurs in about 2% of all pregnancies, it comprises about 10% of ED patients presenting with 1^st trimester bleeding, and up to 14% of PULs. And so, the SOGC also appropriately refers to a PUL as “a transient state used to classify a patient at risk for ectopic pregnancy(18).

So, when we see a PUL in the ED, the next key step is to determine if there is a high suspicion for ectopic or not. Some ED physicians advocate for radiology performed US in all PUL patients presenting with bleeding or cramping, but we know that, unfortunately, in reality that this is not always possible, depending on our available resources and culture of our institution.

So when should we have a higher suspicion for ectopic or not? There is no one historical or exam feature that can say definitively that the patient in front of you has an ectopic – especially in the stable, well-appearing woman. Instead, it comes down to always maintaining an index of suspicion in any patient that has not been diagnosed with an IUP, using your clinical expertise on the risk factors and clinical features of ectopic pregnancy:

• Ectopic risk factors – history
  • Previous
    • Ectopic
    • Miscarriage/abortion
    • Tubal surgery or other pathology (eg. PID)
  • Infertility
  • Use of reproductive technology
• Ectopic features – clinical
  • Significant bleeding
  • Significant pain
  • Unilateral pain or tenderness
  • Peritonitis
  • FF on FAST
  • Abnormal vital signs

Here are a few additional key points to remember when you have a patient in the ED with a PUL (17–19):

• You cannot diagnose a miscarriage in a patient with NDIUP if they did not have previous confirmation of an IUP
  • Yes, if the uterus appears empty, this could be a near-complete abortion, but it could also be an ectopic
• Do not treat a stable patient with a PUL empirically as a miscarriage or ectopic using misoprostol or methotrexate – as this could harm a viable, developing IUP that is just not visible today (with the exception being, of course, if the patient wants an elective abortion anyway)
• Clinically well, low-risk PULs can be safely managed as an outpatient with reliable, early follow-up (more on this in a bit)
• Do not use a single B-HCG level to determine the role for a radiology-performed ultrasound in the ED today
  • Specifically, do not let a B-HCG below the discriminatory zone influence this decision
  • We know that B-HCG’s in ectopics are highly variable, and are often below 1500
  • Instead, determine the need for US today based on the patient’s clinical presentation and risk factors!
• Do not use a single B-HCG to risk-stratify your patient’s likelihood of ectopic
  • Again, B-HCG levels in ectopic pregnancy are highly variable
• If discharged home, all patients with PUL require a repeat β-hCG test in 48 hours
  • Here, the ratio between the 2 β-hCG measurements taken 48 hours apart may be used to stratify the risk of ectopic (see CMAJ article “here” for more)
  • If the location of the pregnancy is never identified but the beta-HCG is decreasing, it can usually just be followed until it reaches zero
  • If the beta is persistently elevated or rising, this is concerning for an ongoing ectopic

So, back to Pula’s case: On your assessment, you rule out any historical risk factors or clinical features of ectopic pregnancy. Unfortunately, it is after routine US hours in your hospital, but you are satisfied she does not meet the mandatory criteria for a radiology-performed US today, and so you discharge her home with a safe follow-up plan within 48 hours for a repeat clinical exam, B-HCG, and a pelvic US, and ensure to provide excellent return instructions, including:

• Heavy bleeding
• Severe pain
• Unilateral pain
• Scapula, back pain
• Faint, dizzy
• Fever

Providing Patient-Centred ED Care in Complications of Pregnancy

To close out this blog post, I want to touch briefly on a few ways to deliver more compassionate, patient-centred care to patients experiencing complications of pregnancy in our busy ED environment.

Previous surveys of ED patient experiences have identified key sources of patient dissatisfaction during these often-distressing visits. The top 3 areas patients want us to improve upon include:

1. Delays to definitive diagnosis and care
2. Lack of clear communication
3. Lack of emotional sensitivity and empathy

Addressing point number 1 is not always easy in our current strained system, but hopefully the above post helps you streamline the appropriate care for your future patients with these common presentations. In addition, it is imperative to know the system that are you are working within; sometimes just knowing what resources are available in your community makes all the difference to providing a patient the follow-up she needs. You should know if your ED patients can access an EPEC, or if your local OB/Gyne team has an alternate referral pathway, or if your ED has created their own protocol for patients without rapid access to a PCP or OB-provider.

In addition to knowing what resources are at your disposal, I think that by improving upon points 2 and 3, we might be able to at least find some shared understanding around the timeline for care. By that I mean take a moment to communicate clearly why, for example, a stable patient with a threatened miscarriage does not require a radiology performed US in the ED today (in addition to your bedside scan), and explain how this will not impact the course of the pregnancy.

Acknowledge the frustration that comes with an uncertain prognosis in her pregnancy, and let her know what to expect at home – specifically, that she could continue to have bleeding and cramping, and that that is likely a sign of a miscarriage.

Be sure to tell her there is nothing she did wrong to cause early pregnancy bleeding or loss, and that many women who bleed during the 1^st trimester will go on to have a healthy pregnancy. And if not, one miscarriage is not associated with increased risk for infertility in the future.

And finally, take a second to ponder the discordance in priorities between physician and patient in these cases (specifically that the patient is often worrying “is my baby okay?” while the physician is usually focused on “is this an ectopic that could kill her?”), and how this could lead to a perceived lack of empathy.

I think it’s important to address this elephant in the room in these cases, to remind ourselves that there is a whole patient in front of us, and that we should take a second to explain the medical process so we are all on the same page.

References

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