Bleeding & Hemorrhage

EARLY RECOGNITION of BLEEDING COMPLICATIONS

What should patients know about recognizing early medical abortion complications?

Early identification of excessive bleeding may help to prevent the risk of serious health complications. Early recognition is particularly important when the patient is at home. ⁽¹⁾

Since medical abortion occurs mainly in the patient’s home setting, self-assessment of blood loss is variable and symptoms suggestive of hypovolemia (such as dizziness with standing) can sometimes be the result from medication side effects, fear, pain, fatigue, or even cultural or ethnic perceptions. ⁽²⁾

It is important for patients to be aware of the risk of severe bleeding that may be caused by trauma (to the vagina, cervix, uterus) or retained pregnancy tissue, infection, uterine atony or rupture. ^{(1) (3) (4)}

In spite of extensive research, troublesome vaginal bleeding after medical abortion remains an unsolved problem. ⁽⁵⁾

HEAVY BLEEDING OVERVIEW

What is the most common medical abortion complication?

Heavy bleeding is probably the most common medical abortion complication for patients. ⁽⁹⁾

Prolonged heavy bleeding may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed. Patients are advised to seek immediate medical attention if they experience prolonged heavy vaginal bleeding . ⁽⁶⁾  (See WARNINGS)

Prolonged heavy bleeding (soaking through two thick full-size sanitary pads per hour for two consecutive hours) may be a sign of incomplete abortion or other complications. ⁽⁶⁾  (See WARNINGS)

Medical abortion patients experience more discomfort with their procedure and in the follow-up interval, bleed for a longer period, and remain at risk for surgical completion curettage for several weeks than women who choose the option of a suction curettage abortion. ⁽⁷⁾

Women must be informed to return for a clinical examination in cases of acute or prolonged bleeding, pain or fever, as these signs may be indicators of failure or other complications that need treatment. ⁽⁸⁾  (See BOXED WARNINGS)

Some women may experience a heavy bleeding episode 3-5 weeks after the abortion. ⁽³⁾

A curettage procedure by surgical scraping and scooping to the lining of the uterus may be required to stop heavy bleeding in about 10 per 1000 women. ^{(6) (9)}

The majority of surgical interventions due to heavy bleeding take place between 2 and 5 weeks after the beginning to the medical abortion regimen. ⁽¹⁰⁾

Emergency surgical interventions may take place if the patient: ^{(9) (10) (11)}

• reports prolonged heavy bleeding (for example, soaking 1 pad per hour for longer than 10-12 hours, or ≥ 2 pads/hour for longer than 4 hours) ⁽¹⁰⁾
• exhibits pale appearance and symptoms that might suggest excessive blood loss (hypovolemia), such as lightheadedness, dizziness, weakness, fatigue, or rapid heart rate (tachycardia)
• hemorrhaging/abundant gushing blood

The risk of surgical curettage, hospitalization, or intravenous fluid administration was 2 times greater for women at pregnancy greater than 49 days’ gestation than among those less than 49 days’ gestation. ⁽²⁾

• 200 per 1000 women for pregnancy up to 49 days gestation
• 400 per 1000 women for pregnancy more than 49 days gestation

Continued and severe genital bleeding can lead to the risk of shock. ⁽³⁾

BLEEDING PATTERNS & COMPLICATIONS

What types of bleeding patterns may increase the risks of complications?

Bleeding complications encompasses a range of bleeding patterns where it may be tiresome or problematic for the woman, or, in rare cases, are true emergencies. ⁽¹²⁾

• Some women may experience persistently heavy bleeding that may be continuous after administration of misoprostol where a surgical intervention may be recommended if the patient is feeling weak.
• Some women may experience erratic bleeding and have days of very little bleeding, no bleeding, or spotting, and erratically experience very heavy, gushing bleeding. Surgical intervention may be required if the patient is symptomatic for anemia.
• Hemorrhage causing hemodynamic instability is an emergency and is treated with an immediate surgical intervention and uterine evacuation to empty the uterus. (See BOXED WARNINGS and WARNINGS)
  • If the hemorrhage has been very serious, blood or fluid transfusion should be considered.

BLEEDING RISKS –  U.S. & FRENCH CLINICAL TRIALS ⁽⁶⁾

What kinds of bleeding risks were reported from the clinical trials?

• All women should expect to experience vaginal bleeding or spotting for an average of 9 to 16 days
• 80 per 1000 women may experience some type of bleeding for 30 days or more
• 10 per 1000 women may experience heavy bleeding requiring a surgical intervention
• 1 per 1000 women may require a blood transfusion for hemorrhage
• 48 per 1000 women may be administered uteronic drugs (U.S Trials)
• 10 per 1000 women may require intravenous fluids (U.S. Trials)
• 43 per 1000 women may be administered vasoconstrictor drugs (French Trials)

HEMORRHAGE

What is hemorrhage after medical abortion?

Heavy bleeding is an expected side effect, but it becomes a complication if hemorrhage necessitates transfusion or surgical evacuation. ⁽²⁾ (See BOXED WARNINGS)

Hemorrhage is best defined as the loss of large amounts of blood, as indicated by details of sanitary pad saturation, often associated with signs or symptoms of hypovolemia (state of decreased blood volume). ⁽²⁾

The need for a blood transfusion for excessive bleeding in patients after medical abortion is estimated to be about 1 per 1000 women. ⁽¹³⁾

Hemorrhaging following mifepristone abortion appears to be more severe than those found in surgical or spontaneous abortions. ^{(14) (15) (16)}

Excessive hemorrhage associated with mifepristone abortions can be attributed to a pathopharmacologic mechanism by which mifepristone alters the innate immune system. ⁽¹⁴⁾

Following the expulsion of the products of conception, it is proposed that hemorrhage may be aggravated by mifepristone’s blockade of glucocorticoid receptors, resulting in prolonged and excessive levels of nitro oxide (NO). ⁽¹⁴⁾

Vacuum aspiration is frequently used as the first option treatment for hemorrhage; this enables the uterus to contract and decrease bleeding. ⁽¹¹⁾

Severe hemorrhage and prolonged heavy bleeding require immediate attention. With significant bleeding; fluid replacement, blood transfusion and oxygen administration should be considered. ⁽¹¹⁾ (See WARNINGS)

Women who present with hemorrhage following mifepristone abortion, yet who have no retained tissue fragments from pregnancy termination, as determined by ultrasound, may be at additional risk for the etiology of hemorrhage. Women should be informed of the need for closer medical follow-up. ⁽¹⁴⁾

Of special concern are patients who require prolonged follow‐up and treatment for retained pregnancy tissue or products of conception that causes bleeding for several weeks. Surgical curettages may be performed for persistent bleeding several weeks after medical abortion treatment. ⁽¹⁷⁾

BLOOD CLOTS & HEMATOMETRA

What should a patient know about possible complications from blood clots in the uterus?

Passage of blood clots in varying sizes and amounts occurs commonly, particularly during expulsion of the pregnancy. ⁽²⁾

Most patients will initially experience moderate to heavy bleeding, with clots ranging in size from small to very large during medical abortion: ⁽¹⁰⁾

• Small blood clots = the size of a dime
• Large blood clots = the size of a lemon
• Very Large blood clots = the size of an orange

What is Hematometra?

Hematometra refers to the accumulation of blood clots in the uterine cavity. (1) Hematometra is a rare and delayed complication of medical termination of pregnancy. ⁽¹⁸⁾

Acquired acute hematometra also termed the postabortal syndrome or the redo syndrome is a rare complication of suction evacuation with incidence ranging from 1-10 per 1000 suction curettage abortion. ⁽¹⁸⁾

The treatment consists of prompt evacuation of both liquid and clotted blood leading to rapid resolution. An oxytocic is administered after the repeat evacuation. ⁽¹⁸⁾

FAILURE TO BLEED

What can happen if there is a failure to bleed after taking mifepristone and misoprostol?

Occasionally, a patient will experience little or no bleeding in the first 24 hours after the administration of the second drug, misoprostol. ⁽¹⁰⁾

Patients should seek prompt medical attention and evaluation where the lack or failure to bleed may be a possibly the result of: ⁽¹⁰⁾

• Undiagnosed ectopic pregnancy (See WARNINGS)
• Ongoing or continued pregnancy where surgical abortion will be necessary (See WARNINGS)