Applied Evidence

Oral contraceptives and breakthrough bleeding: What patients need to know

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3 aspects of managing breakthrough bleeding

Managing breakthrough bleeding involves effective pretreatment and ongoing counseling, reassurance, and timely and appropriate diagnostic testing (TABLE 3). In some instances, pill-switching or other forms of medical management may be helpful, but these options are largely unproven.

TABLE 3
What to review with patients who are starting a combination OC

  • Breakthrough bleeding in the initial months after starting OCs is common
  • Breakthrough bleeding, if experienced, usually diminishes over the first 3 months of OC use and abates by the 4th cycle
  • Skipping even one pill can result in breakthrough bleeding
  • Avoidance of breakthrough bleeding can be aided by taking your pill at the same time every day; you may find it helpful to make pill-taking part of another daily routine such as tooth brushing
  • Tell me about other medications you are taking, including over-the-counter preparations or herbal supplements
  • If you smoke, the chances of breakthrough bleeding are increased
  • If bleeding continues beyond the 4th cycle, there are diagnostic tests available to explore possible underlying causes
  • If bleeding continues without adequate explanation and despite adherence to the regimen, we can try switching you to a different formulation to see if that helps

Counseling reduces anxiety and improves satisfaction, adherence

In a recent survey, 649 Canadian women who were picking up prescriptions for OCs were asked to complete a questionnaire at the pharmacy while they waited.48 Over one third (34.5%) reported they had not received counseling from their health-care provider about breakthrough bleeding. Furthermore, only 28.3% of women who were counseled, and 26.1% of women who were not counseled, gave the optimal response to breakthrough bleeding as defined in this study (“continue taking pill and not call my doctor”).

Lack of counseling can lead to poor method satisfaction and significant cost expenditures due to visits and phone calls by women experiencing unexpected bothersome side-effects.5 Compared with women who reported the highest satisfaction with the care they received from their provider, those reporting the lowest scores were 1.6 to 2.2 times as likely to be dissatisfied with the pill.

Inform women that breakthrough bleeding is common in the first 3 to 4 cycles of OC use, that bleeding irregularities tend to decline with each successive cycle, and that they should not discontinue pill use without discussing their concerns with you. Remind women to keep sanitary protection with them during the first few months. The impact of poor counseling was underscored in a study of women enrolled in clinical trials of OCs, contraceptive vaginal rings, and Depo-Provera. Women taking OCs were the least likely to have been warned of menstrual irregularities and thus tended to stop using that method more often than those using a ring or Depo-Provera.49 Of women who discontinue OCs, 47% use a less effective method and 19% use no method at all.1

Give specific instructions for specific regimens. Given the array of OC regimens available, make sure women know how to take them properly. This will help ensure contraceptive efficacy and cycle control. Women who do not understand pill-package instructions are up to 2.8 times more likely to miss pills, which increases the risk of breakthrough bleeding and impacts contraceptive efficacy.5 Among women who were counseled about the consequences of missed pills, 76% reported knowing what to do in response (“use another form of birth control that month”). Of women who received no such counseling, only 48% gave the appropriate response (P<.001).48 To improve adherence, advise women to establish a routine for pill-taking: taking the pill at the same time each day or linking pill ingestion with another daily activity, such as tooth brushing. Women without an established routine were 3.6 times more likely to miss 2 or more pills per cycle than women with a routine.5

Reassurance regarding contraceptive efficacy

Reassure users who take their pills routinely that breakthrough bleeding and contraceptive efficacy are not linked.50 Breakthrough bleeding is not a sign that OCs are not working.4 On the other hand, approximately 1 million unintended pregnancies in the United States each year are associated with misuse or discontinuation of OCs.51

When to consider diagnostic testing

For OC users who continue to experience breakthrough bleeding beyond 3 to 4 cycles, other potential causes must be ruled out using appropriate diagnostic tests. A pregnancy test, appropriate testing for cervical infection, a pregnancy test, pelvic ultrasound, Pap smear, or endometrial biopsy may be warranted depending on clinical circumstances.

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