ACOG Practice Advisory: Counseling Patients About Breast Cancer Risk and Hormonal Contraception
SUMMARY:
ACOG has reaffirmed a practice advisory that had initially been in response to a prospective cohort study. The results from the paper by Mørch and colleagues (NEJM, 2017) was based on Danish nationwide registries (see ‘Related ObG Topics’ below) and identified the following
Overall risk of breast cancer in current or recent users compared to women who never used hormonal contraception
Increased Risk of breast cancer: Relative Risk (RR): 1.20 (95% CI, 1.14 to 1.26)
Risk increased with duration of use: RR 1.09 (95% CI, 0.96 to 1.23) at < 1 year vs 1.38 (95% CI, 1.26 to 1.51) after > 10 years (P=0.002)
Risk remains elevated after ≥5 years but not < 5 years
Oral Combined Contraceptives
Little evidence of major differences between various OCPs after statistical adjustments for multiple testing
Levonorgestrel-releasing intrauterine system (LNG-IUD)
No significant differences compared to OCPs
RR of breast cancer was 1.21 (95% CI, 1.11 to 1.33)
Contraceptive implants
Few breast-cancer events among users of the progestin-only implant and depot medroxyprogesterone acetate
KEY POINTS:
Relative vs Absolute Risk
Absolute risks remain low
Overall: 1 additional case of invasive breast cancer for every 7,690 women using hormonal contraception
Women <35 years: 1 additional case of invasive breast cancer for every 50,000 women using hormonal contraception
Benefits of Hormonal Contraceptives
ACOG addresses these benefits clearly in this Practice Advisory
Non-hormonal benefits (see ‘Related ObG Topics’ below)
Decreased risk of ovarian, endometrial, and colon cancer
Overall cancer risk may be lower in hormonal contraceptive users despite possibility of small increased breast cancer risk
Hormonal benefits
Maternal mortality rate in the US: 26.4 deaths per 100,000 women (2015)
The above risk is twice that of developing invasive breast cancer in the NEJM study
More study required regarding relationship between progestin-only contraceptives and breast cancer risk
Study results were inconsistent regarding progestin-only formulations
Counseling recommendations
ACOG supports shared decision making and counseling should include the following
This recent study showed that women who use hormonal birth control methods may have a small increased risk of breast cancer, but the overall risk of breast cancer in hormonal birth control users remains very low
Hormonal birth control is very effective in preventing pregnancy and may lower a women’s overall risk of cancer by providing protection against other types of cancer
There are nonhormonal methods of birth control that are also good options
Women can do things to help lower their risk of breast cancer, like breastfeeding, getting more exercise, and limiting alcohol intake
CDC Guidelines on How to Start Combined Hormonal Contraceptives
CLINICAL ACTIONS
Combined hormonal contraceptives contain both estrogen and a progestin. This contraceptive category includes combined oral contraceptives, transdermal patches and vaginal rings. They are effective when taken as directed, reversible and can be used by women of all ages. It is important to alert women that they will not protect against STDs and other preventative measures will be required to protect against infections. The following assumes there are no contraindications to estrogen component (e.g., breast cancer, hyperlipidemia, liver disease etc.). Only BP is “essential and mandatory” and when BP cannot be measured by a provider, a measurement obtained in other setting can be reported by the woman to her provider. The following are highlights from the CDC recommendations on initiation:
CDC Criteria to determine with ‘reasonable certainty’ that woman is not pregnant (≥1 of the following)
≤7 days after the start of normal menses
No sexual intercourse since the start of last normal menses
Correctly and consistently using a reliable method of contraception
≤7 days after spontaneous or induced abortion
Within 4 weeks postpartum
Fully or nearly fully breastfeeding (exclusively breastfeeding or the vast majority [≥85%] of feeds are breastfeeds), amenorrheic, and <6 months postpartum
Timing
Start at any time if ‘reasonably certain’ not pregnant criteria are met
Back-Up Contraception
If combined hormonal contraception begun within the first 5 days since menstrual bleeding started
No additional contraceptive protection is needed
If combined hormonal contraception started >5 days since menstrual bleeding started
Abstain from sexual intercourse or
Use additional contraceptive protection for the next 7 days
Obesity
Combined hormonal contraceptives are a category MEC 2 and therefore can be prescribe to women regardless of BMI
Obesity is a risk factor for VTE, but lower than risk from pregnancy
Patient with Amenorrhea (Not Postpartum)
Timing
Start at any time if ‘reasonably certain’ not pregnant criteria
Back-up contraception
Abstain from sexual intercourse or
Use additional contraceptive protection for the next 7 days
Postpartum (Breastfeeding)
Timing
Start when the woman is medically eligible (MEC guidance) and meets ‘reasonably certain’ not pregnant criteria
US MEC postpartum guidance (combined hormonal contraceptives)
Avoid combined hormonal contraceptives during the first 3 weeks (risk of VTE)
Avoid combined hormonal contraceptives during the first 4 weeks (concerns regarding breastfeeding performance)
Caution: Women who are postpartum with additional risk factors for VTE should not use combined hormonal contraceptives 4–6 weeks after delivery (please see ‘Primary Sources’ and ‘Related ObG Topics below for further guidance on medical eligibility)
Back-up contraception
<6 months postpartum, amenorrheic, and fully or nearly fully breastfeeding (exclusively breastfeeding or the vast majority [≥85%] of feeds are breastfeeds)
no back-up needed
If not in the above category, and patient is ≥21 days postpartum and has not experienced return of her menstrual cycle
Abstain from sexual intercourse or
Use additional contraceptive protection for the next 7 days
Menstrual cycles have returned and >5 days since menstrual bleeding started
Abstain from sexual intercourse or
Use additional contraceptive protection for the next 7 days
Postpartum (Not Breastfeeding)
Timing
Start when the woman is medically eligible (MEC guidance) and meets ‘reasonably certain’ not pregnant criteria
US MEC postpartum guidance (combined hormonal contraceptives)
Avoid combined hormonal contraceptives during the first 3 weeks (risk of VTE)
Caution: Women who are postpartum with additional risk factors for VTE should not use combined hormonal contraceptives 4–6 weeks after delivery (Please see ‘Primary Sources’ and ‘Related ObG Topics’ for further guidance on medical eligibility)
Back-up contraception
<21 days postpartum
No additional contraceptive protection needed
≥21 days postpartum and whose menstrual cycles have not returned
Abstain from sexual intercourse or
Use additional contraceptive protection for the next 7 days
Menstrual cycles have returned and it has been >5 days since menstrual bleeding started
Abstain from sexual intercourse or
Use additional contraceptive protection for the next 7 days
Postabortion (Spontaneous or Induced)
Timing:
Start combined hormonal contraception within the first 7 days following first-trimester or second-trimester abortion, including immediately postabortion
Back-up contraception
If combined hormonal contraception not started at time of surgical abortion
Abstain from sexual intercourse or
Use additional contraceptive protection for the next 7 days
SYNOPSIS:
There may be times there is uncertainty whether a woman is pregnant. According to the CDC, “the benefits of starting combined hormonal contraceptives likely exceed any risk; therefore, starting combined hormonal contraceptives should be considered at any time, with a follow-up pregnancy test in 2–4 weeks.” In a situation where a woman needs to use additional contraceptive protection when making the switch to combined hormonal contraception, consider continuing previous contraceptive methods for 7 days after starting combined hormonal contraception
KEY POINTS
Need for Routine Follow-Up
The CDC states that if a patient is otherwise healthy, “No routine follow-up visit is required”
Women should be advised to return at any time to discuss
Side effects | Desire to change contraceptive method | Any other issues or concerns
At other routine visits, assess
Patient satisfaction | Concerns
Change in health status and medications that may impact use of combined hormonal contraceptives (e.g., move to MEC category 3 and 4 conditions)
Blood pressure
Weight changes, including if patients are concerned regarding perceived changes
Switching from Another Contraceptive Method
Timing
Start at any time if ‘reasonably certain’ not pregnant criteria are met
Waiting for her next menstrual cycle is unnecessary
Back-up contraception
If combined hormonal contraception started >5 days since menstrual bleeding started
Abstain from sexual intercourse or
Use additional contraceptive protection for the next 7 days
Switching from an IUD
If the woman has had sexual intercourse since the start of her current menstrual cycle and it is >5 days since menstrual bleeding started, consider any of the following
Retain the IUD for at least 7 days after combined hormonal contraception initiated and return for IUD removal or
Abstain from sexual intercourse or use barrier contraception for 7 days before removing the IUD and switching
If cannot return for IUD removal and has not abstained from sexual intercourse or used barrier contraception for 7 days
Use emergency contraceptive pills at the time of IUD removal
Combined hormonal contraceptives can be started immediately after use of emergency contraceptive pills (except for ulipristal acetate)
Ulipristal acetate: Combined hormonal contraceptives can be started no sooner than 5 days after use
Note: The CDC considers IUDs separately because in theory, if a woman has had sexual intercourse and it is >5 days from the time of her period, residual sperm could still potentially be active with a risk for fertilization
VTE WARNING Category 3 or 4 (risk outweigh benefits or unacceptable risk)
The following factors elevate risk of VTE sufficiently to classify as 3 or 4 and alternate methods should be used
Smoking ≥35 years of age
Postpartum <21 days
Postpartum 21-42 days with additional risk factors
≥35 years of age | Previous VTE | Thrombophilia | Immobility | Transfusion at delivery | Peripartum Cardiomyopathy | BMI ≥30 | PPH | Postcesarean delivery | preeclampsia | smoking
Major surgery with immobilization
History of DVT or PE
Hereditary thrombophilia including antiphospholipid syndrome
Inflammatory Bowel Disease with
Active or extensive disease | Surgery | Immobilization | Steroid use | Vitamin deficiencies | Fluid depletion
SLE with positive or unknown antiphospholipid antibodies
Are Drug Interactions between Antibiotics and Hormonal Birth Control a Reality or Myth?
BACKGROUND AND PURPOSE:
Limited data regarding hormonal contraception and antibiotics
Rifamycin antibiotics (rifampin, rifabutin) induce key hepatic enzymes that are part of hormonal birth control pathway metabolism but this mechanism may not be generalizable to other more common antibiotics
There is data that most pharmacists recommend backup contraception for women who use antibiotics with hormonal contraception due to concern for unintended pregnancy
Simmons et al. (AJOG, 2018) sought to examine potential interactions between non-rifamycin antibiotics and hormonal contraceptives
METHODS:
Systematic review
Search included trials, cohort, case-control, and pharmacokinetic studies when non-rifamycin antibiotics and hormonal contraceptive that addressed:
pregnancy rates
pharmacodynamics
pharmacokinetic outcomes
Reviews were independently assessed by two authors to avoid bias
Risk of bias was assessed using the USPSTF evidence grading system
Findings were tabulated by drug class
RESULTS:
Study quality ranged from good to poor and addressed only oral contraceptive pills, emergency contraception pills, and the combined vaginal ring
Ethinyl estradiol was affected when administered with dirithromycin (a macrolide) and showed increased clearance but this effect was not seen with any other drug
Two studies demonstrated no difference in pregnancy rates in women who used oral contraceptives with and without non-rifamycin antibiotics
There was no observed differences in ovulation suppression or breakthrough bleeding in any study that combined hormonal contraceptives with any antibiotic
No significant decreases in any progestin pharmacokinetic parameter occurred during co-administration with any antibiotic
CONCLUSION:
Clinical and pharmacokinetic outcome studies do not support the existence of a drug interaction between hormonal birth control and non-rifamycin antibiotics
Authors do note that
There may be individual differences in drug metabolism and they suggest a small subset of women (likely <1%) may be at risk for hormonal contraceptive failure when taking antibiotics
Switching to another contraceptive or backup method if compliance is good and there is an unintended pregnancy
Obesity may play a role in drug metabolism that could impact these study results
IUDs and Implants: How to Manage Potential LARC Complications
Use of long-acting reversible contraceptive (LARC) methods, both intrauterine devices and subdermal contraceptive implants, has increased dramatically in the past ten years. Although the risk of complications is low, as use increases the absolute number of complications will increase.
CLINICAL ACTIONS:
Intrauterine device:
Pain
Lidocaine paracervical block reduces pain scores on insertion
Misoprostol does not improve pain scores and may be associated with nausea and vomiting
Strings not visualized
Rule out pregnancy and expulsion
Recommend backup contraception until IUD position can be verified
Ultrasound and X-ray of abdomen and pelvis can be used for localization
Possible expulsion
IUDs seen in the cervix are partially expelled and should be removed
Replacement or use of another method are both acceptable options
Low-lying IUDs (lower uterine segment) can be expectantly managed
Risk factors for expulsion include
Young age
Heavy menstrual bleeding and dysmenorrhea
Placement postpartum or post second trimester abortion
Presence of anatomic distortion of the uterine cavity
Uterine perforation
Is rare and generally asymptomatic
Usually occurs at the time of insertion
Do not use misoprostol routinely prior to insertion in nulliparous women but may be considered with difficult insertions
Rule out pregnancy and remove surgically unless the surgical risks of removal outweigh the benefits
PID
Can be treated with the IUD left in situ
Consider removal if no clinical improvement after 48-72 hours of antibiotics
Pregnancy with an IUD in place
Remove the IUD if the strings are visible or IUD within the cervix
IUD can be removed at time of procedure if patient elects termination
Evaluate for ectopic pregnancy
Implant:
Infection prevention
Use antiseptic technique and cover the insertion/removal site
Skin flora are the most common cause of infection
Remove implant if infection does not resolve
Bruising
Is common
Ice and anti-inflammatory medication can help
Nonpalpable implant
Locate with high frequency (>/= 10 MHz) ultrasound probe, two dimensional X-ray, or CT scan/fluoroscopy
Obtain a serum etonogestrel level if all studies are negative/equivocal
Refer to a surgeon with knowledge of the anatomy of the arm if implant is within muscle or neurovascular bundle
Pregnancy
Is rare
Remove the implant if the pregnancy is to be continued
Rule out ectopic pregnancy
SYNOPSIS:
LARCs are highly effective contraceptives with a low risk of complications. Those mentioned above should be discussed with patients as part of informed consent.
KEY POINTS:
Recognition and prompt diagnosis/treatment of the untoward outcomes described above are important aspects of care
Overall, complication rates are low and LARCs remain a very effective mode of birth control
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presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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