and should consider using a backup contraception or changing to a different method.
Irregular menses, decreased duration, and amount of menstrual flow, spotting, or
amenorrhea commonly occur in women taking the minipill.
associated with the minipill may mask underlying disease such as uterine fibroids or
uterine cancer causing irregular bleeding. Other side effects reported with minipills
include headaches, breast tenderness, mood changes, and nausea.
Minipills should be avoided if there is a personal history of breast cancer or
unexplained vaginal bleeding. Caution should be exercised when using minipills in
women with hepatic disease, multiple risk factors for cardiovascular diseases,
ischemic heart disease, a current deep venous thrombosis or PE, or complicated
diabetes (e.g., diabetes with nephropathy, neuropathy, retinopathy), or those taking
medications that may interact with COCs such as hepatic inducers, St. John’s-wort,
PATIENT INSTRUCTIONS FOR THE PROGESTIN-ONLY PILL
CASE 47-3, QUESTION 4: What instructions should P.K. receive regarding the use of a minipill?
P.K. may begin taking the minipill on the first day of her menses.
breast-feeding and recently postpartum, she is less likely to have a menses. She could
begin taking minipills immediately postpartum if she were not breast-feeding.
Because she is breast-feeding, it is recommended that she has to wait until 3 weeks
postpartum if partially breast-feeding and 6 weeks postpartum to begin minipills if
solely breast-feeding. If at 6 weeks postpartum, P.K. started her minipills on the first
day of her menses, a backup contraception is not needed with the day 1 start.
Alternatively, P.K. can use the quick start method, starting any day of her cycle and
using a backup method for 48 hours.
P.K. should be instructed to take the pill at the exact same time each day. If she is
more than 3 hours late taking a pill, she should take the pill as soon as she remembers
and should use backup contraception for 48 hours. This is quite different from the
directions for COCs, so this point should be stressed with patients.
Injectable Medroxyprogesterone Acetate
Progestin-only contraceptives are available in two different injectable formulations
of medroxyprogesterone acetate (MPA). Depo-Provera is given as a 150-mg
intramuscular injection in the deltoid or gluteus maximus every 11 to 13 weeks.
More recently, depo-subQ provera 104 was approved. This product also contains
MPA; however, it is given subcutaneously as a 104-mg dose every 12 to 14 weeks.
Injectable MPA inhibits ovulation, thickens the cervical mucus, and suppresses
endometrial growth, making it a very effective contraceptive. Package inserts instruct
the patient to begin the injectable MPA methods in the first 5 days of her menses and
then no backup is required; however, P.K. may also begin any other time and use
CASE 47-3, QUESTION 5: P.K. is now lactating and returns to the gynecology clinic for her second IM
advantages and disadvantages of injectable MPA? How are the side effects managed?
low failure rate of 0.3% to 3% (Table 47-1), ease of use, lack of estrogenic side
effects, decreased dysmenorrhea and monthly blood loss, and a reduced risk of
3,26 Other noncontraceptive benefits may include a reduction in
seizure frequency in epileptic patients and a possible reduction in ovarian cancer.
Furthermore, contraceptive efficacy is not reduced by the concurrent use of
anticonvulsants or certain antibacterials as is seen with COCs.
104 is also indicated for pain caused by endometriosis.
Patients with breast cancer should not use injectable MPA owing to concerns that
breast cancers are hormonally sensitive and the prognosis may worsen for some
Injectable MPA should be used with caution in women with unexplained
vaginal bleeding (MPA may cause irregular bleeding and may mask conditions
resulting in vaginal bleeding such as cervical or uterine cancer), multiple risk factors
for cardiovascular diseases, ischemic heart disease or multiple risk factors for
cerebrovascular disease, or a current VTE or PE (for medical eligibility, see
https://www.cdc.gov/mmwr/volumes/65/rr/rr6503a1.htm?s_cid=rr6503a1_w).
Because clotting factors have not been shown to be clinically affected by injectable
MPA, some experts disagree with the manufacturer’s labeling for the injectable MPA
products, which lists a history of prior thromboembolism as a
5–7,103,104 Some clinicians also begin injectable MPA immediately
postpartum rather than waiting 6 weeks postpartum, as directed by the package
Estrogen production declines in women using injectable MPA, so P.K. should be
told that injectable MPA may decrease bone mineral density (BMD).
may be of particular concern in adolescent patients. Numerous studies have found
that women receiving injectable MPA have lower BMD compared with nonusers.
Although there have been reports of stress fractures in injectable MPA users, no
studies to date have documented an increased rate of hip or vertebral fractures in
106 Also, BMD has been shown to recover after discontinuation
4 The manufacturer of both products recommends that patients do not
use injectable MPA longer than 2 years unless they are unwilling or unable to use
P.K. must understand that injectable MPA frequently causes irregular bleeding or
spotting during the first few months or more of use because estrogen is insufficient to
maintain the endometrium. After 1 and 2 years of Depo Provera use, 55% and 68% of
women experience amenorrhea, respectively.
103 With depo-subQ provera 104, 56.5%
of patients experienced amenorrhea after 1 year.
In addition, during the postpartum
period, irregular bleeding may occur as well. Although not harmful, amenorrhea
leads to discontinuation of injectable MPA in 13% of patients.
beginning injectable MPA should be informed that during the first year of use they
might have menstrual changes. If unusually heavy or continuous bleeding occurs, P.K.
should be evaluated. P.K. should be counseled and reassured that her intermenstrual
bleeding probably will resolve in the next few months. If the bleeding is bothersome,
a 4- to 21-day course of oral estrogen (e.g., conjugated estrogen 0.625–2.5 mg/day)
or a COC with 20 mcg of EE will minimize or eliminate the bleeding.
bleeding may recur after discontinuation of the estrogen. Low-dose estrogen may be
Weight gain is another concern with injectable MPA. The mean weight gain after 1
year of therapy with injectable MPA was about 5 lb in two-thirds of users.
103 DepoProvera users typically gain a total of about 8 lb in 2 years, nearly 14 lb in 4 years,
6 years. Depo-subQ provera users gain a little less weight, 3.5 lb in the first year
of use, and 7.5 lb after 2 years.
104 Other side effects include mood changes, hair loss,
and headaches. P.K. should be counseled on the weight gain associated with
injectable MPA. P.K. has already reported an increase in weight since she gave birth
3 months ago, which may be caused by injectable MPA, or possibly her weight is
fluctuating because of her recent delivery.
The long return to fertility time is another disadvantage of injectable MPA. After
the last injection of 150 mg of MPA, conception was delayed approximately 10
96 The remaining users took longer to become pregnant, with
nearly all users becoming pregnant by 18 months. There are less data on return of
fertility with the 104-mg dose of MPA. A small study showed that the median time to
ovulation was 10 months, with most women ovulating within 1 year of their last
104 Because P.K. is 35 years old, she should be counseled on the return to
fertility time with injectable MPA use in case she desired to have children in the near
future. She has indicated that she is not interested in having any more children;
however, the long return to fertility time with injectable MPA should be explained to
all women, especially those older than 35 years of age.
information should you give P.K.?
The contraceptive implant (Nexplanon) contains 68 mg of etonogestrel in a single,
107 The rod is inserted subdermally in the upper inner arm using
a needle and a local anesthetic. Once inserted, the implant is effective for up to 3
years. Nexplanon should be inserted during the first 5 days of menses, and no backup
contraception is required. A small incision is required to remove the implant. The
etonogestrel implant has the same mechanism of action as injectable MPA. The
product was first marketed as Implanon; however, Implanon was not radiopaque and
at times difficult to locate for removal. The radiopaque property of Nexplanon is
preferred for ease of removal; therefore, Implanon is no longer manufactured.
The contraceptive implant is a relatively new product, so information on its
protection against cancers or effects on other diseases such as cardiovascular disease
is limited. Women using the implant reported amenorrhea, decreased menstrual
cramping, and less anemia than nonusers.
3 Also, decreases in BMD have not been
shown with this product. Fertility returns quickly after the removal of the implant,
and this will be a benefit to P.K. if she decides to have another child, given her age.
As with the injectables, irregular bleeding is likely and is the most common cause of
discontinuation. Side effects reported with the implant are headaches, mood changes,
and acne. Nexplanon is not recommended for patients on medications that induce
hepatic enzymes (e.g., anticonvulsants) as they may decrease contraceptive efficacy.
Weight gain is also common, with users gaining 2.8 lb after 1 year and 3.7 lb after 2
108 So P.K. may still experience weight gain with this product. The implant is
not recommended for patients with a current VTE; however, it may be used in
patients with a personal or family history of VTE.
INTRAUTERINE DEVICE AND INTRAUTERINE
Background and Mechanism of Action
Despite concerns (increased risk of PID, tubal scarring, and infertility) with early
IUDs, also known as intrauterine contraceptives (IUCs), the current devices offer a
safe and effective method of contraception.
110 Currently, there are four products on
the market that include the ParaGard T 380A (copper) IUD, Mirena, Skyla, Kyleena,
and Liletta (levonorgestrel) IUSs. Although the IUDs and IUSs available today are a
safe and effective method of contraception, they are still not as popular in the United
States (1%–6% of women are users) as they are worldwide (12% of married women
of reproductive age are users).
The copper IUD has a polyethylene body that is wound with copper wire. Once
inserted, the copper IUD may be left in place for 10 years.
Kyleena, and Liletta IUSs also have polyethylene bodies, with levonorgestrel
reservoirs in the vertical stem of the T that provide levonorgestrel daily. Mirena and
Kyleena are effective for 5 years and provide 20 mcg and 17.5 mcg of levonorgestrel
114,115 Skyla is slightly smaller in size and provides 14 mcg of
levonorgestrel daily after 24 days and is effective for up to 3 years.
Liletta is effective for 3 years and provides levonorgestrel 18.6 mcg daily,
decreasing to 16.3 mcg at 1 year, 14.3 mcg at 2 years, and 12.6 mcg at 3 years.
Failure rate of the copper IUD is 0.6% to 0.8% for the first year compared with
0.2% for the levonorgestrel IUS (Table 47-1). Both IUDs and IUSs are inserted by a
healthcare provider in the office. The procedure usually takes only a few minutes and
does not require sedation. Many providers will recommend that patients take a dose
of an NSAID before the insertion visit.
Possible mechanisms of action for copper IUDs include prevention of fertilization
and implantation and the copper interfering with sperm transport, viability, or
113 The levonorgestrel IUS is believed to work by thickening the cervical
mucus, preventing sperm from entering the uterus, altering the endometrial lining,
preventing ovulation, and altering sperm activity.
3 The copper IUD is a particularly
beneficial option for women who desire a nonhormonal method of contraception. The
levonorgestrel IUS has the advantages of reducing menstrual bleeding and cramping
Although the initial cost of inserting an IUD or IUS is high (around $500 for the
device plus insertion costs), there are no ongoing monthly costs to P.K. as there are
with other methods. Therefore, the IUD or IUS becomes more cost-effective when
Menstrual changes are the most common side effect of IUDs and IUSs.
users are more likely to have heavier menstrual bleeding and cramping.
Levonorgestrel users should expect to have irregular bleeding and spotting during the
first 3 months after insertion. After 3 months, however, levonorgestrel IUS users
report lighter menses and reduced cramping.
Both IUDs and IUSs are contraindicated in women with certain anatomic
abnormalities of the uterus (e.g., distortion of the uterus, cervical stenosis, or
cervical lacerations), unexplained vaginal bleeding, cervical cancer, and PID or
other active genital infections. They should be used with caution in women who are
HIV-positive or are immunosuppressed (for medical eligibility, see
https://www.cdc.gov/mmwr/volumes/65/rr/rr6503a1.htm?s_cid=rr6503a1_w).
The levonorgestrel IUSs should be used with caution in women with a current VTE
or PE. Although the serum levels of levonorgestrel are low, the manufacturers
currently do not recommend that women with active or past breast cancer use the
Both IUDs and IUSs are preferred for women in monogamous relationships or who
are able to have strict use of condoms as IUD users are more likely to experience
PID than nonusers. For all patients, the greatest risk of PID occurs shortly after
118 To prevent this from occurring, all patients should be tested for
gonorrhea and chlamydia before IUD or IUS insertion and evaluated for risk factors
of contracting STIs (e.g., multiple partners, unprotected intercourse). Women who
are positive for an STI should consider an alternative form of contraception until the
infection has resolved. Alternatively, once treatment is provided, an IUD or IUS may
be initiated and the woman counseled on ways to prevent STIs.
If an IUD or IUS user becomes pregnant, the likelihood that the pregnancy is
ectopic is higher (i.e., the ratio of ectopic to uterine pregnancies is higher in IUD or
113,114 Common complaints of IUD use include excessive uterine bleeding,
spotting, or pain. The device may be removed as a result of these issues. Spontaneous
expulsion of the IUD occurs in about 2% to 6% of women within the first year.
Rarely, an IUD or IUS may become embedded in the endometrium or partially or
totally perforate the uterine wall. P.K. should be instructed to look for the warning
signs of a possible complication with IUD or IUS use, such as abdominal pain or
OTHER NONHORMONAL CONTRACEPTION
QUESTION 1: C.J. is a 22-year-old HIV+ woman presenting to the clinic for routine checkup and depot
Respiratory rate, 12 breaths/minute
Laboratory test results: CD4, 581
HIV-1 RNA, <75 copies/mL (undetectable)
The diaphragm is a soft latex or silicone rubber cap with a metal spring reinforcing
3 The device is inserted vaginally and placed over the cervical os to
mechanically block access of sperm to the cervix. The diaphragm is held in place by
the spring tension of the rim, vaginal muscle tone, and the pubic bone.
A cervical cap marketed as FemCap is made of silicone.
place by suction formed between the cervix and the device. Because all of these
devices do not fit tightly enough to be a complete barrier to sperm, spermicidal gel
must be applied to each device before it is inserted.
The first-year failure rate with diaphragms is 6% to 16% (Table 47-1).
should be counseled that diaphragms are less effective than other available methods.
Because breast-feeding offers some protection against pregnancy, breast-feeding
women may be the best candidates for the diaphragm. Failure rates of cervical caps
range from 9% to 16% in nulliparous women and 20% to 32% in parous women
3 Studies of an earlier version of the FemCap found a failure rate of
about 14% and about 8% for the second-generation FemCap.
Diaphragms must be properly fitted to be effective. They are available in different
sizes (50–95 mm in diameter) and different styles of construction of the circular rim.
The goal of fitting a diaphragm is to select the largest rim size that is comfortable for
3 A diaphragm that is too small may become dislodged during intercourse
because vaginal depth increases during sexual arousal. Conversely, a diaphragm that
is too large may cause vaginal pressure, abdominal pain or cramping, vaginal
ulceration, or recurrent urinary tract infections. Proper size is estimated during
bimanual examination, and several diaphragm sizes may need to be tried by the
healthcare provider to find the right size for the patient. If C.J. gains or losses 10 to
20 lb, has a pregnancy, or has abdominal or pelvic surgery, the diaphragm would
The FemCap is shaped like a sailor’s hat
(see http://www.femcap.com/). It is
available in three sizes, and size selection depends on the patient’s pregnancy
history; the 22-mm FemCap is for patients who have never been pregnant, the 26-mm
one is for women who have miscarried or had a cesarean section, and the 30 mm size
is for women who have vaginally delivered a full-term baby.
C.J. would likely be able to tolerate the diaphragm or FemCap. Fitting will depend
on the device that she selects. These barrier methods, however, do not protect against
STIs, which is important to C.J. when selecting her barrier method, and therefore, are
PATIENT INSTRUCTIONS, ADVANTAGES, AND DISADVANTAGES
The diaphragm and FemCap offer pregnancy prevention without the use of hormones,
and women only need to use the devices when they are sexually active.
these devices are available only by prescription, should not be used during
menstruation, may be difficult to insert and remove for some patients, and are not as
effective as the hormonal methods or IUD. All devices should be inspected for holes
or puckering (small areas of wrinkle) before use.
The diaphragm should not remain in the vagina for more than 24 hours.
shock syndrome (TSS) has been associated with diaphragm use, and women should
be alert to its symptoms, which include fever, diarrhea, vomiting, muscle aches, and
a sunburn-like rash. Allergic reactions to the latex or spermicides also have been
The diaphragm should always be inserted before intercourse; it can be inserted as
long as 6 hours before intercourse if desired.
3 The diaphragm should not be removed
for at least 6 hours after intercourse. One teaspoon of spermicidal gel should be
placed into the dome of the diaphragm before insertion. If intercourse is repeated, a
new application of spermicide should be inserted vaginally without removal of the
To use the FemCap, first apply about one-fourth teaspoon of spermicide inside the
bowl and one-half teaspoon on the other side that will face the vagina (between the
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