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Half of all pregnancies each year in the United States are unin- tended (Finer,
2011). These may follow contraceptive method failure or stem from lack of
contraceptive use. Specifically, 10 percent of sexually active American women not
pursuing preg- nancy did not use any birth control method (Jones, 2012). And, for
sexually active fertile women not using contraception, pregnancy rates approach
90 percent at 1 year.
For those seeking contraception, various effective contracep- tive methods are
available. Preferences of United States women are shown in Table 38-1. With
these methods, wide variations are seen between estimated failure rates of perfect
and typical use during the first year. Similarly, the World Health Organization
(WHO) has grouped methods according to effectiveness tiers that reflect these
failure rates (Table 38-2). Implants and intra- uterine devices are found in the top
tier. They are effective in lowering unintended pregnancy rates and are considered
long-acting reversible contraception (LARC) (Winner, 2012).
In the US MEC, reversible contraceptive methods are orga- nized into six groups
by their similarity: combination hormonal contraceptives (CHCs), progestin-only
pills (POPs), depot medroxyprogesterone acetate (DMPA), implants, levonorg-
estrel-releasing intrauterine system (LNG-IUS), and copper intrauterine devices
(Cu-IUDs). For a given health condition, each method is categorized 1 through 4.
The score describes a method’s safety profile for a typical woman with that
condition:
TABLE 38-2. Contraceptive Failure Rates During the First Year of Method Use
in Women in
Method
Percentage
the United States
Methoda
Intrauterine devices
Condom Male
Ovulation
Fourth Tier: Least Effective
Spermicides Sponge
Parous women
No WHO Category
Withdrawal No contraception
Perfect Use
0.5 0.1
Typical Use
0.5 0.15
Female sterilization
16.5
Male sterilization
6.2
Combination pill
Implants or patch
DMPA
17.1
Progestin-only pill
0.4
Levonorgestrel system
0.9
T 380A copper
0.6 0.8
2.3
0.05 0.05
Vaginal ring
1.3
Intrauterine devices
3.5
Male condom
10.2
Periodic abstinence
Calendar method
a
Methods using physiological changes to signal ovulation.
0.6
0.3 9
0.1
Withdrawal
3.2
Other methodsb
0.3
37.8
0.3 9
b
Includes diaphragm, female condom, cervical cap,
contraception.
c
Includes those seeking pregnancy, surgically sterilized
0.3 9
Standard days
6 12
24
Two day
Symptothermal
0.4
18 28
(1) no restriction of method use, (2) method advantages out- weigh risks, (3)
method risks outweigh advantages, and (4) method poses an unacceptably high
health risk.
0.3 9 0.2 6
218 521
20 24
4 22
Nulliparous women
9 12
85 85
a
Methods organized according to tiers of efficacy by World Health Organization
(WHO), Johns Hopkins Bloomberg School of Public Health, 2007.
DMPA
depot medroxyprogesterone acetate.
Data from Trussell, 2011a.
The third device is the T 380A IUD, named ParaGard. It has a polyethylene and
barium sulfate T-shaped frame wound with copper, and two strings extend from
the stem base. Originally
0.2 0.2
SECTION 10
Contraception 697
AB
FIGURE 38-1 Intrauterine devices (IUDs). A. ParaGard T 380A cop- per IUD. B.
Mirena levonorgestrel-releasing intrauterine system.
blue, the strings are now white. It is currently approved for 10 years of use
following insertion (Teva Women’s Health, 2011). In addition to these three
currently marketed, women may retain discontinued brands of IUD. A Lippes
Loop has two “S” shapes stacked one on the other. The Dalkon Shield has a crab
form, whereas a Copper 7 mirrors that number. Progestasert is an early T-shaped
progestin-releasing IUD. Last, various metal-
■ Contraceptive Action
All these IUDs are effective. Failure rates are well below 1 per- cent and similar
overall to those of tubal sterilization (American College of Obstetricians and
Gynecologists, 2013a; Thonneau, 2008; Trussell, 2011b). Their mechanisms have
not been pre- cisely defined, but prevention of fertilization is now favored. Within
the uterus, an intense local endometrial inflammatory response is induced,
especially by copper-containing devices. Cellular and humoral components of this
inflammation are expressed in endometrial tissue and in fluid filling the uterine
cavity and fallopian tubes. These lead to decreased sperm and egg viability (Ortiz,
2007). Also, in the unlikely event that fertil- ization does occur, the same
inflammatory actions are directed against the blastocyst. The endometrium is
transformed into a hostile site for implantation. With the copper IUD specifi-
cally, copper levels increase in the cervical mucus of users and decrease sperm
motility and viability (Jecht, 1973). With the LNG-IUS, in addition to an
inflammatory reaction, long-term progestin release leads to endometrial atrophy,
which hinders normal implantation. Moreover, progestins create scant viscous
cervical mucus that obstructs sperm motility. The LNG-IUS may also
inconsistently release sufficient progestin to inhibit ovulation, although this is a
lesser effect than its local actions.
Perforation
During uterine sounding or IUD insertion, the uterus may be perforated, which is
identified by the tool traveling further than the expected uterine length based on
initial bimanual exami- nation. Rates approximate 1 per 1000 insertions, and risks
include puerperal insertion, lactation, provider inexperience, and extremes of
uterine flexion (Harrison-Woolrych, 2003). Although devices may migrate
spontaneously into and through the uterine wall, most perforations occur, or at
least begin, at the time of insertion.
With the more common fundal perforation, bleeding typi- cally is minimal due to
myometrial contraction around the site. If no brisk or persistent bleeding is noted
from the os following instrument removal, then patient observation alone is
reason- able. Rarely, lateral perforations may lead to uterine artery lac- eration and
brisk bleeding, which may prompt laparoscopy or laparotomy for control.
Following any perforation, although this is not firmly evidence-based, a single
dose of broad- spectrum antibiotic may mitigate infection.
Lost Device
Expulsion of an IUD from the uterus is most common during the first month.
Thus, women should be examined approximately 1 month following IUD
insertion, usually after menses, to identify the tails trailing from the cervix.
Following this, a woman should be instructed to palpate the strings each month
after menses.
If the tail of an IUD cannot be visualized, the device may have been expelled, may
have perforated the uterus, or may be malpositioned. Some have found that IUD
perforation, rotation, or embedding may cause pain or bleeding (Benacerraf, 2009;
Moschos, 2011). Alternatively, the device may be normally posi- tioned with its
tail folded within the endocervical canal or uterine cavity. To investigate, after
excluding pregnancy, a cytological brush can be twirled within the endocervical
canal to entangle the strings and bring them gently into the vagina. If unsuccessful,
the uterine cavity is probed gently with a Randall stone clamp or with a
specialized rod with a terminal hook to retrieve the strings.
It should never be assumed that the device has been expelled unless it was seen.
Thus, if tails are not visible and the device is not felt by gentle probing of the
uterine cavity, transvaginal sonography can be used to ascertain if the device is
within the uterus. Although traditional sonography will document IUD position
adequately in most cases, three-dimensional sonography offers improved
visualization, especially with the levonorgestrel- releasing IUD (Moschos, 2011).
If sonography is inconclusive or if no device is seen, then a plain radiograph of the
abdomi- nopelvis is taken. Computed tomography (CT) scanning or less
commonly, magnetic resonance (MR) imaging is an alternative (Boortz, 2012). It
is safe to perform MR imaging at 1.5 and 3 Tesla (T) with an IUD in place
(Pasquale, 1997; Zieman, 2007).
CHAPTER 38
698 The Puerperium
TABLE 38-3. Contraindications and Cautions with Specific Contraceptive
Methods Condition CHCa
444 444
21 days 4
21–42 days
35 yr
5 yr
3/4c
33333
3/4d
Rifampin/rifabutin
4 4 4 44
434343
3/4d
3/4d
3/4d
20 yr
3/4d
3e 3
2/3d
43333
Condition S/C
444444
2/3b
4 3 3 33
44
33
44
33
44
3333
3
S/C
Start/Continue (S/C)h
S/C
S/C
S/C
S/C
2/3
3/3
2/3
2/3
2/3
3/3
2/3
2/3
2/3
2/3
2/3
35 yr
2/3
35 yr
3/4
4/2
4/2
4/2
4/2
4/2
4/2
2/3j
4/2
4/2
4/2
3/2
3/2
4/3
4/3
SECTION 10
Contraception 699
Condition
S/C
a
Combination hormone contraception (CHC) group includes pills, vaginal ring,
and patch.
S/C
Start/Continue (S/C)h
S/C
S/C
S/C
S/C
3/2
3/2
3/2
b
Associated risks that increase category score include: age
g
These include phenytoin, barbiturates, carbamazepine, oxcarbazepine, primidone,
topiramate.
h
In those methods under Start/Continue columns, the first US MEC number refers to
whether a
method may be initiated in an affected patient. For patients who initially develop the
condition
30,
while using a specific method, the second number refers to risks for continuing
that method. iPrior to evaluation.
jThose on chronic corticosteroids and at risk for
bone fracture.
t-
m
Adapted from Centers for Disease Control and Prevention, 2010b, 2011,
2013.
A device may penetrate the muscular uterine wall to vary- ing degrees. Those with
a predominantly intrauterine loca- tion are typically managed by hysteroscopic
IUD removal. In contrast, devices that have nearly or completely perfo- rated
through the uterine wall are more easily removed lapa- roscopically. Chemically
inert devices usually are removed easily from the peritoneal cavity. An
extrauterine copper- bearing device, however, frequently induces an intense local
inflammatory reaction and adhesions. Thus, copper IUDs may be more firmly
adhered. Laparotomy may be necessary, and bowel preparation is considered.
Perforations of large and small bowel and bladder and bowel fistulas have been
reported remote from insertion (Lyon, 2012; Mascarenhas, 2012; Zeino, 2011).
Menstrual Changes
Women who choose the copper IUD should be informed that dysmenorrhea and
menorrhagia may develop. These are often treated with nonsteroidal
antiinflammatory drugs (NSAIDs) (Grimes, 2006). Heavy bleeding may cause
iron deficiency ane- mia, for which oral iron salts are given (Hassan, 1999).
With the LNG-IUS, women are counseled to expect irregu- lar spotting for up to 6
months after placement, and there- after to expect monthly menses to be lighter or
even absent (Bayer HealthCare Pharmaceuticals, 2013a). Specifically, the Mirena
device is associated with progressive amenorrhea, which is reported by 30 percent
of women after 2 years and by 60 per- cent after 12 years (Ronnerdag, 1999). This
is often associated with improved dysmenorrhea.
Infection
The device-related infection risk is increased only during the first 20 days
following insertion (Farley, 1992). Of those who develop an infection during this
time, most usually have an unrecognized coexistent cervical infection.
Accordingly, women at risk for sexually transmitted diseases (STDs) should be
screened either before or at the time of IUD insertion (Centers for Disease Control
and Prevention, 2010a; Sufrin, 2012). That said, device insertion need not be
delayed while awaiting Neisseria gonorrhoeae, Chlamydia trachomatis, or PAP
screen- ing results in asymptomatic women. If these bacteria are found and the
patient is without symptoms, then the IUD may remain and treatment prescribed
as detailed in Chapter 65 (p. 1269). Importantly, routine antimicrobial prophylaxis
before insertion is not recommended (Grimes, 2001; Walsh, 1998). Moreover, the
American Heart Association does not recommend infective endocarditis
prophylaxis with insertion (Wilson, 2007).
After these first 3 weeks, infection risk is not increased in IUD users who would
otherwise be at low risk of STDs. Correspondingly, IUDs appear to cause little, if
any, increase in the risk of infertility in these low-risk patients (Hubacher, 2001).
For these reasons, the American College of Obstetricians and Gynecologists
(2011a, 2012a) recommends that women at low risk for STDs, including
adolescents, are good candidates for IUDs (Table 38-3). The IUD is also safe and
effective in HIV- infected women and may be used in others who are immuno-
suppressed (Centers for Disease Control and Prevention, 2012).
If infection does develop, it may take several forms and typically requires broad-
spectrum antimicrobials. Septic
CHAPTER 38
700 The Puerperium
If the tail is not visible, attempts to locate and remove the device may result in
abortion. However, some practitioners have successfully used sonography to assist
in device removal in cases without visible strings (Schiesser, 2004). After fetal
viabil- ity is reached, it is unclear whether it is better to remove an IUD whose
string is visible and accessible or to leave it in place. There is no evidence that
fetal malformations are increased with a device in place (Tatum, 1976).
■ Insertion Timing
Immediately following miscarriage, surgical abortion, or delivery, an IUD may be
inserted in the absence of infec- tion. Also, Shimoni and colleagues (2011)
describe “immedi- ate” insertion 1 week after medical abortion. The risk of IUD
expulsion is slightly higher if it is placed immediately follow- ing any of these
recent pregnancies. That said, the advantages of preventing future unplanned
pregnancies appear to out- weigh this (Bednarek, 2011; Chen, 2010; Grimes,
2010a; Steenland, 2011).
Insertion techniques depend on uterine size. After first- trimester evacuation, the
IUD can be placed using the manufac- turer’s standard instructions. If the uterine
cavity is larger, the IUD can be placed using ring forceps with sonographic guid-
ance (Stuart, 2012). Immediately following vaginal or cesarean delivery, an IUD
can be placed by hand or with an instrument (Grimes, 2010b). To reduce
expulsion rates and to minimize the perforation risk, some may choose to wait for
complete involution—at least 6 weeks after delivery. Women delivered at
Parkland Hospital are seen 3 weeks postpartum, and IUDs are inserted 6 weeks
postpartum or sooner if involution is complete.
For placement not related to pregnancy, insertion near the end of normal
menstruation, when the cervix is usually softer and somewhat more dilated, may
be easier and at the same time may exclude early pregnancy. But, insertion is not
limited to this time. For the woman who is sure she is not pregnant and does not
want to be pregnant, insertion is done at any time.
Technique
Before insertion, several procedural steps are carried out. Any contraindications
are identified. If there are none, the woman is counseled and written consent
obtained. An oral NSAID, with or without codeine, can be used to allay cramps
(Karabayirli, 2012). Strong evidence does not support an advantage to
supplemental misoprostol, intrauterine or cer- vical canal instillation of lidocaine,
or paracervical blockade to lessen insertional pain (McNicholas, 2012; Nelson,
2013; Swenson, 2012). Bimanual pelvic examination is performed to identify
uterine position and size. Abnormalities are evaluated, as they may contraindicate
insertion. Mucopurulent cervici- tis or significant vaginitis should be appropriately
treated and resolved before IUD insertion.
The cervical surface is cleansed with an antiseptic solution, and sterile instruments
and a sterile IUD should be used. A tenaculum is placed on the cervical lip, and
the canal and uter- ine cavity are straightened by applying gentle traction. The
uterus is then sounded to identify the direction and depth of the uterine cavity.
Specific steps of ParaGard and Mirena inser- tion are shown in Figures 38-2 and
38-3 and outlined in their respective package inserts.
Following insertion, only the threads should be visible trail- ing from the cervix.
These are trimmed to allow 3 to 4 cm to protrude into the vagina, and their length
is recorded. If there is suspicion that the device is not positioned correctly, then
placement should be confirmed, using sonography if necessary.
SECTION 10
AB
Arm
ms
Contraception 701
rel
cervix
eased
Inserte
er tube
IUD
Fla
a
ge 1.5 cm
nge
Flan from
Slider
Handle e
Slide
back
String
s in cleft
Inserter tube
advan
nced
Aft
ter slider
oved back,
in
serter tube
Flan
ge
rem
abut
moved
s cervix
Sl l
ider
ack
D fro
moved b
Strin ngs
relea ased
m cleft
FIGURE 38-2 Insertion of the Mirena intrauterine system. Initially, threads from behind
the slider are first released to hang freely. The slider found on the handle should be
positioned at the top of the handle nearest the device. The IUD arms are oriented horizon-
tally. A flange on the outside of the inserter tube is positioned from the IUD tip to reflect
the depth found with uterine sounding.
A. As both free threads are pulled, the Mirena
IUD is drawn into the inserter tube. The threads are then tightly fixed from below into the
handle’s cleft. In these depictions, the inserter tube has been foreshortened. The inserter
tube is gently inserted into the uterus until the flange lies 1.5 to 2 cm from the external
cervical os to allow the arms to open. B. While holding the inserter steady, the IUD arms
are released by pulling the slider back to reach the raised horizontal mark on the handle,
but no further. C. The inserter is then gently guided into the uterine cavity until its flange
touches the cervix. D. The device is released by holding the inserter firmly in position
and pulling the slider down all the way. The threads will be released automatically from
the cleft. The inserter may then be removed, and IUD strings trimmed.
CHAPTER 38
702 The Puerperium
Base of IUD
Inserter tube
Tip of inserter
Flange
rod
AB
CD
FIGURE 38-3 Insertion of ParaGard T 380A. The uterus is sounded, and the IUD is
loaded into its inserter tube not more than 5 minutes before insertion. A blue plastic
flange on the outside of the inserter tube is positioned from the IUD tip to reflect uterine
depth. The IUD arms should lie in the same plane as the flat portion of the oblong blue
flange. A. The inserter tube, with the IUD loaded, is passed into the endometrial cavity. A
long, solid, white inserter rod abuts the base of the IUD. When the blue flange contacts
the cervix, insertion stops. B. To release the IUD arms, the solid white rod within the
inserter tube is held steady, while the inserter tube is withdrawn no more than 1 cm. C.
The inserter tube, not the inserter rod, is then carefully moved upward toward the top of
the uterus until slight resis- tance is felt. At no time during insertion is the inserter rod
advanced forward. D. First, the solid white rod and then the inserter tube are withdrawn
individually. At completion, only the threads should be visible protruding from the
cervix. These are trimmed to allow 3 to 4 cm to extend into the vagina.
SECTION 10
If the IUD is not positioned completely within the uterus, it is removed and
replaced with a new device. An expelled or par- tially expelled device should not
be reinserted.
■ Levonorgestrel Implants
The first progestin implants contained levonorgestrel, and systems are still
available outside the United States. Jadelle, originally named Norplant-2, provides
levonorgestrel and con- traception for 5 years through two subdermally implanted
Silastic rods. After this time, rods may be removed and if desired, new rods
inserted at the same site (Bayer Schering Pharma Oy, 2010). Jadelle is approved
by the FDA, however, it is not marketed or distributed in the United States
(Population Council, 2013). Sino-implant II is a two-rod implant with the same
amount (150 mg) of levonorgestrel and same mecha- nism of action as Jadelle but
provides 4 years of contraception (Shanghai Dahua Pharmaceutical, 2012). Sino-
implant II is manufactured in China and approved for use by several coun- tries in
Asia and Africa.
Both implant systems are highly effective, and the mecha- nism of action for
progestin-only products is described on page 704. Like the etonogestrel implant,
these systems are placed subdermally on the inner arm approximately 8 cm from
the elbow and have similar removal steps. Implants vary regard- ing their insertion
technique, and manufacturer instructions should be consulted.
The forerunner of these implants was the Norplant System, which provided
levonorgestrel in six Silastic rods implanted subdermally. The manufacturer
stopped distributing the sys- tem in 2002.
■ Insertion Timing
For those not currently using hormonal contraception, the etonogestrel implant is
ideally inserted within 5 days of menses onset. If inserted later in the cycle, then
alternative contracep- tion is recommended for 7 days following placement. With
levonorgestrel-releasing implants, contraception is established within 24 hours if
inserted within the first 7 days of the men- strual cycle (Sivin, 1997; Steiner,
2010). For transitioning methods, an implant is placed on the day of the first
placebo COC pill; on the day that the next DMPA injection would be due; or
within 24 hours of taking the last POP (Merck, 2012a). Related to pregnancy, an
implant may be inserted before dis- charge following delivery, miscarriage, or
abortion.
With sterile implant removal, the proximal end of the implant is depressed with a
finger to allow the distal end to bulge toward the skin. After anesthetizing the skin
over this bulge, the skin is incised 2 mm toward the elbow along the long axis of
the arm. The proximal butt of the implant is then pushed toward this incision.
Once visible, the distal implant is grasped with a hemostat and removed. If
present, superficial
Contraception 703
CHAPTER 38
704 The Puerperium
ABCD
FIGURE 38-4 Nexplanon insertion. A sterile pen marks the insertion site, which is 8 to
10 cm proximal to the medial humeral con- dyle. A second mark is placed 4 cm
proximally along the arm’s long axis. The area is cleaned aseptically, and a 1-percent
lidocaine anesthetic track is injected along the planned insertion path. A. The insertion
device is grasped at its gripper bubbles found on either side, and the needle cap is
removed outward. The device can be seen within the needle bore. The needle bevel then
pierces the
skin at a 30-degree angle. B. Once the complete bevel is subcutaneous, the
needle is quickly angled downward to lie horizontally.
C. Importantly, the skin is tented
upward by the needle as the needle is slowly advanced horizontally and subdermally. D.
Once the needle is completely inserted, the lever on the top of the device is pulled
backward toward the operator. This retracts the needle and thereby deposits the implant.
The device is then lifted away from the skin. After placement, both patient and operator
should palpate the 4-cm implant.
Progestin-only methods do not impair milk production and are an excellent choice
for lactating women. There are no increased risks of genital tract or breast
neoplasia (Wilailak, 2012; World Health Organization, 1991a,b, 1992). Weight
gain and bone mineral density loss are not prominent side effects of this
contraceptive group, except for DMPA, as noted on page 711 (Funk, 2005; Lopez,
2011). Functional ovar- ian cysts develop with a greater frequency in women
using progestin-only agents, although they do not usually necessi- tate intervention
(Brache, 2002; European Society of Human Reproduction and Embryology,
2001). Last, an association between depression and DMPA or POPs is unclear
(Civic, 2000; Svendal, 2012; Westhoff, 1995). Women with depres- sion may be
prescribed these methods, but surveillance follow- ing initiation is reasonable.
There are a few instances in which manufacturer restric- tions differ from the US
MEC. First, manufacturer prescribing information lists thrombosis or
thromboembolic disorders as contraindications (Merck, 2012a; Pfizer, 2012).
However, for individuals with these disorders, US MEC considers progestin-
containing methods category 2. Second, for many progestin products,
manufacturers note prior ectopic pregnancy as a contraindication. This is
secondary to progesterone’s effect to slow fallopian tube motility and thereby
delay fertilized egg transport to the endometrial cavity. But again, US MEC
considers progestin injectables and implants category 1, and progestin-only pills
are category 2 for those with prior ectopic pregnancy.
SECTION 10
COCs also contain one of several progestins that are struc- turally related to
progesterone, testosterone, or spironolactone. Thus, these progestins bind variably
to progesterone, andro- gen, estrogen, glucocorticoid, and mineralocorticoid
receptors. These affinities explain many pill-related side effects and are often used
to compare one progestin with another.
Most progestins used in COCs are related to testoster- one and may impart
androgenic side affects such as acne and adverse HDL and LDL levels. To avoid
these effects, progestins more structurally similar to the progestone molecule have
been developed. Medroxyprogesterone acetate is one example, but it is mainly
used in a progestin-only injectable form. Another, nomegestrol acetate, is used in a
COC approved outside the
Since the development of COCs, their estrogen and pro- gestin content has
dropped remarkably to minimize adverse effects. Currently, the lowest acceptable
dose is limited by the ability to prevent pregnancy and to avoid unacceptable
breakthrough bleeding. Thus, the daily estrogen content var- ies from 10 to 50 g
of ethinyl estradiol, and most contain 35 g or less.
With COCs termed monophasic pills, the progestin dose remains constant
throughout the cycle. In others, the dose fre- quently is varied, and terms biphasic,
triphasic, or quadriphasic pill are used depending on the number of dose changes
within the cycle. In some formulations, the estrogen dose also var- ies. In general,
phasic pills were developed to reduce the total progestin content per cycle without
sacrificing contraceptive efficacy or cycle control. The theoretical advantage of a
lower total progesterone dose per cycle has not been borne out clini- cally
(Moreau, 2007). Cycle control also appears to be compa- rable among mono-
through triphasic pills (van Vliet, 2006, 2011a,b).
Administration
Hormones are taken daily for a specified time (21 to 81 days) and then replaced by
placebo for a specified time (4 to 7 days), which is called the “pill-free interval.”
During these pill-free days, withdrawal bleeding is expected.
With the trend to lower estrogen doses to minimize side effects, there is concern
for follicular development and ovula- tion. To counter this, the active-pill duration
in some formu- lations is extended to 24 days. And, these 24/4 regimens do appear
to reduce ovulation and breakthrough bleeding rates (Fels, 2013).
Contraception 705
CHAPTER 38
706 The Puerperium
Monophasic Preparations
20–25 m
g estrogen
Yaz, Loryna EE EE
20 (24)
Beyazb
20 (24)
3.00 (24)
Loestrin Fe 1/20c
, Gildess Fe 1/20c
EE 20 Levonorgestrel
0.10
, Junel Fe 1/20c,
Microgestin Fe 1/20c
Loestrin 24 Fec EE
30–35 m
g estrogen
20 (24)
Norethindrone acetate
1.00 (24)
EE 30 Desogestrel
0.15
Yasmin, Syeda
Safyralb
Kelnor, Zovia 1/35
EE 35 Ethynodiol diacetate
1.00
EE 30 Norgestrel
0.30
EE 35 Norethindrone 0.40
, Junel Fe 1.5/30c
, Microgestin Fe
EE 35 Norethindrone 0.50
Dasetta 1/35
EE 35 Norethindrone 1.00
Loestrin 1.5/30, Junel 1.5/30, Microgestin 1.5/30 EE 30 Norethindrone acetate
1.50 Loestrin Fe 1.5/30c EE 30 Norethindrone acetate 1.50
1.5/30c
Gildess Fe 1.5/30c
EE 35 Norgestimate
0.25
50 m
g estrogen
Ogestrel
EE 50 Norgestrel
0.50
Zovia 1/50
EE 50 Ethynodiol diacetate
g estrogen
1.00
Norinyl
20 m
g estrogen
10 (24)
10 (2)
25 mg estrogen
0 (2)
10 (5)
0.215 (7)
0.25 (7)
30–35 mg estrogen
0.125 (7)
0.15 (7)
0.25 (7)
30 (10)
0.125 (10)
1
SECTION 10
Contraception 707
Product Name
Estrostepc
, Tri-Legestc
Extended-Cycle Preparations
g estrogen
Estrogen
None
mg (days)a
Progestin
mg (days)
EE
20 (5)
30 (7)
Norethindrone acetate
Tri-Norinyl, Aranelle
Natazia
Progestin-Only Preparations
EE
EE
EV
35
35
Norethindrone
Dienogest
1.00
35 (9)
0.50 (7)
0.75 (7)
1.0 (7)
Norethindrone
0.50 (7)
1.00 (9)
3
(2
)
2
(5
)
2.00 (5)
2 (17) 1 (2)
3.00 (17)
Norethindrone
0.35 (c)
20 m LoSeasoniqued
30 m
g estrogen
EE
20 (84)
10 (7)
Seasonaled, Quasensed
EE
30 (84)
Levonorgestrel
0.15 (84)
Seasoniquee
Continuous Preparation
EE
Amethystf
EE
30 (84)
10 (7)
Levonorgestrel
0.15 (84)
20 (28)
Levonorgestrel
0.09
b
0.451 mg of levomefolate calcium, which is a form of folic acid, is found in each
pill.
For general initiation, women should ideally begin COCs on the first day of a
menstrual cycle. In such cases, a supplemen- tary contraceptive method is
unnecessary. With the more tra- ditional “Sunday start,” women begin pills on the
first Sunday that follows menses onset, and an additional method is needed for 1
week to prevent conception. If menses begin on a Sunday, then pills are begun that
day and no supplementary method is required. Alternatively, with the “Quick
Start” method, COCs are started on any day, commonly the day prescribed,
regard- less of cycle timing. An additional method is used during the first week.
This latter approach improves short-term compli- ance (Westhoff, 2002, 2007b). If
the woman is already preg- nant during Quick Start initiation, COCs are not
teratogenic (Lammer, 1986; Rothman, 1978; Savolainen, 1981). Similarly, same-
day initiation can be implemented with the contraceptive vaginal ring or patch
(Murthy, 2005; Schafer, 2006).
For maximum efficiency, pills should be taken at the same time each day. If one
dose is missed, contraception is likely not diminished with higher-dose
monophasic COCs. Doubling the next dose will minimize breakthrough bleeding
and maintain the pill schedule. If several doses are missed or if lower-dose pills
are used, the pill may be stopped, and an effective barrier technique used until
menses. The pill may then be restarted. Alternatively, a new pack can be started
immediately following identification of missed pills, and a barrier method used for
1 week. If there is no withdrawal bleeding, the woman should continue her pills
but seek atten- tion to exclude pregnancy.
benefit from an increase in the pill’s estrogen dose, whereas those with bleeding
during the second part may improve with a higher progestin dose (Nelson, 2011).
In obese women, COCs are highly effective (Lopez, 2010). That said, some but
not all studies point to a potential increased pregnancy risk with COC use due to
lowered hormone bio- availability (Brunner, 2005; Holt, 2002, 2005; Westhoff,
2010). With the transdermal patch method, however, there is stronger evidence
that obesity may alter pharmacokinetics and lower efficacy (p. 701).
Metabolic Changes
Although their effects on carbohydrate metabolism are considered clinically
insignificant, COCs do have notable effects on lipid and protein synthesis. In
general, COCs increase serum levels of triglycerides and total cholesterol.
Estrogen decreases LDL cholesterol concentrations but increases HDL and very-
low density (VLDL) cholesterol levels. Some progestins cause the reverse. Despite
this, the clinical consequences of these perturbations have almost certainly been
overstated. Oral contraceptives are not athero- genic, and their impact on lipids is
inconsequential for most women (Wallach, 2000). But in women with
dyslipidemias, the American College of Obstetricians and Gynecologists
TABLE 38-5. Drugs Whose Effectiveness Is Influenced by Combination Oral
Contraceptives
Analgesics
Acetaminophen
Aspirin
Anticoagulants
Imipramine
Tranquilizers
Adequate
Meperidine
Suspected
Morphine
Probable Larger doses of analgesic may be required
Anticonvulsant
Lamotrigine monotherapy
Antidepressants
Adequate Avoid
Suspected
Diazepam, alprazolam
Suspected
Decrease dose
Temazepam
Other benzodiazepines
Suspected
Anti-inflammatories
Aminophylline, caffeine,
dose accordingly
Bronchodilators
theophylline
Antihypertensives
Cyclopenthiazide
Adequate
Increase dose
Metoprolol
Suspected
Antibiotics
Regarding carbohydrate metabolism, there are fortunately lim- ited effects with
current low-dose formulations in women who do not have diabetes (Lopez,
2012a). And, the risk of developing dia- betes is not increased (Kim, 2002).
Moreover, COCs may be used in nonsmoking, diabetic women younger than 35
years who have no associated vascular disease (American College of Obstetricians
and Gynecologists, 2013e). Last, studies have not supported a connection between
COCs and weight gain (Gallo, 2011).
Cardiovascular Effects
Despite increased plasma angiotensinogen (renin substrate) levels, most women
using low-dose COCs formulations rarely develop clinically significant
hypertension (Chasan-Taber, 1996). However, it is common practice for patients
to return 8 to 12 weeks after COC initiation for evaluation of blood pres- sure and
other symptoms.
For women with prior stroke, COCs should not be consid- ered due to risks for
repeat events. The risk for a first stroke is substantially increased in women who
have hypertension, who smoke, or who have migraine headaches with visual aura
or other focal neurological changes and use oral contracep- tives (MacClellan,
2007). However, for nonsmoking women younger than 35, the risk of ischemic
and hemorrhagic strokes is extremely low, and method benefits considerably
outweigh risks (World Health Organization, 1996, 1998). Moreover, because of
this low risk, the American College of Obstetricians and Gynecologists (2013e)
notes that COCs may be considered for women with migraines that lack focal
neurological signs if they are otherwise healthy, normotensive nonsmokers
younger than 35 years.
For women with prior myocardial infarction, COCs should not be considered.
Also, in women with multiple cardiovas- cular risk factors, which include
smoking, hypertension, older age, and diabetes, the risk for myocardial infarction
outweighs the benefits of this method. However, for those without these risks,
low-dose oral contraceptives are not associated with an increased risk of
myocardial infarction (Margolis, 2007; World Health Organization, 1997).
It has long been known that the risk of deep-vein thrombo- sis and pulmonary
embolism is increased in women who use COCs (Stadel, 1981). These clearly are
estrogen-dose related, and rates have substantively decreased with lower-dose
formu- lations containing 10 to 35 g of ethinyl estradiol. The inci- dence of
venous thromboembolism (VTE) with COC use is only 3 to 4 per 10,000 woman-
years and is lower than the incidence of 5 to 6 per 10,000 woman-years estimated
for preg- nancy (Chap. 52, p. 1028) (Mishell, 2000). The enhanced risk of VTE
appears to decrease rapidly once COCs are stopped. And because these
complications are increased in women smokers older than 35 years, COCs are not
recommended for this population (Craft, 1989).
Those most at risk for VTE include women with thrombo- philias (Comp, 1996).
Other clinical factors that increase the risk of VTE with COC use are
hypertension, obesity, diabe- tes, smoking, and a sedentary lifestyle (Pomp, 2007,
2008). Moreover, COC use during the month before a major opera- tive procedure
appears to double the risk for postoperative VTE (Robinson, 1991). Thus, the
American College of Obstetricians and Gynecologists (2013d) recommends
balancing the risks of VTE with those of unintended pregnancy during the 4 to 6
weeks required to reverse the thrombogenic effects of COCs before surgery. In the
early puerperium, VTE risks are also increased, and COCs are not recommended
for women within the first 4 weeks after delivery. For all women, an increased
VTE risk with drospirenone-containing COCs has been shown in two studies.
Accordingly, the FDA has encouraged an assess- ment of benefits and VTE risks
in users of these pills (Food and Drug Administration, 2011; Jick, 2011; Parkin,
2011).
Neoplasia
Fortunately, most studies indicate that overall, COCs are not associated with an
increased risk of cancer (Hannaford, 2007). In fact, a protective effect against
ovarian and endometrial can- cer has been shown (Collaborative Group on
Epidemiological Studies of Ovarian Cancer, 2008; Tsilidis, 2011). Protection from
these cancers decreases, however, as time from pill use lengthens (Tworoger,
2007). In contrast, the relative risk of cer- vical dysplasia and cervical cancer is
increased in current COC users, but this declines after use is discontinued.
Following 10 or more years, risk returns to that of never users (International
Collaboration of Epidemiological Studies of Cervical Cancer, 2007).
Although COC use in the past was linked to develop- ment of hepatic focal
nodular hyperplasia and benign hepatic adenoma, large studies do not support this
(Heinemann, 1998). Moreover, there is also no evidence for increased risk of
hepatocellular cancer (Maheshwari, 2007). For women with known tumors, COCs
may be used in those with focal
Contraception 709
CHAPTER 38
710 The Puerperium
nodular hyperplasia, but avoided in those with benign hepatic adenoma and
hepatocellular carcinoma (Kapp, 2009b). Rates of colorectal cancer appear to be
reduced in ever users (Bosetti, 2009; Kabat, 2008).
Other Effects
As summarized in Table 38-6, many noncontraceptive benefits are associated with
COC use (American College of Obstetricians and Gynecologists, 2012c). And
indeed, COCs may be used for these effects, even in those without contraceptive
needs.
Cholestasis and cholestatic jaundice are uncommon, but they resolve when COCs
are discontinued. For women who have active hepatitis, COCs should not be
initiated, but these may be continued in women who experience a flare of their
liver disease while already taking COCs. Use of progestin-only contraception in
these women is not restricted. Moreover, there is no reason to withhold COCs
from women who have recovered. With cirrhosis, mild compensated disease does
not limit the use of COCs or progestin-only methods. However, in those with
severe decompensated disease, all hormonal meth- ods should be avoided (Kapp,
2009a).
The progestin component of COCs reduces serum free tes- tosterone levels and
inhibits 5-reductase to limit conversion of testosterone to its active metabolite,
dihydrotestosterone. The estrogen component increases SHBG production and
also low- ers circulating androgen levels. The expected results of these actions are
to improve androgenic conditions such as acne and hirsutism.
■ Transdermal Patch
The Ortho Evra patch is another combination hormonal con- traceptive
formulation. It has an inner layer containing an adhesive and hormone matrix, and
a water-resistant outer layer. Thus, women can wear the patch in bathtubs,
showers, swim- ming pools, saunas, and whirlpools without decreased efficacy.
The patch may be applied to buttocks, upper outer arm, lower abdomen, or upper
torso, but the breasts are avoided. Because the hormones are combined with the
adhesive, improper skin adherence will lower hormone absorption and efficacy.
Therefore, if a patch is so poorly adhered that it requires rein- forcement with tape,
it should be replaced.
Initiation of the patch is the same as for COCs, and a new patch is applied weekly
for 3 weeks, followed by a patch-free week to allow withdrawal bleeding.
Although a patch is ideally worn no longer than 7 days, hormone levels remain in
an effec- tive range for up to 9 days. This affords a 2-day window for patch
change delays (Abrams, 2001).
In general, the transdermal patch and vaginal ring produce metabolic changes, side
effects, and efficacy rates comparable to those with COC pills. However, the patch
has been associated with a higher VTE risk in some but not other studies (Cole,
2007; Jick, 2010; Lidegaard, 2012). And despite this lack of convincing
association, the FDA (2008) ordered labeling for the patch to state that users may
be at increased risk for developing VTE. Obesity—90 kg or greater—may be
associated with an increased risk for patch contraceptive failure (Zieman, 2002).
Last, application-site reaction and breast tenderness are more frequent during
initial cycles in patch wearers (Urdl, 2005).
■ Transvaginal Ring
The NuvaRing is yet another form of combination hormonal contraception and is a
flexible intravaginal ring. Constructed of ethinyl vinyl acetate, the ring measures
54 mm in diameter and 4 mm in cross section (Fig. 38-5). During insertion, the
ring is compressed and threaded into the vagina, but no specific final intravaginal
position is required. Its core releases ethinyl estradiol and the progestin
etonogestrel, which are absorbed across the vaginal epithelium. Before being
dispensed, the
Improvement of acne
Prevention of atherogenesis
SECTION 10
Contraception 711
rings are refrigerated, and once dispensed, their shelf life is 4 months. The ring is
placed within 5 days of menses onset and after 3 weeks of use, is removed for 1
week to allow withdrawal bleeding. Contraception will still be afforded if a ring is
left in place for a fourth week (Merck, 2012b).
during the 7 days following injection, and a second pregnancy test after 3 to 6
weeks to identify an early pregnancy (Rickert, 2007; Sneed, 2005). Fortunately,
pregnancies conceived dur- ing DMPA use are not associated with an increased
risk of fetal malformation (Katz, 1985). For women who present for intra-
muscular DMPA reinjection more than 13 weeks or subcutane- ous DMPA
reinjection more than 14 weeks after the prior dose, the manufacturer recommends
exclusion of pregnancy before reinjection (Pfizer, 2010, 2012).
As with other progestins, DMPA has not been associ- ated with cardiovascular
events or stroke in otherwise healthy women. However, in those with severe
hypertension, an increased risk of stroke has been found in DMPA users (World
Health Organization, 1998). Moreover, the US MEC expresses concerns regarding
hypoestrogenic effects and reduced HDL levels from DMPA in women with
vascular disease or multiple risks for cardiovascular disease.
Weight gain is generally attributed to DMPA, and these increases are comparable
between the two depot forms (Bahamondes, 2001; Nault, 2013; Westhoff, 2007c).
In long- term users, loss of bone mineral density is also a potential prob- lem
(Petitti, 2000; Scholes, 1999). In 2004, the FDA added a black box warning to
DMPA labeling, which notes that this concern is probably most relevant for
adolescents, who are building bone mass, and perimenopausal women, who will
soon have increased bone loss during menopause. That said, it is the opinion of the
World Health Organization (1998) and American College of Obstetricians and
Gynecologists (2008) that DMPA should not be restricted in those high-risk
groups. And, it seems prudent to reevaluate overall risks and benefits during
extended use (d’Arcangues, 2006).
■ Progestin-Only Pills
So-called mini-pills are progestin-only contraceptives that are taken daily. These
contraceptives have not achieved widespread popularity and are used by only 0.4
percent of American
CHAPTER 38
712 The Puerperium
women (Hall, 2012). Unlike COCs, they do not reliably inhibit ovulation. Rather,
their effectiveness depends more on cervical mucus thickening and endometrial
atrophy. Because mucus changes are not sustained longer than 24 hours, mini-
pills should be taken at the same time every day to be maxi- mally effective. If a
progestin-only pill is taken even 4 hours late, a supplemental form of
contraception must be used for the next 48 hours. Progestin-only pills are
contraindicated in women with known breast cancer or pregnancy. Other cautions
are listed in Table 38-3.
not absolute protection against a broad range of STDs. These include gonorrhea,
syphilis, trichomoniasis, and HIV, herpetic, and chlamydial infections.
For individuals sensitive to latex, condoms made from lamb intestines are
effective, but they do not provide infection pro- tection. Fortunately, nonallergenic
condoms have been devel- oped that are made of polyurethane or of synthetic
elastomers. Polyurethane condoms are effective against STDs but have a higher
breakage and slippage rate than latex condoms (Gallo, 2006).
■ Female Condom
The only female condom available is marketed as the FC2 Female Condom. It is a
synthetic nitrile sheath with one flexible polyurethane ring at each end. Its open
ring remains outside the vagina, whereas its closed internal ring is fitted under the
symphysis like a diaphragm (Fig. 38-6). The female condom can be used with
both water-based and oil-based lubricants. Male condoms should not be used
concurrently because simul- taneous use may cause friction that leads to condom
slipping, tearing, and displacement. Following use, the female condom outer ring
should be twisted to seal the condom so that no semen spills. As an added value, in
vitro tests have shown the female condom to be impermeable to HIV and other
STDs.
AB
FIGURE 38-6 FC2 Female Condom insertion and positioning. A. The inner ring is
squeezed for insertion. The sheath is inserted similarly to a diaphragm. B. The inner ring
is pushed inward with an index finger.
SECTION 10
FIGURE 38-7 A diaphragm in place creates a physical barrier between the vagina and
cervix.
With use, the diaphragm and spermicide can be inserted hours before intercourse,
but if more than 6 hours elapse, additional spermicide should be placed in the
upper vagina for maximum protection and be reapplied before each coital episode.
The diaphragm should not be removed for at least 6 hours after intercourse.
Because toxic shock syndrome has been described following its use, it may be
worthwhile to remove the diaphragm at 6 hours, or at least the next morning, to
minimize this rare event. Diaphragm use is associated with a slightly increased
rate of urinary infections, presumably from urethral irritation by the ring under the
symphysis.
■ Cervical Cap
FemCap is currently the only available cervical cap in the United States. Made of
silicone rubber, it has a sailor-cap shape with a dome that covers the cervix and a
flared brim, which allows the cap to be held in place by the muscular walls of the
upper vagina. Available in 22-, 26-, and 30-mm sizes, it should be used with a
spermicide applied once at insertion to both sides of the dome cup. For
contraception, it should remain in place for 6 hours following coitus and may
remain for up to 48 hours. Even with proper fitting and correct use, pregnancy
rates with this method are higher that with the diaphragm (Gallo, 2002; Mauck,
1999).
successful use, women must have regular monthly cycles of 26 to 32 days. Those
who use this method can mark a calendar or can use Cycle-Beads, which is a ring
of counting beads, to keep track of their days.
The Calendar Rhythm Method requires counting the num- ber of days in the
shortest and longest menstrual cycle during a 6- to 12-month span. From the
shortest cycle, 18 days are subtracted to calculate the first fertile day. From the
longest cycle, 11 days are subtracted to identify the last fertile day. This is
problematic because ovulation most often occurs 14 days before the onset of the
next menses. Because this is not neces- sarily 14 days after the onset of the last
menses, the calendar rhythm method is not reliable.
The Cervical Mucus Method, also called the Two-Day Method or Billings
Method, relies on awareness of vaginal “dryness” and “wetness.” These reflect
changes in the amount and quality of cervical mucus at different times in the
menstrual cycle. With the Billings Method, abstinence is required from the
beginning of menses until 4 days after slippery mucus is identified. With the Two-
Day method, intercourse is consid- ered safe if a woman did not note mucus on the
day of planned intercourse or the day prior.
High pregnancy rates are primarily attributable to inconsis- tent use rather than to
method failure. Even if inserted regularly and correctly, however, they are
considered a less effective method (see Table 38-2). Fortunately, if pregnancy
does occur, they are not considered teratogenic (Briggs, 2011).
Contraception 713
CHAPTER 38
714 The Puerperium
FIGURE 38-8 Today sponges. The sponge is moistened with tap water and gently
squeezed to create light suds. It is then posi- tioned with the dimple directly against the
cervix. The fabric loop trails within the vagina and can be hooked with a finger to later
extract the sponge.
■ Contraceptive Sponge
The Today contraceptive sponge is an over-the-counter, one- size-fits-all device.
The nonoxynol-9–impregnated polyure- thane disc is 2.5 cm thick and 5.5 cm
wide and has a dimple on one side and satin loop on the other (Fig. 38-8). The
sponge can be inserted up to 24 hours prior to intercourse, and while in place, it
provides contraception regardless of coital frequency. It should remain in place for
6 hours after intercourse. Pregnancy is prevented primarily by the spermicide
nonoxynol-9 and to a lesser extent, by covering the cervix and absorbing semen.
Although the sponge is possibly more convenient than the diaphragm or condom,
it is less effective than either (Kuyoh,
EMERGENCY CONTRACEPTION
Many women present for contraceptive care following unpro- tected sexual
intercourse. In this situation, several emer- gency contraception (EC) regimens
substantially decrease the likelihood of an unwanted pregnancy when used
correctly. Current methods include COCs, POPs, progesterone antag- onists, and
copper-containing IUDs (Table 38-7). Patients can obtain information regarding
emergency contraception by calling 1-888-NOT-2-LATE or accessing The
Emergency Contraception Website: http://not-2-late.com.
Method
Progestin-Only Pill
Formulation
Number of Dosesa
0.75 mg levonorgestrel
150 mg levonorgestrel
PRM Pill
Ella
30 mg ulipristal acetate
COC Pillsb,c
Ogestrel
0.05 mg EE
0.5 mg norgestrel
Lo/Ovral, Low-Ogestrel
0.03 mg EE
0.03 mg EE
0.3 mg norgestrel
44
0.125 mg levonorgestrel
22
0.03 mg EE
0.15 mg levonorgestrel
0.1 mg levonorgestrel
Copper-Containing IUD
Paragard T 380A
a
Doses taken 12 hours apart.
b
Other COC brands with formulations identical to those above may also be used
(see Table 38-4).
c
Use of an antiemetic agent before taking the medication will lessen the risk of
nausea, which is a common side effect. COC combination oral contraceptive; EE
ethinyl estradiol; PRM progesterone-receptor modulator.
SECTION 10
regimen, the second dose follows 12 hours later, although a 24-hour interval
between the doses is also effective (Ngai, 2005). One progesterone-receptor
modulator currently available for EC is ulipristal acetate and is marketed as Ella. It
is taken as a single 30-mg tablet up to 120 hours after unprotected inter-
course (Brache, 2010; Watson, 2010).
The major mechanism with all hormonal
regimens is inhi-
With EC administration, nausea and vomiting can be a sig- nificant side effect
(Gemzell-Danielsson, 2013). Accordingly, an oral antiemetic may be prescribed at
least 1 hour before each dose. If a woman vomits within 2 hours of a dose, the
dose must be repeated.
PUERPERAL CONTRACEPTION
For mothers who are nursing exclusively, ovulation during the first 10 weeks after
delivery is unlikely. Nursing, however, is not a reliable method of family planning
for women whose infants are on a daytime-only feeding schedule. Moreover,
waiting for first menses involves a risk of pregnancy, because ovulation usu- ally
antedates menstruation. Certainly, after the first menses, contraception is essential
unless the woman desires pregnancy.