Transcript Title in Initial Caps: 40-point Arial

Provider Education and Training to
Increase Use of Intrauterine
Contraception
Association of Reproductive Health
Professionals
www.arhp.org
Acknowledgment
This program was made possible through
educational grants from Bayer HealthCare
Pharmaceuticals and Teva Pharmaceuticals.
Disclosure Declarations
Name
Disclosure
Barbara Clark, MPAS, PA-C (Planner)
Nothing to disclose.
Linda Dominguez, RN-C, NP (Planner)
Linda Dominguez is a consultant and
speaker for Teva , Bayer, and Merck.
Mark Hathaway, MD, MPH (Planner)
Mark Hathaway is a trainer/speaker for
Merck.
Carole Chrvala, PhD (Medical Writer)
Nothing to disclose.
Aleya Horn Kennedy, MPP
(Planner)
Nothing to disclose.
Beth Jordan Mynett, MD (Planner)
Nothing to disclose.
Amy Swann, MA
(Planner)
Nothing to disclose.
Learning Objectives
• Explain the differences between the three
forms of intrauterine contraception available
in the United States
• Select appropriate candidates for
intrauterine contraception
• Describe two possible side effects of each
type of intrauterine contraceptive
more…
Learning Objectives (continued)
• Describe pain management strategies
during and after insertion
• Discuss strategies for follow-up of
intrauterine contraceptive users
• Develop skills required for proper insertion
techniques for the three methods of
intrauterine contraception
Terms for Intrauterine Contraception
IUC
IUD
IUS
Unintended Pregnancy in the US
6.8 MILLION PREGNANCIES
over one year
Unintended: 49%
Intended: 51%
51%
23%
Unintended births
21%
5%
Elective abortions
Fetal losses
Finer LB. Contraception. 2011; Finer LB. Fertil Steril. 2012; Finer LB. Perspect Sex Reprod
Health. 2006; Henshaw SK. Fam Plann Perspect. 1998.
Presentation Outline
1. Contraceptive Use Globally and in the
United States
2. Overview of Current IUC Methods
3. Patient Screening and Counseling for IUC
▪
Case presentations
4. IUC Insertion and Management
5. Hands-on Practicum
Contraceptive Use Globally and
in the United States
Worldwide Use of IUC
% Using IUCs
Use for Married Women of Reproductive Age
Asia
Europe
Latin
Africa
America &
Caribbean
Oceania
Population Reference Bureau. 2002; Mosher WD. Vital Health Stat. 2010.
North
America
History of Successful IUC Use
1909:
Grafenberg
develops ringshaped IUC
device
1967:
T-shaped device
developed
1976:
Copper T 200
becomes first
copper IUD
1968:
1962:
Contraceptive
First international
action of
conference on IUC;
designs for plastic spiral intrauterine copper
reported
and plastic loop presented
1988:
Copper T 380 IUD
available in the
United States
1980:
LNG IUC tested
in randomized
clinical trials
2013: LNG 13.5
IUS available in
the United
States
2001:
LNG 52 IUS
available in the
United States
Richter R. Deutsche Med Wochenschr. 1909; Grafenberg E. 1930; Ishihama A. Yokohama Med Bull. 1959;
Oppenheimer W. Am J Obstet Gynecol. 1959; Berelson B. 1964; Marguiles LC. 1962; Lippes J. 1962;
Hubacher D. Contraception. 2004; Lee NC. Obstet Gynecol. 1983; Mosher WD. 2004.
Need for Effective Reversible
Methods
There is a need for effective contraceptive methods
that are “forgettable”
1 in 5
pregnancies ends
in abortion
20%
of women selecting sterilization
at age 30 years or younger
express regret later
Finer LB. Perspect Sexual Reprod Health. 2003; Stanwood NL. Obstet Gynecol. 2002; Hillis
SD. Obstet Gynecol. 1999.
Why an Update on IUC?
• Myths exist about IUC
• Selection of candidates is
unduly restrictive
• Misinformation about IUC
among providers and
patients is common
Stanwood NL. Obstet Gynecol. 2002; Weiss E. Contraception. 2003.
Why IUC Is Underused in the
United States
• Lack of awareness of
method among women
• Myths about IUC safety
• Negative publicity
• Misconceptions
• Upfront cost
• Lack of positive marketing
• Fear of litigation
Stanwood NL. Obstet Gynecol. 2002; Steinauer JE. Fam Plann Perspect. 1997; Weir E.
CMAJ. 2003.
% Using IUC
Use of IUC by Female Ob/Gyns vs.
All Women in the United States
Female Ob/Gyn
Physicians
General Population
Population Reference Bureau. 2002; The Gallup Organization. 2004.
Considerations in Choice of
Contraceptive Methods
• Effectiveness
• Side effects
• Convenience
• Duration of action
and childbearing
plans
• Patient choice
• Reversibility
• Non-contraceptive
benefits
• Cost
• Privacy
Overview of Current IUC Methods
Characteristics of IUC
• Highest patient
satisfaction among
methods
• Rapid return of fertility
• Safe
• Immediately effective
• Long-term protection
• Highly effective
Fortney JA. J Reprod Med. 1999; Belhadj H. Contraception. 1986; Skjeldestad F. Adv
Contracept. 1988; Arumugam K. Med Sci Res. 1991; Tadesse E. East Afr Med J. 1996.
Dispelling Myths About IUC
In fact, IUDs:
• Are not abortifacients
• Do not cause ectopic
pregnancies
• Do not cause pelvic
infection
• Do not decrease the
likelihood of future
pregnancies
• Are not large in size
• Can be used by
nulliparous women
• Can be used by women
who have had an ectopic
pregnancy
• Do not need to be
removed for PID
treatment
• Do not have to be
removed if inflammatory
changes are noted on a
Pap test
Duenas JL. Contraception. 1996; Forrest JD. Obstet Gynecol Surv. 1996; Hubacher D. N Engl J Med. 2001;
Lippes J. Am J Obstet Gynecol. 1999; Otero-Flores JB. Contraception. 2003; Penney G. J Fam Plann
Reprod Health Care. 2004; Stanwood NL. Obstet Gynecol. 2002; WHO. 2009.
IUC Available in the United States
• Copper T 380A IUD
▪
▪
Copper ions
Approved for 10 years
of use
more…
ParaGard® PI. 2013; Teva. 2013.
IUC Available in the United States
(continued)
• LNG 52 IUS
▪
▪
Releases 20 μg of LNG
per day
Approved for 5 years of
use
• LNG 13.5 IUS
▪
▪
Mirena® PI. 2013; SkylaTM PI. 2013.
Releases 14 μg of LNG
per day
Approved for 3 years of
use
IUC Mechanism of Action
Mechanism
of Action
Primary
Copper T IUD
•
•
•
Secondary
•
LNG 52 IUS
LNG 13.5 IUS
Prevents fertilization
Reduces sperm
motility and viability
Inhibits development
of ova
•
•
•
Inhibits fertilization
Causes cervical mucus to thicken
Inhibits sperm motility and function
Inhibits implantation
•
Inhibits implantation
Ortiz ME. Contraception. 2007; Alvarez F. Fertil Steril. 1988; Segal SJ. Fertil Steril. 1985;
ACOG. 1998; Jonsson B. Contraception. 1991; Silverberg SG. Int J Gynecol Pathol. 1986.
Efficacy: First-Year Failure Rates of
Selected Contraceptives (Typical Use)
LNG IUS
Sterilization—female
Copper T IUD
Injectable (DMPA)
Pills/patch/ring
Condom—male
Spermicides
No contraception
Percent
Trussell J. 2011; WHO. 1987; Peterson HB. Am J Obstet Gynecol. 1996.
Return to Fertility (Reversibility)
Pregnancies (%)
100
80
IUC
60
OC
Diaphragm
40
Other methods
20
0
0
12
18
24
30
36
Months After Discontinuation
42
Vessey MP. Br Med J. 1983; Andersson K. Contraception. 1992; Belhadj H. Contraception.
1986.
Continuation Rates at 1 Year
84%
of
Copper T IUD
users
88%
55%
of
LNG 52 IUS
users
of
Non-LARC*
users
VS.
*LARC = long-acting reversible contraception. Non-LARC methods include
the contraceptive pill, patch, and ring.
The Contraceptive Choice Project. 2013; Rosenstock JR. Obstet Gynecol. 2012; Peipert JF.
Obstet Gynecol. 2011.
Potential Side Effects
Type
During
insertion
First few
days
During
insertion
Copper T:
Heavier or
prolonged
menses
Variable pain
and/or
cramping
Light bleeding
Intermenstrual
cramping
LNG IUS:
Gradual
decrease in
menstrual
flow
Vasovagal
reactions
Mild cramping
Cramping
Silverberg SG. Int J Gynecol Pathol. 1986; Sivin I. Contraception. 1991; Hidalgo M.
Contraception. 2002; Crosignani PG. Obstet Gynecol. 1997.
IUC Non-contraceptive Benefits
Protection
against
endometrial
cancer
Copper T IUD
√
LNG 52 IUS
√
Alternative to
hysterectomy
or endometrial
ablation
Treatment of
heavy
bleeding/
dysmenorrhea
√
√
Andersson JK. Br J Obstet Gynaecol. 1990; Hurskainen R, et al. Lancet. 2001; Hurskainen R.
JAMA. 2004; Hill DA. Int J Cancer. 1997; Rosenblatt KA. Contraception. 1996; Skyla™ PI.
2013.
LNG 52 IUS Non-contraceptive Uses
Good evidence:
• Heavy menstrual bleeding*
• Dysmenorrhea and pain
• Endometrial protection during hormone or
tamoxifen therapy in perimenopausal and
postmenopausal women
*FDA-approved indication.
Varma R. Eur J Obstet Gynecol Reprod Biol. 2006; Gupta B. Int J Gynecol Obstet. 2006;
Backman T. Obstet Gynecol. 2005.
Costs for Patients
• Patient costs are a factor in choosing a
contraceptive method.
• Up-front costs concern some women.
• The costs of side effects associated with some
contraceptives are high compared with those for
IUC.
• Public clinics and patient assistance programs
offered by pharmaceutical companies can be
explored for low-income or uninsured patients.
Safety: Overview
Recent data continue to
demonstrate the safety
of current methods of
IUC.
Hubacher D. N Engl J Med. 2001; Nelson AL. Obstet Gynecol Clin North Am. 2000; Meirik
O. Obstet Gynecol. 2001.
Safety: Medical Eligibility Criteria for
Contraceptive Use
Category
1
2
3
4
Risk Level
Method can be used without restriction.
Advantages generally outweigh theoretical or
proven risks.
Method not usually recommended unless other,
more appropriate methods are not available or
not acceptable.
Method not to be used.
CDC. MMWR Recomm Rep. 2010; WHO. 2009.
Safety: Medical Eligibility Criteria for
Contraceptive Use (continued)
Condition
Diabetes mellitus
Qualifier for condition
LNG IUS
Copper T IUD
Past gestational diabetes
1
1
Diabetes without vascular disease
2
1
Diabetes with end-organ damage or
>20 years’ duration
2
1
1
2
Endometriosis
Obesity
BMI >30 kg/m2
1
1
Uterine fibroids
IUC OK unless fibroids block
insertion
1
1
CDC. MMWR Recomm Rep. 2010; WHO. 2009.
Safety: Medical Eligibility Criteria for
Contraceptive Use (continued)
Condition
Postpartum,
not breastfeeding
Postpartum IUD
insertion
(breastfeeding or
not breastfeeding)
Postpartum &
breastfeeding
Qualifier for condition
LNG IUS
Copper T IUD
>3 weeks postpartum
1
1
<10 minutes after placenta delivery
2
1
10 minutes after placenta delivery
to 4 weeks postpartum
2
2
>4 weeks postpartum
1
1
>1 month postpartum
1
1
First trimester
1
1
Second trimester
2
2
Post-abortion
CDC. MMWR Recomm Rep. 2010; Goodman S. Contraception. 2008; Grimes DA.
Cochrane Library. 2000; Pakarinen P. Contraception. 2003; WHO. 2009.
Safety: Medical Eligibility Criteria for
Contraceptive Use (continued)
Condition
Qualifier for condition
LNG IUS
Copper T IUD
High risk or HIV+
2
2
AIDS (without drug interactions)
3
3
Past, with subsequent pregnancy
1
1
Past, without subsequent
pregnancy
2
2
Current
4
4
Vaginitis/increased risk of STI
2
2
Very high risk of STI
3
3
Current gonorrhea, chlamydia, or
purulent cervicitis
4
4
HIV infection
PID
STI
CDC. MMWR Recomm Rep. 2010; WHO. 2009.
Safety: IUC Does Not Cause PID or
Infertility
• PID incidence among IUC users is similar
to that among the general population
• Risk is increased only during the first
month after insertion
• Preexisting STI at time of insertion, not
IUC itself, increases risk
• Chlamydial infection, not use of IUC, is
associated with increased risk of tubal
occlusion
Svensson L. JAMA. 1984; Sivin I. Contraception. 1991; Farley TM. Lancet. 1992; Andersson
K. Contraception. 1994; Hubacher D. N Engl J Med. 2001.
Patient Screening and
Counseling for IUC
Screening & Counseling Goals
for Providers
• Review contraceptive options with
patients
• Allow patients to hold devices
• Promote successful use of
method
• Allow time for questions
• Provide written materials in the
appropriate language and literacy
level
Comparing Typical Effectiveness of
Contraceptive Methods
How to make your method
most effective
More effective
<1 pregnancy per
100 women in 1 year
After procedure, little or nothing to
do or remember
Implant
6-12 pregnancies per
100 women in 1 year
Injectable
Vasectomy
Pills
Female
Sterilization
Patch
IUC
Ring
Diaphragm
Vasectomy: Use another method for
first 3 months after procedure.
Injections: Get repeat injections on
time.
Pills: Take a pill each day.
Patch, ring: Keep in place, change
on time.
Diaphragm: Use correctly every time
you have sex.
Condoms, sponge, withdrawal,
spermicides: Use correctly
every time you have sex.
Male
Condoms
Female
Condoms
Sponge
Withdrawal
Less effective
≥18 pregnancies per 100
women in 1 year
Spermicides
Trussell J. 2011; WHO. 2007.
Chart adapted from WHO 2007.
Fertility
Awareness–Based
Methods
Fertility awareness–based
methods: Abstain or use
condoms on fertile days. Newest
methods (Standard Days Method
and Two-Day Method) may be the
easiest to use and consequently
more effective.
Outcomes for Women Referred for
Sterilization
15% did
not
attend
clinic
54% had
sterilization
N = 100 women
Smith RA. J Fam Plann Reprod Health Care. 2006.
29%
chose
alternative
method
Appropriate Candidates for IUC
Women of any reproductive age
seeking long-term, highly effective
contraception
Appropriate Candidates for IUC
Copper T IUD
LNG 52 IUS
• Women who
don’t want
hormonal
contraception
• Women seeking
emergency
contraception
• Nulligravid
women
• Women who
want less
menstrual flow
• Women who
experience
dysmenorrhea or
dysfunctional
uterine bleeding
• Nulligravid
women
ParaGard® PI. 2013; Mirena® PI. 2013; SkylaTM PI. 2013.
LNG 13.5 IUS
• Nulligravid
women
• Women who
want a lowerdose LNG IUD
Contraindications to IUC
There are few contraindications to IUC use
• Known or suspected
pregnancy
• Puerperal sepsis
• Immediate postseptic abortion
• Unexplained vaginal
bleeding
CDC. MMWR; 2010. WHO. 2009.
• Uterine fibroids that
interfere with
placement
• Uterine distortion
(congenital or
acquired)
• Active purulent
cervicitis/PID
IUC Use for Adolescents
• Appropriate for properly
selected and counseled
adolescents
• Follow-up and side-effect
monitoring are important
• Encourage use of condoms
with new partners
The Contraceptive Choice Project. 2013; Eisenberg D. J Adolesc Health. 2013;
Rosenstock JR. Obstet Gynecol. 2012; Secura GM. Am J Obstet Gynecol. 2010;
Tomas A. J Pediatr Adolesc Gynecol. 2006.
Copper T IUD Labeling Does Not
Exclude Nulliparous Women
Copper T labeling change was
approved in 2005 to include
more potential candidates
beyond women who have had
one child and are in a mutually
monogamous relationship
ParaGard® PI; Mirena PI.
Case Presentation: Nulligravid
Adolescent
• “Anna,” 17-year-old high-school
senior
• Has been sexually active with
boyfriend for 3 months
• Has been using condoms for
birth control
• Does not want to use hormonal
method of contraception
Consider: Copper T IUD, LNG
13.5 IUS, or LNG 52 IUS*
*After the first few months, very little LNG enters the circulation.
Nulligravid Adolescent:
Clinical Considerations
• Insertion may be difficult (smaller cervical os
and uterus than in parous woman)
• Insertion pain
• Possible increased risk of STIs (chlamydia)
and PID (because of age <25 years)
Deans EI. Contraception. 2009; Grimes DA. Lancet. 2000.
Nulligravid Adolescent: Practice Tips
• Can do same-day STI testing
(with normal clinical exam):
No need to wait for test results
before insertion
 Positive tests should prompt
treatment without need to remove
device

Clinical Pearl
more…
Nulligravid Adolescent: Practice Tips
(continued)
• Non-pharmacologic pain
management:
▪
▪
Reassure patient about the
procedure
“Verbicain” or distraction therapy
Clinical Pearl
• Pharmacologic pain
management:
▪
▪
NSAID before procedure
Paracervical block
more…
Czarnecki ML. Pain Manag Nurs. 2011; Reproductive Health Access Project. 2012; Edelman AB. Contraception. 2011; Grimes
DA. Cochrane Database Syst Rev. 2006; Hubacher D. Am J Obstet Gynecol. 2006; Allen RH. Cochrane Database Syst Rev.
2009; Rabin JM. Obstet Gynecol. 1989; Speroff L. 2005; Swenson C. Obstet Gynecol. 2012.
Nulligravid Adolescent: Counseling
Points
• Follow-up and side effect
monitoring important
• Counsel regarding signs of
of expulsion
• Encourage use of
condoms with new
partners
Hubacher D. Contraception. 2007; Tomas A. J Pediatr Adolesc Gynecol. 2006; Grimes DA.
Cochrane Database Syst Rev. 2006.
IUD Insertion After Spontaneous or
Induced Abortion
• IUD may be safely inserted immediately after
spontaneous or induced abortion
• IUD insertion is not recommended after
septic abortion.
Grimes D. Cochrane Libr. 2000; WHO. Stud Fam Plann. 1983; ParaGard® PI.
Case Presentation:
Post-Abortion IUD Insertion
• “Ellen,” 28-year-old
nullipara
• Presents for 1-week
follow-up after medical
abortion
• Wants highly effective,
long-term, “forgettable”
contraceptive method
Consider: Copper T IUD or LNG 13.5 IUS
Post-Abortion IUD Insertion:
Clinical Considerations
• IUD may be safely inserted immediately after
spontaneous or induced abortion
• Advantages:
▪
▪
▪
Patient is known not to be pregnant
Motivation may be high because patient may be
thinking about birth control
Studies in US and Finland document significant
reductions in repeat abortion
Grimes D. Cochrane Libr. 2000; ParaGard® PI. 2013; WHO. 1983.
Post-Abortion IUD Insertion:
Practice Tips
• Medical abortion: Insertion can
be done at 1-week follow-up visit
• Surgical abortion: Insertion can
be done:
▪
▪
Immediately after procedure
At follow-up visit
Grimes DA. Cochrane Libr. 2000.
Clinical Pearl
Post-Abortion IUD Insertion:
Counseling Points
Counsel patient about possible signs of
expulsion:
• Unusual vaginal discharge
• Severe cramping or heavy bleeding
• Longer-than-usual or absent strings
protruding from cervix
• Tip of device protruding from cervix
IUC for Postpartum Use
• May be safely inserted in postpartum women
• Both LNG IUS and Copper T IUD can be
inserted safely within 10 minutes of placental
delivery
• All three IUDs can be used between 10
minutes and 4 weeks
• Some evidence to suggest higher expulsion
rates should not deter insertion in the
postpartum period
CDC. MMWR. 2011; WHO. 2009.
IUC Use During Lactation
• Effectiveness not decreased
• Uterine perforation risk unchanged
• Expulsion rates unchanged
• Decreased insertional pain
• Reduced rate of removal for bleeding and
pain
• LNG 52 IUS is comparable to Copper T in
breastfeeding parameters
Chi I-C. Contraception. 1989; Shaamash AH. Contraception. 2005; Skyla™ PI. 2013;
Mirena® PI. 2013
Case Presentation:
Heavy Menstrual Bleeding
• “Diane,” 24-year-old
nulligravida
• Medical history: heavy
menstrual bleeding,
dysmenorrhea
• Presents for relief of heavy
bleeding and cramping
• Has tried OCs in the past, dislikes having to take a
daily pill
Consider: LNG 52 IUS
Heavy Menstrual Bleeding:
Clinical Considerations
• Evaluate for underlying cause of heavy
bleeding
• Differential diagnoses:
▪
▪
▪
Coagulopathy
Endometrial lesion, fibroid, or polyp
Anovulation
James AH. Am J Obstet Gynecol. 2009; Kingman CEC. Br J Obstet Gynaecol. 2004;
Mansour D. Best Pract Res Clin Obstet Gynecol. 2007.
Heavy Menstrual Bleeding Case:
Practice Tips
• Evaluate cause:
▪
▪
▪
▪
▪
Menstrual history
History of other types of bleeding
suggesting coagulopathy
Endometrial biopsy
Possible vaginal ultrasound
Sonohysterogram
Clinical Pearl
Heavy Menstrual Bleeding Case:
Counseling Points
• To be expected:
▪
▪
▪
▪
▪
Lower volume of menstrual bleeding
Dysmenorrhea may improve
Breakthrough spotting
Unpredictable bleeding
3–6 months for LNG 52 IUS to have full effect on
endometrium
Case Presentation: Uterine Fibroids
• “Barbara,” 42-year-old G3P3
• Medical history:



Uterine fibroids
Obesity (BMI = 35)
Heavy menstrual bleeding, dysmenorrhea
• Has completed childbearing, does not
desire sterilization
• Seeks nonsurgical treatment for
fibroids
Consider: LNG 52 IUS
Kaunitz AM. Contraception. 2007; WHO. 2009.
more…
Uterine Fibroids:
Clinical Considerations
• Obesity may complicate location of uterus
and/or cervical os
• Fibroids must not obstruct cervical os
• Fibroids distal to uterine cavity do not
preclude IUC use
Kaunitz AM. Contraception. 2007; WHO. 2009.
Uterine Fibroids:
Practice Tips for Obese Patients
To determine fibroid size and
location:
• Transvaginal ultrasound
• Use clinical judgment
Clinical Pearl
more…
Uterine Fibroids: Practice Tips for
Obese Patients (continued)
To visualize cervix:
Clinical Pearl
Uterine Fibroids:
Counseling Points
• Expulsion rates possibly higher for women
with fibroids
• Counsel patient about possible signs of
expulsion:
▪
▪
▪
▪
Unusual vaginal discharge
Severe cramping or heavy bleeding
Longer-than-usual or absent strings protruding
from cervix
Tip of device protruding from cervix
Kaunitz AM. Contraception. 2007.
Case Presentation:
Cervical Stenosis
• “Cathy,” 32-year-old
G1P1
• Medical history:
▪
Cervical stenosis after LEEP
• Seeking long-term,
“forgettable” contraceptive
method
Consider: Copper T IUD,
LNG 13.5 IUS, or LNG 52 IUS
Cervical Stenosis:
Clinical Considerations
Insertion
difficulty
Insertion pain
Cervical Stenosis:
Practice Tips
• Os finder as needed
• Cervical dilation:
▪
▪
▪
▪
Start with lacrimal duct probe
Increase size until regular dilators will pass
Consider ultrasound guidance
Needs experienced hands
Clinical Pearl
• Pain management options:
▪
▪
▪
Oral NSAIDs
Paracervical block
Consider parenteral analgesia (midazolam and fentanyl)
Güney M. Obstet Gynecol. 2006; Edelman AB. Contraception. 2011.
Cervical Stenosis:
Counseling Points
• Counsel patient about the chance of
insertion failure
• Potential for vasovagal reaction
• Have patient get up from horizontal position
slowly and in stages
• If future colposcopy is needed, IUD can
remain in place
• Continue Pap screening per recommended
schedule
IUC Use for Older Women
• LNG 52 IUS can be an
appropriate choice for
perimenopausal women,
especially those with
dysfunctional uterine bleeding
• LNG 52 IUS can be used offlabel as an adjunct to
estrogen therapy for
postmenopausal women
Penney G. J Fam Plann Reprod Health Care. 2004; Varila E. Fertil Steril. 2001; Peled Y.
Menopause. 2007.
LNG 52 IUS Can Be Combined with
Oral Estrogen During Menopause
• High intrauterine/low systemic
progestin reduces vaginal bleeding
while minimizing progestin side effects
• Endometrium remains in
nonproliferative state with no
hyperplasia
Boon J. Maturitas. 2003; Peled Y. Menopause. 2007; Suvanto-Luukkonen E. Fertil Steril.
1999.
LNG 52 IUS Can Reduce Other
Progestin-Related Side Effects
• Studies of LNG 52 IUS as progestin
component of hormone replacement therapy:
▪
▪
▪
Endometrial changes—Decreased or no
proliferation; no cases of premalignant
transformation
Breast cancer—Possible reduced risk with nonsystemic progestin administration
Both older IUCs (Copper T and LNG 52 IUS) have
shown an association with reduced incidence of
endometrial cancer
Peled Y. Menopause. 2007.
IUC Counseling Topics
 Effectiveness
 Mechanism of action
 Characteristics of
method, including
changes in menstrual
flow
 Insertion and removal
procedures
 Side effects and
possible complications
 Instructions on followup
 Non-contraceptive
benefits
 Use of condoms with
new partners
Three-Prong Approach to Contraception
Education
Discuss efficacy, benefits, and
side effects
Employ “Teach-Back” method
to demonstrate the patient’s
understanding
Provide time for patient to
review and sign informed
consent form for LARC
procedure
“Teach-Back” Method
BENEFITS
Tell me about some of the benefits of this method.
How will this method have a positive impact for you?
SIDE EFFECTS
Tell me the three most common normal side effects
women have when they start this method.
Tell me what you will use if you experience cramps.
FOLLOW-UP
What would be abnormal symptoms with this
method?
Tell me what you will do if you experience spotting
that is bothering you.
IUC Use and Follow-up
• Schedule follow-up visits at:
▪
▪
Around 3–6 weeks, at clinician’s discretion
Routine well-woman care
• Advise return visit if there is:
▪
▪
Possible expulsion or displacement
Severe cramping or bleeding
• No data on routine thread checks by patient
Penney G. J Fam Plann Reprod Health Care. 2004.
Plan Follow-Up for Side Effects
• Ensure that patient knows to call or return if
having bothersome side effects
• Create a plan with patient about “preemptive”
treatment options in the event of bothersome
spotting
• Reassure that there will be an adjustment
period the first few months
• Discuss a non-prescription treatment plan in the
event of cramping
Patient Follow-up
• Ask follow-up questions:
▪ Are you satisfied with your
contraceptive method?
▪ Consider speculum string check
▪ Is there anything you would
change?
▪ Are you having bleeding problems
or other side effects?
• Address primary care/annual
appointments and STI counseling
ARHP. Clinical Proceedings. 2004.
IUC Insertion and Management
Timing of Insertion for Copper T IUD
First day of LMP:
≤5 days ago
>5 days ago
Urine pregnancy test negative
Insert
IUD
today
First instance of unprotected sex since LMP:
≤5 days ago
Insert IUD today
>5 days ago
None
Insert IUD within 5 days
of next menses
Insert IUD today
CDC. MMWR. 2013; Hatcher RA. 2005.
Timing of Insertion for LNG IUS
First day of LMP:
≤5 days ago
>5 days ago
Insert
LNG IUS
today
Offer pill/patch/ring as
bridge to LNG IUS
Urine pregnancy test negative
Yes
Patient accepts pill/patch/ring
Unprotected sex since LMP?
Patient declines pill/patch/ring,
uses barrier method instead
2 weeks later, pregnancy test is negative
Insert LNG IUS today
CDC. MMWR. 2013; Hatcher RA. 2005.
No
Insert LNG IUS within 5
days of next menses
Insert
LNG IUS
today
Timing of Insertion of IUDs
Timing
Pros
With menses
Ensures patient not
pregnant
Midcycle, any
time
Convenience; low rate
of expulsion
Emergency
Convenience;
contraception
pregnancy prevention
(Copper T IUD)
Cons
Scheduling;
interim
pregnancy
Must rule out
pregnancy
Pregnancy
more…
Alvarez Pelavo J. Ginecol Obstet Mex. 1994; Hatcher RA. 2005; O’Hanley K.
Contraception. 1992.
Timing of Insertion of IUDs (continued)
Timing
Cesarean delivery
Postplacental
Pros
Cons
Convenience;
low rate of
expulsion
Strings may not
be visible or
palpable at cervix
Convenience
Increased rate of
expulsion
(7%–15%)
Alvarez Pelavo J, et al. Ginecol Obstet Mex. 1994.; O’Hanley K, et al. Contraception. 1992.
Copper T IUD as Emergency
Contraception
• Can be inserted up to 5
days after unprotected
intercourse to prevent
pregnancy
• More effective than
emergency oral
contraceptives
Trussell J. 2011; D’Souza RE. 2003.
Prophylactic Antibiotics Before
Insertion
• Antibiotics have not been shown
to reduce risk of PID when given
prophylactically
Grimes D. Contraception. 1999; Grimes DA. Cochrane Database Syst Rev. 1999;Dajani AS.
JAMA. 1997; Penney G. J Fam Plann Reprod Health Care. 2004; WHO. 2002.
Signs of Possible Complications
Symptom
Possible Explanation
Severe bleeding or
abdominal cramping 3–5 Perforation, infection
days after insertion
Irregular bleeding and/or Dislocation or
pain every cycle
perforation
Fever, chills, unusual
vaginal discharge
Infection
more…
Signs of Possible Complications
(continued)
Symptom
Possible Explanation
Pain during intercourse
Infection, perforation,
partial expulsion
Missed period, other
signs of pregnancy,
expulsion
Pregnancy
(uterine or ectopic)
Shorter, longer, or
missing threads
Partial or complete
expulsion, perforation
Management of Cramping
• Mild: recommend NSAIDs
• Severe or prolonged:
▪
▪
Examine for partial
expulsion, perforation, or PID
Remove IUD if severe
cramping is unrelated to
menses or is unacceptable
to patient
CDC. MMWR. 2013.
Management of Heavy Bleeding with
IUC
Heavy bleeding lasting >6 months:
•
•
•
•
Evaluate for infection, fibroids, or displaced device
Consider ultrasound/x-ray to evaluate bleeding
Replace device if displaced
For Copper T IUD:
• Check for anemia and treat if indicated
• Prescribe NSAIDS
• If bleeding cannot be managed or is unacceptable to
patient, consider removal
ARHP. 2004.
LNG 52 IUS: Management of Late
Abnormal Bleeding
Matched-pair, case-control study
• 15 users with unacceptable bleeding after >6
months of use vs. 15 control users with no
abnormal bleeding
• Device displacement or leiomyomas
detected more commonly in cases than
controls
more…
Ronnerdag M. Contraception. 2007.
LNG 52 IUS: Management of Late
Abnormal Bleeding (continued)
Conclusion:
• Consider ultrasonography and
hysteroscopy to evaluate bleeding in longterm users of LNG IUS
• Replace device if it is displaced
Ronnerdag M. Contraception. 2007.
Bleeding with the Copper T IUD
• Bleeding and/or pain rates are highest during
first year of use
• Rates of expulsion and removal for bleeding
and/or pain are higher in nulliparous than in
parous women
• Bleeding appears to decrease over time with
most users
Hubacher D. Contraception. 2007, 2009; Sivin I. Contraception. 2007.
Expulsion
• Partial or unnoticed expulsion may present
as irregular bleeding and/or pregnancy
• Risk of expulsion related to:
▪
▪
▪
▪
Provider’s skill at fundal placement
Age and parity of woman
Time since insertion
Timing of insertion
WHO. 2009; CDC. MMWR. 2010.
Management of Missing Threads
• Rule out pregnancy
• Probe for threads in cervical canal
• Prescribe back-up contraceptive method
• Obtain ultrasound or x-ray, as needed
• Promptly remove a displaced Copper T IUD
in the abdomen
Management of STIs
If STI is diagnosed:
• IUD removal not necessary if symptoms
improve within 72 hours of treatment
• Treat infection
• Counsel patient about prevention of STI
transmission
Penney G. J Fam Plann Reprod Health Care. 2004; WHO. 2002.
Management of PID
If PID is diagnosed:
• IUD removal may not be necessary
• Treat infection
• Recommendations to remove IUD are not
evidence based
Grimes D. Lancet. 2000.
Risk of Uterine Perforation
• Rare:1 per 1,000 insertions
• Perforation risk is linked to:
▪
▪
▪
Uterine position and consistency
Provider’s skill and experience with technique
required
Time of insertion after childbirth
▫ Risk doubled within first 12 weeks postpartum
• Perforation risk is reduced through directed
training and observation
Caliskan E. Eur J Contracept Reprod Health Care. 2003; Van Houdenhoven K.
Contraception. 2006; Prema K. Contracept Deliv Syst. 1981; Markovitch O. Contraception.
2002; Harrison-Woolrych M. Contraception. 2003; WHO. 1987.
Management of Perforation at
Insertion
If perforation occurs at insertion:
• Remove device
• Provide alternative contraception
• Monitor for excessive bleeding
• Follow-up as appropriate
• Can insert another device after next menses
Pregnancy with IUD in Place
• Determine site of pregnancy
▪
Intrauterine or ectopic
• Remove IUD if threads are accessible
• Removal decreases risk of:
▪
▪
Spontaneous abortion
Premature delivery
ParaGard® PI. 2013; Mirena® PI. 2013; SkylaTM PI. 2013; UK Family Planning Research
Network. Br J Fam Plann. 1989; Foreman H. Obstet Gynecol. 1981; Atrash HK. 1994.
Risk of Fetal Abnormality
• IUC is extra-amniotic
• No increase in birth
defects for Copper T
IUD
Atrash HK. 1994; Layde PM. Fertil Steril. 1979; Simpson JL. Res Front Fertil Regul. 1985.
Hands-on Practicum
Steps for Insertion: Technique Varies
According to Product
1. Perform pelvic exam to assess size and
position of uterus
2. Apply speculum, antiseptic, and tenaculum
3. Sound the uterus
4. Load the device
5. Place the device
6. Cut the threads
7. Add documentation to patient’s chart (string
length, uterine device, lot number, etc.)
Animated Insertion: LNG 52 IUS
Animated Insertion: LNG 13.5 IUS
Summary
• Three forms of IUC approved in U.S.
▪
Copper T IUD, LNG 52 IUS, and LNG 13.5 IUS
• IUC is the most effective reversible method
available
• There are few contraindications to IUC use
• Potential side effects of IUC use include
changes in menses and cramping
• Counseling and discussion/management of side
effects help increase uptake
Resources
• Association of Reproductive Health Professionals
(www.arhp.org)
• WHO/CDC Medical Eligibility Criteria
▪
▪
http://www.who.int/reproductivehealth/publications/family_
planning/9789241563888/en/index.html
http://www.cdc.gov/reproductivehealth/UnintendedPregna
ncy/USMEC.htm)
• Family Pact (www.familypact.org)
• BEDSIDER (www.bedsider.org)
Supplemental Slides: 109–123
LNG 52 IUS vs. OCs in Nulligravid
Women: Discontinuation Rates
LNG 52 IUS
OC
discontinuation
discontinuation
rate per 100
6.66
4.95
2.52
0
1.20
2.13
rate per 100
0
9.75
0
1.25
NA
1.09
Reason
Pain*
Hormonal
Bleeding
Spotting
Expulsion
Other medical
*Statistically significant difference
Suhonen S. Contraception. 2004.
Percentage of Women with Fertilized
Eggs in Oviducts After Midcycle Coitus
Group
Normal
development
(%)
No
development
(%)
Abnormal
development
(%)
Control
(n = 20)
50
15
35
IUC*
(n = 14)
0
64
36
*IUDs studied included Copper T 200 (4 women), Lippes loop (5 women), and
progestin IUDs (5 women)
Alvarez F. Fertil Steril. 1988.
IUC Efficacy Is Comparable to
Sterilization
5-year gross cumulative failure rate
Cu T 380
1.4
All sterilization
1.3
WHO. 1987; Peterson HB. Am J Obstet Gynecol. 1996.
Postpartum
salpingectomy
0.5
Discontinuation and Continuation
Rates per 100 Women
Event
LNG 52 IUS
LNG 13.5 IUS
1 Year
5 Years
1 Year and 3 Years*
Pregnancy
0.1
0.3
0.4 (1 year)
0.9 (3 year)
Bleeding
5.8
10.9
4.6
Device expulsion
3.4
4.9
3.2
Pain (not further
specified)
1.6
4.2
—
Pain, abdominal
—
—
2.5
Pain, pelvic
—
—
1.8
Continuation
80
47
82
*Combined data; 1,383 patients for 1 year, 993 for 3 years
Safety: Rate of PID by Duration of
IUC Use
N = 20,000 women
Farley T. Lancet. 1992.
Safety: IUC 5-Year Cumulative Gross
Removal Rate for PID
Per 100 women
Nova-T
LNG 52
Andersson K. Contraception. 1994.
Safety: IUC Does Not Cause
Infertility
• IUC is not related to infertility
• Chlamydia is related to infertility
Tubal infertility by
previous Copper T IUD
use and presence of
chlamydia antibodies,
nulligravid women
Hubacher D. N Engl J Med. 2001.
Safety: IUC May Be Used by HIVPositive Women
• No increased risk of
complications compared
with HIV-negative
women
• No increased cervical
viral shedding
• WHO and CDC
Category 2 rating
WHO. 2009; CDC. MMWR Recomm Rep. 2010; Morrison CS. Br J Obstet Gynaecol. 2001;
Richardson B. AIDS. 1999.
Safety: IUC May Be Used in
Nulligravid Women
• No evidence of increased
infertility in nulliparous
users of IUC
• Risk of PID and
subsequent infertility is
dependent on non-IUC
factors
WHO. 2009; Hubacher D. N Engl J Med. 2001; Delbarge W. Eur J Contracept Reprod
Health Care. 2002; Hov GG. Contraception. 2007; Penney G. J Fam Plann Reprod Health
Care. 2004.
Nulligravid Adolescent: Practice Tips
(continued)
• Os finder
• Uterine dilators
• Timing of Insertion algorithm
more…
Westhoff C. Contraception. 2002.
Pain Decreases with Time After
Insertion
Hubacher D. Contraception. 2009.
Young Pregnant Women Need More Counseling
About IUC Safety and Efficacy
How safe/effective is IUC compared with pills,
injections, or tubal sterilization?
Unsure of safety
71%
Unsure of efficacy
58%
Stanwood NL. Obstet Gynecol. 2006.
What Do Women Find Unacceptable
About IUC?
• Lack of objective
information
• Reported side effects
• Anxiety about IUD
insertion
• Infection risk
• Lack of personal control
of IUC after insertion
Asker C. J Fam Plann Reprod Health Care. 2006.
IUC Is Cost Effective
• Higher one-time startup cost,
but incurs substantially lower
cost over time
• Both IUC manufacturers offer
patient payment plan options
• Bulk discounts are available
to clinicians
Darney P. NEJM. 2001; Trussell J. Am J Public Health. 1995; Chiou CF. Contraception.
2003.
IUC Side Effects vs. Complications
Side Effects
Menstrual
effects
Complications
Infection
Perforation
Pregnancy
Expulsion
Missing threads