Transcript IUCs - California Association for Nurse Practitioners

Intrauterine Contraception;
A Method That Will Prevail!
IUC/EMB/PCB
Patty Cason, MS, FNP-BC
UCLA School of Nursing
Disclosure
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Expert Input Forum HPV Vaccine; Merck
Speaker Merck; Gardasil, NuvaRing
Trainer Merck; Nexplanon, Implanon
Advisory board; ParaGard Teva
Speaker & trainer; ParaGard Teva
Outline
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Attributes of LARC Methods
Characteristics of the IUC’s
Reducing barriers to IUC use
Management of side effects and
complications
• Step-by step insertion
• Tips for difficult insertions
3
“Politically Correct” Terminology
Old name
• IUD: Intrauterine Device
New names
• IUC: Intrauterine Contraception
– Applied to Cu-T380 (ParaGard®)
– Generic term for both types
• IUS: Intrauterine System
– Applied to LNG-IUC (Mirena®)
4
The Case for LARC Methods
• More than 1/3 of all U.S. women will
have had an induced abortion by age 45
• 20% of women selecting sterilization at
age < 30 years later express regret
• Need for effective contraceptive methods
that are “forgettable”
Henshaw. Fam Plann Perspect 1998
Hillis et al. Obstet Gynecol 1999
Stanwood, NL. Obstet Gynecol 2002
5
U.S. Pregnancies:
Unintended vs. Intended
Intended 51%
Unintended 49%
Unintended births
22.5%
Elective Abortions
Henshaw: Fam Plann Perspect 1998;30:24-29.
26.5%
6
Contraceptive Use During Month of
Unintended Pregnancy
43% used contraception
5% consistent
method use:
method failure
52% did not use
contraception
Guttmacher Institute In Brief Series 1 2008.
7
What are LARC Methods?
• Long Acting Reversible Contraception
– IUCs: LNG-IUC ,Cu-T380
– Implants: Etonogestrel Implant
• Long term continuous protection 24/7/365
protection… for 3-10 years
• Do not require episodic patient initiative for use
• Not daily
• Not weekly
• Not monthly
• Not even every 12 weeks
8
Why LARC Methods?
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They are “forgettable”
Require just one motivational act
The most effective reversible methods available
Superior continuation rates
Are among the safest contraceptive
methods…very few US-MEC category 3 or 4
grades
Highest patient satisfaction among methods
No need to take time to refill prescriptions
An alternative to surgical sterilization
The most cost saving method of contraception
9
Contraceptive Efficacy
Top Tier: Most Effective
Female/male sterilization; IUC, Implant
Middle Tier: Effective
DMPA, Oral Contraceptive (OC), Patch, Ring
Bottom Tier: Less Effective
Barriers, Spermicides, Behavioral methods
10
Contraceptive Effectiveness and
Continuation Rates
Implant (Implanon)
Male sterilization
IUC
•LNG-IUC (Mirena)
•Cu-T 380 (ParaGard)
Female sterilization
DMPA
OCs, Patch, Ring
Perfect
Use
0.05
0.10
Typical
Use
0.05
0.15
Continuation
rate
84%
100%
0.2
0.6
0.5
0.3
0.3
0.2
0.8
0.5
3.0
8.0
80%
78%
100%
56%
68%
Hatcher, RA et al; Contraceptive Technology 19th Edition,: 2007
11
Cost savings per dollar expenditure by
contraceptive method, Family PACT 2003
Foster, D. G. et al. Am J Public Health 2009;99:446-451
12
Intrauterine Contraception in the U.S.
Mechanism
Copper T-380
LNG-IUC
Spermicidal
effect of copper
Up to 10 years
0.8 failures/hwy
No hormones
None
Thickening of
cervical mucus
Up to 5 years
0.2 failures/hwy
Less bleeding
Menorrhagia
Menstrual pain
$703
Duration
Efficacy
Benefit
Noncontraceptive use
Cost (retail)
$598/568
13
Client Choice of IUC Type
• LNG IUC
• Copper T IUC
– Good method for
–Good method
women who
for women
request
less
who don’t
menstrual
flow
or
want
who experience
hormonal
dysmenorrhea
contraception
14
Copper T IUC:
Mechanism of Action
• Primary mechanism is
prevention of fertilization
– Reduce motility and viability
of sperm
– Inhibit development of ova
• Inhibition of implantation is a
secondary mechanism
Alvarez F, Brache V, Fernandez E, et al. Fertil Steril. 1988;49:768
Segal SJ, Alvarez-Sanchez F, et al. Fertil Steril. 1985;44:214.
ACOG. Statement on Contraceptive Methods, Washington DC:ACOG, July 1998
Rivera R, Yacobson I, Grimes D, Am J Obstet Gynecol 1999;181:1263-9
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Stanford JB, Mikolajczyk RT, Am J Obstet Gynecol 2002; 187:1699-708
LNG-IUC Physical Characteristics
Steroid
reservoir
levonorgestrel
20 g/day
16
LNG-IUC: Contraceptive
Mechanism
• Cervical mucus thickened
• Sperm motility and function
inhibited
• Endometrium suppressed
• Ovulation inhibited (in some
cycles)
Jonsson et al. Contraception 1991;43:447
Videla-Rivero et al. Contraception 1987;36:217
Rivera R, Yacobson I, Grimes D, Am J Obstet Gynecol 1999;181:1263-9
Stanford JB, Mikolajczyk RT, Am J Obstet Gynecol 2002; 187:1699-708 17
Plasma concentrations (pg/mL)
Plasma Concentrations of
Levonorgestrel
3000
2500
2000
1500
1000
500
0
MIRENA
Implant
Nilsson et al. Acta Endocrinol 1980;93:380
Diaz et al. Contraception 1987;35:551
Mini-pill
Combined OCs
18
Meta-Analysis: Mirena® vs. Ablation
for Heavy Menstrual Bleeding
• No difference between rates of treatment failures
– 21.2% LNG-IUC vs. 17.9% endometrial ablation
• Both resulted in similar improvements in quality of life
• Less need for analgesia/anesthesia in LNG-IUC group
• Ablation requires additional effective contraception
Kaunitz, et al. OG. 2009 May;113(5):1104-16b.
19
So….if IUCs are so good…
Why Aren’t They Used More
Frequently in the US?
20
Contraception by Age (2008)
60
49
50
40
IUD
Steriliz
OCP
Ring
30
20.7
18.8
20
10
20.9
12.5
2.1 0.9
2.2
4.4
1.9
3.8
0.5
0
15-24
25-34
35-44
Mosher WD. National Survey of Family Growth. Series 23, Number 29 August 2010
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Increased Use of Intrauterine
Contraception in California, 1997 to 2007
• Modern intrauterine contraception is safe and
highly effective, but is used by fewer than 4%
of women in the United States.
• Previously recommended only for women
with at least one child, now recommended for
most women regardless of parity or age.
• 10 years of the California Women's Health
Survey
Thompson KM, et al. Womens Health Issues. 2011
Increased Use of Intrauterine
Contraception in California, 1997 to 2007
• Use of IUC in California almost doubled over the
study period from 4.0% to 7.2%
• Women with the greatest increases were:
–
–
–
–
younger
born in the US
without a college degree
Asian
• IUC use among nulliparous women did not
increase and IUC users were 71% less likely to be
nulliparous
Thompson KM, et al. Womens Health Issues. 2011
Increased Use of Intrauterine
Contraception in California, 1997 to
2007
CONCLUSION:
• IUC use in California is higher than the
national average and growing
• Disproportionately low use among nullips
• Efforts to inform women of IUC's effectiveness
and safety, as well as efforts to ensure that
health care providers have the necessary
clinical skills, are timely and important.
Thompson KM, et al. Womens Health Issues. 2011
Why is the IUC Underutilized
in the United States?
• Dearth of trained and willing professionals
to insert devices
• Negative publicity about method in ’70s
• Misconceptions by health care providers
and the public
• Fear of litigation
Weir. CMAJ 2003
Stanwood, NL. Obstet Gynecol 2002
Steinauer JE. Family Planning Perspectives 1997
25
Family PACT Provider Practices With IUCs
• Survey of 1,246 providers with at least one IUC
insertion claim in 2005; response rate 65% (n=813)
• Providers who think an IUC should not be inserted
in clients if:
– Nulliparous: 50%
– Adolescent: 58%
– History of ectopic pregnancy: 63%
• Provider’s concern about PID affected willingness
to recommend IUC
– “A lot” (29%)
– “Some” (61%)
Harper C, et. al. OB GYN 2008
26
IUC Use By Female Ob/Gyns
vs. All Women in the U.S.
50
% of population
40
30
20
18%
10
0.7%
0
Female Ob/Gyn
Physicians
General Population
Population Reference Bureau, 2002.; The Gallup Organization, 2004.
27
Why is the IUC Underutilized
in the United States?
• Dearth of trained and willing professionals
to insert devices
• Misconceptions by health care providers
and the public
• Negative publicity about method in ’70s
• Fear of litigation
Weir. CMAJ 2003
Stanwood, NL. Obstet Gynecol 2002
Steinauer JE. Family Planning Perspectives 1997
28
Rate of PID by Duration of IUC Use
n=20,000 women.
10
8
Rate per 1000
Woman-Years
6
Baseline PID risk:
1-2 cases /TWY
4
2
0
20 days
21 days - 8 years
Duration of Use
Adapted from Farley T, et al. Lancet. 1992;339:785-788.
29
IUCs Do Not Cause PID
• PID incidence for IUC users is similar to that
of the general population
• Risk is increased only during the first month
after insertion
• Preexisting STI at time of insertion, not the
IUC itself, increases risk
• No reason to restrict use based on sexual
behaviors
Svensson L, et al. JAMA. 1984.
Sivin I, et al. Contraception. 1991.
Farley T, et al. Lancet. 1992.
Grimes DA, Lancet 2000.
Hubacher D, et al. Engl J Med 2001
30
Why is the IUC Underutilized
in the United States?
• Dearth of trained and willing professionals
to insert devices
• Misconceptions by health care providers
and the public
• Negative publicity about method in ’70s
• Fear of litigation
Weir. CMAJ 2003
Stanwood, NL. Obstet Gynecol 2002
Steinauer JE. Family Planning Perspectives 1997
31
Dalkon Shield
32
Dalkon Shield- multi-filament string
33
Fertility Rates in Parous Women After
Discontinuation of Contraceptive
100
Pregnancies (%)
80
IUC
60
OC
Diaphragm
40
Other methods
20
0
0
12
18
24
30
Months After Discontinuation
Vessey MP, et al. Br Med J. 1983.
Andersson K, et al. Contraception. 1992.
Belhadj H, et al. Contraception. 1986.
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42
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Use of the levonorgestrel releasingintrauterine system in nulliparous
women
To evaluate the insertion procedure and
continuation rates of the levonorgestrel
releasing-intrauterine system (LNG-IUS) in
nulliparous women who, due to fear of
complications, are often denied this very
effective contraceptive method.
Marions L, et al. Eur J Contracept Reprod Health Care. 2011
Use of the levonorgestrel releasingintrauterine system in nulliparous
women
• The insertions were considered easy by 72% of
inserters *
• Only 5% of pts were dissatisfied
• No perforations
• No pregnancies
CONCLUSION:
Our results support the current practice in
Sweden of offering LNG-IUS routinely to
nulliparous women
* mostly carried out by midwives
Marions L, et al. Eur J Contracept Reprod Health Care. 2011
US Medical Eligibility Criteria
Category
Definition
Recommendation
1
No restriction in contraceptive Use the method
use
2
Advantages generally
outweigh theoretical or
proven risks
More than usual
follow-up needed
3
Theoretical or proven risks
outweigh advantages of the
method
Clinical judgment
that this patient can
safely use
4
The condition represents an
Do not use the
unacceptable health risk if the method
method is used
38
Indications for IUC Use
• Both IUC products
– Long term contraception in fertile
women
• 2010 US Medical Eligibility Criteria
 Menarche to age 20 Category-2
 Age 20 and older
Category-1
 Nulliparity
Category-2
 Parous
Category-1
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SFP on Nullips
Lyus R, Lohr P, Prage S, Board of the Society of
Family Planning. Use of the Mirena LNG-IUS
and Paragard CuT380A intrauterine devices in
nulliparous women. Contraception
2010;81:367–71
Both IUC Products:
US MEC 2010







Category 4
Distorted uterine cavity
Post-partum endometritis
Post-abortion endometritis
Malignant GTD or ↑ hCG
Cervical/endometrial cancer
Current GC/CT/purulent
cervicitis/PID
− Initiate: 4; Continue: 2
Pelvic TB
− Initiate: 4; Continue: 3
Category 3
 Postpartum (48h-4 wk)
 Benign GTD with ↓ hCG
 Increased risk of STIs
−Initiate**: 2/3;
Continue: 2
** very high individual risk of
exposure to GC or Ct is 3
US Medical Eligibility Criteria 2010
LNG-IUS
only
Copper
IUC only
Category 4
Category 3
Current
 Breast cancer (> 5 yrs NED)
breast
 Liver tumors, severe cirrhosis
cancer
 Current MI or angina
 Migraines with aura
 AIDS (ARV drug interactions)
 Complicated transplant
 Lupus with anti-PL antibody
 Lupus with thrombocytopenia
Timing of Insertion of
Intrauterine Contraception
Timing
With menses
Any time
Emergency
contraception
(Cu T only)
Pros
• Ensures patient
not pregnant
• Convenience
• Low expulsion
rate
• Pregnancy
prevention
• Convenience
Alvarez PJ. Ginecol Obstet Mex. 1994.
O’Hanley K, et al. Contraception. 1992.
Cons
• Scheduling
•Interim
pregnancy
•Must exclude
pregnancy
•Not cost
effective if used
only for EC
43
Copper T380A intrauterine device for
emergency contraception: a prospective,
multicentre, cohort clinical trial.
• Eighteen family planning clinics in China
• 1963 women requesting EC within 120 hours of
unprotected intercourse.
• followed at 1, 3 and 12 months after insertion of
CuT380A.
• No pregnancies occurred prior to or at the first followup visit, making CuT380A 100% effective as emergency
contraception in this study.
Wu S, et al. BJOG 2010
Copper T380A intrauterine device for
emergency contraception: a prospective,
multicentre, cohort clinical trial.
• The pregnancy rate over the 12-month period was 0.23
per 100 women
• 1.5% women experienced a difficult IUD insertion
– requiring local anesthesia or prophylactic antibiotics.
• No uterine perforations occurred.
• The 12-month postinsertion continuation rate was 94.0
per 100 woman-years.
• CuT380A is a safe and effective method for emergency
contraception. The advantages of CuT380A include its
ability to provide effective, long-term contraception.
Wu S, et al. BJOG 2010
A survey of women obtaining EC:
are they interested in using the Cu IUD?
• 34.0% of 941 said they would be interested in an EC
method that was long term, highly effective and
reversible.
• Interested women were not significantly different from
non-interested women in relation to age, marital
status, education, household income, gravidity,
previous abortions, previous STIs or relationship status.
• 37.5% of those interested or 12.8% of all those
surveyed would wait an hour, undergo a pelvic exam to
get the method and would still want the method
knowing it was an IUD.
• Only 12.3% of these women could also pay $350 or
Turok DK, et al. Contraception. 2011
more for the device.
A pilot study of the Copper T380A IUD
and oral levonorgestrel for emergency
contraception.
• (60%) chose oral LNG and (40%) chose the
copper IUD.
Turok DK, et al. Contraception. 2010
Postpartum IUC Insertion
US MEC 2010
•Vaginal delivery or C/S
LNG-IUS Cu-IUD
•Breast-feeding or non-lactating
<10 min after delivery of placenta
2
1
10 min after delivery of placenta
to <4 wks
2
2
>4 wks post partum
1
1
Puerperal sepsis
4
4
How Is Postpartum IUC
Placement Performed?
•
IUC placement after vaginal delivery
– Insert IUC within 10 minutes of placental delivery
– Use sponge forceps on cervical lip
– 2nd forceps to place IUC at uterine fundus
– Cut string flush with external cervical os
– Trim strings at postpartum visit
How Is Postpartum IUC
Placement Performed?
•
IUC placement at of caesarean section
– After delivery of placenta
– Manually place IUC at fundus
– tuck strings thru cervix
– Repair uterus
– Trim strings at postpartum visit
IUC Use During Lactation
• Effectiveness not decreased
• No increased risk of
– uterine perforation
– Expulsion
• Decreased insertional pain
• Reduced rate of removal for bleeding and pain
• LNG comparable to copper T in breastfeeding
parameters
Chi I-C, et al. Contraception. 1989
Shaamash AH, et al. Contraception. 2005.
51
Post Abortion IUC Insertion
(WHO MEC, Cochrane Review)
• No difference in complications for immediate
versus delayed insertion of an IUC after abortion
• There were no differences in safety or expulsions
after insertion of an LNG-IUC compared to Cu-IUC
• Expulsion slightly greater when inserted after a 2nd
trimester vs. a 1st trimester abortion
• US Medical Eligibility Criteria 2010
– First trimester abortion:
USMEC-1
– Second trimester abortion:
USMEC-2
52
Excellent Time for IUC InsertionPost Abortion
• Most women ovulate by 21 days post abortion
(range 8-37 days)
• This is true for 1st trimester, 2nd trimester,
medical abortion and spontaneous abortion
Sober S, et al. Contraception 2010
Donnet ML, et al. Clin Endocrinol (Oxf) 1990
Cameron IT, et al. Acta Endocrinol 1988
R.P. Marrs, et al. Am J Obstet Gynecol 1979
53
Excellent Time for IUC InsertionPost Abortion
• Of 1.3 million abortions annually in US, about half
are repeat procedures
• 40% of women scheduled for delayed IUC
insertion did not return for the procedure
• Immediate post-abortal IUC insertion is a safe,
effective, practical, and underutilized intervention
that can reduce repeat unintended pregnancy
and repeat abortion by two-thirds
P Bednarek, et al N Engl J Med 2011; 364:2208-2217
M Cremer, et al Contraception 2011; 83:522-527
Stanek AM, et al. Contraception 2009
54
Why Do A Post-Abortion
IUC Placement?
• Advantages
– One procedure rather than two
– Less or no pain with insertion, since cervix is dilated
– Immediate protection
– Reduce repeat unintended pregnancy risk
– 2nd visit often delayed or doesn’t occur
• Disadvantages
– Slightly higher expulsion rate
• 2nd tri TAB: 3-10%, 1st trimester TAB: 5-6%
• No TAB: 1-4%
– Is the decision to use an IUC biased while
pregnant?
P Bednarek, et al N Engl J Med 2011; 364:2208-2217
M Cremer, et al Contraception 2011; 83:522-527
Intrauterine device insertion after
medical abortion
• The day a woman presents for verification of a
completed medical abortion may be an ideal
time to insert intrauterine contraception
• 4.1% expulsions
• No diagnosed pelvic infections, pregnancies,
or uterine perforations
• The continuation rate at 3 months was 80%.
Betstadt SJ, et al.Contraception. 2011
Pre-IUC Insertion Screening
• Evidence supports no routine screening tests
– CT, GC: if high risk sexual behaviors or < age
26 and due for annual screening CT
– Pregnancy test: only if pregnancy suspected
– Pap smear: only if due for a routine Pap
• Any indicated screening test can be done on
the day of IUC insertion
Intrauterine Contraceptives (IUCs), Family PACT Clinical Practice Alert. 2011
Sufrin C, et al. Contraception 2010
Secura G, et al. Am J Obstet Gynecol 2010
Martínez F, et al. Acta Obstet Gynecol Scand.
57
Faúndes A, et al.Contraception 1998
Pre-Insertion Guidelines
• Prophylactic antibiotics
– No value for routine administration
– May reduce PID in high prevalence GC/CT
sites
• Premedication
– NSAID 30-60 minutes before insertion is
common, but no effect on pain or
discontinuation
– Consider paracervical block if history of
F, et al. Acta Obstet Gynecol Scand.
cervical os orMartínez
canal
stenosis
Lancet. 1998 Apr 4;351(9108):1005-8.
Randomised controlled trial of prophylactic antibiotics
b
58
Walsh T, Grimes D, Frezieres R, Nelson A, Bernstein L, Cou
Is A Follow Up Visit Necessary?
• Practices vary
• Two studies by WHO in Africa with non-medicated
IUCs conclude that a follow-up visit is unnecessary
• Arguments Pro:
– Detect early asymptomatic expulsion
– Further counseling
– Medico-legal “standard of practice”?
• Arguments con:
– Almost all adverse events have symptoms
– Patient knows to return if string cannot be felt
59
Post-IUC Insertion Counseling
• The client should return if
– String cannot be located (use barrier method)
– Symptoms of pregnancy
– Symptoms of infection
• Pain, deep dysparunia, fever, foul discharge
– Sudden unexplained pelvic pain occurs
– Excessively heavy bleeding
60
Ectopic pregnancy risk when
contraception fails. A review.
Furlong , Reprod Med. 2002
IUC Removal Post Menopause?
• Menopause
– Strings seen: remove
– No strings: weigh benefit vs. hazard of
removal
– Tail-less IUC (e.g., stainless steel coil ring)
does not require removal unless
requested by the client
62
IUCs: Bleeding Days Per Month
Days
6
Copper IUC
4
2
LNG-IUC
0
0
4
8
12
16
20
24
Months
Luukkainen and Toivonen. 1992;90
63
LNG-IUC: “Resting State”
Endometrium
• Lower volume of menstrual bleeding
– Shorter, lighter menses
– Less iron deficiency anemia
– Therapeutic for menorrhagia
• Less dysmenorrhea
– Suppression of endometriosis, adenomyosis
BUT…
• 3-6 months for full effect on the endometrium
• Spotting is common during this time
64
Menstrual Effects of IUCs:
LNG-IUC
• Hypomenorrhea; intermenstrual bleeding
• Management
– Exclude PID, pregnancy, coagulopathy
– Supplemental estradiol for 2-3 wks
– NSAID’s
– If persistent bleeding, check for anemia
• Remove IUC if abnormal bleeding is
unacceptable to patient
65
Menstrual Effects of IUCs:
Copper IUC
• Heavier or longer menses (or dysmenorrhea)
– Exclude PID, pregnancy, coagulopathy
– NSAIDs prophylactically WITH FOOD
• Pre-emptive use for first 3 cycles
• Start before onset or with onset of menses for antiprostaglandin effect
– Naproxen sodium 220mg x2 BID (max
1100mg/day)
– Ibuprofen 600-800mg TID (max 2400mg/day)
– If heavy or persistent bleeding, check for anemia
• Remove IUC if bleeding is unacceptable to patient
66
IUCs: 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 unacceptable
to patient
Ms B: “I Faint Easily”
• Ms B is a 25 year old G0 P0 woman requesting IUC
placement
• She states that she has had a number of fainting
episodes in the past…most recently at the dentist
and another during a HPV vaccine injection
• She has told her PCP about this problem…heart
auscultation and an ECG were normal.
• Are there any special precautions for her IUC
placement?
68
Lightheadedness and Syncope:
Vasovagal Attack
• Mechanism
– Due to bradycardia + peripheral vasodilation
– AKA: non-cardiogenic syncope, cervical shock
• Association with IUC insertion
– Syncope in 2% of insertions
– Convulsions in 1 per 2,000 insertions
– More likely with
• Pain with cervical manipulation
• Nulliparity
• Previous episodes of vaso-vagal fainting
• Dehydration or NPO
Lightheadedness and Syncope:
Vasovagal Attack
• Prodromal symptoms
– Lightheadedness, diaphoresis, nausea, anxiety
• Prodromal physical signs
– Facial pallor, yawning, pupillary dilation
• Convulsive syncope occasionally follows
faint
– Seizure-like movements
– Rapid recovery with little or no post-ictal state
– Followed by pallor, headache, weakness
Lightheadedness and Syncope:
Vasovagal Attack
• Prevention
– Good hydration (electrolyte/ sports drink)
– Eat before insertion
– Isometric muscle tensing during procedure
• “Grip your hands together, then pull hard”
• “Squeeze your leg muscles as hard as you can”
• Management
– Continue isometric muscle tensing
– Elevate patient’s legs while remaining supine
– If HR remains <60 bpm or convulsive syncope, give
atropine 0.4 mg IV push
Grubb BP N Engl J Med 2005
Lightheadedness and Syncope:
Other Causes
• Hyperventilation
– Due to low CO2 levels (respiratory alkalosis)
– Heart rate normal or tachycardia
– Treat with shallow breaths or re-breathing bag
• Local anesthetic toxicity (if cervical block)
– CNS: lightheadedness, restlessness, anxiety,
tinnitus, tremor, twitch, perioral numbness, visual
changes, seizure, respiratory arrest
– CV: bradycardia, arrythmia, hypotension
72
Bleeding from Tenaculum Site
• Remove tenaculum slowly
• Apply pressure for at least 60 seconds
• Chemical cautery
− Silver nitrate
− Monsel’s solution
• Suturing very rarely is necessary
73
IUC Complications
Absolute
risk
Comment
Perforation
1/1,000
Mostly benign
Expulsion
1-6/100
Most are self-recognized
Unsuccessful
placement
9/ 100
6% when different device is
used after unsuccessful attempt
Pregnancy
<1/HWY
Minimal impact if removed
early in pregnancy
PID
1-2/TWY
Same as gen’l population
Sivin I, Stern J.Fertil Steril 1994
HWY: per 100 women per year
TWY: per 1,000 women per year
IUC Complications
Absolute
risk
Comment
Perforation
1/1,000
Mostly benign
Expulsion
1-6/100
Most are self-recognized
Unsuccessful
placement
9/ 100
6% when different device is
used after unsuccessful attempt
Pregnancy
<1/HWY
Minimal impact if removed
early in pregnancy
PID
1-2/TWY
Same as gen’l population
Sivin I, Stern J.Fertil Steril 1994
Signs of Possible Complications
Symptom
Severe bleeding or
abdominal cramping 3–5
days after insertion
Possible Explanation
Perforation, infection
Irregular bleeding and/or
Dislocation or perforation
pain every cycle
Fever, chills, unusual
vaginal discharge
Infection
more…
Signs of Possible Complications
Symptom
Pain during intercourse
Possible Explanation
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
Genital Tract Infections
• If cervical or vaginal infection diagnosed
– IUC removal not necessary
– Treat infection
– Counsel re: prevention of STI transmission
• If PID diagnosed
– IUC removal usually not necessary
– Treat infection
– Recommendations to remove IUC are not
evidence-based
– Consider removal if no improvement 48-72
hours after starting treatment
Penney G. J Fam Plann Reprod Health Care. 2004
WHO. Selected Practice Recommendations for Contraceptive Use. 2004
78
Actinomyces-Like Organisms (ALO)
• Actinomyces israelii has characteristics of both
bacteria and fungus; part of GI flora
• May asymptomatically colonize the frame of the
IUC, which in itself is not dangerous
• Very small percentage of women with IUC +
actinomyces will develop pelvic actinomycosis
– Presentation is similar to severe PID
• Women with ALO on Pap smear
– Should be examined to exclude PID
– If none, don’t treat actinomyces or remove IUC
79
Uterine Perforation
• More likely to occur in relation to
– Posterior uterine position
– Extreme flexion
– Skill/experience of provider
– Insertion 2 days-4 weeks after childbirth
• Typical location is midline at uterine fundus…if
so, perforation often is asymptomatic, benign
• Suspect if sounding is much deeper than
expected
Grimes, et al. Cochrane Library, 2001, Issue 2.
Markovitch O, et al. Contraception 2002
Caliskan E, et al. The European Journal of
Contraception and Reproductive Health Care 2003 80
Harrison-Woolrych M, et al. Contraception 2003;
Management of
Uterine Perforation
•
•
•
•
•
If before insertion of IUC, stop procedure
If during insertion of IUC, remove IUC
Monitor for 30 min for excessive bleeding, pain
Provide alternative method of contraception
Can insert another device after next menses
81
Prevention of
Uterine Perforation
• Why sound the uterus at all?
– Determine the “pathway” to the fundus
– Preliminary dilation of the internal os
– Establish depth to fundus to set flange
– Ensure depth within 6-10 cm limits
• Bend sound to mimic uterine flexion
• Brace fingertips on speculum to achieve control of
force while advancing the sound
• EMB device can be used instead of metal sound
• Open IUC package after sounding completed
82
IUC Expulsion
• Occurs in 1-10% IUC insertions within first year
• Risk of expulsion related to
– Provider’s skill at fundal placement
– Age, parity, BMI,uterine configuration
– Time since insertion (↑ within first 6 mos)
– Timing of insertion (menses, postpartum, postabortion)
• Asymptomatic expulsion often presents with an
(unanticipated) pregnancy
• Partial expulsion may present with
– Pelvic pain, cramps, intermenstrual bleeding
– Pregnancy
P Bednarek, et al N Engl J Med 2011; 364:2208-2217
M Cremer, et al Contraception 2011; 83:522-527
83
Missing IUC String: Diagnosis
• Possibilities…
– Expulsion, pregnancy, embedment,
translocation
• Initial management
– Probe for strings in cervical canal
Cytology brush to tease from canal
Endocervical speculum or forceps
– Rule out pregnancy
– Prescribe back-up contraceptive method until
intrauterine location is confirmed
Prabhakaran S. et, al. Contraception.2011
84
Missing IUC String: Management
•No IUC string in canal
•Pregnancy test negative
Desires
retention
Desires
removal
+ initial UTZ
Attempt extraction
In Situ
Extracted
Embedded
Op hysteroscopy
Extracted
OR
UTZ
Absent
KUB
Absent
Present
KUB
Not felt
Present
Translocated
UTZ
Absent
Expelled
In Situ
Absent
Translocated
85
Missing IUC String: Treatment
• In situ (intrauterine) placement: desires continuation
– Leave in place for remainder of IUC lifespan
• In situ placement: desires removal
– Use straight or “alligator” forcep, + simultaneous
real time pelvic ultrasound
– Crochet hook best for circular IUCs; less helpful with
T-shaped IUCs
– If unsuccessful, extract via operative hysteroscopy
• Translocation (IUC in peritoneal cavity)
– Extract via operative laparoscopy
86
Pregnancy With IUC In Situ
• Determine site of pregnancy (IUP or ectopic)
• If intrauterine pregnancy confirmed
– Termination planned: await procedure
– Continue pregnancy: remove IUC if strings
visible
– Removal decreases risk of spontaneous
abortion, premature delivery
• Retention of IUC (if strings not visible)
– Increase surveillance for SAB, pre-term birth
– No greater risk of birth defects (extra-amniotic)
87
Family PACT IUC Policy:
Purchase and Records
• IUCs must be FDA-approved devices, labeled for
US use, and obtained from FDA approved
distributors
• Providers must record the lot number in the
med record and keep a written or electronic log
of all IUCs inserted for at least 3 years from
insertion
• Maintain invoices > 3 years from date of invoice
• Patients must be provided with a record of the
dates of insertion and expiration
88
Billing Instructions for IUCs
Primary Diagnosis Codes
• S401: Evaluation prior to initiation of the method,
whether or not the IUC is inserted that day
– Use S401 when performing the insertion of the
first IUC for this client
• S402: Maintain adherence and surveillance for a
current user of an IUC, whether or not the client is
new to the provider
– Use S402 when replacing an IUC with another of
the same type or a different type
– Both insertion and removal may be billed on the
same date of service
89
Billing Instructions for IUCs
Insertion or Removal Procedures
• Insertion
– CPT 58300: Insertion of IUC
– 58300-ZM: Insertion supplies
– Kit: X1522 (ParaGard) or X1532 (Mirena)
– E&C: contraceptive counseling visit
• Removal
– CPT 58301: Removal of IUC
– 58301-ZM: Removal supplies
– E&C: contraceptive counseling visit
90
IUC Complication Coverage
• New Family PACT benefits for IUCs
– CPT-4 code 76857: Ultrasound, pelvic
(nonobstetric)
– CPT-4 code 76830: Ultrasound, transvaginal
– Billing requirements for code 74000 are revised
• 3 codes billed in conjunction with primary diagnosis
code S402 and secondary diagnosis code V45.51
(intrauterine contraceptive device). A Treatment
Authorization Request is not required.
• S4032 will no longer be a valid Family PACT PDC
effective for dates of service on or after June 1, 2011.
91
IUC Complication Coverage
• IUC complications
– S403 Vaso-vagal episode
– S4031 Pelvic infection (secondary to IUC)
– S4032 “Missing” IUC- no longer a valid code
– S4033 Perforated or translocated IUC
• Covered complication services include
– Hysteroscopy, dilation and curettage
– Laparoscopy/ laparotomy
• All complication services must be approved by
TAR
• Please consult PPBI @ familypact.org
92
IUC Insertion Practicum
• Insertion of LNG-IUC
• Insertion of Cu-T IUC
• The “Difficult” IUC Insertion
93
Steps for IUC Insertion
•
•
•
•
•
•
Perform bimanual pelvic exam to determine
anterior or retro- flexion
Inspect cervix for mucopus
Cleanse cervix with antiseptic
Use of sterile gloves vs. “no-touch” technique
Apply tenaculum
– Routine vs. selective local anesthetic injection
– Hold hand in palm-up position
– “Squeeze” closed; don’t “snap” ratchet
– Horizontal or vertical application (purchase)
Routine vs. selective use of cervical block
94
Steps for IUC Insertion
• Sound the uterus
– Purposes
Determine the “pathway” to the fundus
Preliminary dilation of the internal os
Establish depth to fundus to set flange
Ensure depth within 6-9 cm limits
– Bend sound to mimic uterine flexion
– Brace fingertips on speculum to achieve control
of force while advancing the sound
– EMS* device can be used instead of metal sound
EMS*: endometrial sampling
95
Mirena: The Inserter
“Never let go of the Slider!!”
96
Steps for Mirena
Insertion*
1. Open sterile package
2. Release the threads
3. Make sure the slider is
….in the furthest position
….away from you
4. Check that the arms of
the IUC are horizontal
* Excerpted from package insert
97
Steps for Mirena
Insertion*
5. Pull on both threads
to draw IUC system
into insertion tube
6. Both knobs at ends of
IUC arms are now
within the inserter
98
Steps for Mirena Insertion*
7. Fix threads tightly into the cleft at near end
of inserter shaft
99
Steps for Mirena Insertion*
8. Set upper edge of
movable green flange
to the depth of uterine
sound
100
Steps for Mirena Insertion*
9. Hold slider with
forefinger, or thumb,
firmly in furthermost
position
10. Move inserter thru
cervical canal until flange
is about 1.5- 2.0 cm from
cervix
- allows sufficient space
for IUC arms to open
101
11. While holding
inserter steady,
release arms of IUC
by pulling slider
back until it reaches
the raised mark on
inserter
102
Steps for Mirena Insertion*
12. Push inserter
gently until flange
touches cervix.
The IUC should be
in fundal position
103
Steps for Mirena Insertion*
13. Pull down on
slider all the way;
threads will uncleat
automatically and
release IUC system
Double check that
the strings are
uncleated before
withdrawing the
inserter
104
Steps for Mirena
Insertion*
14. Remove inserter
and cut threads about
2 to 3 cm from cervix
15. Measure and
record in patient’s
chart
16. Have patient feel
for IUC threads
105
ParaGard Insertion*
• Load arms into inserter
* Excerpted from package insert
106
ParaGard Insertion
• Load arms into inserter
107
ParaGard
Insertion
• Advance insertion
tube to fundus
• Fundal resistance
should be
coincident with the
marker reaching
the exocervix
108
ParaGard
Insertion
• Pull back on
inserter tube
while holding
white rod
steady to
deposit IUC in
cavity
109
ParaGard
Insertion
• Push inserter tube
until resistance to
seat the arms of
the IUC in the
fundus
110
ParaGard
Insertion
• Withdraw the
white rod while
holding
inserter tube
steady
111
ParaGard
Insertion
• Slowly withdraw the
inserter from the
cervical canal
• Trim threads to 3-4 cm.
Optional
• Repeat bimanual exam
or perform ultrasound
to check placement
112
IUC Insertion: Tricks of the Trade
A Clinical Update on Intrauterine [email protected]
• For pain management
– Oral NSAID
• Naproxen sodium 440-550mg
• Ibuprofen 600-800mg
– Instill lidocaine in uterine cavity with an
endometrial sampler
– The sampler can be used instead of sound
to measure depth of uterus
more…
113
IUC Insertion: Tricks of the Trade
A Clinical Update on Intrauterine Contraception @arhp.org
• To visualize cervix
– Use large speculum
– If vaginal walls obscure cervix, cut off end
of condom or finger of a glove and slip over
metal speculum
– Get better light
• For women with narrow cervical canal
– Misoprostol 400 mcg SL 1+ hours before
insertion
114
• Reduce expulsion rate by waiting for strings
to be released from cleft before withdrawal
OBG Management | Vol. 21 No. 2 | February
115
What Should I Do if the LNG-IUC Isn’t
at the Fundus?
• There can be significant migration of the LNGIUC within the uterine cavity
• Fundal placement insures that the tail strings
will be long enough to remove the device
• A device that settles within the lower uterine
segment is still effective
• Removal of the device is necessary only if
– A portion of it protrudes from the cervix, or
– There is excessive cramping with a low-lying
IUC
OBG Management | Vol. 21 No. 2 | February
116
What Should I Do if the Cu 380A Isn’t
at the Fundus?
• Fundal placement is necessary for optimal
efficacy
• A copper IUC in the lower uterine segment is
less effective
• Removal of the device and re-insertion of a new
device at the fundus is necessary to insure
efficacy
• Do not “push” a partially expelled or low lying
device up to the fundus
117
Intervention Steps in the
“Difficult IUC Insertion”
• Use greater outward traction on the tenaculum
to minimize canal-to-endometrial cavity
angulation
• Place paracervical or intracervical block to relax
cervical smooth muscle and reduce pain
• Use os finder device, if available
• Dilate internal os with metal dilators to #13F
(4.1 mm)
• If unsuccessful, return at a later date with use
of misoprostol cervical priming
118
Os Finder Device
Cervical Os Finders (Disposable Box/25) $ 49.00
Cervical Os Finder Set (Reusable Set of 3) $ 69.00
Pratt Dilators
119
Paracervical Block
• Target is uterosacral ligaments
• Inject at reflection of cervico-vaginal epithelium
• 2 (5, 7 o’cl) or 4 sites (4,5,7,8 o’cl) submucosally
to depth of 5 mm
• Use spinal needle or 25g, 1 ½” needle + extender
• Moore-Graves speculum allows for more
movement
• Tips
– Start with ½-1 cc. at tenaculum site
– Disguise pain of needle insertion with cough
– WAIT 1-2 minutes for set up before procedure
120
Paracervical Block
X
7 o’clock X
X 5 o’clock
121
Paracervical Block
X
XX
7 o’clock
X
5 o’clock
X
6 o’clock
122
Intra-cervical Block
• Targets the paracervical nerve plexus
• 1 ½ inch 25g needle with 12 cc “finger lock”
syringe
• Inject ½- 1 cc. local anesthetic at 12 o’clock,
then apply tenaculum
• Angulate needle at the hub to 45o lateral
direction
• At 3 or 9, insert needle into cervix to the hub 1
cm lateral to external os, aspirate
• Inject 4 cc of local, then last 1 cc while
withdrawing
• Rotate barrel 180o, then inject opposite side
123
Intracervical Block
X
9 o’clock
X
X
3 o’clock
5 o’clock
7 o’clock
6 o’clock
124
Effects of prophylactic misoprostol
administration prior to intrauterine
device insertion in nulliparous women
• Nulliparous women 400 mcg of buccal misoprostol or placebo 90 min prior
to IUD insertion.
• No significant differences in patient-reported pain with IUD placement
(misoprostol 65 mm , placebo 55 mm) at any other time point.
• The misoprostol group reported significantly more preinsertion nausea
(29% vs. 5%) and cramping (47% vs. 16%) than the placebo group.
• While provider-reported ease of insertion was not significantly different
between groups, three placebo patients required additional dilation vs.
none in the misoprostol group.
• All 35 subjects underwent follow-up at least 1 month postinsertion, and
no expulsions were reported.
CONCLUSION:
• Prophylactic misoprostol prior to IUD placement in nulliparous women did
not reduce patient perceived pain, but it did appear to increase
preinsertion side effects.
Edelman AB, et al. Contraception. 2011
• 80 nulliparas treated 1 hour prior to IUD insertion
– Misoprostol 400 mcg SL and diclofenac 100 mg
– Diclofenac 100 mg PO alone (control group)
• Findings
– Insertion considered easier by the provider with
misoprostol than control group
– Pt pain scores no different in the two groups
– Most side effects equal
• Shivering, diarrhea more common in
misoprostol group
Saav I et. al., Human Reproduction 2007; 22, (10): 2647
126
Misoprostol for IUC Insertion
• Conclusion
– Misoprostol facilitates IUD insertion and reduces
the number of difficult and failed attempts of
insertions in women with a narrow cervical canal
127
Saav I et. al., Human Reproduction 2007; 22, (10): 2647
Prophylactic misoprostol prior to IUD insertion
in nulliparous women
• RCT, nulliparous women, 18–45 years old
– MPL 400 mcg bucally or placebo 90 min prior
– 36 women completed the study
• Findings
– MPL group a trend toward a more painful insertion
– Ease of placement was no different between
groups
– MPL group had more pre-insertion nausea and
cramping than the placebo group (50% vs. 16%)
– No reported expulsions
Shaefer E et al, Contraception 2010
Misoprostol for IUC Placement
Take It Home
• Misoprostol works well to soften and dilate the
cervix in pregnant women
• Studies in non pregnant women having GYN
procedures (hysteroscopy, EMB ) have mixed
results
• MPL prior to IUC placement is often recommended
But
• Little evidence to support a clear benefit of this
practice
• Some evidence that it may be harmful
• It should not be accepted as a “standard practice”
yet
Ms D: “I Have Fibroids”
• Ms D is a 35 year old G0 P0 woman who is seen for
contraceptive counseling
• Over the past 2 years, her periods have been heavier
and longer than previously
• Bimanual exam: Irregular 12 week size uterus
• LNG-IUS chosen for contraception and bleeding control
• Clinical dilemmas…
– LNG-IUS control of fibroid-related bleeding
– Technical IUC insertion issues with uterine fibroids
131
LNG-IUS and Fibroids
• Small studies with mixed results
– Mercorio (2003): 75% persistent menorrhagia
– Starczewski (2000): 92% reduced bleeding
• Recommendations
– Off-label use; may violate precaution
regarding cavity depth and distortion of
uterine cavity
– Reasonable to attempt treatment with Mirena
– Documentation of informed consent content a
must
132
Tips for IUC Insertion in
Women with Fibroids
• Determine fibroid location by ultrasound
– Fundal fibroids (intramural, sub-serous) that do
not distort uterine cavity do not preclude IUC use
– Large sub-mucous fibroids, especially in lower
uterine segment, contraindicate IUC use
– Evaluate for other pathology, e.g., polyp
• Ultrasound guidance may facilitate safe placement
• No data on efficacy, but probably not compromised
with LNG-IUS or with Cu-T if fundal placement
133