intrauterine contraception teva (paragard, lecette) merck ...intrauterine contraception (iuc) •...

8/3/2014

1

Intrauterine

Contraception

Patty Cason MS, FNP-BC

Charlotte Curtis, MSN, WHNP-BC

Suzanne Reiter, MM, MSN, WHNP-BC, FAANP

F a m i l y P l a n n i n g N a t i o n a l C l i n i c a l T r a i n i n g C e n t e r · S u p p o r t e d b y O f f i c e o f P o p u l a t i o n A f f a i r s

Disclosures – Suzanne Reiter

Nothing to disclose


Disclosures – Charlotte Curtis

Nothing to disclose


Disclosures – Patty Cason

Advisory Board

Teva (ParaGard, LeCette)

Merck (HPV vaccines)

Actavis (Levosert IUD in development)

Speakers’ Bureau

Teva (ParaGard)

Merck (Nexplanon, Gardasil, NuvaRing,

Contraception)

Bayer (Mirena, Skyla)


Learning Objectives

Discuss the comparative effectiveness of

IUDs

Describe the myths and explain the

evidence to dispel those myths

regarding patient selection for IUD use

Demonstrate the hand skills necessary for

placement of the copper IUD and the

two levonorgestrel IUDs

F a m i l y P l a n n i n g N a t i o n a l C l i n i c a l T r a i n i n g C e n t e r · S u p p o r t e d b y O f f i c e o f P o p u l a t i o n A f f a i r s6

Terminology

Intrauterine Device (IUD)

Intrauterine Contraception (IUC)

• Generic term for the method or

any of the devices

Terms can be used interchangeably

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Terminology:

Levonorgestrel IUDs

LNG 20 IUD (Mirena)

LNG 13.5 IUD (Skyla)

In reference to either or both:

• LNG IUD

• LNG IUC

• Intrauterine System (IUS)


Terminology:

Copper IUD

Cu IUD

Copper IUD

Cu IUC

Cu-T380A

ParaGard®

Can’t call it an IUS


Take Home the “IUDs”

Keep one in your lab coat

One in each room

Give them to your patient to hold, feel and

play with while discussing the method

Show her how to feel the threads with it


Unintended Pregnancy in U.S.

51%

Of 6.6

million

pregnancies

per year

3.4 million

are

unintended

Finer LB et al. AmJPubHealth, 2014,104(S1):S44-S48


Contraceptive Typical Use:

First Year Failure Rate

Trussel Contraception 2011

85.0


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Characteristics of IUC’s

• Highest patient satisfaction

among methods

• Rapid return of fertility

• Safe

• Offer long-term protection

• Highly effective

• Cost saving


IUC Mechanism of Action

Ortiz ME. Contraception. 2007


Copper-T IUC

Thonneau, PF. Am J Obstet Gynecol. 2008.: Fortney JA. J Reprod Med. 1999.: Trussel J.

Contraceptive Technology. 2007.


Copper IUC: Menstrual Effects

•Longer/heavier menses/

dysmenorrhea

•NSAIDs prophylactically WITH FOOD

• Pre-emptive use for 1st 3 cycles

• Start before onset of menses for

anti-prostaglandin effect

⁻ Naproxen sodium 220mg x2 BID (max

1100mg/day)

⁻ Ibuprofen 600-800mg TID (max 2400mg/day)



Levonorgestrel Intrauterine

System

• Brand name® Mirena Lng - 52 IUS

• 20 mcg levonorgestrel/day

• Approved for 5 years’ use

• Amenorrhea in ~20% of users by 1 year

Mirena Prescribing Information. 2000.: Trussel J. Contraceptive Technology. 2007; Hidalgo M.

Contraception. 2002.

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Newest LNG IUS

Brand name Skyla®

Levonorgestrel releasing like Mirena

Identifiable by silver ring at top

Small inserter tube

Smaller IUD

Ideal for nulliparous women

LNG 13.5 IUS

⁻ 14 mcg per day

Three year effectiveness


LNG 20 IUS: Treatment for

Heavy Menstrual Bleeding

Nelson, AL. Presented at XIX FIGO World Congress, S. Africa, 10/2009

Me

dia

n M

BL

(mL)


LNG-IUC: “Off Label”

Non-contraceptive Benefits

• Decreased

⁻ Dysmenorrhea

⁻ Iron deficiency anemia

⁻ Long term risk of endometrial cancer

• Can be left in place during and after transition to

menopause for use with ET

ACOG Practice Bulletin. No. 73: Use of hormonal contraception in women with

coexisting medical conditions. Obstet Gynecol. 2006;107:1453–1472.


LNG-IUC: “Off Label”

Additional Therapeutic use

• Symptomatic fibroids

• Endometrial hyperplasia

• Symptomatic endometriosis, adenomyosis

Matteson KA, et al. Obstet Gynecol. 2013; 121(3):632-643; Fraser IS. Contraception. 2013

Mar;87(3):273-9


Copper T:

Emergency Contraception

• Prospective, multicenter cohort clinical trial:

1,963 women in China; CuT380 placed within

120 hours of unprotected intercourse

• No pregnancies at 1 month follow-up visit

• 94% parous women and 88% nulliparous

women continued at 1 year

Wu S, et al. BJOG 2010; Epub 2010 Jul7


Will Patients Choose Cu T380A

for EC?

60% chose oral LNG

40% chose the copper IUD

Turok DK, et al. Contraception. 2010

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Client Choice of IUC Type

Copper T IUC

• Don’t want or

can’t use

hormonal

contraception

• Like having a

regular menses

LNG IUC’s

• Want less menstrual

flow

• Hx dysmenorrhea

• OK with possible

amenorrhea


Dispelling Myths About IUCs

• Are not abortifacients

• Do not cause ectopic

pregnancy

• 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

Forrest JD. Obstet Gynecol Surv. 1996.; Lippes J. Am J Obstet Gynecol. 1999. Duenas JL.

Contraception. 1996.; Otero-Flores JB. Contraception. 2003.; WHO. 2009.


Dalkon Shield


Dalkon Shield:

Multi-filament String


IUCs Do Not Cause PID or

Infertility

• PID incidence for IUC users same as the general

population

• Risk is increased only during the first month after

placement

• Preexisting STI at time of placement, not the IUC

itself, increases risk

• Use of IUC is not associated with increased risk

of tubal occlusion; rather chlamydia infection is

• 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


Rate of PID by Duration of IUC

Use

n=∼20,000 women.

Baseline PID risk:

1-2 cases /TWY

Adapted from Farley T, et al. Lancet. 1992;339:785-788.

Rate

per

1000

woman

-years

Duration of Use

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Ectopic Pregnancy Risk with IUC*

If a pregnancy occurs while using these methods, the risk of ectopic pregnancy

is higher.

These methods prevent intrauterine pregnancies better than they prevent

ectopic pregnancies.

Alvarez F, et al. Fertil Steril 1988;49(5):768-773*Per 100,000 Women


Furlong , Reprod Med. 2002

Ectopic Pregnancy Risk When Contraception Fails




Free and User-

Friendly


US Medical Eligibility Criteria

Category Definition Recommendation

1 No restriction in

contraceptive use

Use the method

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

unacceptable health risk if

the method is used

Do not use the

method

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IUC Use with Common Medical

Concerns


IUC Use with Common Medical

Concerns


Poor Candidates for IUC Use (Both IUC’s)


Poor Candidates (cont.)

(By IUC type)


Age/Parity Considerations

� Menarche to age 20 US MEC -2

� Age 20 and older US MEC -1

� Nulliparity US MEC -2

� Parous US MEC -1


Timing of IUC Placement

Grimes DA et al. Cochran Database Syst Rev. 2010;(6):CD003036; Mohamed S et al. Med Princ

Pract. 2005;(12):120-125

• Can be placed anytime in cycle-as long as

patient is not pregnant

No benefit to placement during menses

No impact on pain/discomfort during

placement

• Immediate post-partum

• Immediate post-abortion

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Pre-IUC placement Screening

• No routine screening tests

• CT/GC:

⁻ If age <26 and due for annual screening

⁻ If high risk for STI

• Pap test only if due

• Pregnancy test if pregnancy suspected

• Baseline Hgb-may be helpful for later

management

• Any indicated screening test can be performed at

time of IUC placementSufrin C, et al. Obstetrics and Gynecology 2012; Sufrin C, et al. Contraception 2010; Intrauterine

Contraceptives (IUCs), Family PACT Clinical Practice Alert. 2011


Pre-placement Medication

•Prophylactic antibiotics

⁻ No value for routine administration

•Premedication

⁻ NSAID 30-60 minutes before placement is

common, but no effect on insertion pain or

discontinuation

⁻ Misoprostol given prior to insertion-no effect

on pain scores

⁻ Consider paracervical block if history of

cervical os or canal stenosis

Walsh T et al. Lancet. 1998 Apr 4;351(9108):1005-8.


Post-IUC Placement Counseling

• Remind client about menstrual changes

• Menstrual calendar to track menses helpful

• Should return if

⁻ String cannot be located (use barrier method)

⁻ Symptoms of pregnancy/infection

⁻ Sudden unexplained pelvic pain occurs

⁻ Excessively heavy bleeding


IUC Complications


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. 2012


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Missing IUC String

Absent

•No IUC string in canal

•Pregnancy test negative

In Situ

Ultrasound

Desires

removal

Extract ±

ultrasound

guidance

Desires

retention

Ultrasound Flat plate of abdomen

In Situ Absent

Flat plate of abdomen

Refer for hysteroscopy

Present

Perforated

Absent

Expelled

AbsentAbsent Present

Ultrasound

Absent

Perforated

In Situ

OR

Extracted


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)


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


Vasovagal Reaction

• Due to bradycardia + peripheral vasodilation

• Prevention: advise client to be well fed and hydrated prior to insertion

• Management:

-Isometric muscle contractions of extremities

-Client should remain supine; elevate legs

-If heart rate <60, give atropine 0.4 mg IV

Grubb BP N Engl J Med 2005


IUC Placement Practicum


Take Home the “IUDs”

Keep one in your lab coat

One in each room

Give them to your patient to hold, feel and

play with while discussing the method

Show her how to feel the threads with it

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Honing Your Skills

• Know resources in your area

• For mentorship/proctoring

• To discuss challenging cases

• To manage complications

• CTCFP LARC Mentor Program

• Link you with experienced LARC provider

near you for mentoring/proctoring

www.ctcfp.org/larc


Steps for IUC Placement

• Perform bimanual pelvic exam to determine uterine position

• Achieve good visualization of cervix with speculum

• Inspect cervix for mucopurulent discharge

-Collect pre-insertion CT/GC, pap as indicated

• Cleanse cervix with antiseptic

• Use of sterile gloves vs. “no-touch” technique


Tenaculum Purpose

Stabilize the cervix to allow passage of

sound and IUD through the os

Straighten any irregularities in the cervical

canal

Straighten uterine curvatures or flexion


To Place Tenaculum

Dominant hand in “palm-up” position

Thumb in one ring

Middle or ring finger in the other ring


Tenaculum

Choose Site for Placement

Anterior lip

Posterior lip

Typically a horizontal bite, some

prefer vertical


Tenaculum

Size of Bite

1-1.5 cm wide

1 cm deep

Not too shallow- may tear through

Not too deep- unnecessary

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Tenaculum

Placement

Once the teeth are in contact with

the cervix, press into the tissue

Once the ratchet is closed, test your

application gently to be sure it is

secure


Tenaculum

Pain Prevention

Not too deep or wide

Close the ratchet only 1-2 clicks

Close the ratchet silently

Squeeze closed EXCEEDINGLY slowly


Tenaculum

Pain Prevention

Local anesthetic to tenaculum site

Have patient cough (…hold onto the

speculum)


Tenaculum

Use When Sounding

Change hands; hold the tenaculum with the non-dominant hand while sounding and for IUC placement

OK to let tenaculum lay on speculum when picking up the sound or IUD


Tenaculum Hand Position

While Sounding and for IUC

Placement

“Palm up” with thumb on top of

ratchet and fingers below

Avoid the rings

Avoid inadvertent movements

USE the tenaculum


Uterine Sound

Purpose

Insure that you can pass through the

internal os

Informs the direction and pathway

through the os up to the fundus

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Uterine Sound

Purpose

Measures the depth/distance from

the external os to the fundus

• Appropriate for IUD placement

(6-10 cm)

• Tells you where to set the flange


Sound

Which One?

Can use metal sound , plastic sound or

endometrial sampler


Sound

If metal; bend sound to mimic

uterine flexion

Hold it like a pencil or dart

Use Wrist action

Brace fingertips on speculum to

achieve control of force while

advancing the sound


Placement of Copper IUC


Copper IUC Placement


ParaGard Placement*

• Load arms into inserter

Sterile gloves vs “no-touch”

* Excerpted from package insert

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ParaGard Placement

• Load arms into inserter, adjust flange to

correspond to uterine depth


ParaGard

Placement

• Advance insertion

tube to fundus

• Fundal resistance

should be coincident

with the marker

reaching the exocervix


ParaGard

Placement

• Pull back on inserter tube while holding white rod steady to deposit IUC in cavity


ParaGard

Placement

• Push inserter tube until resistance to seat the arms of the IUC in the fundus


ParaGard

Placement

• Withdraw the white rod while holding inserter tube steady


ParaGard

Placement

• Slowly withdraw the inserter from the cervical canal

• Trim threads to 3-4 cm.

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Placement of LNG-IUS


Mirena: The InserterMirena: The Inserter

“Never let go of the Slider!!”


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

Mirena®

Placement*

* Excerpted from package insert


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

Mirena® Placement


7. Fix threads tightly into the cleft at near end of

inserter shaft

Mirena® Placement*


8. Set upper edge of

movable green flange to the

depth of uterine sound

Mirena® Placement

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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

Mirena® Placement


11. While holding inserter

steady, release arms of

IUC by pulling slider

back until it reaches

the raised mark on

inserter

IMPORTANT: Allow 10-15

seconds for arms to unfold

Mirena® Placement


12. Push inserter

gently until flange

touches cervix.

The IUC should be in

fundal position

Mirena® Placement


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

Mirena® Placement


Reduce expulsion rate by waiting for strings to be

released from cleft before withdrawal

OBG Management | Vol. 21 No. 2 | February 2009


14. Remove inserter

and cut threads about

2-4 cm from cervix

Use inserter tube as a

guide for cutting the

strings

15. Record string length

in chart

Mirena® Placement

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Skyla™ Inserter (continued)Skyla ® Placement:

The Inserter


Skyla ® Placement


Skyla ® Placement


Skyla ® Placement


Skyla ® Placement


Skyla ® Placement

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Skyla ® Placement


Skyla ® Placement


Skyla ® Placement


Difficult IUC Placement


Difficulty Sounding

• 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 for cervical priming


Os Finder Device

Os Finders Pratt DilatorsOs Finders Pratt Dilators

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Prophylactic Misoprostol

• Pain scores no different in the two groups

• Increase in preinsertion side effects

• In one trial:

⁻ Insertion considered easier

⁻ “Misoprostol facilitates IUD placement and

reduces the number of difficult and failed

attempts of placements in women with a

narrow cervical canal”

Saav I et. al., Human Reproduction 2007; 22, (10): 2647; Shaefer E et al, Contraception

2010; Edelman AB, et al. Contraception. 2011


Helpful Resources

National Clinical Training Center for Family

Planning: www.ctcfp.org

U.S. MEC Guidelines: www.cdc.gov/mmwr

LARC Practice Resources: www.acog.org/goto/larc

ParaGard®: www.paragard.com

Mirena®: www.mirena-us.com

Skyla®: www.skyla-us.com

App Store (iPhone/Pod/Pad): U.S MEC Guidelines

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