Provider Education and Training to Increase Use of Intrauterine ContraceptionAssociation of Reproductive Health Professionalswww.arhp.org

Acknowledgment

This program was made possible through educational grants from Bayer HealthCare Pharmaceuticals and Teva Pharmaceuticals.

Disclosure DeclarationsName 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

6.8 MILLION PREGNANCIES over one year

Unintended Pregnancy in the US

Unintended: 49%

Unintended births

Elective abortions

Fetal losses

Intended: 51%

51% 23%

21% 5%

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 Methods3. Patient Screening and Counseling for IUC

▪ Case presentations4. IUC Insertion and Management5. Hands-on Practicum

Contraceptive Use Globally and in the United States

Worldwide Use of IUC

Use for Married Women of Reproductive Age

Asia

% U

sing

IUC

s

Europe Latin America & Caribbean

Africa Oceania NorthAmerica

Population Reference Bureau. 2002; Mosher WD. Vital Health Stat. 2010.

History of Successful IUC Use

1909: Grafenberg develops ring-shaped IUC device

1962: First international

conference on IUC; designs for plastic spiral

and plastic loop presented

1967: T-shaped device

developed

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.

1968: Contraceptive

action of intrauterine copper

reported

1976: Copper T 200 becomes first copper IUD

1980: LNG IUC tested in randomized clinical trials

1988: Copper T 380 IUD

available in the United States

2001: LNG 52 IUS

available in the United States

2013: LNG 13.5 IUS available in

the United States

Need for Effective Reversible Methods

1 in 5 20%pregnancies ends

in abortionof 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.

There is a need for effective contraceptive methods that are “forgettable”

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.

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.

% U

sing

IUC

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

• 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

In fact, IUDs:

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

ParaGard® PI. 2013; Teva. 2013.

more…

• Copper T 380A IUD▪ Copper ions▪ Approved for 10 years

of use

IUC Available in the United States (continued)

Mirena® PI. 2013; SkylaTM PI. 2013.

• LNG 52 IUS▪ Releases 20 μg of LNG

per day▪ Approved for 5 years of

use• LNG 13.5 IUS

▪ Releases 14 μg of LNG per day

▪ Approved for 3 years of use

Mechanism of Action

Copper T IUD LNG 52 IUS LNG 13.5 IUS

Primary • Prevents fertilization• Reduces sperm

motility and viability• Inhibits development

of ova

• Inhibits fertilization• Causes cervical mucus to thicken• Inhibits sperm motility and function

Secondary • Inhibits implantation • Inhibits implantation

IUC Mechanism of Action

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)

Trussell J. 2011; WHO. 1987; Peterson HB. Am J Obstet Gynecol. 1996.

LNG IUS

Copper T IUD

Injectable (DMPA)

Pills/patch/ring

Condom—male

Spermicides

No contraception

Sterilization—female

Percent

Return to Fertility (Reversibility)P

regn

anci

es (%

)

Months After Discontinuation

0

20

40

60

80

100

0 12 18 24 30 36 42

IUCOCDiaphragmOther methods

Vessey MP. Br Med J. 1983; Andersson K. Contraception. 1992; Belhadj H. Contraception. 1986.

Continuation Rates at 1 Year

The Contraceptive Choice Project. 2013; Rosenstock JR. Obstet Gynecol. 2012; Peipert JF. Obstet Gynecol. 2011.

84% of

Copper T IUD users

55% of

Non-LARC* users

88% of

LNG 52 IUS users

*LARC = long-acting reversible contraception. Non-LARC methods include the contraceptive pill, patch, and ring.

VS.

Potential Side Effects

Silverberg SG. Int J Gynecol Pathol. 1986; Sivin I. Contraception. 1991; Hidalgo M. Contraception. 2002; Crosignani PG. Obstet Gynecol. 1997.

Type

Copper T:Heavier or prolonged menses

LNG IUS:Gradual decrease in menstrual flow

During insertion

Variable pain and/or cramping

Vasovagal reactions

First few days

Light bleeding

Mild cramping

During insertion

Inter-menstrual cramping

Cramping

IUC Non-contraceptive Benefits

Protection against

endometrial cancer

Alternative to hysterectomy or endometrial

ablation

Treatment of heavy

bleeding/dysmenorrhea

Copper T IUD√

LNG 52 IUS√ √ √

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

Varma R. Eur J Obstet Gynecol Reprod Biol. 2006; Gupta B. Int J Gynecol Obstet. 2006; Backman T. Obstet Gynecol. 2005.

*FDA-approved indication.

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 UseCategory Risk Level

1 Method can be used without restriction.

2 Advantages generally outweigh theoretical or proven risks.

3Method not usually recommended unless other, more appropriate methods are not available or not acceptable.

4 Method not to be used.

CDC. MMWR Recomm Rep. 2010; WHO. 2009.

Safety: Medical Eligibility Criteria for Contraceptive Use (continued)

Condition Qualifier for condition LNG IUS Copper T IUD

Diabetes mellitus

Past gestational diabetes 1 1

Diabetes without vascular disease 2 1

Diabetes with end-organ damage or >20 years’ duration 2 1

Endometriosis 1 2

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 Qualifier for condition LNG IUS Copper T IUD

Postpartum,not breastfeeding >3 weeks postpartum 1 1

Postpartum IUD insertion (breastfeeding or not breastfeeding)

<10 minutes after placenta delivery 2 110 minutes after placenta delivery to 4 weeks postpartum 2 2

>4 weeks postpartum 1 1Postpartum &breastfeeding >1 month postpartum 1 1

Post-abortionFirst trimester 1 1

Second trimester 2 2

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

HIV infectionHigh risk or HIV+ 2 2

AIDS (without drug interactions) 3 3

PID

Past, with subsequent pregnancy 1 1Past, without subsequent pregnancy 2 2

Current 4 4

STI

Vaginitis/increased risk of STI 2 2

Very high risk of STI 3 3Current gonorrhea, chlamydia, orpurulent cervicitis 4 4

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

More effective

Less effective

<1 pregnancy per100 women in 1 year

≥18 pregnancies per 100 women in 1 year

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.

How to make your method most effectiveAfter procedure, little or nothing to do or rememberVasectomy: Use another method for first 3 months after procedure.

Condoms, sponge, withdrawal, spermicides: Use correctly every time you have sex.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.

Injectable Pills

Female Condoms

Spermicides

Female Sterilization Vasectomy

RingPatch

Male Condoms

Implant

Diaphragm

Fertility Awareness–Based

Methods

Withdrawal

IUC

Sponge

6-12 pregnancies per

100 women in 1 year

Comparing Typical Effectiveness of Contraceptive Methods

Trussell J. 2011; WHO. 2007.Chart adapted from WHO 2007.

Outcomes for Women Referred for Sterilization

Smith RA. J Fam Plann Reprod Health Care. 2006.

N = 100 women

15% did not

attend clinic

54% had sterilization

29% chose

alternative method

Appropriate Candidates for IUC

• Women of any reproductive age seeking long-term, highly

effective contraception

Women of any reproductive age seeking long-term, highly effective

contraception

Appropriate Candidates for IUC

Copper T IUD

• Women who don’t want hormonal contraception

• Women seeking emergency contraception

• Nulligravid women

LNG 52 IUS

• Women who want less menstrual flow

• Women who experience dysmenorrhea or dysfunctional uterine bleeding

• Nulligravid women

LNG 13.5 IUS

• Nulligravid women

• Women who want a lower-dose LNG IUD

ParaGard® PI. 2013; Mirena® PI. 2013; SkylaTM PI. 2013.

Contraindications to IUC

CDC. MMWR; 2010. WHO. 2009.

• Known or suspected pregnancy

• Puerperal sepsis• Immediate post-

septic abortion• Unexplained vaginal

bleeding

• Uterine fibroids that interfere with placement

• Uterine distortion (congenital or acquired)

• Active purulent cervicitis/PID

There are few contraindications to IUC use

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

more…

Clinical Pearl

Nulligravid Adolescent: Practice Tips (continued)

• Non-pharmacologic pain management:▪ Reassure patient about the

procedure▪ “Verbicain” or distraction therapy

• Pharmacologic pain management:▪ NSAID before procedure▪ Paracervical block

more…

Clinical Pearl

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

Consider: LNG 52 IUS

• Has tried OCs in the past, dislikes having to take a daily pill

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

more…Consider: LNG 52 IUSKaunitz AM. Contraception. 2007; WHO. 2009.

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 PatientsTo determine fibroid size and location:• Transvaginal ultrasound• Use clinical judgment

more…

Clinical Pearl

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

• Pain management options:▪ Oral NSAIDs▪ Paracervical block▪ Consider parenteral analgesia (midazolam and fentanyl)

Güney M. Obstet Gynecol. 2006; Edelman AB. Contraception. 2011.

Clinical Pearl

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 off-label 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

Boon J. Maturitas. 2003; Peled Y. Menopause. 2007; Suvanto-Luukkonen E. Fertil Steril. 1999.

• High intrauterine/low systemic progestin reduces vaginal bleeding while minimizing progestin side effects

• Endometrium remains in nonproliferative state with no hyperplasia

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 non-systemic 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 follow-up

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

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 IUDFirst day of LMP:

>5 days ago

InsertIUD

today

Urine pregnancy test negative

First instance of unprotected sex since LMP:

≤5 days ago

≤5 days ago >5 days ago None

Insert IUD today Insert IUD within 5 daysof next menses

Insert IUD today

CDC. MMWR. 2013; Hatcher RA. 2005.

Timing of Insertion for LNG IUS

Insert LNG IUS today

First day of LMP:

>5 days ago

InsertLNG IUS

today

Urine pregnancy test negative

Unprotected sex since LMP?

Insert LNG IUS within 5 days of next menses

Yes NoOffer pill/patch/ring as bridge to LNG IUS

≤5 days ago

InsertLNG IUS

today

Patient accepts pill/patch/ringPatient declines pill/patch/ring,

uses barrier method instead

2 weeks later, pregnancy test is negative

CDC. MMWR. 2013; Hatcher RA. 2005.

Timing of Insertion of IUDs

Timing Pros Cons

With menses Ensures patient not pregnant

Scheduling; interim

pregnancy

Midcycle, any time

Convenience; low rate of expulsion

Must rule out pregnancy

Emergency contraception (Copper T IUD)

Convenience; pregnancy prevention Pregnancy

Alvarez Pelavo J. Ginecol Obstet Mex. 1994; Hatcher RA. 2005; O’Hanley K. Contraception. 1992.

more…

Timing of Insertion of IUDs (continued)

Timing Pros Cons

Cesarean deliveryConvenience;

low rate of expulsion

Strings may not be visible or

palpable at cervix

Postplacental ConvenienceIncreased 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

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.

• Antibiotics have not been shown to reduce risk of PID when given prophylactically

Signs of Possible ComplicationsSymptom Possible Explanation

Severe bleeding or abdominal cramping 3–5 days after insertion

Perforation, infection

Irregular bleeding and/or pain every cycle

Dislocation or 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 unacceptableto 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

Ronnerdag M. Contraception. 2007.

more…

LNG 52 IUS: Management of Late Abnormal Bleeding (continued)

Conclusion: • Consider ultrasonography and

hysteroscopy to evaluate bleeding in long-term 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 tenaculum3. Sound the uterus4. Load the device5. Place the device6. Cut the threads7. 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/UnintendedPregnan

cy/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

Suhonen S. Contraception. 2004.

Reason

LNG 52 IUS discontinuation

rate per 100

OC discontinuation

rate per 100Pain* 6.66 0Hormonal 4.95 9.75Bleeding 2.52 0Spotting 0 1.25Expulsion 1.20 NAOther medical 2.13 1.09*Statistically significant difference

Percentage of Women with Fertilized Eggs in Oviducts After Midcycle Coitus

GroupNormal

development (%)

No development

(%)

Abnormal development

(%)Control (n = 20) 50 15 35

IUC*(n = 14) 0 64 36

Alvarez F. Fertil Steril. 1988.

*IUDs studied included Copper T 200 (4 women), Lippes loop (5 women), and progestin IUDs (5 women)

IUC Efficacy Is Comparable to Sterilization

5-year gross cumulative failure rate

WHO. 1987; Peterson HB. Am J Obstet Gynecol. 1996.

Cu T 380 1.4

All sterilization 1.3

Postpartum salpingectomy

0.5

Discontinuation and Continuation Rates per 100 Women

*Combined data; 1,383 patients for 1 year, 993 for 3 years

Event LNG 52 IUS LNG 13.5 IUS1 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

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

Andersson K. Contraception. 1994.

LNG 52 Nova-T

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 HIV- Positive 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

Stanwood NL. Obstet Gynecol. 2006.

How safe/effective is IUC compared with pills, injections, or tubal sterilization?

71%

58%

Unsure of safetyUnsure of efficacy

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

Menstrualeffects

Complications

InfectionPerforationPregnancyExpulsion

Missing threads