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Birth Control Options - Helping patients make an informed choice Herbert L. Muncie, Jr. M.D. Professor of Family Medicine LSU School of Medicine New Orleans

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Page 1: Helping make a contraceptive choice - Health Sciences Centerhsc.ghs.org/wp-content/uploads/2014/03/0207-Muncie-Birth... · 2019-02-08 · –40% reduction in risk over nonusers •High

Birth Control Options - Helping patients

make an informed choice Herbert L. Muncie, Jr. M.D.

Professor of Family Medicine

LSU School of Medicine – New Orleans

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Ms. J

• 17 year old woman comes in to discuss

contraception

– Senior in HS; plans to attend State

University in the fall

– Physical exam normal; BP 110/64; BMI –

20.6 kg/m2

– LMP 2 weeks ago; non-smoker; no

headaches

– Currently using condoms regularly

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Decision to delay pregnancy

• A woman’s decision to delay pregnancy

or prevent an unintended pregnancy is

very personal – the decision:

– Is influenced by her social norms &

cultural environment

– Her economic situation

– Her long-term goals

– Her personal uniqueness

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Health Care Provider’s Role

• The health care provider’s role in the

woman’s decision process is to:

– Be knowledgeable about all options

– Provide unbiased nonjudgmental

information

– Listen to the woman’s concerns &

questions

– Give the best advice for that unique

patient

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Contraceptive Success

• A woman’s ability to delay pregnancy &

prevent an unintended pregnancy

involves four components:

– Choosing and acquiring a contraceptive

method

– Accurately using the method

– Consistently using the method

– Switching methods correctly

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Ms. J’s Birth Control Options

• Abstinence

• Condom

• Diaphragm/cervical

cap

• Natural family

planning

• Oral contraceptive

• Contraceptive Patch

• Hormonal vaginal

ring

• Injection q 3 months

• IUD

• Contraceptive rod

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Abstinence

• Abstinence

– Delaying the onset of sexual activity until

older

– Safest way to avoid pregnancy and STD

– No randomized trials have shown efficacy

of physician counseling delaying onset

• Cultural norm establishes the prevalence of

delaying onset of sexual activity

– Still reasonable to discuss option to reduce

risk of undue peer pressure

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Condoms

• Condoms

– Only method proven effective

for prevention of STDs

– Combine with more effective

method with new sexual partner

– Use may increase if discussed

as additional protection from

pregnancy (not prevent STD)

– Must be used at time of sexual

activity

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Diaphragm & cervical cap

• Diaphragm & cervical cap

– Combined with contraceptive gel

– Can be put in several hours before

intercourse

– Must be left in 8 hours after intercourse

– Increased risk of UTIs (diaphragm)

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Natural Family Planning

• Natural family planning

– No medication side effects

– Efficacy highly dependent on compliance

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Ms. J’s Birth Control Options

• Abstinence

• Condom

• Diaphragm/cervical

cap

• Natural family

planning

• Oral contraceptives

• Contraceptive Patch

• Hormonal vaginal

ring

• Injection q 3 months

• IUD

• Contraceptive rod

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What about an cOCP for Ms. J?

• Would a combination oral contraceptive

pill (cOCP) be appropriate for Ms. J?

– Does Ms. J have any contraindications to

using a cOCP?

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cOCP Contraindications

• Smoking and ≥ age 35

• Uncontrolled hypertension

– Only clinical exam needed before starting

OCP is BP measurement (no pelvic exam)

– If >160/>100 do not use them

– If 140-159/90-99 or controlled “generally”

should not use them

• Migraine with aura (classic migraine)

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cOCP Contraindications

• History of DVT, PE or arterial clotting

• A positive family history (FH) of clotting or

thrombotic events (relative contraindication)

–A positive FH is:

• If one parent or sibling ever had VTE < age 50 or

• If 2 relatives (either parents or siblings) had VTE at

any age

• Undiagnosed genital bleeding

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cOCP Contraindications?

• Pregnancy – not harmful, just too late

• Sickle cell (SS) or sickle C (SC) disease

not absolutely contraindicated

– DMPA may be preferable for SS disease

– Associated with reduced risk of crisis

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Which combination pill is best?

• cOCPs are a combination of an

estrogen & a progesterone -

– Primarily 3 estrogens & 9 progestins in

varying amounts & various combinations

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Estrogen Dosages

• Ethinyl etradiol (EE) is most common estrogen used

• EE dosage is always ≤ 50 mcg – Most commonly prescribed pills have 30 - 35

mcg

– 20 mcg pill in randomized trial had reduced breast tenderness and bloating

– However, 20 mcg pills had a higher failure rate with missed pills

– 10 mcg pill approved (Lo-Loestrin®)

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cOCP - Progesterones

Progesterone Class Family Examples

• Ethynodiol diacetate

• Norethindrone

• Norethindrone

acetate

1st

Generation

Estrane

(short

½ life)

Demulen® 1/35 Norinyl® 1/35,

Loestrin®

• Levonorgestrel (LNg)

• Norgestrel

2nd

Generation

Gonane

(longer

½ life)

Alesse®, Lybrel®,

Seasonale®,

Ovral®, Lo-Ovral®

• Desogestrel

• Norgestimate

• Dienogest

3rd

Generation

Gonane Desogen®, Mircette®,

Ortho Tri-Cyclen®

Natazia

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Choosing the cOCP

• No pill has clinically significant advantage

– Low EE dosage may have fewer side effects

but may have higher failure rate

– Choice of estrogen or progesterone not critical

• Generally choose low to moderate dose

estrogen with 2nd generation progestin

– Then change pill if not tolerated

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Benefits that could influence

choosing a cOCP

• Decreased dysmenorrhea

• Reduced menstrual flow

• Reduced risk of anemia

• Improves acne

• Eliminate mittelschmerz

• Decreased risk of

ectopic pregnancy

• Decreased risk of PID

• Decreased sxs of PMS

• Improvement in

endometriosis

• Suppression of ovarian

& breast cyst formation

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cOCP – Cancer Benefit

• Endometrial cancer risk reduced

– 50% reduction if used in prior 12 months

– Maximum protection if use continues for

3 years

– Protection lasts for 15 + years

– High or low dose pills provide protection

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cOCP – Cancer Benefit

• Ovarian cancer risk reduced

– 40% reduction in risk over nonusers

• High dose or low dose pills - same benefit

– Begins after 3-6 months of use

• 80% reduction after 10 years of use

– Reduced risk with family history ovarian

CA & 4-8 yrs. use

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cOCP Risks

• What would be Ms. J’s risks in using a

cOCP?

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cOCP & VTE Risk

• VTE Risk

– 3-6 fold increased risk VTE, highest first

6-12 months of use (SOR B)

– Older women have greater risk

• > age 39 - 100/100,000 women/year

• Adolescents - 25/100,000 women/year

• Pregnancy - 200/100,000 women/year

– Obesity doubles the risk

– Risk decreases with longer duration of use

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VTE Risk & dropirenone/desogestrel

• Increased VTE Risk

– For same estrogen dose – drospirenone

(Yasmin®,Yaz®) & desogestrel (Desogen®, Mircette®)

have significantly higher VTE risk

• Absolute risk is low

• No study has found a reduced risk

• However, for women on these progestins would

need to change 10,000 to prevent 1 VTE

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cOCP & Cardiovascular Risk

• Increased MI risk in smokers > age 35

– No increased MI risk with low dose pill for

non-smoking women, without hypertension

or migraine with aura at any age

• Increased risk of ischemic stroke

– 2-6 fold increase of ischemic stroke with

history of migraine with aura

• No increased vascular risk with progestin

only contraception

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Cervical Cancer Risk

• Risks (SOR B)

– Increase in cervical cancer after 8 or more

years of use after adjusting for HPV infection

– Risk of CIN 2 or 3 with oncogenic HPV

• Decreased with depot-medroxyprogesterone (DMPA

- Depo-Provera®)

• No increase with cOCPs

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cOCP & SLE

• cOCP use associated with increased risk

of developing systemic lupus

erythematosus (SLE)

– Especially if recently started

– However, very low absolute risk

• However, in women with previously

diagnosed SLE which is stable

– Starting a cOCP did not increase the risk of

flares

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Not cOCP Risks

– No increased risk of weight gain (SOR A)

• Weight gain does occur with DMPA –

average of 5.1 kg

– No increased risk breast cancer (SOR B)

– No increased risk of death later in life

• In fact a net benefit was found

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Frequency of menstruation?

• Before prescribing a cOCP ask how often

a woman wants to menstruate?

– Monthly? (every 4 weeks)

– Bimonthly? (Bicycling) (every 2 months)

– Quarterly? (Tricycling) (Every 91 days)

– Never?

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Menstruate monthly or bimonthly

• Monthly (every 4 weeks)

–Use standard 28 pill cOCP

• Bimonthly (bicycling)

– Use 2 standard 28 pill cOCPs but skip the

placebo pills with the 1st pack

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Menstruate Quarterly (Tricycling)

• Seasonale®

– 84 active pills [LNg (0.15 mg) & EE (30 mcg)] 7

placebo

– Increased risk of unsuspected bleeding first 6 months

of use

• Quartette® – increasing dosages of EE [LNg dosage

uniform (0.15 mg/day)]

– 42 days with 20 mcg EE

– 21 days with 30 mcg EE

– 21 days with 35 mcg EE

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Menstruate never

• Lybrel® approved for continuous use

– 365 days active pills

– EE 20 mcg & levonorgestrel 0.09 mg every

day

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cOCP - Other Formulations

OCP Active Placebo EE

Standard 21 7 0

Mircette® 21 2 5

Seasonique® 84 0 7

Lo-Seasonique® (20 mcg EE) 84 0 7

Loestrin® 24 Fe 24 4 0

Yaz® (20 mcg EE) 24 4 0

Femcon® Fe (chewable pill) 21 7 0

Natazia® 26 2 0

Beyaz ® (Yaz with folate); Safyral® (Yasmin

with folate)

24 4 0

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What is the best way to

initiate a cOCP?

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Starting cOCP – Sunday Start

“Sunday start” – take the 1st pill of the 1st

pack the 1st Sunday after onset of next

menses

– Reduces menses on weekend

– If start > 5 days from onset of menses

either abstain or use additional

contraception 1st 7 days of pills

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Starting cOCP – 1st day Start

“First-day start” - take the 1st pill of the 1st

pack the 1st day of next menses

– Easier for patients to remember & to

explain to patient

– As long as start < 5 days from onset of

menses no additional contraceptive

needed

– Less breakthrough bleeding

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Starting cOCP – Visit day start

“Visit day start” - take the 1st pill of the

1st pack the day of the visit

– “Quick start” - watch patient take 1st pill

• Negative pregnancy test & no intercourse prior

2 weeks, no immediate follow-up

• If intercourse within prior 2 weeks, repeat

pregnancy test in 2 weeks

• Additional contraception the first 7 days

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Quick-Start Benefit

• Main benefit is reduced time explaining how to

start pills

– No evidence reduced risk of pregnancy or

discontinuation rates for OCPs

– Fewer women on quick-start Depo-Provera became

pregnant than women who started another method

• Other than the IUD, can start any contraceptive

immediately without UPT

– Can do UPT 2 – 4 weeks later if concerned about

pregnancy

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Writing the OCP Prescription

• Ordering 13 packs at the

visit lead to better

continuation rates &

decreased cost

– Also were more likely to have

PAP & chlamydia screening

• Had fewer pregnancies

RX

Dr. Fleur de Lis

New Orleans, LA

Ms. R

Sig: 13 OCP Packs

Refill: x 0

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Another OCP Prescription Option?

• Giving 7 packs lead to a

greater continuation rate

compared to giving 3

packs

• Women who received a

prescription were not more

likely to continue

compared to having the

packs in hand

RX

Dr. Fleur de Lis New Orleans, LA Ms. R

Giving 7 packs of pills at time of visit (not an Rx)

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Missed Pills

Some women are excellent at taking the

pill consistently & some are not

No demographic characteristic can identify

which patient will remember consistently

Compliance was not enhanced with group

motivation, structured, peer or

multicomponent counseling or intensive

reminders

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How many pills are missed?

Using electronic monitoring an average of

2.6 pills were missed each cycle.

However, in a text-messaging trial, the

average number of missed pills was

4.9 per cycle

No pregnancies occurred with this level of

non-compliance

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Missed pill instructions

• First ask which pill was missed:

– If placebo pill just skip it

• If active pill and < 24 hrs late

– Take immediately

• If active pill and ≥ 24 but < 48 hrs late

– Take missed pill immediately & other pill at

usual time (may mean both at same time)

– Additional contraception not required

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> 2 Missed pills

• If > 2 consecutive active pills missed

– Take most recent missed pill immediately (discard other missed pills)

– Take remaining pills at usual time (may mean two pills on the same day)

• If missed pills were in the last week of hormones (day 15 – 21), omit placebos and start new pack instead of placebos

– Use additional contraceptive method for 7 days

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> 2 Missed pills (Cont.)

• If > 2 consecutive active pills missed

– Should consider emergency contraception if unprotected intercourse in previous 5 days or if missed pills during the 1st week

• May be considered at other times

– Discuss alternative contraceptive options that do not require daily compliance

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Most Dangerous pill to miss?

• Most dangerous pill to miss

is the 1st pill of the new pack

– Pill free > 7 days increases

risk ovulation

• If miss 1st pill use additional

form of contraception until taken

7 consecutive active pills

• Stress compliance with starting

each new pack

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Special Populations & cOCP

Postpartum

Breastfeeding

Seizure disorder on medication

Migraine headaches

Antibiotic concomitant use

Obesity

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Postpartum

• ACOG guideline

– No cOCP < 21 days postpartum

(high risk of VTE)

– If not breastfeeding may start after 21 days if

no increased VTE risk (e.g. C-section)

– If C-section must wait 42 days (6 weeks) to

start cOCP

• For delivery of < 20 weeks gestation -

can begin cOCP immediately

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Breastfeeding

• Progestin only pills are often recommended for women breastfeeding because:

– No effect on quality or quantity of breast milk

• They work by thickening cervical mucous & preventing sperm ascending through os

– However, erratic ovulation suppression

• Irregular bleeding common

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Progestin only pills

• Daily compliance crucial

– Must take same time every day (> 3 hr difference can allow ovulation)

– If >3 hr delay occurs take pill immediately & use additional contraception until taken at correct time for 2 consecutive days

– Consider EC if unprotected intercourse

• Not contraindicated in smokers > age 35

• No increased risk of VTE

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cOCP & Breast feeding

• Can start cOCP > 4 weeks post-partum

(PP) if lactation is well established &

other forms of contraception are not

acceptable

• If exclusively breastfeeding (> 85% of

feeds) no medical contraception needed*

*MMWR June 21, 2013

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Seizure Disorder on Medication

• Some anticonvulsants reduce efficacy cOCP by increasing metabolism of EE & progesterone – Avoid cOCP with phenytoin, carbamazepine,

barbiturate, primidone, topiramate, oxcarbazepine

– Mirena®, Skyla® & Depo-Provera® not effected by these medications

– If cOCP is used with these medications, WHO advises either 50 µg EE pill or continuous cOCP

• These anticonvulsants do not effect cOCPs – – Gabapentin (Neurontin®), lamotrigine (Lamictal®),

levetiracetam (Keppra®), tiagabine (Gabitril®)

– However, cOCPs may lower lamotrigine levels

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Migraine Headaches & cOCPs

• For migraine without aura cOCPs:

– May increase or decrease headaches

• Can give trial of cOCP and see what happens

– If HAs persist with normal BP & no deficit

• Lower dosage of estrogen, progestin or both (no

studies reported) SOR - C

– If HAs persist with increased BP or deficit

• Discontinue cOCP

• For migraine with aura cOCPs are

contraindicated

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cOCPs & Concomitant Antibiotic

• CDC guideline – most antibiotics have no

effect on cOCP effectiveness

– No additional contraceptive method needed

– Except with griseofulvin & rifampicin

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Contraception & Obesity

• What contraception is most effective for

obese women (BMI > 30 kg/m2)?

– Depo-Provera® & NuvaRing® are not affected

by body weight (SOR B)

– Obese women using cOCP or patch have

increased risk of pregnancy (SOR B)

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HORMONAL CONTRACEPTION

TRANSDERMAL

TRANSVAGINAL

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Contraceptive Patch (Transdermal)

• Ortho Evra® (EE 20 mcg; norelgestromin

150 mcg/day)

– Apply abdomen, buttocks upper torso

(exclude breast) or upper outer arm

– One patch a week for 3 weeks, 4th week

patch free

– Can use continuous patches for 12 weeks

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Contraceptive Patch

(Transdermal)

• Equally efficacious to cOCP

– Less effective - women > 90 kg

• Side effects

– Breast discomfort, headache, nausea &

cramps – perhaps more than with cOCP

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Hormonal vaginal ring (Transvaginal)

• NuvaRing® (EE 15 mcg & etonogestrel 12 mcg/day)

– One ring for three weeks

• No ring for one week

– Does not have to be in specific position

• Hormones absorbed anywhere in vagina

– If ring is out > 3 hours use additional

contraception until ring in place for 7 days

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Hormonal vaginal ring

• NuvaRing®

– Contraceptive hormone levels last for 35 days

– Alternative regimen

• One ring every 30 days (once a month)

• Same day of the month (e.g. 12th of every month)

• Reduces number of menses & hormonal

withdrawal side effects

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Patch or Ring vs cOCP?

• Cochrane review found:

– Patch caused more side effects than cOCP

– Ring caused fewer side effects than cOCP

• Except for vaginal discharge & vaginitis

• Compared to non-users same age, ring/patch

users had 6.5-7.9x increased risk VTE

– Increased SHBG & protein C sensitivity

– However, would need to switch 2000 ring or

1250 patch users to cOCP with levonorgestrel to

prevent 1 VTE

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Ms. J’s Birth Control Options

• Abstinence

• Condom

• Diaphragm/cervical

cap

• Natural family

planning

• Oral contraceptive

• Contraceptive Patch

• Hormonal vaginal

ring

• Injection q 3 months

• IUD

• Contraceptive rod

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Injection every 3 months

• Medroxyprogesterone acetate IM Q90D (Depo-Provera®; Depo-subQ Provera 104®)

– Associated with weight gain

– Irregular bleeding and most women are

amenorrheic at one year

– May have better compliance than cOCP

– FDA Black-Box Warning – Increased risk

of decreased BMD with > 2 years use

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Ms. J’s Birth Control Options

• Abstinence

• Condom

• Diaphragm/cervical

cap

• Natural family

planning

• Oral contraceptive

• Contraceptive Patch

• Hormonal vaginal

ring

• Injection q 3 months

• IUD

• Contraceptive rod

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Long-acting Reversible

Contraception (LARC) - IUD

• IUD – levonorgestrel

– 5 years duration (Mirena®)

– 3 years duration (Skyla®)

• Smaller & perhaps easier to insert

• IUD – intrauterine copper

– 10 years duration (ParaGard®)

– Can be used for emergency contraception up

to 5 days after unprotected intercourse

– Discrete method since will not effect

menstrual cycle regularity

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LARC - Implant

• Etonogestrel SD (Implanon®; Nexplanon®-

radiopaque)

– Single subdermal rod for 3 years duration

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LARC - Indications

• Indications

– Can be used in almost any female who

desires the most effective contraceptive

method

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LARC – not contraindications

• Not contraindications to LARC are:

– Nulliparity

– Age – neither too young or too old

– Prior STD

– Prior ectopic pregnancy

– Prior PID

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IUD Contraindications (risk>benefits)

• IUD contraindications – never to use

– Distorted uterine cavity

– Gestational trophoblastic disease

– SLE with positive antiphospholipid antibodies (exception ParaGard®)

– Pelvic tuberculosis

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IUD Contraindications to Initiate

Use

• IUD contraindications to initiating use until

condition is treated

– Cervical cancer awaiting treatment or uterine

cancer

– AIDS, until clinically well on antiretrovirals

– Current PID or purulent cervicitis

– Postabortal or postpartum sepsis

– Unexplained or unevaluated vaginal bleeding

– Complicated solid organ transplant

– SLE with severe thrombocytopenia (exception

Mirena®)

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Indications to Remove IUD

• Indications to remove IUD

– Headaches with aura that develop with use (exception ParaGard®)

– Ischemic heart disease that develops during

use (exception ParaGard®)

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Implant contraindications

• Contraindications to ever using

– SLE with positive antiphospholipid

antibodies

• Contraindications (initiation of use) until

condition treated

– Unexplained or unevaluated vaginal

bleeding

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Indications to remove implant

• Indications to remove implant

– Headaches with aura that develop with

use

– Ischemic heart disease that develops

during use

– Stroke during use

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Advising a Contraceptive Method

• Before advising a woman regarding

contraception assess two things:

– First, how important is it to her that she not

become pregnant?

• The more important it is

• The more important to advise the most effective

method for her

– Second, what is her understanding of the

effectiveness of contraceptive options?

• She may have unrealistic understanding

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Contraceptive Failure*

1000 women

No method

850

Withdrawal

Periodic abstinence

220

Condom

180

Diaphragm

120

cOCP

Patch

Ring

90

IUD

2

Implant

0.5

*Number of pregnancies during one year of typical use

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The Contraceptive Recommendation

• Women overestimate the effectiveness of pills,

patch, ring or condom

• Risk of pregnancy is 20x greater for pill, patch,

or ring users compared to IUD, implants

– And women < 21 yo were 2x more likely than older

women to get pregnant with pill, patch or ring

• If delaying pregnancy is strongly desired

– Recommend IUD or implant (LARC)

• No clear best way to present this evidence to

women that allows for an informed choice

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Providing Effective Counseling

• Characteristics of effective counseling:

– Demonstrate expertise, trustworthiness &

accessibility

– With adolescents address confidentiality

and parent’s role in the decision process

– Engage the woman in the learning process

– Address choosing the method, correct

use, consistent use and method switching

– Give priority to more effective methods

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Providing Effective counseling (continued)

• Determine if method fits her lifestyle

(social norms, image, stigma, etc.)

• Recommend condom use with any

method as “extra” protection from

pregnancy (does reduce risk of STD)

• Discuss how to avoid inconsistent use

• Address side effects at the beginning

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Key Points

• Multiple contraceptive options exist with

moderate to excellent efficacy

– Moderate – cOCP, patch, ring, depo

– Excellent – IUD, implant

• Know the main benefits and risks for

each method

– If prescribe a cOCP use “visit day” start

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Key Points

• Generally recommend a LARC method

for women whom delaying pregnancy &

preventing unintended pregnancy is

highly valued

– Essentially very few contraindications to

LARC methods

• Provide “effective” counseling

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Ms. J’s Conclusion

• Ms. J strongly does not want to become

pregnant in the near future

• After reviewing her options she

chooses to have an implant placed

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Questions