Contraception, Sterilization and Abortion

Alternatives, Counseling and ManagementSuzanne Trupin, MD

Women’s Health PracticeClinical Professor of Obstetrics and Gynecology

Contraceptive Practices in USA

The typical American woman wants only two children; she spends roughly five years pregnant or trying to become pregnant, and three decades trying to avoid unwanted pregnancy. Yet many women find it difficult to practice contraception consistently or correctly over the course of their entire reproductive lives and lack the information and services that would assist them in doing so. As a result, roughly one in three American women will have had an abortion by age 45.

Counseling: GATHER

Greet the patient in a warm and friendly manner, help her to feel at ease (Gather information on what she knows)Ask the patient about her needs and goals, STI risks nondirective counseling improves outcomesTell the patient about her choicesHelp her decide Explain the correct use of the method or drug being prescribedRepeat important instructions and set up Return appointments

World Population Growth

Oct 12th 1999 we reached 6 billion, US just reached 300 million this year

Mourning Picture for Polly Botsford and Her Children (c. 1813)

Medical Evaluation for Contraception Prescription: WHO

Class A: Mandatory Pelvic for IUD, Cervical Cap and Diaphragm,

Sterilization STI risk for IUD BP screening for women getting sterilization

Class B: Contributes substantially to safe and effective use, but consider context Hb for IUD and Sterilization

Class C: does not contribute substantially to safe and effective use of the method

U.S. Pregnancies: Unintended vs. Intended

Henshaw: Fam Plann Perspect 1998;30:24-29.

Unintended

Intended

Unintended births

Elective Abortions

49%:

22.5%

26.5%

51%

Incidence of Fatal Complication

1 6 11

HormonalContraception

LaparoscopicSterilization

Pregnancy &Childbirth

1111

2.62.6

1.51.5

Ory Fam Plann Perspect 1983;15:50-56.

Exposure Per 100,000 Woman Years

Long-Term Reversible Contraception: A dialogue among Andrew M. Kaunitz MD, David A. Grimes, MD, and Anita L. Nelson, MD, held on October 29, 2006. OBG Management: S1-S10, December 2006.

Cost Estimates of Contraception & Pregnancy over 5 Years: No method over 5 yrs: 4.25 unintended pg at cost of %14, 663

Trussel: Am J Public Health, 1995;85:494-503.

$540$764 $850

$1,290

$1,784$2,042

$2,424 $2,584

$3,278 $3,450$3,666

$5,700 $5,730

$4,102

$4,872

$0

$1,000

$2,000

$3,000

$4,000

$5,000

$6,000

Copper-T IUD Injectable Male Condom PeriodicAbstinence

FemaleCondom

Categories of Contraceptive Risk

WHO Category 4 (old ‘contraindications’, now ‘refrain from use’) Condition which represents an unacceptable health risk if the contraceptive method is used. Do not use the method.WHO Category 3 (exercise caution) A condition where the theoretical or proven risks usually outweigh the advantages. Use of method is not usually recommendedWHO Category 2 (advantages outweigh risks) Generally use the method with clinical judgementWHO Category 1 (no restrictions)

Use of Contraception with Coexisting Medical Conditions

FDA package labeling is the same for POP as COC without supporting evidence in many casesCurrent labeling for Norethindrone POP no longer lists history of thromobembolism as contraindication but does for norgesterel POP

Conditions that expose a woman to increased risk as a result of unintended pregnancy

Breast cancer or Estrogen Dependent NeoplasiaComplicated valvular heart diseaseDiabetes: Vascular Complications

WHO Category 4most apply to COC, R, P

Known thromobegenic mutations do not use COC or CICUterine Fibroids with cavity distortion do not use Cu-IUD or LGN-IUDPID or purulent cervicitis or active GC or CT do not Initiate IUDsFor conditions of high risk of HIV and AIDS spermacide use is a category 4Cerebrovascular or coronary artery disease multiple risk factorsMigraines with Aura or migraines over the age of 35

Lactation (<6 weeks postpartum) do not use COC, P, RLiver diseaseHeadaches with focal neurologic symptomsMajor surgery and prolonged immobilizationAge >35 years and smoke >14 cigarettes per day or more do not use COC, P, RHypertension (blood pressure of >160/100 mmHg or concomitant vascular disease)Venous thromboembolism historyMajor surgery with prolonged immobilization

WHO Category 3 (exercise caution)

Postpartum <21 days

Lactation (6 weeks to 6 months)

Age >35 years and smoke <15 cigarettes per day

History of breast cancer but no recurrence in past 5 year

Interacting drugs (that affect liver enzymes)

Gallbladder disease

WHO Category 2 (advantages outweigh risks)

CINSevere headaches after initiation of oral contraceptive pillsUndiagnosed vaginal or uterine bleedingDiabetes mellitusMajor surgery without prolonged immobilizationSickle-cell disease or sickle-cell hemoglobin C diseaseBlood pressure of 140/100 to 159/109 mm HgUndiagnosed breast mass

ObesityAge >40 yearsHigh BP in PregnancyConditions predisposing to medication noncomplianceFamily history of lipid disordersFamily history of premature myocardial infarction or DVTUncomplicated valvular heart disease

WHO Category 1 (no restrictions)

Postpartum >=21 daysPos-tabortion, with abortion performed in first or second trimesterHistory of gestational diabetesVaricose veinsMild headachesIrregular vaginal bleeding patterns without anemiaPast history of PIDCurrent or recent history of PIDCurrent or recent history of STDVaginitis without purulent cervicitis

Increased risk of STDHIV-positive or at high risk for HIV infection or AIDS Benign breast diseaseFamily history of breast cancer or endometrial or ovarian cancerCervical ectropionViral hepatitis carrierUterine fibroidsPast ectopic pregnancyThyroid conditions

 

Oral Contraception

Oral Contraceptives and Shorter Acting

Steroid Contraception

Contraceptive Cases

A 16 year old wants pills but refuses a pelvic, do you give them to her?19 year old U of I sophomore says her menses comes on Sunday, so she wants to know does she start this Sunday or next?To take a break from pills a 21 year old stops the pills for a month while her partner is off visiting medical schools. How long a break does she need?A 16 year old presents with her mother requesting pills for acne, the mother insists you give her the ones that are the cheapest, the patient wants the ones she sees on TV that are good for your skin, which do you choose?A 23 year old is getting monthly PMDD, what do you advise?A 55 year old comes in on birth control pills from her previous physician, is this dangerous?A 26 year old with three previous ME presents for contraceptive advice, she has a sister and a mom with breast cancer and she refuses to take the pills, can she use them?

Prescription of Oral Contraceptives

Counseling Begin COC or POP at any time if reasonably certain is

not pg If begun within 5 days of bleeding no extra protection If not within 5 days use back up for 7 days if on COC,

and for 2 days if on POP Begin immediately post abortion Rapidly reversible, within 2-3 months conceptions are

seenMedical history and physical examinationSelection of a particular preparationUser instructions Missed pill instructions No evidence that obese patients suffer decreased

efficacy

Establishing that a patient is protected by her contraception

Mode of action for contraceptive protection Molecular: P suppresses LH, E suppresses

FSH Cellular: E increases intracellular P receptors Reproductive Organs: Endometrial atrophy,

hostile cervical mucus Reproductive Processes

WHO in last report said that it is not reliably known how accurately ultrasound findings, hormonal measurements or evaluation of the cervical mucus predict the risk of pregnancy during most contraceptive use

ProgestinProgestin EstrogenEstrogen

Ovarian and pituitary Ovarian and pituitary inhibitioninhibition

Thickening of Thickening of cervical mucuscervical mucus

Thinning of/increase Thinning of/increase in cervical mucusin cervical mucus

Cycle controlCycle control Cycle controlCycle control

Endometrial Endometrial atrophy/transformationatrophy/transformation

Endometrial Endometrial proliferationproliferation

Pharmacologic Actions ofProgestin and Estrogen

Ovarian and pituitary Ovarian and pituitary inhibitioninhibition

Progestins in Oral Contraceptives

*Not available in the United States.

19-Nortestosterone19-Nortestosterone

GonanesGonanes

LevonorgestrelLevonorgestrel NorgestrelNorgestrel DesogestrelDesogestrel NorgestimateNorgestimate Gestodene*Gestodene*

EstranesEstranes

NorethindroneNorethindrone Norethindrone Norethindrone

acetateacetate Ethynodiol Ethynodiol

diacetatediacetate NorethynodrelNorethynodrel Lynestrenol*Lynestrenol*

DrospirenoneDrospirenone

Spironolactone

Adapted from Sulak PJ. OBG Management. 2004;Suppl:3-8.

Multiphasic vs Monophasic Preparations*

Day of pill cycle

Norethindrone (mg)

Endogenous progesterone

(ng/mL)

18

10

5

0 7 14 2128

1.0

0.75

0.5

0.4

0

Monophasic (Ovcon 35)Multiphasic (Ortho Novum 7/7/7)Endogenous progesterone level* Ethinyl estradiol content is constant (35

µg) for both preparations.Adapted from Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 3rd ed. 1996:1416.

20

menses

Available Formulations

Monophasic: consistent dose in each active pillPhasic Preparations: dosing of E/P varies through the cycle Biphasic Triphasic

Shortened pill-free intervalProgestogen only containing pills Greater percentage of cycles are ovulatory (>50%)

Typical Use Issues 8/year Failure greater if pills are miss early in cycle Contraceptive Efficacy of all marketed pills are similar

0.3% failure perfect use about 8.0% failure typical use Benefits are identical in spite of package insert

Cardiovascular Impact of Risk Factors

• Obesity

• Pregnancy

• Malignancy

• Recent Surgery

Venous= VTE Venous= VTE (DVT, PE)(DVT, PE)

Arterial= Strokes Arterial= Strokes and MIand MI

• Smoking

• Diabetes

• Hypertension

• Obesity

CV Mortality Risk with Smoking and OC Use

0

5

10

15

20

25

30

Oral contraceptive user

Oral contraceptive nonuser

Smoker Nonsmoker Smoker Nonsmoker

< 35 years of age ≥ 35 years of age

Cases p

er

100,0

00 W

om

an

-Years

Attributable Risk/100,000 User-Years

0.06 1.73 3.03 19.4

Sherif K. Am J Obstet Gynecol. 1999;180(Pt 2):S343-S348.

Risks of Oral Contraceptives:Nonfatal VTE

0

20

40

60

80

100

Food and Drug Administration. FDA Talk Paper. Nov. 24, 1995.

Esti

mate

d A

vera

ge R

isk/

10

0,0

00

Wom

en

/Year

Non-Oral Contraceptive

Users

Oral Contraceptive

Users

Pregnant Women

Cardiovascular Impact of OCs

• No difference in risk between 2nd- and 3rd- generation progestins

• No difference in risk among low-dose OCs (20 µg to 35 µg)

• Increased clotting factors

VenousVenous ArterialArterial

• Estrogens increase HDL

• Progestins lower HDL

• High E/P ratio increases HDL

• Estrogen has a dilating effect on arterial wall

Reproductive Tract Cancers

1.24 risk of breast cancer in OC users Existing cancers may

have earlier development

Protective effect against colon cancer

Endometrial and ovarian cancer risk reduction is greater with increasing duration of use

Duration of OC use

Relative risk of cancer BREAST

OVARIAN

ENDOMETRIAL T

Oral Contraceptives and the Risk of Breast Cancer

Results of a large epidemiologic study suggest that oral contraceptives do not cause breast cancerBreast cancer risk in women who have not taken oral contraceptives for ≥10 years is the same as those who have never used them There is a slightly increased risk of diagnosis in current users of oral contraceptives and in those who stopped taking them ≤10 years agoTumors are more likely to be localized in oral contraceptive users than in nonusers

Collaborative Group on Hormonal Factors in Breast Cancer. Lancet.1996;347:1713-1727; Collaborative Group on Hormonal Factors inBreast Cancer. Contraception. 1996;54:1S-106S.

Acne and Androgen Metabolism

Total testosteroneTotal testosterone Sex hormone-Sex hormone-binding globulinbinding globulin

Free testosteroneFree testosterone

AR

5-reductase

Dihydrotestosterone

Sebum productionSebum production

Azziz R, et al. Semin Reproduct Endocrinol. 1989;7:246-254; Imperato-McGinley J, et al. J Clin Endrocrinol Metab. 1993;76:524-528; Murphy AA, et al. Fertil Steril. 1990; 53:35-39; Pye RJ, et al. Br Med J. 1977;2:1581-1582.

AR = androgen receptor within the sebaceous gland

Kleerekoper M et al. Kleerekoper M et al. Arch Intern Med. Arch Intern Med. 1991;151:1971-1976.1991;151:1971-1976.

Bone Mineral Density QuartileBone Mineral Density Quartile(Low)(Low) (High)(High)

% W

om

en

%

Wom

en

0

20

40

60

80

100 OC usersNon-OC users

11 22 33 44

Higher Bone Density More Likely in OC Users

Slide Source:ContraceptionOnlinewww.contraceptiononline.org

Noncontraceptive Benefits of Oral Contraceptives

BENEFITS DUE TO CONTINUOUS PROGESTIN

Less endometrial cancerLess benign breast disease

50% reduction in breast tumors

Fewer uterine fibroidsRegular uterine bleedingLess amount uterine bleeding

less anemialess salpingitis 50% reduction in PID

Less cyclic mood changes (PMS)

BENEFITS DUE TO INHIBITION OF OVULATION

Less ovarian cancerLess ectopic pregnanciesLess functional ovarian cysts

Suppression better with 35 mcg EELess dysmenorrhea

OTHER BENEFITS

Less acne and hirsutismLess rheumatoid arthritisIncreased bone density

Rosenberg MJ, et al. Am J Obstet Gynecol. 1998;179:577-582.

Discontinuation of Oral Contraceptives

0

2

4

6

8

10

12

IrregularBleeding

Nausea Weight Gain

Mood Changes

Breast Tenderness

Headaches

% D

isco

nti

nu

ing

Shortened Hormone-Free Intervals

Brand NameEstrogen

DoseProgestin Dose Regimen

Seasonale® 30 µg EE 150 µg levonorgestrel 84/7

SeasoniqueTM 30 µg EE 150 µg levonorgestrel84/7**7 days 10 µg EE

Yaz 20 µg EE 3 mg drospirenone 24/4

Loestrin 24 Fe 20 µg EE 1 mg norethindrone acetate24/4**4 days of iron

Lybrel 20 µg EE 90 µg levonorgestrel365 days (non-cyclic daily dosing)

EE= ethinyl estradiol

0

2

4

6

8

10

12

1 2 3 4

Breakthrough Bleeding and Spottingand Extended Regimen

Anderson FD, Hait H. Contraception. 2003;68:89-96.

Med

ian

Nu

mb

er

of

Bre

akth

rou

gh

B

leed

ing

/Sp

ott

ing

Days/C

ycle

CycleDay 1-84 92-175 183-266 274-357

*30 µg ethinyl estradiol/150 µg levonorgestrel.

Vaginal Ring: NuvaRing

Roumen FJ, et al. Hum Reprod. 2001;16:469-475.

www.contraceptiononline.org

NuvaRing releases 15 g of ethinyl estradiol and 120 g of etonogestrel daily

Worn for 3 out of 4 weeks

Self insertion and removal it is about 2.1 inches in diameter

Pregnancy rate 0.65 per 100 woman–years

If removed for >3hrs use back up method for 7 days

Vaginal Contraceptive Ring: Administration

If Ring Is removed

If under three hours reinsert

If over three hours reinsert and use 1 week of back up

Only 2.6% of women report ring expulsion

54 mm

4 mm

www.contraceptiononline.org

0

25

50

75

Incid

en

ce o

f in

ten

ded

b

leed

ing

patt

ern

(%

)

NuvaRing® Compared to OC: Intended Bleeding Pattern

Cycle

NuvaRing® COC

1 2 3 4 5

**** ** ** **

Bjarnadottir RI, et al. Am J Obstet Gynecol. 2002;186:389-395.Copyright ©2002, Mosby Inc.

****

*P<0.01**P<0.0001

www.contraceptiononline.org

Contraceptive Patch: Ortho EvraPatch contains 6 mg norelgestromin and 0.75 mg ethinyl estradiol

Delivers continuous systemic doses of hormones

150 -250 µg norelgestromin (NGMN)

20-25 µg ethinyl estradiol (EE)

Direct comparisons to oral contraceptive delivery doses cannot be made but compliance enhanced

If patch is removed for >24 hours apply a new patch and use back up for 7 days and the day of the week for patch change is now the day you found the patch off

Per day

www.contraceptiononline.org

Transdermal Patch: Disadvantages

Application site reactions Not as effective in women weighing >198 poundsSide effects are similar to oral contraceptives except for:

- higher rates of breast pain during first 2 months

- higher rates of dysmenorrheaMay be difficult to concealNo protection against HIV or other sexually transmitted infections

Zieman M, et al. Fertil Steril. 2002;77(Suppl 2):S13-S18.

Patch:Patient Counseling

Application: Use a new location for each patch Apply to clean, dry skin Apply where it won’t be rubbed by clothing: on buttocks,

abdomen, upper outer arm, upper torso Do not use on irritated or abraded skin Do not use on the breasts Avoid oils, creams, or cosmetics until after patch placement Bathe and swim as usual

Anticipate more breast discomfort during the first 2 monthsStore at room temperature Do not cut, alter or damage the patch as if may alter contraceptive efficacyDo not flush a used patch into the water system; fold the used patch in half and place in the trash

28-Day Cycle (Days 1-28)

Patch #1

Days 1-7

Patch #2

Days 8-15

Patch #3

Days 16-21No Patch

Next 28-Day Cycle (Days 29-56)

This patch was not applied:• Apply a new patch immediately; this is the new “patch change day”• Use backup protection for 7 days• Consider emergency contraception

Patch application is 1 to 2 days late:• Apply new patch immediately; Make this the new “patch change day” • No backup protection is required

Patch application is >2 days late:• Immediately start new 21-day application cycle•Use backup protection for 7 days•Consider emergency contraception

Patch #1

This patch was not removed:• Remove immediately• Start cycle on day 29

Patch: Managing

Perc

en

tag

e o

f p

ati

en

ts

Cycle

Contraceptive Patch

Oral Contraceptive

18.3

11.410.0

8.89.5

7.1 6.7

4.65.5

7.1

0

2

4

6

8

10

12

14

16

18

20

1 3 6 9 13

Breakthrough Bleeding and/or Spotting:Patch Versus Pill

Audet MC, et al. JAMA. 2001;285:2347-2354.©2001, American Medical Association.

0

30

60

90

120

150

180

0

10

20

30

40

Estrogen Exposure: Patch, OCs, Ring

van den Heuvel, et al. Contraception. 2005;72:168-174.

Cmax (pg/mL)AUC 0-21 (ng.h/mL)

Ring (15 µg EE/day) Patch (20 µg EE/day) OC (30 µg EE/day)

*

OCs = oral contraceptive; EE = ethinyl estradiol

†P<0.05 vs ring

*P<0.05 vs patch and ring

*

†

*P<0.05 vs ring and OC

Transdermal Contraceptive Patch:Risk for VTE Events*

Jick SS, et al. Contraception. 2006;73:223-228;Cole JA, et al. Obstet Gynecol. 2007;109:339-346.

Relevant Studies Odds Ratio (95% Confidence Interval)

Jick SS, et al., 2006 0.9 (0.5–1.6)

Cole JA, et al., 2007 2.4 (1.1–5.5)

*Women should be counseled that all combined contraceptive products increase the risk of venous thromboembolic events; use of these products should be discontinued if a patient becomes immobilized.

What is Emergency Contraception?

“A therapy for women who have had unprotected sexual intercourse, including sexual assault.” –ACOG

Not just the “morning-after pill” – hormonal EC can be given up to 72 hours after unprotected intercourse PREVEN, Plan B upto 120 hours post IC

but effective is reduced 150 mg of Levo Copper IUD (up to 5 days after ovulation) Mifepristone (off label, up to 120 hours after

unprotected sex)ACOG Practice Bulletin. Int J Gynecol Obstet. 2002;78:191-198.LaValleur J. Obstet Gynecol Clin North Am. 2000;27(4): 817-839.

EPC Effectiveness

If unprotected sex during wk 2 or 3 8% will become pregnant if not treated 2% will be pregnant following use of combined

ECP (equivalent to a 75% reduction) 1% will become pregnant if use emergency POP

(equivalent to an 88% reduction) 0.1% will become pregnant following emergency

copper IUD insertion (99% reduction)Even late in the cycle a % chance of pregnancy is possible

There is an algorithm to predict when menses will come

Long-Acting Steroid Contraceptive Options

Contraceptive Cases

A 22 year old healthy patient wants to use DMPA but she cannot get in to the office on her menstrual week as that’s the week she travels, can she start the shots any other time?A 33 year old breast feeding mom wants DMPA before leaving the hospital after her delivery, is this permissible?A woman has been on DMPA for greater than 2 years, should she continue? Should she get a Bone Density test?

Depot-Medroxyprogesterone Acetate

Depo-Provera - 150 mg of DMPA via deep intramuscular injection in the gluteal or deltoid muscleDepo-subQ Provera 104 - 104 mg of DMPA via subcutaneous injection into the anterior thigh or abdomenMechanism of action:Duration of protection: 3 m(13 wks)Inhibits ovulation Suppresses levels of follicle-stimulating hormone and

luteinizing hormone Eliminates surges in luteinizing hormone

Thickens cervical mucus Prevents sperm penetration Reduces sperm transport in the fallopian tubes

Atrophies the endometrium

Slide Source:Contraception Onlinewww.contraceptiononline.org

DMPA = depot-medroxyprogesterone acetate

0

1

2

3

4

5

6

7

8

9

10

Injectables: Failure Rate Among Typical Users

Combined Oral Contraceptive

Patch Ring Implant FemaleSterilization

InjectableContraceptive

IUD

Hatcher R. In: Contraceptive Technology. 18th rev ed. 2004:461-494.

Perc

en

tag

e o

f W

om

en

Exp

eri

en

cin

g

an

Un

inte

nd

ed

Pre

gn

an

cy

8% 8% 8%

3%

0.1% 0.05%0.5%

Subcutaneous DMPA : Decreased Bleeding Over Time

0%

20%

40%

60%

80%

100%

Month 3 Month 6 Month 12

Bleeding Only Bleeding/ SpottingSpotting Only Amenorrhea

Perc

en

tag

e o

f P

ati

en

ts

Rep

ort

ing

Jain J, et al. Contraception. 2004;70:269-275.

-6

-5

-4

-3

-2

-1

0

1

24 48 96 144 192 240 24 48 96

DMPA (150 mg) Nonhormonal contraceptive

DMPA: Changes in Bone Mineral Density Over Time

Mean

Ch

an

ge in

Lu

mb

ar

Sp

ine

Bon

e M

inera

l D

en

sit

y (%

)

During Treatment Posttreatment(Weeks)

Kaunitz AM, et al. Contraception. 2006;74:90-99.

*P<0.001

*

*

** * *

*

*

Return to Fertility

0

20

40

60

80

100

120

0 5 10 15 20 25 30 35

Months after Removal or Since Last Injection

DMPA users

Nonhormonalcontraceptive users*

50th Percentile

*Intrauterine device or other barrier method.

Cu

mu

lati

ve C

on

tracep

tion

R

ate

(%

)

Schwallie PC, Assenzo JR. Contraception. 1974;10:181-202.

Timing of DMPA

Initial injection: On day 1 to 5 of menstrual cycle Within first 5 days of the postpartum period if

not breastfeeding After the 6th postpartum week if breastfeeding Immediately or within the first 7 days after an

abortionReinjection: At week 11 to 13 If injection is missed or late (+14 weeks), back-

up contraception should be used and absence of pregnancy should be confirmed

Implants

Implanon

Contraceptive Implants: Characteristics

Serum levels of etonogestrel are detectable within hours of insertion

Suppresses ovulation Occurs within 1 day of insertion Ovulation in <5% of users after 30 months of use Rapid return of fertility

Menstrual cycle returns within three months Continuous contraceptive protection for three yearsDoes not contain estrogen

Appropriate for lactating women after the fourth postpartum week

No fluctuating hormone levels InconspicuousRequires clinician visit for insertion and removalDoes not protect against sexually transmitted infections

Croxatto HB Eur J Contracept Reprod Health Care. 2000;5 Suppl 2:21-28; Reinprayoon D et al. Contraception. 2000;62:239-246; Diaz S. Contraception. 2002;65:39-46; Mascarenhas L. Eur J Contracept Reprod Health Care. 2000;5 Suppl 2:29-34.

IMPLANON™

Single-rod implant (4 cm in length and 2 mm in diameter) made of ethylene vinyl acetate and contains 68 mg of etonogestrelDuration of use: 3 yearsPearl index: 0.38 with typical use

Slide Source:Contraception Onlinewww.contraceptiononline.org

Croxatto HB. Eur J Contracept Reprod Health Care. 2000;5 Suppl 2:21-28; Le J, Tsourounis C. Ann Pharmacother. 2001;35:329-336.

Contraceptive Implant: Tolerability

A 2-year study investigated the efficacy and tolerability of IMPLANONTM (N=330)Reasons for discontinuing participation in the study: Irregular bleeding: 13% Other adverse events: 23%

Adverse events attributed to the study medication: Acne: 14.5% Emotional lability: 14.2% Headache: 12.7% Weight gain: 12.1% Dysmenorrhea: 9.7% Depression: 7.3%

Implant site symptoms: Mild pain of short duration: <5%

The IMPLANON US Study Group. Contraception. 2005;71:319-326.Slide Source:Contraception Onlinewww.contraceptiononline.org

Contraceptive Implant: Noncontraceptive Benefits

0%

10%

20%

30%

40%

50%

60%

70%

0%

10%

20%

30%

40%

50%

Changes in Acne (n=315)

Changes in Dysmenorrhea (n=315)

Decrease NoChange

Increase Decrease NoChange

Increase

Funk S, et al. Contraception. 2005;71:319-326.

Perc

en

tag

e c

han

ge f

rom

baselin

e

Intrauterine Contracetion

IUDIUSIUC

Contraceptive Case

A patient wants to get her pap and her IUD but the nurse insists she come on her period for the IUD insertion, who is right?A 29 year old exotic dancer comes for an IUD insertion, her most frequent partner has offered to pay for it, do you recommend this method for her?The nurse asks you if you want to give the patient antibiotics before or after IUD insertion?A patient wants to know fertilization rates with IUDs?

IUC History

Guidelines overly restrictive in the past. These obsolete recommendations reflected concerns about infection and resultant infertility. This cloud of suspicion concerning infection has now been lifted from the IUD by data from both cohort and case-control studies. A landmark case-control study from Mexico City showed that among nulligravid women, use of a copper IUD was not associated with tubal infertility; in contrast, prior exposure to Chlamydia trachomatis was associated with a significant increase in risk.[1] Cohort studies from Norway[2] and New Zealand[3] have found that upon discontinuation of an IUD, women had problems with unwanted fertility, not involuntary infertility.

Almost any woman interested in highly effective contraception can use an IUD. IUDs today are appropriate for women who have never been pregnant as well as for those who have had upper genital tract infection or a prior ectopic pregnancy. For example, the World Health Organization Medical Eligibility Criteria give nulliparity a category 2 rating, meaning that, in general, the benefits of IUDs for such women outweigh the potential harms. A few contraindications exist, such as an established pregnancy, undiagnosed uterine bleeding that might represent cancer, mucopurulent cervicitis, etc.

Leukocytic Infiltration of Superficial Layers of Endometrium in Contact with IUD: Day 16 of Cycle

LNG-IUS (Mirena®)

Contraceptive efficacy due to cervical mucus change and sperm motility and function inhibition plus weak foreign body action.20 mcg/d LNG (30 would suppress ovulation).5 year cumulative failure rate 0.71/100 in 12,000 US women.Spotting for first 3-6 months of use.Low EP rate (0.2-0.6/1000)Rapid return to fertility.

LNG IUS

1. As with other progestin-only methods, persistent follicles can occur (in less than 8 % of women). They do not require treatment.

2. Produces both cervical barrier and intrauterine barrier to fertilizaiton

Pakarinen et al. Fertil Steril 1997;68:59

Candidates for IUDs: ParaGard T380

Nulliparous or parous womenNo longer a requirement to be mutally monogamous, but do avoid if high risk for STD or PID.Appropriate for all stages of reproductive life whether young, pg spacing or finished with childbearing. Not for someone with post-pg

or post-ab infection within the past three months

Uterine or cervical cancer Cervical infection Allergies.

Possible Complications: IUS

Symptoms Consider

Return of menstruation Expulsion

Fever/chills Infection

Continuous bleeding and/or pain after first month post-insertion

Perforation, infection, or partial expulsion

Irregular bleeding and/or pain in every cycle

Dislocation or perforation

Missing string Dislocation or perforation

PID Rate by InsertionIUD

Farley et al. Lancet 1992;339:785

0

2

4

6

8

1 2 3 4 5 6 7 8 9 10 11 12

Month (first year)

2 3 4 5 6 7 8

Year

Time Since Insertion

Combined WHO clinical trial data for all IUDs - 22,908 IUD insertions(per 1000 woman years)

IUD Counseling

No risk of infertility after discontinuing IUCNo increased risk of PID except in the first 20 days after insertionNo difference in complications for parous or nulliparous women

IUD Counseling, continued

Cu IUD at any time in the cycle if it is reasonably sure she is not pg, no additional protection is necessary It is not known exactly how soon it becomes effective

If she is less than 48 hours postpartum she can have a Cu-IUD, or 4 or more weeks post partum and amenorrhoeic she can have a either IUD insertedImmediately post first trimester abortion and post second trimester she can generally have the IUD inserted Cu-IUD can be inserted within 5 days of unprotected intercourse, not farther as the risk of serious pelvic infection and septic spontaneous abortionIf the LNG-IUD has been inserted more than 7 days into the cycle use protection for 7 days

Bleeding with IUD use

Spotting or light bleeding is common during first 3-6 months for either IUD NSAIDs

Amenorrhea with Mirena doesn’t require treatmentPersistent problem work up for gynecologic causesHeavier than normal menses with the Cu-IUD NSAIDs Tranexamic acid (a hemostatic agent) Do NOT use Asprin Treat anemia If anemia persists remove the IUD

Barrier Methods

Contraceptive Cases

A 18 year old reports that she and her partner were mutually stimulating each other and suddenly decided to have intercourse, she didn’t want to fuss with her diaphragm so she inserted a vaginal film immediately before penetration, was she protected?A woman’s cervical cap was discolored so she’s been cleaning it with Listerine, is it ok?Your patient is worried about HIV she makes her partner use two condoms but he thinks this is unsafe, who’s right?

Phases of the Cervical Mucus Method

Calendar (or calculation) methodBasal body temperature (BBT) methodCervical mucus method (the Billings method)Sympto-thermal method

Barrier Methods

Not as effective as hormonal methods

Most require concomitant spermicide

Efficacy is highly dependent on consistent and correct use

Some require partner cooperation

Vaginal insertion and removal may be unacceptable

Increased risk of urinary tract infection when used with a spermicide

Some require fitting by a clinician

Most are less effective in parous women

No hormonal side effects

Some methods available without prescription

Some reduce sexually transmitted infections

Efficacy:

In a 28-week multicenter, randomized, parallel group study of unadjusted typical use (with spermicide), the probability of pregnancy was 7.9%

Advantages:

Can be inserted hours before intercourse

Does not require removal between acts of intercourse

Cost:

Approximately $30.00

Diaphragm

Mauck C, et al. Contraception. 1999;60:71-80; Trussell J, et al. FamPlann Perspect. 1993;25:100-105, 135; Cates W Jr, Raymond EG. In: Contraceptive Technology. 18th rev ed. 2004:355-363; Cates W Jr,Stewart FH. In: Contraceptive Technology. 18th rev ed. 2004:365-389.

Some are made of rubber, a potential allergen

Must be prescribed and fitted by a clinician

Requires vaginal insertion and removal

Spermicide must be reapplied before each act of intercourse

Must be worn for at least 6 hours after last intercourse, but not more than 24 hours

May increase risk of urinary tract infections and toxic shock syndrome, based on the package insert of the Ortho All-Flex® diaphragm

Diaphragm: Disadvantages

Cates W Jr, Raymond EG. In: Contraceptive Technology. 18th rev ed. 2004:355-363; Cates W Jr, Stewart FH. In: Contraceptive Technology.18th rev ed. 2004:365-389; Association of Reproductive Health Professionals. Non-hormonal Contraceptive Methods: A Quick Reference Guide for Clinicians. Available at: http://www.arhp.org/files/QRGNonHormonalContraception.pdf.

Inserting a Diaphragm and Correct Position of a Diaphragm

Contraindications to Diaphragm Use

Uterine prolapseLarge cystocele or rectocoele or poor pelvic musculature Retroversion of the uterusHistory of toxic shock syndrome Insert up to 6 hrs prior, keep for 24 hrs

Current vaginitis or cervicitis Avoid antifungals, antibiotics, petrolum

productsRepeated urinary tract infectionsAllergy to latex rubber or spermicide Must use 2 tlbs spoons ( 2/3 full)

Today® Sponge

Efficacy:

12-month cumulative life-table pregnancy rate is 17.4%

Parity affects failure rate: Nulliparous – 9% to 10% Parous – 19% to 21%

Advantages:

Made of latex-free material (polyurethane)

One size fits all

Does not require a prescription

Preloaded with nonoxynol-9 spermicide

Can be inserted up to 24 hr before intercourse

Can be left in place for up to 30 hoursKuyoh MA, et al. Contraception. 2003;67:15-18;Trussell J, et al. Fam Plann Perspect. 1993;25:100-105, 135.

Cost:$17.00 for pack of six sponges

Today® Sponge

Disadvantages:

Vaginal insertion and removal

Should remain in place for six hours after last intercourse

May increase risk of urinary tract infections and toxic shock syndrome

Not recommended for use more than once per day

Reduced efficacy among parous women

Cates W Jr, Stewart FH. In: Contraceptive Technology. 2004:365-389; Association of Reproductive Health Professionals. Non-hormonalContraceptive Methods: A Quick Reference Guide for Clinicians. Available at: http://www.arhp.org/files/QRGNonHormonalContraception.pdf.

Types of Cervical Caps

PrentiffLea’s Shield (Yama Inc)Oves Cervical Cap (Veos plc)FemCap (FemCap, Inc) Insert behind the

pubic bone as far as it can go

If greater than 8 hours since insertion give some vaginal estrrogen

Female Condom

Efficacy:

During the first year of typical use, 21% of women experience an unintended pregnancy

Advantages:

Provides some protection against sexually transmitted infections

Does not require a prescription

Can be inserted well before intercourse

Made of latex-free material (polyurethane)

.

Trussell J, et al. Fam Plann Perspect. 1994;26:66-72.

Female Condom

Disadvantages:

May not be as effective against pregnancy as the male condom

Must be inserted and removed by woman

Available in only one size

Labeled for single use

May be noisy

Outer ring may be visually unappealing and uncomfortable

.

Cates W Jr, Stewart F. In: Contraceptive Technology. 2004:365-389; Association of Reproductive Health Professionals. Non-hormonal Contraceptive Methods: A Quick Reference Guide for Clinicians. Available at: http://www.arhp.org/files/QRGNonHormonalContraception.pdf.

Male Condom

Efficacy:

6-month typical-use pregnancy probability: Latex condom - 5.4% Polyurethane condom – 9.0%

Advantages:Provides greater protection against sexually transmitted infections than any other method of contraceptionProvides substantial protection against pregnancy when used with a spermicideDoes not require a prescriptionCan be used with other methodsInexpensive and widely available

Two Types:

Latex

Polyurethane

Steiner, MJ, et al. Obstetrics & Gynecology 2003;101:539-547.Association of Reproductive Health Professionals. Non-hormonalContraceptive Methods: A Quick Reference Guide for Clinicians.Available at: http://www.arhp.org/files/QRGNonHormonalContraception.pdf.

Male Condom

Disadvantages:Can be used for only one act of intercourseCan tear or slip during use, but this is less frequent with lubricated condomsMay decrease sexual pleasureMay interfere with spontaneityRequires cooperation of male partner

Two Types:

Latex

Polyurethane

Association of Reproductive Health Professionals. Non-hormonal Contraceptive Methods: A Quick Reference Guide for Clinicians.Available at: http://www.arhp.org/files/QRGNonHormonalContraception.pdf.

Contraception: Spermicides

N-9 (menfegol, benzalkonium chloride, chlorhexidine, sodium dousate)Surfactant that destroys sperm cell membrane in concentrations ranging from 1-18%.Insert no more than 1 hour prior to intercourse.FDA mandates that warnings say this product won’t protect against STDs or HIVMay damage vaginal mucosa or cervical epithelium, and can and increase STI vulnerability, and FDA mandates these products warn that these products may increase the risk of getting HIV/AIDS from an infected partner

ContraceptionCondoms

Over 100 products available in the US

90% are made of latex

Animal skin products or polyurethane make of the rest of the products

Most are lubricatedNote: anal intercourse doubles risk of breakage

Extra thick condoms blunt sensation and reduce premature ejaculation

$0.50 for latex, 0.80 for poly, several dollars for designer condoms

Spermacide reduces shelf life to 2 years, 5 normally

Condoms, counselingLatex are the best protection against STI, including HIV and HSVApply over an errect penis immediately before intercourse with half-inch reservoir at the tip of the condom should be created by carefully pinching the tip of the condom after placementWithdrawal should occur prior to loss of erectionHold the rim during withdrawal to prevent spillageOnly water based lubricants should be used with the latex condoms

Putting it on inside out, taking it out, flipping it over and wearing during intercourse.Completely unrolling it before wearing.Removing the condom during intercourse.Putting the condom on after IC has begun.Using too large a condom.

Sterilization

Contraceptive Cases

A 25 year old after delivery wants to know how likely it is she’ll regret it if she has you perform a post partum tubal ligation.A 20 year old G4 P4 says her previous doctor refused to perform her tubal ligation, and she says she’s got insurance from the state now and she wants it done. What do you recommend?A 33 year old wants permanent contraception what technique should you select?A woman wants to know what is her chance of needing a hysterectomy if she gets a tubal?

Usage of sterilization

0

10

20

30

40

50

60

15-19 20-24 25-29 30-34 35-39 40-44

Age

% o

f W

om

en

Usin

g M

eth

od

Female Sterilization Male Sterilization

Oral Contraceptive Other Methods Injection

Condom

Chandra A, et al. Vital Health Stat. 2005;23(25).

Advantages of Sterilization

Ideal for those desiring no more children Quick recovery Lack of long-term effects Cost-effective No need to remember to use contraception

before intercourse No need for partner compliance High degree of safety; low mortality rates

Failure rate 0.5 to 3.6%

Disadvantages of Sterilization

Permanence Reversal is expensive, requires major surgery,

and is not guaranteedRegret for the decisionExpense at time of procedureProcedure requires aseptic conditions, surgical equipment, trained clinicians, and anesthesiaDoes not protect against HIV or other sexually

Complications AssociatedWith Sterilization

1 to 2 deaths/100,000 women when compared to a maternal mortality rate of 12.1/100,000 live birthsProcedural complications Excessive bleeding or hemorrhage Infection Anesthesia-related complications Trauma – tears, perforations, and burns to

abdominal organsEctopic pregnancy – but the risk is lower than for nonsterilized women

Peterson HB, et al. Am J Obstet Gynecol. 1983;146:131-136

Female Sterilization:Techniques

Clips – block the fallopian tubes by clamping down and cutting off the blood supply, thereby causing scarring or fibrosis Filshie clip – titanium with a silicone rubber lining Wolf (Hulka) clip – plastic

Rings – cinch a loop of the midportion of the fallopian tube Fallope ring – small Silastic band

Microinserts – two concentric expanding metal coils surrounding PET mesh fibers that produce a local inflammatory response

Hulka JF, et al. Am J Obstet Gynecol. 1976;125:1039-1043; Yoon IB, et al. Am J Obstet Gynecol. 1977;127:109-112.

Hysteroscopic Placement of Permanent Birth Control Micro-Insert Within Tubal Lumen

Taken from Kerin, Carignan & Cher. The safety and effectiveness of a new hysteroscopic method for permanent birth control. Aust N Z J Obstet Gynaecol 2001;41:364-370.

Regret After Sterilization

Hillis SD, et al. Obstet Gynecol. 1999;93:889-895.

Years After Sterilization*

Characteristic 3 7 14

Overall (N=744) 3.9 7.5 12.7

Age at sterilization

18-30 5.1 10.5 20.3

>30 2.6 4.8 5.9

MarriedNo 4.5 9.4 20.4

Yes 3.6 6.8 10.2

RaceWhite 3.5 6.0 7.4

Black 4.3 10.2 21.7

Time between birth of last child and sterilization

Postpartum – vaginal 5.6 10.2 17.8

Postpartum – cesarean 8.8 14.0 16.1

Interval

15 d-1 yr 3.3 8.8 17.6

2-3 yrs 4.5 8.2 12.6

4-7 yrs 3.4 7.0 9.5

* Cumulative probability/100 procedures

Surgical Abortion

Pregnancy Termination Counseling

• Discuss all options regarding pregnancy• Discuss decision-making process• Provide information

• Offer medical abortion• Review medical history and discuss previous procedures• Referral for long-term counseling

Issues in Elective Termination of Pregnancy

• Sonography • Need for more comprehensive evaluations

• Neonatal advances• Fetal tissue research• Rise in infertility• Dearth of adoptive children• Advances in assisted reproductive technologies

(ART)• Selective Termination• Rarely medically indicated

(Contraceptive) Cases

A 24 year old with NYHA Class 4 CVD presents because she was told she “has to have an abortion,” do you agree?A 13 year old patient who has never had a pelvic examination presents requesting an abortion under general anesthesia, is this as safe as under local anesthesia?A 28 year old Russian woman presents for her 7th surgical abortion, how do you counsel her?

Preoperative Evaluation

Targeted History• Pelvic examination

Falls within preset dating criteria Adequate cervical visualization and uterine palpation Patient suitable for local anesthesia

Rh typingHemoglobinSonographyGC/CT testingReview counseling session and the contraceptive alternatives

Vacuum Aspiration

Complications

• Inability to dilate cervix• No tissue or villi obtained• Obvious uterine

perforation• Immediate hemorrhage

Cervical Uterine

• Severe postoperative pain Endomyometritis Salpingitis Uterine subinvolution

• Pregnancy continues• Ectopic gestation• Molar pregnancy• Ovarian cyst pathology

Medical Abortion

Abortion performed without primary surgical intervention

Rachel Benson Gold discusses a particularly troubling aspect of state laws in “The Implications of Defining When a Woman is Pregnant,” which appears in the same issue of TGR. According to both the scientific community and long-standing federal policy, a pregnancy is established when a fertilized egg has implanted in the wall of a woman’s uterus. However, definitions of pregnancy in state law vary widely. And although they have not yet been used to impede women’s access to legal hormonal contraceptive methods, such restrictions are a goal of at least some antiabortion and anticontraception activists.

To date, 22 states have enacted one or more laws that include a definition of “pregnancy.” The definitions found in 18 of these laws are based on the idea that pregnancy begins at fertilization or conception. The ongoing debate around emergency contraception–a concentrated dosage of the same hormones found in birth control pills–has brought the question of when pregnancy prevention ends and disruption of an existing pregnancy begins to the forefront of public discussion. Attempts to define pregnancy as beginning before implantation could have serious implications for women’s access to both emergency contraceptives and other hormonal contraceptive methods.

“The fact is the majority of Americans have sex before marriage; virtually all U.S. women (98%) use a contraceptive method at some point in their lives; and most women rely on contraception, not abstinence, to help them responsibly manage their sexual lives in the long term,” says Dailard. “As long as politicians continue to ignore the realities of women’s lives, the United States will continue to have the highest rates of unintended pregnancy and abortion in the developed world–a dubious honor that most Americans would prefer not to have.”

(Contraceptive) Case

A 21 year old patient presents for an abortion but she doesn’t have a positive pregnancy test, she wants a medical abortion, what do you give her?

Medical Abortion Regimens

Prostaglandin

Anti-progesterone

Mifepristone +Misoprostol

Anti-metabolite

Methotrexate +Misoprostol

Medical AbortionAdvantages

Can be performed without delayAvoids surgical and anesthetic riskPotential to increase access through expanding providers (not true)Potential to shield abortion providers (also not true)Increases choice

Medical AbortionDisadvantages

Longer waiting period for completionRequires multiple visits (2-3)Less effective than surgical (95% vs 99%)Not available after about 7 weeksExpense(Cumbersome) regimen

Surgical AbortionAdvantages

More effectiveShorter time to completionFewer visits Shorter bleeding durationAlways has pathologic confirmationCan be performed in later gestation

Surgical AbortionDisadvantages

More serious risks involvedLimited accessRequires more equipment and investmentProviders more vulnerable to risk

Medical Abortion Counseling

Desires termination of pregnancyUsual method and efficacy of alternativesRisks, side effects, tetarogenicity and adverse events for each medication and for failed medicalInformed consent and administer the MifeprexTM

Medication Guide and Patient AgreementMedical ascertainment of contraindications to the medicationsClarify the amount of pain and the number of visits and the possibility of need for outside medical care at own expense

Mifepristone: Mechanism

Softens and dilates the cervixCauses decidual necrosis by affecting the capillary endothelial cells of the decidua and detachment of pregnancyIncreases prostaglandin releaseIncreases uterine contractions and sensitivity to exogenous prostaglandin

Mifepristone + Misoprostol

Medical history and physical examPregnancy dating (HCG titers if no sac)Rh status and administration of RhogamHematocrit or hemoglobinCounseling/informed consent Offer surgical abortion Explain 4 hour waiting requirements of visit 2? FDA

wanted both drugs administered in the office Explain only placenta and blood will be visible to the

naked eye

Mifepristone + Misoprostol

Administer mifepristone 200 mg Schedule the next visit The literature supports home administration safety

for the misoprostol, the FDA is not supportive

Instructions on self care and how to contact the clinic Provision of emergency contact, verbal and written

use instruction

Mifepristone + Misoprostol

Confirm with sonography patient has not aborted (no decisive HCG change for 10d)6% complete abortion prior to misoprostolIf not completed abortion administer misoprostol 400 mcg PO in two 200 mcg tablets (800 PV, done but not licensed in any country)(Observe for 4 hours about 50% will abort)84% abort within the next 24 hoursMonitor patient for home administrationPain medication for cramping and medication for GI symptoms

Mifepristone + Misoprostol

Return in 7-10 days to confirm abortion by sonographyVaginal bleeding lasts for 17 +/-11 days and tapers off rapidly after initial expulsion, tell patients to expect 9-20 days of bleeding8-9% of women have bleeding >30 daysPathologic confirmation: decide about tissue disposal if patient should bring the tissue with her

Medical Abortion Overview

“Expected” side effects

“Expected” bleeding“Expected” cramping Medication requirements Hospitalization rates

“Expected” Side Effects

GI: Nausea, Vomiting, DiarrheaMild temperature elevation (PD effect)CrampingHeadache, dizzinessBleeding

“Expected” Bleeding

Bleeding-moderate to heavySome clots-small to largeOnset average 2-4 hours after misoprostolHeaviest bleeding may last 1-4 hours as pregnancy is expelledContact us if 2 maxipads/hour for 2 hours: call (pads should be ‘dripping wet’)

“Expected” Cramping

Cramps are light to heavyPain usually managed with ibuprofen 600-800 mg/4-6 hoursPrescription for acetaminophen with codeine may be given on day 1 or day 3Night cramping usually worse before expulsion

Ultrasonography

Ultrasonography

Diagnosis of Complete Abortion

Any abortion without suction curettage must have a confirmatory examination before the patient’s treatment course is completeUltrasound disappearance of the gestational sac this usually mandates a transvaginal ultrasoundNegative pregnancy test (<50 mIU/ml in urine)90% drop in b-HCG

Management of Complications

Pain: May assess on an Likart scaleTemperature: returns to normal 3-4 hours after misoprostolFailure to bleed: Do not treat EP with this regimenHeavy or prolonged bleeding: stops 1-2 hrs after passing pregnancy Rest, heating pads, NSAID or non-ASA Plenty of non-alcoholic beverages Clinician should call back 30-60 minutes to assess

the patient’s conditionCompletion may take up to 3-4 weeksReturn visits are the only way to assure completion80-85% will abort within two weeks with Mtx-Misoprostol and 95-97% within two weeks with RU486-Misoprostol

Complication Rates

Surgical abortion: 9/100,000 overall with mortality <1/100,000Most surgical complications result from instrumentation in the uterus and from second trimester proceduresMedical abortion: complications are more difficult to assess: bleeding is expected, it can be heavy, hemorrhage is a complication US Trial 1/859 Tx adverse event rate of 0.17%Specific AEs From Medical Abortions of first 80,000 5 EP, one of which was fatal 13 transfusions (one was EP case) 117 had curettages, nearly all were non-emergent 10 received antibiotics for presumed infection 6 had allergic reactions

50 women had ongoing pregnancies, of which all but two terminated surgically

Conclusions

Conclusions

Contraception is good primary prevention of diseasePerceptions of safety and convenience Provider Education Reducing mythology Increasing knowledge of non-contraceptive

benefitsMany methods available but cost and access seem to still limit their use and increase risk of unplanned pregnancyMost women will use many methodsAbortion should be safe, legal and rare

“We have not inherited the earth from our grandparents, we have borrowed it from our grandchildren.”

---attributed to Ancient Chinese