Evidence_Based_Contraception_

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Evidence Based Contraception:
Providing the Best Birth Control
to Your Patients
Rachael Phelps MD
Associate Medical Director
Planned Parenthood of the
Rochester/Syracuse Region
Unintended Pregnancy in the U.S.
6.3 million pregnancies
Intended
51%
Unintended
22% Birth
49% 20% Abortion
7%
Miscarriage
Finer LB, Henshaw SK. Perspect Sex Reprod Health. 2006.
Current Contraceptive Options
Most
effective
Very
effective
Moderately
effective
Effective
Prevents
pregnancy
>99% of the
time
Prevents
pregnancy
~91-99% of
the time
Prevents
pregnancy
~81-90% of
the time
Prevents
pregnancy
up to 80% of
the time
Sterilization
IUD/IUS
Implants
Pills
Patch
Ring
Injectables
Condom
Sponge
Diaphragm
Withdrawl
Fertility
awareness
Cervical
cap
Spermicide
Factors Affecting
Contraceptive Use
Do any of my
friends use it?
Do I want to prevent
pregnancy?
Will I be able to
afford it?
Will it
hurt me?
How will it help me?
What have I heard about it?
Will my parents or partner find out?
Contraceptive Use and
Effectiveness
31%
(% of US women 15-44 years)
Chandra A, et al. CDC 2005.
27%
Most effective
24%
Very effective
Effective
8.70%
5.30%
in
g
1.30%
Pa
tc
h/
R
D
IU
PA
M
D
ith
dr
aw
l
W
s
on
do
m
C
St
er
ili
za
tio
n
O
CP
2.10%
Satisfaction with Contraceptive
Methods
% Satisfied
87
86
80
79
75
60
4.6
4.5
4.1
MOST SATISFIED
4.1
52
3.9
3.6 3.8
LEAST SATISFIED
Revisiting Your Regular Women’s Health Care Visit. 2004.
Current Contraceptive Options
Extremely
Effective
Very
Effective
Moderately
Effective
Effective
Extremely
Effective
Male Sterilization
No-scalpel vasectomy
(NSV) is the standard
of care
 A small (few mms) opening is
made in the skin of the scrotal
sac to deliver vas deferens
 Ligate/cauterize
 No scalpel or sutures required
Extremely
Effective
Female Sterilization:
Nonsurgical Tubal Occlusion
Brand name: Essure®
Brand name: Adiana ®
 Micro-inserts placed into
proximal
fallopian tubes
 No reported pregnancies to
date
 Low-level radiofrequency delivered
to fallopian tubes
 Micro-inserts placed in fallopian
tubes
 98% effective in preventing
pregnancy based on 3 years of
clinical data
Pollack AE. Contraceptive Technology. 2007. Ogburn T. Obstet Gynecol Clin North Am. 2007. et al.
Characteristics of Intrauterine
Contraception
 Highest patient
satisfaction among
methods
 Rapid return of fertility
 Safe
 Long-term protection
 Highly effective
Belhadj H, et al. Contraception. 1986.; Skjeldestad F, et al. Advances in Contraception.
1988.; Arumugam K, et al. Med Sci Res. 1991.; Tadesse E. Easr Afr Med J. 1996.
Extremely
Effective
Levonorgestrel IUD
(MIRENA)
• 20 mcg levonorgestrel/day
• 5 years use
• Amenorrhea in ~20% of users
by 1 year
• Primary mechanism is
fertilization inhibition
• Cervical mucus thickening
• Sperm Inhibition (function/motility)
Mirena Prescribing Information. 2000.: Trussel J. Contraceptive Technology. 2007;
Hidalgo M. Contraception. 2002.
Extremely
Effective
Copper-T IUD: PARAGARD
• Copper ions
• Approved for 10 years’ use
• Can be used as emergency
contraceptive
• Primary mechanism is
prevention of fertilization
• Reduce motility and viability
of sperm
Thonneau, PF. Am J Obstet Gynecol. 2008.: Forrtney JA. J Reprod Med.
1999.: Trussel J. Contraceptive Technology. 2007.
Dispelling Common Myths
About IUDs
In fact, IUDs:
 Can be used by nulliparous women
 Can be used by women who have had an
ectopic pregnancy
 Can be used by women with multiple partners
 Can be used by women with h/o STI/PID
 Can be used by teens
 Do not need to be removed for PID treatment
MacIsaac L. Obstet Gynecol Clin N Am. 2007;
Toma A. J Pediatr Adolesc Gynecol. 2006.
Safety: IUDs Do Not Cause PID
 PID incidence for IUD users is similar to
that of the general population
 Risk is increased only during the first
month after insertion
 Preexisting STI at time of insertion, not
the IUD itself, increases risk
Rule Out GC/CZ Prior to Insertion
Svensson L, et al. JAMA. 1984; Sivin I, et al. Contraception. 1991;
Farley T, et al. Lancet. 1992.
Safety: IUD Does Not Cause
Infertility
 2000 women case-control
 IUD users not more likely to have infertility
than gravid controls (OR=0.9)
 Women with Cz antibodies more likely to
be infertile (OR=2.4)
 IUD is not related to infertility
 Chlamydia is related to infertility
 Similar results in multiple studies
Hubacher D, et al. NEJM. 2001.
Rapid Return to Fertility
Pregnancies (%)
100
80
IUC
60
OC
Diaphragm
40
Other methods
20
0
0
12
18
24
30
36
Months After Discontinuation
Based on data from Vessey MP, et al. Br Med J. 1983.
42
Screening: Appropriate Candidates
for Intrauterine Contraception
Copper T IUD (Paragard)
LNG IUD (Mirena)
• Want regular periods
• Want no hormones
• No h/o dysmenorrhea
• No h/o menorrhagia
 OK w/irregular bleeding
 OK w/amenorrhea
 H/O dysmenorrhea
 H/O menorrhagia
Extremely
Effective
Implant: IMPLANON
 Contains etonogestrel
 Effective for 3 years
 Mechanism: Inhibits
ovulation
 Side effects: amenorrhea
or irregular bleeding
Implanon insert: Diaz S., Contraception, 2002: Trussel J, Contraceptive Technology, 2007
Croxatto HB, Contraception, 1998; Diaz S, Contraception, 2002; Funk S, Contraception,
2005. Implanon Prescribing Information. et al.
IMPLANON™ Applicator
IMPLANON™ Insertion
IMPLANON™ [package insert]. Roseland, NJ:
Organon USA Inc; 2006.
What is the timing of insertion???
That pregnancy can be excluded
Alvarez PJ. Ginecol Obstet Mex. 1994. O’Hanley K, et al. Contraception. 1992.
How can you exclude pregnancy?
Negative pregnancy test
+
No unprotected sex for 2 weeks
Current Contraceptive Options
Extremely
Effective
Very
Effective
Moderately
Effective
Effective
Very
Effective
Combined Oral
Contraceptives
 Contain estrogen & progestin
 Most newer formulations
contain 20 – 35 mcg of ethinyl
estradiol
 1 of 8 available progestins
Trussel J. Contraceptive Technology. 2007:Rosenberg MJ. Reprod Med. 1995: Potter L.
Fam Plann Perspect. 1996; Mosher WD. AdvanceData. 2004. Hardman JG. McGraw-Hill.
1996.: Goldzieher JW. Fertil Steril. 1971.: Moghissi KS. Fertil Steril. 1971.
Estrogen-Related Side Effects
Estrogen dose 20-35 mcg





Breast tenderness
Nausea
Vomiting
Headaches
Elevated blood pressure (rare)
Progestin-Related Side Effects
Most Androgenic: levonorgestrel, norgestrel
Androgenic: norethindrone, ethynodiol diacetate
Least Androgenic: desogestrel, norgestimate
Spirinolactone like: drosperinone




Bloating
Anxiety/Irritability/Depression
Menstrual irregularities
Libido
30
Very
Effective
Transdermal Patch:
Ortho Evra
Beige-colored patch
changed once per week
3 weeks on/1 week off
9 days of medication in
each patch
Abrams LS. Fertil Steril. 2002: Ortho Evra Prescribing Information. Archer DF, et al. Fertil
Steril. 2002.; Zacur HA, et al. Fertil Steril. 2002.; Zieman M, et al. Fertil Steril. 2002.; Archer
DF, et al. Contraception. 2004.; Audet MC, et al. JAMA. 2001.
Counseling Issues and
Facilitating Use
Application
Reapplication
•Place on clean,
dry skin on
arm, torso,
buttocks, or
stomach, NOT
the breast
•Must stick
directly to skin
•No patch
during the 4th
week
Apply a new
patch after day
7 even if still
bleeding
Missed or Late
Patch
Use back-up
method when:
•On for >9 days
•Off for >7 days
•Falls off >24 hrs
Very
Effective
Vaginal Ring: Nuva Ring
 Flexible, unfitted ring placed
in vagina
 In 3 weeks/out 1 week
 4 weeks of medication in ring
 Continuous use: change first
of each month
NuvaRing Prescribing Information. Organon. 2001: Timmer CJ. Clin Pharmacokinet. 2000.
Herndon EJ. Am Fam Physician. 2004: Dieben TO. Obstet Gynecol. 2002: Linn ES. Int J
Fertil. 2003. et al.
Counseling Issues and
Facilitating Use
Placement
Reinsertion
Pinch ring and
place into
vagina. There
is no wrong way
to place. If its
uncomfortable,
place deeper.
Insert ring for 3
weeks, then
remove for 1
week. After 7
ring free days,
place a new
ring even if still
on menses.
Missed or Late
Ring
Use back-up
when:
In for > 5 weeks
Out for > 7 days
Falls out > 3 hrs
Extended Hormonal
Contraception
 Delays or eliminates
menstruation
 Menstrual and nonmenstrual
benefits
 Extended methods:
• Continuous use of COCs, transdermal
patch & vaginal ring
• Seasonale®, Seasonique ® & Lybrel ® dedicated extended OC regimen
Anderson FD. Contraception. 2003. Kaunitz AM. Contraception. 2000. ARHP. 2003.
NuvaRing Product Information. 2001. Stewart FH. Obstet Gynecol. 2005. Kwiecien M.
Contraception. 2003. Sulak PJ. Am J Obstet Gynecol 2002.
Very
Effective
Injectable: DMPA
• Depot Medroxyprogesterone
Acetate (Depo-Provera )
• IM or SQ injection every
3 months (13 weeks)
Trussel J. Contraceptive Technology. 2007. Cromer BA. Am J Obstet Gynecol. 2005.
Trussel J. Contraception. 2004.; Westhoff C. Contraception. 2003. et al.
Very
Effective
Progestin-Only Oral
Contraceptives
 Called the “mini-pill”
 Two formulations:
norethindrone & norgestrel
 No placebo week
 Timing crucial
Apgar BS. AFP. 2000; WHO MEC. 2004. Contraception Report. 1999. Apgar BS. AFP.
2000. et al.
Current Contraceptive Options
Extremely
Effective
Very
Effective
Moderately
Effective
Effective
Moderately
Effective
Withdrawal
Effectiveness is similar to male condom
96%
98%
Withdrawal
Male condom
82%
Perfect Use
83%
Typical Use
Jones RK. Contraception. 2009.
Emergency Contraception (EC):
 Dispelling Myths:





The morning after pill is not the abortion pill
EC does not cause an abortion
EC does not harm an existing pregnancy
EC does not affect future fertility
EC does prevent unwanted pregnancy and
abortion
EC Methods
Brand: Plan B® One-Step (one pill)
Generic: Next Choice (two pills)
• behind counter > 17 year
• prescription <17 years
Ella Ulipristal Acetate- FDA approved
High doses of OCs
Copper-T IUD
Emergency Contraception
 Most effective the sooner it is taken
 Taking 2 generic pills at once increases compliance
without more side effects
 Can be taken up to 5 days after unprotected intercourse
 Advance provision increases use and effectiveness
Piaggio G. Lancet. 1999. Task Force on Postovulatory Methods. Lancet. 1998. Grimes DA. Ann Intern Med.
2002. Croxatto HB. Contraception 2001. Raine T. Obstet Gynecol. 2000. Gold MA. J Pediatr Adolesc
Gynecol. 2004. Grimes DA. Ann Intern Med. 2002.
Initiation of Hormonal Contraceptives
Pregnancy test
Pelvic exam
Pap smear
STI screening
Leeman L. Obstet Gynecol Clin N Am. 2007
Quick Start Method: New Approach
Improving Contraceptive Initiation
 Start method (OCP, Ring, Patch, DMPA) today (if
pregnancy test is negative)
 If unprotected IC in past 5 days:
 Start method today
 Also offer EC
 If unprotected IC in past 2 weeks:
 Start method today
 RTC for pregnancy test in 3 weeks
 Back-up for 7 days
When is she protected
from pregnancy?
Immediately:
Copper-T IUD
After 7 Days:
LNG IUS
Implant
Pills
Patch
Ring
Injectable
Weighing the Risks & Benefits
Burkman R. Am J Obstet Gynecol. 2004.
Risk Perception
“When providers and/or patients
hold misperceptions about the
risks associated with
contraception, women’s choices
may be unnecessarily limited.”
Combined Hormonal Contraception Has
Many Health Benefits
 Menstrual-related health benefits:
 Decreased dysmenorrhea
 Decreased menstrual blood loss and anemia
 May reduce menstrual-related PMS symptoms
 Decreased risk of:




Ectopic pregnancies
Endometrial and ovarian cancer risk
Benign breast conditions
PID
Decreases Effectiveness of
OCP, Patch, Ring, POP, :








Carbamazepine (Tegretol, Equetro, Carbetrol)
Oxcarbazepine (Trileptal)
Phenobarbital
Phenytoin (Dilantin)
Primidone (Mysoline)
Topiramate if >200 mg/day (Topamax)
Modofinil (Provigil)
Lamictal (not a problem for POP)
Combined Hormonal Contraception
Has Few Contraindications
(all related to estrogen)
 Clotting disorders
 History of DVT or PE
 Migraine with aura or focal neurological
deficit
 Uncontrolled HTN
 Smoker over age 35
 SLE w/ + antiphospholipid antibody
Resource: CDC U.S. Medical Eligibility Criteria
Incidence of VTE per
100,000 woman-years
Comparative Risks of VTE
60
40
20
0
Pregnancy High-dose Low-dose
(50) OC
(20-35)
OC
Shulman LP. J Reprod Med. 2003.
Chang J. In: Surveillance Summaries. 2003.
General
Population
Fatal Cardiovascular Events
(MI,VTE,Stroke) per 100,000
35.9
AGE:
40-44
35-39
30-34
15
13.1
3.7
2.3
1.5
Non-smoker
Non-user
6.3
3.4
2.1
Non-smoker
OC-user
6.6
3.6
5.9
Smoker Nonuser
Smoker OCuser
Farley TMM, Collins J, Schlesselman JJ. Contraception. 1998
Cardiovascular Adverse
Events in Context
 Incidence is low in reproductive-age women, with or
without OC use
 Mortality associated with combined OC use is low
among women aged less than 35 years, even if
they smoke.
 Among healthy women over 35 years, the additional
mortality associated with oral contraceptive use is
1.4 per 100 000 users per year
 Smoking has greater effect on cardiovascular event
incidence and mortality than OC use at all ages
Farley TMM, Collins J, Schlesselman JJ. Contraception. 1998.
A Final Thought
“…Two times a very rare
event is still a very rare event.”
David Grimes, MD
2006
DMPA and Bone Loss
Women lose 1-3% of BMD/year of use
In 2004: FDA added a black box warning to
address DMPA and BMD
Loss appears to
be transient.
2005 study:
Recovery complete in 12
months following
discontinuation
Duration of use does not
impact recovery
Scholes D, et al. Arch Pediatr Adolesc Med 2005;159:139–144
Berenson AB, et al. Am J Obstet Gynecol 2001;98:576-82
57
DMPA and Weight Gain
18% of
adolescents
report
discontinuing
for this
reason
2
retrospective
analyses :
DMPA
associated
with an
increase of 9
lbs.
Only
randomized
trial: DMPA
had no effect
on weight
over a 3
month period
Polaneczky M, et al. J Adolesc Health 1998;23:81-88
Bahamondes L, et al. Contraception 2001;64:223-225
Mangan SA, et al. J Pediatr Adolesc Gynecol 2002;15:79-82
CDC U.S. Medical eligibility criteria
(USMEC)
www.managingcontraception.com
Provider Resources
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


Resources:
www.prch.org - Physicians for Reproductive Choice and Health
www.aap.org - The American Academy of Pediatrics
www.acog.org - The American College of Obstetricians and Gynecologists
www.adolescenthealth.org - The Society for Adolescent Medicine
http://www.aclu.org/reproductiverights/ - The Reproductive Freedom
Project of the American Civil Liberties Union
www.advocatesforyouth.org – Advocates for Youth
www.guttmacher.org – Guttmacher Institute
www.cahl.org/ - Center for Adolescent Health and the Law
www.gynob.emory.edu - The Jane Fonda Center of Emory University
www.siecus.org - The Sexuality Information and Education Council of the
United States
www.arhp.org - The Association of Reproductive Health Professionals
Provider Resources:
Contraception
 PRCH’s Emergency Contraception: A Practitioner’s
Guide
 ARHP Reproductive Health Model Curriculum
 For emergency contraception, women can call 1-888NOT-2-LATE.
 Managing Contraception:
http://www.managingcontraception.com
 Back Up Your Birth Control: Building Emergency
Contraception Awareness Among Adolescents, A Tool
Kit, Academy for Educational Development,
http://www.aed.org/Publications/upload/ECtoolkit3283.pd
f
Web Resources for Patients
www.arhp.org
www.plannedparenthood.org
www.familydoctor.org
www.ashastd.org
www.reproductiveaccess.org
(section for consumers/patients)
www.reproline.jhu.edu
Fertility Postpartum
Not Breastfeeding
 Most nonlactating women
resume menses within 4
to 6 weeks, but are
anovulatory
 Average, first ovulation
occurs 45 days
postpartum
 Duration of postpartum
infertility is variable and
unpredictable!
Breastfeeding
 Ovulation can occur even
though menstruation has
not started.
 Probability that ovulation
will proceed the first
menses increases over
time:
 33% to 45% during first
3 months pp
 64% to 71% during
months 4 through 12
 87% to 100% after 12
months
Postpartum BC methods:
Not Breastfeeding
 Immediate post delivery:




DMPA
Progesterone Only Pills
Implanon
IUD (Paragard only)
 3 weeks postpartum
 Combined OCP
 Patch
 Vaginal Ring
 4 weeks postpartum
 IUD (Paragard or Mirena)
Postpartum BC methods:
Breastfeeding
 Immediate post delivery:




Progesterone Only Pills
Implanon
DMPA (or wait 4-6 weeks)
IUD (Paragard)
 After breastfeeding established or baby’s diet
supplemented (6 wks-6 months)
 Combined OCP
 Patch
 Vaginal Ring
 4 weeks postpartum
 IUD (Paragard or Mirena)
Breastfeeding- USMEC
 CHC: PILLS/RING/PATCH
 <6wk - 4
 6wk-6months - 3
 >6 months - 4
 Progestin-ONLY: POP/DMPA/IMPLANT
 <6wk - 3
 6wk-6months - 1
 >6 months - 1
 IUD
 <4wks - Paragard - 1/ Mirena - 3
 >4wks - 1 for both
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