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Andrew  M.  Kaunitz,  M.D.  Professor  and  Associate  Chairman  

Department  of  Obstetrics  and  Gynecology  University  of  Florida  College  of  Medicine  -­‐  Jacksonville  

Skouby.debate.5.13.13b

Latin America/Caribbean All pregnancies (million) 17.1 Unintended 58%

Globally,  Many  Pregnancies  Are  SFll  Unintended1  

2

aExcludes Japan.

1. Singh S et al. Stud Fam Plann. 2010;41(4):241–250.

Asiaa

All pregnancies (million) 118.8 Unintended 38%

Europe All pregnancies (million) 13.21 Unintended 44% North America

All pregnancies (million) 7.2 Unintended 48%

Oceania All pregnancies (million) 0.9 Unintended 37%

Africa All pregnancies (million) 49.1 Unintended 39%

World All pregnancies (million) 208.2 Unintended 41%

Global  Data  (2008)  

Unintended  Pregnancy  is  a  ParFcular  Concern  in  Adolescents  Worldwide  

●  Around  the  world,  about  16  million  girls  and  women  aged  15  to  19  years  give  birth  each  year.  –  Most  of  these  pregnancies  are  unintended.  

World Health Organization. Making pregnancy safer. Adolescent pregnancy. www.who.int/making_pregnancy_safer/topics/adolescent_pregnancy/en/index.html. Accessed 21 November 2011.

Youngest  Women  Experience  the  Highest  Rate    of  Unintended  Pregnancy  

Finer LB et al. Contraception. 2011;84:478–485.

Unintended  Pregnancy  in  the  United  States  (2006)  

Age, years

Total Pregnancy Rate/

1,000 Women

Unintended Pregnancy Rate/

1,000 Women

Unintended Pregnancy

Rate, %

15–17   42   33   79  

18–19   124   103   83  

20–24   168   107   64  

25–29   174   71   41  

30–34   139   46   33  

35–39   80   22   28  

≥40   21   10   48  

Reversible  ContracepFves:  First  Year  Failure  Rates  with  Typical  Use  

J Trussell et al. Contraception 2004 K Kost et al. Contraception 2008 S Funk et al. Contraception 2005

Long-acting reversible methods: efficacy comparable to sterilization

*Estimates in lieu of actual data

Percent

Available  Long-­‐AcFng  Reversible  ContracepFves  

Type Duration of Use

Intrauterine  devices  Replaced  in    3,  5  ,  10  years  

Implants  Replaced  in    3  to  5  years  

Injectable  contracepKves  InjecKons  repeated    every  8  or  12  weeks  

National Institute for Health and Clinical Excellence. www.nice.org.uk/nicemedia/live/10974/29912/29912.pdf. Accessed 20 September 2011.

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Percent  of  all  US  Women  Aged  15-­‐44  Years  Using  Hormonal    ContracepFves  or  IUDs  (2006-­‐2008)  

Mosher  WD,  Jones  J.  Use  of  ContracepKon  in  the  United  States:  1982-­‐2008.   NaKonal  Center  for  Health  StaKsKcs.  Vital  Health  Stat  23  (29).  2010.

OC All IUDs & Implants = 4.7

Use  of  Selected  ContracepFves,  by  Country:  Percent  of  Overall  Hormonal  ContracepFve  Use:  September  2012  

IMS Midas ™

OC Progestin IUD & Implants

28.6 1.1 1.5 1.2

=

Clinicians  Have  QuesFons  re  LARCS  in  Teens  

–  IUDs  o Desired  by  teens?  -­‐Placement  feasible?  o Safe?      -­‐ConKnuaKon  rates?  o Rates  of  unintended  pregnancy  /  induced  aborKon?  

–  Implants  o Desired  by  teens?  -­‐ConKnuaKon  rates?  

–  DMPA  o Skeletal  health  safety?   Jeffrey F. Peipert, MD, PhD

Objective: - To decrease unintended pregnancy by promoting the use of long-acting reversible contraception (LARC) in St. Louis, USA - Assess acceptability and continuation of a variety of contraceptive methods

Contraceptive Choice Project. http://www.choiceproject.wustl.edu/studyfindings.html. Last Accessed 12/20/2011.

IntroducFon  to  the  ContracepFve  CHOICE  Project  in  the  United  States  

●  Sexually  acKve  women  who  wanted  to  avoid  pregnancy  but  were  not  currently  using  a  contracepKve  or  wanted  to  start  a  new  reversible  method  were  recruited.  

●  Counseling  increased  awareness  of  LARC  methods.    

●  Each  parKcipant  was  provided  her  contracepKve  method  of  choice  at  no  cost  for  3  years.  

●  9,250  women  enrolled  from  2007-­‐2011.  –  CHOICE  parKcipants  diverse,  similar  to  overall  women  in  St.  Louis  region.  

Secura GM et al. Am J Obstet Gynecol. 2010;203:115.e1–115.e7. Peipert JF et al. Obstet Gynecol. 2011;117(5):1105–1113.

What  Method  Did  Women  Choose?  

Contraceptive Choice Project. http://www.choiceproject.wustl.edu/studyfindings.html. Last Accessed 12/20/2011.

•  75% of women chose a long-acting reversible contraception method (LARC: IUD or implant)

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LARCs  and  Teens  

Contraceptive Choice Project. http://www.choiceproject.wustl.edu/studyfindings.html. Last Accessed 12/20/2011.

•  Young  women  under  the  age  of  21  were  also  interested  in  IUDs  and  implants  

•  >  40%  of  young  women  14-­‐17  years  chose  the  implant  •  >  40%  of  young  women  18-­‐20  years  chose  an  IUD  

LARCs  Associated  With  Highest  ConFnuaFon  and  SaFsfacFon  Rates  at  12  Months  

ConFnuaFon  Rates  and  SaFsfacFon  Levels1  

1. Peipert JF et al. Obstet Gynecol. 2011;117(5):1105–1113.

0

20

100

Wom

en, %

60

40

80

Long-Acting (n=2,846)

Non–Long-Acting (n=1,321)

Continuation rate Very satisfied Somewhat satisfied Not satisfied

86.2

66.9

16.8 16.4

54.7

42.7

10.0

47.3

LARC=long-­‐acKng  reversible  contracepKve.  

 CumulaFve  Percentage  of  ParFcipants  Who  Had  a  ContracepFve  Failure  at  1,  2,  or  3  Years  

B Winner, JF Peipert, et al. N Engl J Med 2012

DMPA: women who returned for scheduled reinjections

Probability  of  Not  Having  an  Unintended  Pregnancy,  According  to  ContracepFve  Method  and  Age  

B Winner, JF Peipert, et al. N Engl J Med 2012

Births  Per  1,000  Females  Aged  15-­‐19  

J Peipert, et al. Obstet Gynecol 2012

AborFon  Rates  per  1,000  Women  &  Adolescents,  2008  

J Peipert, et al. Obstet Gynecol 2012

Authors estimate implementing CHOICE policies nationwide could prevent 62%-78% of induced abortions in US

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ACOG Practice Bulletin #121. July 2011

•  IUDs do not increase adolescents’ risk of PID •  IUDs may be placed without difficulty in most adolescents and nulliparous

women •  IUD expulsion uncommon in adolescents •  Adolescents should be screened for STIs at time of IUD placement

A  Smaller  Levonorgestrel  IUD    

●  Smaller  progesKn  IUD  approved  for  up  to  3  years  of  use  available  in  the  US  as  of  early  2013  –  Incrementally  thinner  width  of  ‘T’  ,  shorter  length  and  more  narrow  

gauge  outer  diameter  of  inserKon  tube  may  facilitate  inserKon  in  teens  and    nulliparous  women  

 CumulaFve  Percentage  of  ParFcipants  Who  Had  a  ContracepFve  Failure  at  1,  2,  or  3  Years  

B Winner, JF Peipert, et al. N Engl J Med 2012

DMPA  

●  Failures  rare  in  consistent  users  –  Low  conKnuaKon  rate    can  lead  to  higher  failure  rates  –  Amenorrhea  the  norm  in  long-­‐term  users    

●  Return  to  ferKlity  may  be  delayed  by  10-­‐18  months  aher  disconKnuaKon  

–  Menses  may  not  return  for  months  aher  disconKnuaKon  

–  A  useful  method  for  teens  and  other  women  who  may  not  use  other  contracepKves  consistently  

–  Not  appropriate  for  women  who  may  wish  to  conceive  in  the  next  1-­‐2  years  

AM Kaunitz, Depot Medroxyprogesterone Acetate for Contraception, In UpToDate, Rose BD (Ed), Waltham MA

DMPA  and  Skeletal  Health  Concerns  

●  DMPA→  ↓  estradiol  levels  →  lower  bone  mineral  density  (BMD)  

●  FDA:  Black  Box  placed  2004  ●  However  

–  Declines  in  BMD  associated  with  DMPA  are  fully  reversible  in  teens  and  adult  women  

–  Prior  use  of  DMPA  not    

 associated  with    postmenopausal  osteoporosis  

MM Isely, AM Kaunitz. Rev Endocr Metab Disor 2011

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BMD  Changes  in  Women  IniFaFng  DMPA  

Clark MK et al. Fertil Steril. 2004;82:1580-1586

3-4% decline at one year 3-4% decline at one year

Is there a physiologic model for transient, estrogen-mediated declines in BMD in women?

BMD  Changes  With  DMPA-­‐IM  150  Mirror  Those  With  LactaFon  

Mea

n C

hang

e in

Spi

ne B

MD

(%)

Kalkwarf HJ et al. Obstet Gynecol. 1995;86:26-32.

During lactation and weaning

Months of Follow-Up

BMD declined 4-5% at 12 months

-6 -4 -2 0 2 4 6

0 12 24 36

During Lactation After Weaning Weaning Lactation Two  recent  case-­‐control  studies  

found  that  DMPA  users  have  more  fractures  than  non-­‐users  

2008  Danish  Case-­‐control  Study  

P Vestergaard, et al. Contraception 2008

●  OR  for  DMPA  use  =  1.44  (95%  CI  1.01-­‐2.06);  ORs  higher  with  longer-­‐term  DMPA  use  –  OR  for  IUD  use  =  0.75  (95%  CI  0.64-­‐0.87)  

●  DMPA  use  rare  in  Denmark:  only  0.1%  of  study  populaKon  used  DMPA  

–  Alcoholism:  14%  in  DMPA  users,  3%  in  IUD  users  

–  Higher  educaFon:  12%  in  DMPA  users,  33%  in  IUD  users  

–  Authors  pointed  out  ‘…use  of  injectable  contracepKon  is  so  rare  in  Danish  women  that  it  is  likely  that  baseline  characterisKcs  among  DMPA  users…  do  not  reflect  the  characterisKcs  of  contracepKve  users  overall.’      

2010  UK  Case-­‐control    Study  

●  InvesKgators  used  General  PracKce  Research  Database  (GPRD)  

●  Cases  w/  fractures  (N=17,527)  compared  to  controls  (70,130)  

●  DMPA  ever-­‐use  ~10%  

●  Adjusted  ORs  for  DMPA  use:    1.17  to  1.54  

–  ORs  higher  with  longer-­‐term  DMPA  use  

C Meier, et al. J Clin Endocrinol Metab 2010

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2013  UK  RetrospecFve  Cohort  Study  of  DMPA  &  Fractures  Using  the  GPRD  (Funded  by  Pfizer  [markets  DMPA])  

●  Fracture  (fx)  rate  in  DMPA  users  higher  than  in  users  of  other  hormonal  contracepKves  (predominantly  OC)  

●  But  cohort  study  design  allowed  separaKon  of  Kming  of  DMPA  use  and  occurrence  of  fx  

–  Among  women  who  later  iniKated  DMPA,  fx  rate  higher  (before  DMPA  iniKated)    than  in  women  who  later  iniKated  other  contracepKves  (OC)  

–  Fx  rate  did  not  increase  aher  DMPA  was  started  

–  Fx  rate  did  not  increase  with  a  greater  number  of  DMPA  injecKons    

●  Women  who  choose  DMPA  may  be  more  likely  to  experience  trauma  (motor  vehicle  accidents,  domesFc  violence)    resulFng  in  fx  

LL Lanza, et al. Obstet Gynecol 2013

Summary:  LARC=First-­‐line  ContracepFve  Choice  for  Women  of  All  Ages    

●  LARC  contracepKve  conKnuaKon  and  efficacy  dramaKcally  higher  than  for  short-­‐acKng  methods,  parKcularly  in  young  women  

–  Greater  use  could  substanKally  ↓  unintended  pregnancies/aborKons  

●   IUDs  and  implants  safe  in  adult  women  and  teenagers  

●  Placement  of  IUDs  and  implant  safe  and  appropriate  immediately  postpartum/postaborKon  

Madden T et al., Obstet Gynecol 2012 Tocce KM et al., Am J Obstet Gynecol 2012 Bednarek PH et al. N Eng J Med 2011

Summary:  LARC=First-­‐line  ContracepFve  Choice  for  Women  of  All  Ages    

●  Injectable  contracepKon/DMPA  should  be  viewed  not  as  a  niche  method  for  special  needs  women  but  rather  as  a  first-­‐line  contracepKve  choice  for  women  of  all  ages  

–  BMD  ↓s  reversible  

– DMPA  does  not  cause  osteoporosis/fractures       QuesFons?  

THANK YOU!