1. Roxanne Jamshidi, MD, MPH May 30, 2018
Long-Acting Reversible Contraception: A Guide for College Health Providers
Roxanne Jamshidi, MD, MPH
May 30, 2018

2. Disclosure Conflict of Interest Off Label Use:
Nexplanon Trainer (Merck)
Off Label Use:
None

3. Learning objectives
Describe current recommendations to encourage consideration of LARC as a first line contraceptive for college age women
Examine best practices in effective contraceptive counseling to promote uptake
Compare and contrast the various LARC methods with regard to mechanisms of action, duration of therapy, side effects, insertion techniques, and patient eligibility
Discuss management of common side effects and possible complications from LARC methods

4. Abridged talk…
LARC effective and recommended as first line contraception
Counseling matters
Side effects can happen but usually can be managed

5. Approximately 6.7 Million Annually
Pregnancy in the U.S.
Approximately 6.7 Million Annually
Intended Pregnancy
49%
Unintended Pregnancy
51%
Finer and Zolna. Contraception 2011;84:
Finer and Zolna. Am J Pub Finer and Zolna. Contraception 2011;84:

6. Unintended Pregnancy Outcomes
Sooner than when a woman would have desired a pregnancy
When a woman desired no (or no more) children
Half end in abortion
1.21 million abortions in 2008 according to Guttmacher Institute latest data
Need to decrease this number
Rate of unintended pregnancies in the first year postpartum is 10-44%
One great study of post-abortal DMPA showed that only 22% of women continued DMPA at 1 year, and 22% were pregnant within 1 year
What can we do to reduce the number of unintended pregnancies?
Half of target pop will be seen in AB clinics
~3 million unintended pregnancies annually
~3 million unintended pregnancies annually
Finer and Zolna. Am J Pub Health 2014;104:S43-8.
Jones and Jerman. PerspecFiner and Zolna. Am J Pub Health 2014;104:S43-8. 6

7. College Students
Women age 18 to 24 experience the highest rates of unintended pregnancy
College women report using contraception only about 50% of the time
19% reported using emergency contraception within the last 12 months
1.4% of college women who had vaginal intercourse within the last 12 months reported experiencing an unintentional pregnancy
Poor knowledge: Nearly 79% of college women surveyed reported little or no knowledge of IUDs or implants.
Finer and Zolna. NEJM. 2016;374: ACHA-National College Health Assessment 2015.
Hall, Ela, Zochowski, et al. Contraception

8. Long-Acting Reversible Contraceptive (LARC) methods are highly effective and have few contraindications
Pregnancy rates in first year of use (per 100 women)
LARC is 20 TIMES MORE EFFECTIVE than shorter acting methods at preventing pregnancy
0.6
0.2
0.05
Trussell, Contraception, 2011

9. Levonorgestrel IUD Duration: 3 – 5* years
Primary mechanism: inhibits fertilization
Cervical mucus thickened (barrier to sperm passage)
Sperm motility and function inhibited
Ovulation may be inhibited for first few months after placement, but not reliably
May inhibit implantation
Endometrium suppressed by progestin
Weak foreign body inflammatory reaction induced
Can reduce menstrual flow and frequency .
Jonsson et al. Contraception 1991;43:447
Videla-Rivero et al. Contraception 1987;36:217

10. Progestin-IUD: Endometrial Effect
Months
Ovulation
Source
Pakarinen PI, Suvisaari J, Luukkainen T, Lahteenmaki P. Intracervical and fundal administration of levonorgestrel for contraception: endometrial thickness, patterns of bleeding, and persisting ovarian follicles. Fertil Steril 1997 Jul;68(1):59.
Days of cycle
Endometrium in “resting state” with LNG IUD: flow decreased by >50%; 20% amenorrheic
Endometrium in normal menstrual cycle

11. LNG IUD Skyla Kyleena Mirena Liletta Size (mm) 28 x 30 32 x 32
Total LNG dose
13.5 mg
19.5 mg
52 mg
Initial LNG release
14 mcg
17.5 mcg
20 mcg
19 mcg
Duration (years) 3 5
5 (7)
4 (7)

12. Copper IUD Up to 10* years of use Mechanism:
Copper has direct effects on sperm and ova
Sterile endometrial inflammation (chronic endometritis) releases cytokines that are toxic to sperm/egg/ embryo
Can also be used for post-coital contraception up to 5 days after intercourse (off label) 12

13. Nexplanon™ Etonogestrel Implant
Subdermal implant placed in upper arm
Prevents ovulation
Long-acting (3 years)
Main side-effect is unpredictable menstrual cycles
Side effects rapidly reversed and fertility returns within a few days of removal
In drug company trials, d/c rate 1/3…in U.S. ½

14. Contraceptive Implant
4 cm
2 mm
40% ethylene vinyl acetate
60% etonogestrel (68 mg)
Rate controlled release:
2 mm
This graph shows the mean serum concentration versus time profile of etonogestrel achieved during two years of IMPLANON™ use and immediately after removal. It clearly demonstrates the “burst” release of etonogestrel from the free ends as seen by rapid rise of serum levels. By six months the serum levels stabilize and remain fairly even until removal. After removal, the serum levels of etonogestrel decreased to below detectable levels by the 5th day. Return to pre-existing fertility will be discussed later on in the program.
NEXPLANON™ [package insert]. Roseland, NJ: Organon USA Inc; 2011.

15. CDC Medical Eligibility Criteria (MEC)
Evidence-based guidelines for safety of methods with co-existing conditions
Similar to WHO but US-specific
released May, 2010!
Similar to WHO but with US-specific modifications and updated evidence
Obesity and bariatric surgery
VTE updates
Breastfeeding and postpartum
Endometrial hyperplasia
Ovarian cancer
Valvular heart disease, cardiomyopathy, IBD, RA
Transplants

16. MEC Categories 1
Can use the method
No restrictions 2
Advantages generally outweigh theoretical or proven risks. 3
Should not use method unless no other method is appropriate
Theoretical or proven risks generally outweigh advantages 4
Should not use method
Unacceptable health risk

17. Birth Control Methods
Medical Condition
MEC Category
MEC Category

18. Category 3 Conditions: Implant
Lupus with antiphospholipid antibodies
Unexplained vaginal bleeding
Past history of breast cancer
Severe cirrhosis, malignant hepatoma
Initiation vs continuation – discuss
Eg – history of stroke – ok to put implant in later

19. Category 4 conditions: Implant
Current breast cancer
Per CDC MEC

20. Category 3 conditions for IUD use
AIDS (vs. HIV),
Solid organ transplant with complication,
Malignant hepatoma or severe cirrhosis (LNG)
Positive antiphospholipid antibodies (LNG)
Severe thrombocytopenia (Cu Only)
High risk for STI*
* STI b/c it can mean different things – assess INDIVIDUAL risk – e.g. adolescents are at inc risk of STI compared to older women in general, but IUDs are just fine for a lot of adolescents

21. Category 4 conditions for IUD use:
Pregnancy,
Infected uterus
Undiagnosed vaginal bleeding
Current gestational trophoblastic disease
Active cervical or endometrial cancer, breast cancer (LNG only)
Uterine cavity distortion

22. http://core.arhp.org/ DMPA Combined hormonal contraceptives
Cite chroms

23. Evidence behind Larc: CHOICE Project
LARC – not SARC
Focus on highly effective, low cost/free methods
CHOICE project
Counseling focuses on LARC
Evidence-based provision
Immediate availability
Free products
9,256 subjects enrolled Aug 2007 – Sept 2011
Barriers of cost, knowledge, and access removed
Winner B, et al. NEJM 2012;366:
Peipert JF, et al. Obstet Gynecol 2012;120:

24. CHOICE “choices” 14-17 yo 25% IUD 42% Implant 33% SARC 18-20 yo

25. Contraceptive Failure: LARC vs. the rest
LARC is 20 TIMES MORE EFFECTIVE than shorter acting methods at preventing pregnancy
Cumulative % of women with contraceptive failure
Winner B, et al, NEJM 2012

26. CHOICE Study: Teen Birth Rates
Annual medical costs of UP in the United States were estimated to be $4.6 billion, and 53% of these were attributed to imperfect contraceptive adherence. If 10% of women aged years switched from oral contraception to LARC, total costs would be reduced by $288 million per year.
Births per 1,000 teens, ages 15-19
Peipert, et al., OBG 2012

27. CHOICE Study: LARC use and abortion rates
Abortion rates per 1,000
Peipert, et al., OBG 2012

28. Continuation CHOICE project
Implant users more likely to discontinue than IUD users (p<0.001) by 24 months
LARC more likely to continue to 24 months than SARC (adj HR = 0.29, 95% CI )
O’neill-Callahan M, et al. Obstet Gynecol 2013;122:

29. Continuation rates
1-year
2-year
LNG IUD
88%
79%
Cu IUD
85%
77%
Implant
83%
69%
Injection
58%
38%
Pill
59%
43%
Ring
56%
41%
Patch
50%
40%
1-year
2-year
LARC
87%
77%
SARC
57%
41%
LARC (14-19 yo)
82%
67%
SARC (14-19 yo)
49%
37%
LARC (20-45 yo)
78%
SARC (20-45 yo)
59%
42%
Implant users more likely to discontinue than IUD users (p<0.001) by 24 months
LARC more likely to continue to 24 months than SARC (adj HR = 0.29, 95% CI )
O’neill-Callahan M, et al. Obstet Gynecol 2013;122:

30. LARC is first line choice for adolescents

31. Counseling: Patient Centered
Per CHOICE project, start with most effective to least effective
Mechanistic
Ease of use
Frequency of use
Method Effect
Efficacy
Side effectsSocial/normative
Partner support
Prior experience
“Vicarious” experience
Practical
Cost
Availability
And 21 others….

32. Counseling: Patient Centered
Per CHOICE project, start with most effective to least effective
Shared Decision Making: Process by which patient and provider share information, express preferences, and decide jointly on a treatment plan
Women want to make own decisions
Many factors have impact
Clinicians have influence
Respect personal choice
Mechanistic
Ease of use
Frequency of use
Method Effect
Efficacy
Side effectsSocial/normative
Partner support
Prior experience
“Vicarious” experience
Practical
Cost
Availability
And 21 others….
Dehlendorf, et al, Contraception 2012;
Wyatt, et al. BMC Womens Health. 2014; 14: 28

33. Managing Larc

34. GabY 21 yo G0 is interested in using intrauterine contraception.
When she started college, she had Chlamydia.
She has had 3 male partners in the past year.

35. Gaby How do her risk factors for PID influence
your counseling on IUC appropriateness?
Should you screen her for GC/CT?
Is one IUC better for her than another?
What do you do if PID is diagnosed 1 month later?

36. IUD: CDC Guidelines C=continue I= Initiate Past PID Current PID or
cervicitis
High risk STI: caution
C=continue
I= Initiate

37. Do IUDs cause PID?
NO!!!!!!
Transient increased risk at time of insertion with both IUDs
22,908 insertions:
9.7/1000 w/in 20 days
1.4/1000 after 20 days
Beyond time of insertion
Overall decreased risk with LNG IUS
No increased risk of Copper IUD
Farley 1992 Lancet
Walsh 1998 Lancet

38. What are risk factors for PID in IUD users?
Sex without condoms with infected partners leads to cervicitis and PID, not IUDs!!
Thus, previous STIs or PID are NOT contraindications to IUC
Emphasize importance of condom use
Contraception vs. STI prevention

39. IUD, Nulliparity & Infertility
Nulliparity not a contraindication!!!
May have increased pain with insertion
May have decreased risk of expulsion
IUDs do NOT cause infertility
Tubal factor 1° infertility is not associated with prior IUD use (OR=1)
Hubacher 2003 N Engl J Med
Madden 2010 Repro Health ACM

40. STI screening before insertion? Routine screening NOT necessary!
Retrospective cohort, n=57,728 IUDs Evidence-based screening (CDC)1
No cases of PID when Planned Parenthood switched to same day screening2
No benefit to prophylactic antibiotics3
ACOG: no routine screen4
Low Risk Women- Risk of PID:
Non-screening = Screening
OR= 1.05 (0.78, 1.43)
Screened Women: Risk of PID:
Same day = Pre-insertion
OR=.997 (.64, 1.54)
No need for 2 day protocols!
1. Sufrin 2012
2. Goodman 2008 Contraception
3. Grimes 1999 Contraception
4. ACOG Practice Bull #59, 2005

41. Same day STI screening with IUD insertion
1751 IUD insertions
98% had baseline STI screen – 8% of time results not available same day as IUD insertion
29 (1.7%) had baseline positive STI – only 6 known – prior to time of insertion
25 chlamydia
3 gonorrhea
1 both
All women treated with IUD in place – no PID over the following 2 years, no requests for removal
Eliminate 2 visit protocols
Turok et al., Contraception 2016

42. Who should be screened?
Use CDC and USPSTF guidelines for STI screening!
1. Annually < 26 yo and sexually active OR
2. If RFs present (new partner, sx, another STI)
USPSTF 2001 Am J Prev Med

43. What if PID is diagnosed?
Do NOT remove IUD!!!
*unless TOAs or
no improvement on IV antibiotics

44. Hannah 20 yo G0 had a subdermal ETG implant placed 7 months ago.
She has had bleeding every day for the last 6 weeks.

45. Case #7 How do you counsel women on bleeding expectations
with ETG implant?
How do these side effects compare to other methods?
How can you manage these symptoms?

46. Unscheduled bleeding & contraception
Common reason for discontinuation
Mechanism poorly understood
progestin-induced endometrial atrophy?
Vascular fragility, MMPs
Increased with: smoking, inconsistent use
“Quick start” no significant effect
Assess for:
-STI risk
-Pregnancy
Lopez 2008 Cochrane Database
Mansour 2010 Contraception

47. Women who discontinue HC due to bleeding irregularities
CHC
DMPA
LNG-IUD
Cu-IUD
Implant
3% 1
7-12% 2,3
14% 4
5% 5
10% 6
1. Datey 1995 Contraception
2. Cropsey 2010 J Womens Health
3. Colli 1999 Contraception
4. Datey 1995 Contraception
5. Rivera 1999 Contraception
6. Blumenthal 2008 Eur J Contracept Reprod Health Care

48. ETG Implant & Bleeding Infrequent: 34% Amenorrhea 22%
17 bleeding-spotting
days/90d
Infrequent: 34%
Amenorrhea 22%
Prolonged bleeding 18%
Frequent bleeding 6%
Darney 2009 Fertil Steril
Mansour 2010 Contraception
Mansour 2008 Eur J Contr Repro Health Care

49. Implant & Bleeding: Counseling!!!
Pre-insertion expectations
Bleeding usually light
“irregularly irregular”
Unpredictable for entire 3 years
May improve dysmenorrhea
Mansour 2008 Eur J Contr Repro Health Care

50. Implant Bleeding: Management
Scant data– some based on LNG implant
NSAIDs- variable dose and type
RCT 204♀ with prolonged/frequent bleeding
Intervention x 5 days, Q28 days
No difference in overall # bleeding/spotting days
Mife + EE
Mife +Doxy
Doxy
Doxy + EE
Placebo
Days to stop
bleeding
4.0
( )
4.4
( )
6.4
( )
( )
( )
2 days
Phaliwong et al 2004 J Med Assoc Thai
Weisberg et al 2009 Hum Reprod

51. One approach. . . Therapy Evidence? 1. COC x 21d/7d ( up to 3 mo)
Minimal
2. Cyclic progestin (MPA 10 mg bid) x 21d/7d (3mo)
Anecdotal
3. POP daily up to 3 mo
4. Tranexamic acid 500 bid x 5d
Adapted from Mansour et al 2011 Contraception

53. Clinical Guidelines DMPA NSAIDs 5-7 days Implant
Low dose combined oral contraceptives or estrogen (10-20 days)
Levonorgestrel IUD
No treatment recs
Reassurance and expectant management

54. When to worry?
Discuss – put in flow from Uptodate
UpToDate

56. Jenna : History
Jenna is a 22yo G0 who presents to the office with the complaint of vaginal discharge for the the last few days. She had a LNG20 (Mirena) IUD placed for menorrhagia and contraception 2 years ago. She does not know her LMP, as she has essentially become amenorrheic, with the exception of some occasional spotting.

57. Jenna: Physical Exam
Exam is normal except some mild white discharge noted. The cervix is normal but the IUD strings are not seen.
You twist a cytobrush in the endocervical canal to try to draw out the stings, but aren’t successful.
What next?

58. Diagnostic Tests Urine pregnancy test Negative
Explore the cervix to see if IUD in canal
Long Kelly
Bozman uterine packing forceps
Alligator forceps
IUD hook
Ultrasound (office)
Order ultrasound with prn abdominal x-ray (AP and lateral upright)
Back up birth control

59. Follow Up
Ultrasound:

60. Missing Strings Risk of IUD expulsion is low (about 2%)
Do not need routine periodic ultrasounds to confirm correct IUD placement if woman is asymptomatic
May need periodic (e.g. annual or biannual) ultrasound surveillance for women who may have difficulty distinguishing a change in menstrual pattern which could be indicative of expulsion

61. Follow Up
Ultrasound:

62. Follow up
Abdominal x-ray

63. IUD Expulsion Risk Factors First year of use: Nulliparity (?)
3-10% TCu380A (Paragard)
2-10% LNG20 (depends on indication)
3.2% LNG14 (Skyla)
Risk Factors
Nulliparity (?)
Menorrhagia
Severe dysmenorrhea
Age <20
Prior expulsion
Immediate postpartum or post 2nd trimester abortion

64. IUD Expulsion Symptoms (partial or full expulsion) Cramping
Vaginal discharge
Intermenstrual/postcoital bleeding or spotting
Male or female dyspareunia
Lengthened or absent strings
Jenna wants another IUD
Recurrent risk of expulsion increased (31% at one year in one study of 124 women with Tcu-200B IUD)
Faulty technique or uterine factors (severe flexion, abnormally shaped uterine cavity)
Consider preforming placement under ultrasound guidance to ensure IUD is placed at fundus

65. Follow up
Abdominal x-ray

66. Perforation 1 in 1000 Risk factors: Clinician inexperience
Immobile uterus
Retroverted uterus
Interval postpartum
Expert opinion – treat with abx for PID?
If in myometrium: operative hysteroscopy
If in peritoneal cavity: operative laparoscopy
If can’t find, look up at omentum, May need intraoperative x-ray or fluoroscopy

67. Follow up
Ultrasound

68. Malpositioned IUD
Approximately 10% of IUDs are malpositioned, but not all malpositioned IUDs need to be removed
If incidental finding, ask if any symptoms
If symptomatic, offer removal/replacement
If asymptomatic, data is limited
If in lower uterine segment or near (but not at) fundus – do nothing
If below internal os, recommend removal (higher risk of expulsion)
Limited data show more likely to get pregnant if take out IUD (as don’t get replaced) as opposed to leaving it in place

69. Case History: Sylvia
Sylvia is a 19 year old G1 P0010 who had a CuT380A placed 7 weeks ago. She is here for her IUD check. She has had one period since her IUD was placed and she noticed it to be heavier than usual. Also, her partner is complaining the the IUD is “poking” him during intercourse.

70. Sylvia: Physical exam
Normal pelvic exam. On speculum exam, IUD strings noted to be extending from cervix about 1 cm.

71. Sylvia: Advice Partner feels strings:
Ideally strings should be trimmed to 3-4 cm from external os
If strings to short (i.e. partner irritation during intercourse), can trim string flush to cervix
Heavier period
Not uncommon to have slightly heavier/more painful period, but usually improves over time
Can use NSAIDs

72. LARC and acne
First line therapy consists of topical retinoid with or without topical antimicrobial (benzoyl peroxide, clindamycin, azaeilic acid, dapsone)
Consider adding OCPs in addition to LARC method
Progestin containing LARC may cause increase in acne:
Prospective study of 2900 women using implant versus copper IUD saw acne rates of 18% (implant) vesus 13% (IUD) – RR 1.4 (1.2 – 1.6) 9Bitzer J, Tschudin S, Adler J; Swiss Implanon Study Group. Acceptability and side-effects of Implanon in Switzerland: a retrospective study by the Implanon Swiss Study Group. Eur J Contracept Reprod Health Care. 2004;9(4):
-Similarly, prospective study of 320 women using LNG IUD versus copper IUD saw increased acne rates: 17% (LNG) versus 7% (copper) (Nilsson CG, Luukkainen T, Diaz J, Allonen H. Clinical performance of a new levonorgestrel-releasing intrauterine device. A randomized comparison with a Nova-T-copper device. Contraception. 1982;25(4): )

73. conclusions
LARC methods are a good options for college aged women wanting contraception
Most women are satisfied with their LARC method
Counseling is key
Side effects and “issues” can occur but often can be managed

74. Thank You!
Questions?