Simplifying Vide Contraception. University of Utah Department of Ob/Gyn Post Grad Course February 13, 2017 David Turok

Transcription

1 Simplifying Vide Contraception University of Utah Department of Ob/Gyn Post Grad Course February 13, 2017 David Turok

2 Background Objectives At the conclusion of this presentation participants will be able to: 1) Offer the full range of contraceptive options 2) Describe 3 new clinical situations to remove barriers to initiating IUDs and implants 3) Share evidence regarding benefits of free contraception

3 Background Disclosure The University of Utah Program in Family Planning receives research funding from: Bayer, Bioceptive, Contramed, Medicines360, Merck, and Teva. Serve on advisory boards for Allergan, Bayer, and Teva. Consultant for Bioceptive and a speaker for Allergan, Medicines360, and Merck.

4 The University of Utah s catchment area at night

5 2.6 X 5.6 X

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7 Why the Birth Control Pill Isn t Enough 10.7 million pill users x 8.7% of pill users have an unplanned pregnancy/year = 930,700 pregnant pill users

8 8

9 HER-C?s 1) When can an IUD be placed for EC? 2) How long can use an IUD or implant? 3) Can you use a LNG IUD for EC? 4) Increased risk of PID with IUDs? 5) Is sex better with an IUD? 6) Does Immediate Postpartum LNG IUD have a higher expulsion rate than CuT380?

10 #1) When can an IUD be Placed for EC? The copper IUD can be placed for EC within 5 days of unprotected intercourse BUT Can be inserted 6+ days after unprotected sex If the day of ovulation can be estimated AND not more than 5 days since ovulation Could This be Simpler? CDC- Selective practice Recommendations

11 Methods: Original Inclusion Criteria Secondary analysis of a prospective trial of copper T380 IUD EC users in China Age Regular cycles between days* Known LMP Within 5 days (120 hours) of UPI All participants had a negative urine pregnancy test (hcg 25 IU/L).

12 Results No pregnancies 1840 participants (93.7%) had usual cycle lengths of days 850 (46.2%) UPI in the fertile window 84 (4.6%) had IUD insertion > 5 days after ovulation 52 (2.7%) had insertion > 5 days after UPI

13 Day of UPI Relative to Ovulation Hum Reprod Aug 14.

14 IUD EC Insertion by Days Since LMP Hum Reprod Aug 14.

15 #2) Prolonged Use of the LNG IUD LNG IUD N= women-years of follow-up 108 women with 6 years of use 1 pregnancy with partial 5 yrs 1 mth Failure rate 0.51 (95% CI ) per 100 women-years McNicholas, Obstet Gynecol 2015;125:

16 Prolonged Use of Implants ENG Implant N= years of follow up 123 used to 4 years 34 used to 5 years 0 pregnancies (97.5% CI ) per 100 women-years McNicholas, Obstet Gynecol 2015;125:

17 Prolonged Use of the LNG IUD n=263 n=108 5 years 6 years 1 pregnancy with partial 5 yrs 1 mth Failure rate: 0.51 (95% CI ) / 100 women-years McNicholas, Obstet Gynecol 2015;125:

18 Prolonged Use of ENG Implant n=237 n=123 n=34 3 years 4 years 5 years 0 pregnancies (97.5% CI ) per 100 women-years McNicholas, Obstet Gynecol 2015;125:

19 Etonorgestrel levels at 3 and 4 years by BMI 3 years with implant 4 years with implant Minimum ovulation suppression level (90pg/ml) McNicholas, Obstet Gynecol 2015;125:

20 #3) Can You Use The LNG IUD for EC?

21 COLIEC Copper or LNG IUD for Emergency Contraception Contraception. 2016;93(6):

22 Objectives To Determine: LNG IUD uptake among EC users EC pregnancy risk for those having placement of the LNG IUD after taking oral LNG Continuation rates among women initiating an IUD for EC Contraception. 2016;93(6):

23 Methods Prospective observational study EC users at a single clinic in Utah From June 2013 to September 2014 Interested in an IUD years of age Unprotected intercourse < 120 hours Fluent in Spanish or English No charge for chosen EC treatment Negative UCG Contraception. 2016;93(6):

24 Are you here for the Morning After Pill / Emergency Contraception (EC)? You might be interested in a study offering EC users the most effective type of contraception. We would like to be sure women coming to this clinic for emergency contraception (EC) also know about some of the best birth control methods. These methods include the intrauterine device (the IUD). IUDs are placed in the uterus by a doctor or nurse practitioner. When they are taken out, you can get pregnant again right away. There are two IUDs. 1. One is the ParaGard, it doesn t have hormones. It has copper, and can last up to 10 years. This IUD is also the very best to keep you from getting pregnant if you have had sex within the last 5 days without using contraception. If 1,000 women had sex without using contraception and had a copper IUD put in, only 1 would get pregnant that month. With this IUD you ll have regular periods but they might be slightly heavier The other IUD is the Mirena. This IUD has a hormone in it (progestin) and lasts up to 5 years. In the first 3-6 months bleeding can be irregular and after that you ll have less bleeding during your period or you may not have a period at all. We do not know if this IUD works to prevent pregnancy as Emergency Contraception; so women coming here for EC would start this IUD with the Morning After Pill called Plan B one step. The pills work well; if 1,000 women have sex and take Plan B, about 20 will get pregnant that month.

25 n= 1,004

26 n= 188(18%)

27 n= 188(18%) n= 67(36%) n=121(64%)

28 n= 67(36%) n=121(64%) n= 66 n= 110 Failed IUD Insertion 6%

29 2 weeks n= 63(95%) n=105(95%)

30 1 Year n= 53(80%) n=94(85%)

31 Preg #1 Participant #152 Weeks post insertion Used oral EC 3 times previously that month IUD inserted on day 28 of 30 day cycle Luteal phase pregnancy LNG IUD & oral LNG preg rate of 0.9% (95% CI 0-5.1%)

32 70 % 60 % P=0.26 Months

33 #4) Is There Increased Risk of PID at IUD insertion?

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36 ACCESS IUS AComprehensive Contraceptive Efficacy and Safety Study of an Eisenberg DL, et al. Contraception 2015;92:10-6. IUS

37 STI Testing and IUS Placement STI screening Chlamydia screening Gonorrhea screening if no testing since last change of partner IUS could be placed without test results No prophylactic antibiotics at placement Eisenberg DL, et al. Contraception 2015;92:10-6.

38 Pelvic Infection Definition Any clinical diagnosis of endometritis or pelvic inflammatory disease (PID) by a study or non-study provider during clinical trial participation.

39 ACCESS IUS Study Population Reflects US women Age: mean 27 years Race: White 78%, Black 13%, Asian 4% Hispanic ethnicity: 15% Nulliparous: 58% (n=1,011) BMI: mean 26.9 kg/m 2 Overweight: 24% Obese: 25% Morbidly obese: 5% Eisenberg DL, et al. Contraception 2015;92:10-6.

40 Pelvic Infection in ACCESS IUS Subjects in study: 1,751 Successful placement: 1,714 (98%) Baseline STI prevalence Chlamydia: 22 (1.3%) Gonorrhea: 3 (0.2%) Both: 1 (0.1%) Pelvic infection over 2 years: n=9 (0.5%) Total: 1.5% All treated with oral Abx No IUS removal No pelvic infection AJOG 2016 Nov;215(5):599.e1

41 Pelvic Infection Timing Endometritis: 3 cases (days 1, 1, 39) PID: 1 case at day 6, 5 cases after day of 9 (67%) after day 30 8 of 9 (89%) cases in year 1 Endometritis PID AJOG 2016 Nov;215(5):599.e1 Day

42 Pelvic Infection Outcomes Treatment Outpatient: 7 Inpatient: 2 Removal: 2 (0.1% of study population) Removal* Infection Diagnosis Day Removal Day Endometritis 1 of PID 1 of * Both subjects with removals treated as outpatients with oral antibiotics AJOG 2016 Nov;215(5):599.e1

43 Conclusions STI Screening and simultaneous LNG IUD insertion has a low infection risk. Pelvic infection in the first month after Liletta placement is rare (0.2%) Pelvic infection is not more common around the time of IUS placement Liletta removal for pelvic infection in the first two years of use is rare (0.1%)

44 5) Is Sex Better With an IUD?

45 The Intimate Link: Method selection, satisfaction, continuation & the sexual experience Jessica N. Sanders, PhD, MSPH Denver, CO November 6, 2016

46 Rationale Contraception is expressly designed for non-procreative sex

47 The Intimate Link Prospective cohort Women seeking contraception Contraceptive Conversation New-start Cu IUD, LNG IUD or implants Higgins JA, et al. Obstet Gynecol 2016 Nov;128(5):

48 Survey Measures Baseline Demographics Relationship status & length Method selection criteria Repeated (baseline, 1 month, 3 months, 6 months, and 12 months) Female Sexual Function Index (FSFI) New Sexual Satisfaction Scale (NSSS) Perception of method s impact on sexuality In the last 4 weeks, would you say your method made your sex life better, made it worse, or had no effect on your sex life? Vaginal bleeding changes Contraceptive use and satisfaction Higgins JA, et al Obstet Gynecol 2016

49 Method Distribution (N=159) Higgins JA, et al Obstet Gynecol 2016

50 Selection criteria of a new method

51 Validated Scales FSFI no changes NSSS no change Results Perceived Impact on Sex Life showed significant changes overtime Higgins JA, et al Obstet Gynecol 2016

52 Perceived Sexual Changes In the last 4 weeks, would you say your method made your sex life better, made it worse, or had no effect on your sex life? Higgins JA, et al Obstet Gynecol 2016

53 Overall satisfaction with method, by method-related sexual changes Higgins et al Obstet Gynecol 2016

54 Perceived sex detraction: best predictor of discontinuation. Sexual Detraction HR 3.36 (95%CI ) Increased Bleeding HR 2.4 (95%CI )

55 Summary Women may value sexuality as highly as efficacy Validated sexual functioning data subjective perceptions Effective methods sexual well-being Sexual detraction is strongly correlated with discontinuation

56 6) Does Immediate Postpartum LNG IUD have a higher expulsion rate than CuT380?

57 Request LARC N = 473 Received PP LARC N = 426 Did not receive LARC N = 47 LNG IUD N =177 (41%) Cu IUD N = 128 (30%) Implant N = 121 (28%) Enrolled N = 100 Enrolled N = 73 Enrolled N = 80

58 Cumulative Hazard for expulsion by device type Months LNG IUD CU IUD 3 21% 3% 6 23% 3% 12 23% 8% P-value= 0.005